{"after": {"end": 76, "start": 0, "text": "Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe", "truncated": false}, "after_length": 76, "after_sha256": "6c7ff1bbd2f6d8c84f1254cce87065dac51505e1edd888622047a746e34551e6", "annex": "I", "before": {"end": 74, "start": 0, "text": "Spikevax JN.1 50 micrograms dispersion for injection in pre-filled syringe", "truncated": false}, "before_length": 74, "before_sha256": "ebe036d056b86be90e582dc3803425dce3820674579f962bd2fc8976b65c292a", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0033b673e4ac63acf2f17e00", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.3", "section_type": "storage", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6259}
{"after": {"end": 28, "start": 0, "text": "Tél/Tel: + 32 (0)10 85 52 00", "truncated": false}, "after_length": 28, "after_sha256": "21991020d31ee1ff18b7e886e60c72625978ff6aaf6b37b3b94d159c09e80017", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "Tél/Tel: + 32 10 85 52 00", "truncated": false}, "before_length": 25, "before_sha256": "0a43db96a0eb6a17e821e1b2c7fb04323930ea184ab3ecb536a9297f8de45db1", "change_kind": "content", "change_operations": [{"after_end": 17, "after_start": 14, "before_end": 14, "before_start": 14, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 3}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-006f29e2fe544952d072af75", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000112", "medicine_name": "Twinrix Adult", "medicine_slug": "twinrix-adult", "observed_at": "2026-10-12T13:29:23Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "cfad5fb0086c9b5d6a36b454f3f546373def1f56cded73e0652b498d02d68e41", "source_snapshot_id": "source-17627897b0874bf1160c7372", "source_updated_at": "2026-08-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/twinrix-adult-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 912}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "Tel: +44 (0)1304 616161", "truncated": false}, "before_length": 23, "before_sha256": "eba81e6ccdbae471c024a5ba77d9ec9e0617a3c443fd22205a626861e87fbd8c", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 23, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 23, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0084bf7704c957b1deb5cc90", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12164}
{"after": {"end": 18, "start": 0, "text": "info-msdbg@msd.com", "truncated": false}, "after_length": 18, "after_sha256": "a9564ace7f83680b30d249e1267cfecfc6de3252d14464719ba30061fb8124b8", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "info-msdbg@merck.com", "truncated": false}, "before_length": 20, "before_sha256": "0b46e48b14b2f549da86787bd2d27cc0b14ced470375af44415dc160418b8ba4", "change_kind": "content", "change_operations": [{"after_end": 14, "after_start": 12, "before_end": 16, "before_start": 12, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0084df5a92224b314db2f22f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3071}
{"after": {"end": 300, "start": 0, "text": "The other ingredients are anhydrous citric acid (E 330), flavour strawberry, hypromellose, mannitol (E 421); microcrystalline cellulose and carmellose sodium; sodium benzoate (E 211) (see end of section 2 for further information on sodium benzoate and sodium), sucralose (E 955), xanthan gum (E 415).", "truncated": false}, "after_length": 300, "after_sha256": "c7cf017591cd0ab40a094a9d70d789d8e94e434df6722b4a4296bf442ac56c96", "annex": "IIIA", "before": {"end": 300, "start": 0, "text": "The other ingredients are anhydrous citric acid (E 330); flavour strawberry; hypromellose; mannitol (E 421); microcrystalline cellulose and carmellose sodium; sodium benzoate (E 211) (see end of section 2 for further information on sodium benzoate and sodium); sucralose (E 955); xanthan gum (E 415).", "truncated": false}, "before_length": 300, "before_sha256": "c28132ec0200759b84e85d90a93053ada817b1f29e36a0a06efaf5747f5470a4", "change_kind": "content", "change_operations": [{"after_end": 56, "after_start": 55, "before_end": 56, "before_start": 55, "kind": "replace"}, {"after_end": 76, "after_start": 75, "before_end": 76, "before_start": 75, "kind": "replace"}, {"after_end": 90, "after_start": 89, "before_end": 90, "before_start": 89, "kind": "replace"}, {"after_end": 260, "after_start": 259, "before_end": 260, "before_start": 259, "kind": "replace"}, {"after_end": 279, "after_start": 278, "before_end": 279, "before_start": 278, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 5, "chars_inserted": 5}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-00a14b770dee7fc602e04e7b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3349}
{"after": {"end": 54, "start": 0, "text": "Takeda Pharmaceuticals International AG Ireland Branch", "truncated": false}, "after_length": 54, "after_sha256": "81709515d3af1f0e4041ce3c760d8fc81fefa358805810b0b53a84e121d5efa6", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 54, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 54}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-00adc903c258c7f59e180f62", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1716}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 55, "start": 0, "text": "Do not remove the needle cap until instructed to do so.", "truncated": false}, "before_length": 55, "before_sha256": "31e19a488e6bcba148e42b0432b26c21723ca81297fb6ae98b737e5f2bbe22b0", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 55, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 55, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-00b367ad6b3f12612b72d32d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11703}
{"after": {"end": 87, "start": 0, "text": "E: Attach the cartridge sleeve to the housing by turning it 90 degrees, until it stops.", "truncated": false}, "after_length": 87, "after_sha256": "c868cd8bf519e289c7b09cc68216437be68621a0a5cc1340a6d1cc13c5764f62", "annex": "IIIA", "before": {"end": 87, "start": 0, "text": "E: Attach the cartridge holder to the housing by turning it 90 degrees, until it stops.", "truncated": false}, "before_length": 87, "before_sha256": "348b0115961358ad0dbfe1d6816373bc0120a88cff671bf77768f2eec8f49f40", "change_kind": "content", "change_operations": [{"after_end": 25, "after_start": 24, "before_end": 26, "before_start": 24, "kind": "replace"}, {"after_end": 26, "after_start": 26, "before_end": 28, "before_start": 27, "kind": "delete"}, {"after_end": 30, "after_start": 27, "before_end": 30, "before_start": 29, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-00c72825fcf67e0ffab54fe4", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1997}
{"after": {"end": 35, "start": 0, "text": "Tel: 0800 9999 000 (+31 23 5153153)", "truncated": false}, "after_length": 35, "after_sha256": "52e92ac1d067259b9fece48e0e06ad1c09748623062f243703b5d4f40455bd17", "annex": "IIIA", "before": {"end": 36, "start": 0, "text": "Tel: 0800 9999 000 (+ 31 23 5153153)", "truncated": false}, "before_length": 36, "before_sha256": "08802d516c69cefe10e1332d399e866d902441cca33557fa68396eaecaf1d321", "change_kind": "content", "change_operations": [{"after_end": 21, "after_start": 21, "before_end": 22, "before_start": 21, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-00c875af0b117e5004c5c02e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3018}
{"after": {"end": 64, "start": 0, "text": "Medicines whose effect may be influenced by Adempas, for example", "truncated": false}, "after_length": 64, "after_sha256": "90dc9243508ce89b284a6623436aa075942531b30e3ad5b57483c0d37793a92f", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 64, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 64}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-00ce0cac8bba1f1d5f3b7d08", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3215}
{"after": {"end": 8, "start": 0, "text": "D02 HW68", "truncated": false}, "after_length": 8, "after_sha256": "1ed87437489fcb80b59bfa5d17082f438d78a8aff5deaac6125946420fbf0992", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 8, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0175fd915034d1da10506f7b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2180}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 13, "start": 0, "text": "Thaw duration", "truncated": false}, "before_length": 13, "before_sha256": "1192f885dc2df1a806d7eec521b69a527d874ceba16591d76aabb6dbb7166424", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 13, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 13, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-017efe98c30d853f9ce17f11", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13090}
{"after": {"end": 8, "start": 0, "text": "Dublin 2", "truncated": false}, "after_length": 8, "after_sha256": "b9d41e7d3be3ec3e12457949fb5c2f7be98290b5d2919e8b974df9c98fab02b9", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 8, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-018b6a4afdb0c5eda8ba36a8", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2186}
{"after": {"end": 28, "start": 0, "text": "Classe de systèmes d'organes", "truncated": false}, "after_length": 28, "after_sha256": "dc8fbd843fa829b06aa131fd2cd3fa69eab63d5f88fb5308e359f2128af90208", "annex": "I", "before": {"end": 21, "start": 0, "text": "Système organe Classe", "truncated": false}, "before_length": 21, "before_sha256": "503ff59d70228be882240862263d2c94e95ed103eafce1416f5caec3c8c23d24", "change_kind": "content", "change_operations": [{"after_end": 11, "after_start": 0, "before_end": 1, "before_start": 0, "kind": "replace"}, {"after_end": 18, "after_start": 17, "before_end": 7, "before_start": 7, "kind": "insert"}, {"after_end": 21, "after_start": 19, "before_end": 8, "before_start": 8, "kind": "insert"}, {"after_end": 27, "after_start": 27, "before_end": 18, "before_start": 14, "kind": "delete"}, {"after_end": 28, "after_start": 28, "before_end": 21, "before_start": 19, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 14}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-01c7530c5720431e90d4b23f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 543}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 72, "start": 0, "text": "Spikevax JN.1 50 micrograms dispersion for injection (single-dose vials)", "truncated": false}, "before_length": 72, "before_sha256": "41ccaa4784373a30743e6194685d229de5b4a64699df21c150e5a91151740b4d", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 72, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 72, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-01c7d299f981f964eda04143", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.5", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6318}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 5, "start": 0, "text": "Eesti", "truncated": false}, "before_length": 5, "before_sha256": "ed7477d6100948d0d4e6b914d9769159823c21b23bf4846b1676338b9b439b72", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 5, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 5, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-021687331645b26f3f648b5d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1060}
{"after": {"end": 279, "start": 0, "text": "Contactez votre médecin si vous avez utilisé plus d’Adempas que vous n’auriez dû et si vous remarquez des effets indésirables (voir rubrique 4). Si la pression artérielle chute (ce qui peut provoquer des vertiges), une prise en charge médicale immédiate pourrait être nécessaire.", "truncated": false}, "after_length": 279, "after_sha256": "eadbbb8ded582950cd1f235ad902791687706a1b2c60e56dd3acb7a69a90e239", "annex": "IIIA", "before": {"end": 286, "start": 0, "text": "Contactez votre médecin si vous avez utilisé plus d’Adempas que vous n’auriez dû et si vous remarquez des effets indésirables (voir rubrique 4). Si la pression artérielle chute (ce qui peut provoquer des étourdissements), une prise en charge médicale immédiate pourrait être nécessaire.", "truncated": false}, "before_length": 286, "before_sha256": "c5fa30bc6b0e94b07ac622bf25d603894f2c2ee476137760783621ae4ff45ce0", "change_kind": "content", "change_operations": [{"after_end": 207, "after_start": 204, "before_end": 205, "before_start": 204, "kind": "replace"}, {"after_end": 208, "after_start": 208, "before_end": 210, "before_start": 206, "kind": "delete"}, {"after_end": 210, "after_start": 209, "before_end": 213, "before_start": 211, "kind": "replace"}, {"after_end": 211, "after_start": 211, "before_end": 218, "before_start": 214, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 11, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0250b8b1745386ebac61f7b9", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3366}
{"after": {"end": 43, "start": 0, "text": "Pfizer Healthcare Ireland Unlimited Company", "truncated": false}, "after_length": 43, "after_sha256": "1f203777a0ec6fed9c840d52631b6a74c7e25b5d318485d8147e2404f52dc981", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "Pfizer Healthcare Ireland", "truncated": false}, "before_length": 25, "before_sha256": "4beeea9b6d0c491f03a9511d9f9576b9c75cbcdcfd736e4934f768fdded936f5", "change_kind": "content", "change_operations": [{"after_end": 43, "after_start": 25, "before_end": 25, "before_start": 25, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 18}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-02715ce1d621bfaacd9af2be", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 10653}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 18, "start": 0, "text": "Tel: +371 68735006", "truncated": false}, "before_length": 18, "before_sha256": "9fa8f951c84c2d0e6097a397e7b3c0e84ff719a7bbd6bd66ba1de4c337c485e3", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 18, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 18, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0279b93713900539d8f4f55f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1077}
{"after": {"end": 18, "start": 0, "text": "dpoccyprus@msd.com", "truncated": false}, "after_length": 18, "after_sha256": "492fae7e6db021703bcb80e4b139bc2be78a7e6cf4c6056a9314c70cfe643716", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "cyprus_info@merck.com", "truncated": false}, "before_length": 21, "before_sha256": "a6a31d0f7dc84283ce751c4e4d77e632a879da9a362680e26db9aa73403f7008", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}, {"after_end": 10, "after_start": 10, "before_end": 11, "before_start": 6, "kind": "delete"}, {"after_end": 14, "after_start": 12, "before_end": 17, "before_start": 13, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 9, "chars_inserted": 6}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-027d1d40a31b0004800c418c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3503}
{"after": {"end": 809, "start": 0, "text": "Au cours du temps, tous les patients ont montré des augmentations graduelles et prolongées des scores cognitifs moyens et du score total du langage, qui est le score combiné des scores de communications réceptive et expressive. Le score total brut moyen de la sous-échelle cognitive au début de l’étude était de 12,41 (N = 22). La variation moyenne des MC du score cognitif par rapport au début de l’étude a montré une augmentation de 12,4 au mois 12, de 16,5 au mois 24, de 23,3 au mois 60 et de 25,0 au mois 96. Le score total brut moyen pour la sous-échelle du langage au début de l’étude était de 18,09 (N = 22). La variation moyenne des MC par rapport au début de l’étude du score du langage total a montré une augmentation de 7,9 au mois 12, de 10,4 au mois 24, de 15,0 au mois 60 et de 17,8 au mois 96.", "truncated": false}, "after_length": 809, "after_sha256": "ec4eafab03de444860334bc8698678dc105fd776dbea2c97df8a10b1cce24c05", "annex": "I", "before": {"end": 769, "start": 0, "text": "Au cours du temps, tous les patients ont montré des augmentations graduelles et prolongées des scores cognitifs moyens et du score total du langage, qui est le score combiné des scores de communications réceptive et expressive. Le score total brut moyen de la sous-échelle cognitive au début de l’étude était de 12,41 (N = 22). La variation moyenne des MC du score cognitif par rapport au début de l’étude a montré une augmentation de 12,3 au mois 12, de 16,4 au mois 24 et de 23,6 au mois 60. Le score total brut moyen pour la sous-échelle du langage au début de l’étude était de 18,09 (N = 22). La variation moyenne des MC par rapport au début de l’étude du score du langage total a montré une augmentation de 7,6 au mois 12, de 10,1 au mois 24 et de 14,9 au mois 60.", "truncated": false}, "before_length": 769, "before_sha256": "fb4044a85afc4a02be6c8c0fe19d872bf3824fdfc982a6386d77c157b0e26c12", "change_kind": "content", "change_operations": [{"after_end": 439, "after_start": 438, "before_end": 439, "before_start": 438, "kind": "replace"}, {"after_end": 459, "after_start": 458, "before_end": 459, "before_start": 458, "kind": "replace"}, {"after_end": 471, "after_start": 470, "before_end": 473, "before_start": 470, "kind": "replace"}, {"after_end": 479, "after_start": 478, "before_end": 481, "before_start": 480, "kind": "replace"}, {"after_end": 512, "after_start": 490, "before_end": 492, "before_start": 492, "kind": "insert"}, {"after_end": 735, "after_start": 734, "before_end": 715, "before_start": 714, "kind": "replace"}, {"after_end": 755, "after_start": 754, "before_end": 735, "before_start": 734, "kind": "replace"}, {"after_end": 767, "after_start": 766, "before_end": 749, "before_start": 746, "kind": "replace"}, {"after_end": 773, "after_start": 772, "before_end": 755, "before_start": 754, "kind": "replace"}, {"after_end": 775, "after_start": 774, "before_end": 757, "before_start": 756, "kind": "replace"}, {"after_end": 808, "after_start": 786, "before_end": 768, "before_start": 768, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 13, "chars_inserted": 53}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-02b92806d91aed8ae184cb78", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005352", "medicine_name": "Upstaza", "medicine_slug": "upstaza", "observed_at": "2026-10-12T13:36:09Z", "pipeline_version": "2.0.0", "presentation_label": "Upstaza 2,8 × 1011 génomes de vecteur (vg)/0,5 mL, solution pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "42d7861913c7c415a9acf1067eeb3f9f1287a4e4718affc1402af95754bd6fed", "source_snapshot_id": "source-1e1e567efddae34509b5de34", "source_updated_at": "2026-06-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/upstaza-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 363}
{"after": {"end": 7, "start": 0, "text": "17 (77)", "truncated": false}, "after_length": 7, "after_sha256": "95d4e49ee1812236931bb91218f01c09f1e0fe34a5eec20fd88a457f2a1a80d0", "annex": "I", "before": {"end": 7, "start": 0, "text": "16 (73)", "truncated": false}, "before_length": 7, "before_sha256": "436e980a2c225ff8334b0ed687ee08af099979fdb3666e58b8fcbff2b9172d6f", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 1, "before_end": 2, "before_start": 1, "kind": "replace"}, {"after_end": 6, "after_start": 5, "before_end": 6, "before_start": 5, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-02d292c5714b31bfca244897", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005352", "medicine_name": "Upstaza", "medicine_slug": "upstaza", "observed_at": "2026-10-12T13:36:07Z", "pipeline_version": "2.0.0", "presentation_label": "Upstaza 2.8 × 1011 vector genomes (vg)/0.5 mL solution for infusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8561a0c5aed752dd415d30acef76bf620ad205d702080a0bca765e086873fe20", "source_snapshot_id": "source-4b712d5f9e4e2e8cd620aa93", "source_updated_at": "2026-06-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/upstaza-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 304}
{"after": {"end": 645, "start": 0, "text": "Over time, all subjects showed gradual and sustained increases in mean cognitive and total language scores, which is the combined score for receptive and expressive communication scores. The mean raw total score for cognitive subscale at baseline was 12.41 (N=22). The LS mean change from baseline in cognitive score showed an increase of 12.4 at Month 12, 16.5 at Month 24, 23.3 at Month 60, and 25.0 at Month 96. The mean raw total score for language subscale at baseline was 18.09 (N=22). The LS mean change from baseline in total language score showed an increase of 7.9 at Month 12, 10.4 at Month 24, 15.0 at Month 60, and 17.8 at Month 96.", "truncated": false}, "after_length": 645, "after_sha256": "4033187a25252581badac417d6bf8cf2a4fcb4f6d185d1c27f02c2aeb7b7b969", "annex": "I", "before": {"end": 610, "start": 0, "text": "Over time, all subjects showed gradual and sustained increases in mean cognitive and total language scores, which is the combined score for receptive and expressive communication scores. The mean raw total score for cognitive subscale at baseline was 12.41 (N=22). The LS mean change from baseline in cognitive score showed an increase of 12.3 at Month 12, 16.4 at Month 24, and 23.6 at Month 60,. The mean raw total score for language subscale at baseline was 18.09 (N=22). The LS mean change from baseline in total language score showed an increase of 7.6 at Month 12, 10.1 at Month 24, and 14.9 at Month 60.", "truncated": false}, "before_length": 610, "before_sha256": "a078c7fd05064abd99c8c5ddfe694b0930040b1b7d069159551f2389d64eb69c", "change_kind": "content", "change_operations": [{"after_end": 343, "after_start": 342, "before_end": 343, "before_start": 342, "kind": "replace"}, {"after_end": 361, "after_start": 360, "before_end": 361, "before_start": 360, "kind": "replace"}, {"after_end": 375, "after_start": 375, "before_end": 379, "before_start": 375, "kind": "delete"}, {"after_end": 379, "after_start": 378, "before_end": 383, "before_start": 382, "kind": "replace"}, {"after_end": 413, "after_start": 392, "before_end": 396, "before_start": 396, "kind": "insert"}, {"after_end": 574, "after_start": 573, "before_end": 557, "before_start": 556, "kind": "replace"}, {"after_end": 592, "after_start": 591, "before_end": 575, "before_start": 574, "kind": "replace"}, {"after_end": 606, "after_start": 606, "before_end": 593, "before_start": 589, "kind": "delete"}, {"after_end": 608, "after_start": 607, "before_end": 595, "before_start": 594, "kind": "replace"}, {"after_end": 610, "after_start": 609, "before_end": 597, "before_start": 596, "kind": "replace"}, {"after_end": 644, "after_start": 622, "before_end": 609, "before_start": 609, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 15, "chars_inserted": 50}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-02ff622d6e96fe6ce3aba412", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005352", "medicine_name": "Upstaza", "medicine_slug": "upstaza", "observed_at": "2026-10-12T13:36:07Z", "pipeline_version": "2.0.0", "presentation_label": "Upstaza 2.8 × 1011 vector genomes (vg)/0.5 mL solution for infusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8561a0c5aed752dd415d30acef76bf620ad205d702080a0bca765e086873fe20", "source_snapshot_id": "source-4b712d5f9e4e2e8cd620aa93", "source_updated_at": "2026-06-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/upstaza-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 437}
{"after": {"end": 82, "start": 0, "text": "Red, round, biconvex tablet, engraved with E277 on one side and ‘4’ on other side.", "truncated": false}, "after_length": 82, "after_sha256": "6bc8578abd9ec1ca441878fee4424546dc72523c1d1e2e720c37a561211da333", "annex": "I", "before": {"end": 81, "start": 0, "text": "Red, round, biconvex tablet, engraved with E277 on one side and ‘4’ on other side", "truncated": false}, "before_length": 81, "before_sha256": "4b1ff32027c6e1227a643311e5b34b7b1a4f639eb486b99c08db6c9b3b782874", "change_kind": "content", "change_operations": [{"after_end": 82, "after_start": 81, "before_end": 81, "before_start": 81, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-032cf57297aae0243a8fc1ee", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "Fycompa 2 mg filmcoated tablets Fycompa 4 mg filmcoated tablets Fycompa 6 mg filmcoated tablets Fycompa 8 mg filmcoated tablets Fycompa 10 mg filmcoated tablets Fycompa 12 mg filmcoated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "3", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 95}
{"after": {"end": 117, "start": 0, "text": "Adultes et adolescents (âgés de 12 ans et plus) pour le traitement des crises partielles et des crises généralisées :", "truncated": false}, "after_length": 117, "after_sha256": "7f9838fa5b951ce9273aacbe89618d11cd9b4a6a9416329f40b6188c307d6c4a", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 117, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 117}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-03791121ea4cb827d0c812ee", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:32:00Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3ff8cd4d67d22ba799aa348aeda944d6d896a16dcf54b030db101cbc095fc8ad", "source_snapshot_id": "source-a79a7cba8bf5dbc72fd40574", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2724}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 18, "start": 0, "text": "Medis Adria d.o.o.", "truncated": false}, "before_length": 18, "before_sha256": "9b45905f5bb1f7f631c00c103a5a406afd1cae41339f56b79ed37f9802cbeca4", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 18, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 18, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-037cd7d6defff594b2bb12ef", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1101}
{"after": {"end": 25, "start": 0, "text": "Affections psychiatriques", "truncated": false}, "after_length": 25, "after_sha256": "11e8e5c226ea62fc10f89e56e1901a5afedf8a75d8e5660f4a4b6ec29ef4a165", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 25, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 25}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-038bc39dbbe787ae472f3124", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "9ac80b0d56ebad4970f7a8335a177613af59ef25517bcd0bdd3397c207cc1bac", "source_snapshot_id": "source-c11aa9e32420f125a88005bc", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2727}
{"after": {"end": 31, "start": 0, "text": "Critère secondaire d’évaluation", "truncated": false}, "after_length": 31, "after_sha256": "c3e07e32ad358479ee2c95d92fa6efaee1fbd741b63de746b459f94bd4730982", "annex": "I", "before": {"end": 18, "start": 0, "text": "Critère secondaire", "truncated": false}, "before_length": 18, "before_sha256": "eb26303f379ef015cbdae0d636c5c2a0a12eb821c12bca7caa779c7caf7caaa8", "change_kind": "content", "change_operations": [{"after_end": 31, "after_start": 18, "before_end": 18, "before_start": 18, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 13}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-03adb0823581f6a151a15f8a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2107}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 20, "start": 0, "text": "10 single-dose vials", "truncated": false}, "before_length": 20, "before_sha256": "389860e7b0c5930334ac8ab3f137b5fb5c8e0748f5a28c351a21dcaee30126f4", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 20, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 20, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-03eb335f8807b9da474c7e8a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.5", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6324}
{"after": {"end": 244, "start": 0, "text": "Les tableaux 1 et 2 présentent les effets indésirables associés à l’utilisation d’Avastin en association à différents protocoles de chimiothérapie dans diverses indications, selon la classification MedDRA par Classe de systèmes d'organes (SOC).", "truncated": false}, "after_length": 244, "after_sha256": "47fd7b97555d954327494481f3753484483411e3fe8958f8ce5469094c6778c4", "annex": "I", "before": {"end": 231, "start": 0, "text": "Les tableaux 1 et 2 présentent les effets indésirables associés à l’utilisation d’Avastin en association à différents protocoles de chimiothérapie dans diverses indications, selon la classification MedDRA par Système Organe Classe.", "truncated": false}, "before_length": 231, "before_sha256": "477c63d81dd4e484f9cabdaf62cdad62d20dce8c300686ceca35e0ff529d9c0f", "change_kind": "content", "change_operations": [{"after_end": 220, "after_start": 209, "before_end": 210, "before_start": 209, "kind": "replace"}, {"after_end": 227, "after_start": 226, "before_end": 216, "before_start": 216, "kind": "insert"}, {"after_end": 231, "after_start": 228, "before_end": 218, "before_start": 217, "kind": "replace"}, {"after_end": 237, "after_start": 236, "before_end": 223, "before_start": 223, "kind": "insert"}, {"after_end": 241, "after_start": 238, "before_end": 224, "before_start": 224, "kind": "insert"}, {"after_end": 243, "after_start": 242, "before_end": 230, "before_start": 225, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 20}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-03ff6a71f019bfdf4e94158a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 324}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IV", "before": {"end": 249, "start": 0, "text": "Sur la base des conclusions scientifiques relatives au pérampanel, le CHMP estime que le rapport bénéfice risque du/des médicament(s) contenant du pérampanel demeure inchangé, sous réserve des modifications proposées des informations sur le produit.", "truncated": false}, "before_length": 249, "before_sha256": "85e3442b9de93fe3ae9ea6eeaf12efe6d51bba12ac79c2140574eee438fa3a4a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 249, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 249, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0402e3f736f099330e3f7649", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:32:00Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "3ff8cd4d67d22ba799aa348aeda944d6d896a16dcf54b030db101cbc095fc8ad", "source_snapshot_id": "source-a79a7cba8bf5dbc72fd40574", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3526}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 17, "start": 0, "text": "Byk-Gulden-Str. 2", "truncated": false}, "before_length": 17, "before_sha256": "5dc95d013d793b6958719e5db82aa51cd0c1864e2e8bc9bfcf2cfded1a05eba6", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 17, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 17, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0407f34e2cdd9f0f12835309", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1338}
{"after": {"end": 5, "start": 0, "text": "BOITE", "truncated": false}, "after_length": 5, "after_sha256": "1b1d08f5410c5ffada766987117be91ac56027bdf92b1822ed66807fbaf8c3a0", "annex": "IIIA", "before": {"end": 4, "start": 0, "text": "ETUI", "truncated": false}, "before_length": 4, "before_sha256": "7b1f93054fda33f5ac26e1fcca4f88911b34102404c41298bf20bbf7f5191106", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}, {"after_end": 5, "after_start": 5, "before_end": 4, "before_start": 1, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 3, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-04730be09bec3b4e06ca7269", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2774}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 14, "start": 0, "text": "Mundipharma AB", "truncated": false}, "before_length": 14, "before_sha256": "6cf8d25c6640dec825037c0530131ec0c883b9dff60d21efb53dd7e9d7f8c9d1", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-047bd6df47de584a1300516e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1144}
{"after": {"end": 143, "start": 0, "text": "Les données sont limitées chez les patients avec une atteinte de la fonction cardiaque. Aucune recommandation spécifique de dose n’a été faite.", "truncated": false}, "after_length": 143, "after_sha256": "5d2fd26198e0e27ae52ea6f39923ec8865943e3d957b238c3d23c1241e7323e3", "annex": "I", "before": {"end": 134, "start": 0, "text": "Les données sont limitées chez les patients atteints d’insuffisance cardiaque. Aucune recommandation spécifique de dose n’a été faite.", "truncated": false}, "before_length": 134, "before_sha256": "40628a1b552cfbd578673f10714b56cee3d06840a8ef35f4e6f445d8b34ecc79", "change_kind": "content", "change_operations": [{"after_end": 54, "after_start": 45, "before_end": 45, "before_start": 45, "kind": "insert"}, {"after_end": 61, "after_start": 60, "before_end": 52, "before_start": 51, "kind": "replace"}, {"after_end": 68, "after_start": 63, "before_end": 59, "before_start": 54, "kind": "replace"}, {"after_end": 70, "after_start": 69, "before_end": 64, "before_start": 60, "kind": "replace"}, {"after_end": 76, "after_start": 72, "before_end": 67, "before_start": 66, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 11, "chars_inserted": 20}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-048d5225b4a72be838067300", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002640", "medicine_name": "Cometriq", "medicine_slug": "cometriq", "observed_at": "2026-10-12T19:00:55Z", "pipeline_version": "2.0.0", "presentation_label": "COMETRIQ 20 mg, gélules COMETRIQ 80 mg, gélules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "c7f8aa8da9127064263770c4aed5506128bacd0c40693b863c48a757d735203e", "source_snapshot_id": "source-e4fa0b9c95a2e427d4c95a33", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/cometriq-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 103}
{"after": {"end": 25, "start": 0, "text": "Tel: +49 (0)89 36044 8701", "truncated": false}, "after_length": 25, "after_sha256": "76a5baaa61395f016fced6d58ba2f7d813c34e258f9cb9ec8535af61c1b1aaf2", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "Tel: + 49 (0)89 360448701", "truncated": false}, "before_length": 25, "before_sha256": "2f356779a4495e7e76f16001e1d565254865df88ad1783cab9de20e20f154a8a", "change_kind": "content", "change_operations": [{"after_end": 6, "after_start": 6, "before_end": 7, "before_start": 6, "kind": "delete"}, {"after_end": 21, "after_start": 20, "before_end": 21, "before_start": 21, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-04cd2b527d4e71341195f7ce", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000112", "medicine_name": "Twinrix Adult", "medicine_slug": "twinrix-adult", "observed_at": "2026-10-12T13:29:23Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "cfad5fb0086c9b5d6a36b454f3f546373def1f56cded73e0652b498d02d68e41", "source_snapshot_id": "source-17627897b0874bf1160c7372", "source_updated_at": "2026-08-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/twinrix-adult-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 945}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 9, "start": 0, "text": "Nederland", "truncated": false}, "before_length": 9, "before_sha256": "8a869db3fa453526573e4f2c956528743cf246af5d1b5eac4879257589776797", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 9, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 9, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-05219a970c7a69da7df5ebe9", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1071}
{"after": {"end": 344, "start": 0, "text": "Allaitement : Il n’est pas recommandé d’allaiter pendant l’utilisation de ce médicament car il pourrait être nocif pour l’enfant. Si vous allaitez actuellement ou prévoyez d’allaiter, informez-en votre médecin avant d’utiliser ce médicament. Votre médecin déterminera avec vous si vous devez arrêter l’allaitement ou arrêter d’utiliser Adempas.", "truncated": false}, "after_length": 344, "after_sha256": "1ab3220d6175215cb9775f5684eb634baa0c1e92dd997a12da27b25350212526", "annex": "IIIA", "before": {"end": 344, "start": 0, "text": "Allaitement : Il n’est pas recommandé d’allaiter pendant l’utilisation de ce médicament car il pourrait être nocif pour l’enfant. Si vous allaitez actuellement ou prévoyez d’allaiter. Informez-en votre médecin avant d’utiliser ce médicament. Votre médecin déterminera avec vous si vous devez arrêter l’allaitement ou arrêter d’utiliser Adempas.", "truncated": false}, "before_length": 344, "before_sha256": "f84fbe861d9b2a53e2169c34d1ec3726560eb97eb740250fd8b829c3aec089bb", "change_kind": "content", "change_operations": [{"after_end": 183, "after_start": 182, "before_end": 183, "before_start": 182, "kind": "replace"}, {"after_end": 185, "after_start": 184, "before_end": 185, "before_start": 184, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-052b685dfb330287caa64b7d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2881}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 14, "start": 0, "text": "78467 Konstanz", "truncated": false}, "before_length": 14, "before_sha256": "ee960a86a16086f43d4c7f3f51bd93d39025d5227fb1a6f1c825d1015754ff53", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-054938f3b56bd48b290e25fd", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1713}
{"after": {"end": 70, "start": 0, "text": "Wash your hands carefully with soap to minimise the risk of infection.", "truncated": false}, "after_length": 70, "after_sha256": "36ac5d80cccb711cb8b7b4abf3eaa3a505ef4d59890c0a4e1971bb9b23dca7f0", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 70, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 70}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-057844be1ec8343be40cc80e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1968}
{"after": {"end": 131, "start": 0, "text": "muscle pain or stiffness or weakness or rapid tiring of the muscles (may be signs of inflammation or other problems of the muscles)", "truncated": false}, "after_length": 131, "after_sha256": "334adeb5c41adf5abb9411d3a1f0a349bd28c6a75d170f135c346b9d7912f1c1", "annex": "IIIA", "before": {"end": 118, "start": 0, "text": "muscle pain or weakness or rapid tiring of the muscles (may be signs of inflammation or other problems of the muscles)", "truncated": false}, "before_length": 118, "before_sha256": "fd7204efcc707a9e6175a62aca938fe895715566c19452dfe86ef9256b1d0565", "change_kind": "content", "change_operations": [{"after_end": 28, "after_start": 15, "before_end": 15, "before_start": 15, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 13}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-05894cdd8588268d3f33bff3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2074}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 29, "start": 0, "text": "Mundipharma Polska Sp. z o.o.", "truncated": false}, "before_length": 29, "before_sha256": "5e6140688b90710113e04659df6f0ddaf7cd759aa25f2b444fd5a94495e5a1d4", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 29, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 29, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-05abb3d412a5d2154c905027", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1086}
{"after": {"end": 130, "start": 0, "text": "Caution: Hold the pen with the needle pointing upwards. Never hold the pen with exposed needle towards your face or other persons.", "truncated": false}, "after_length": 130, "after_sha256": "4a6928b16ed0b8fc506369db9b09a3723e63fc497287f9fd63030e171cb98765", "annex": "IIIA", "before": {"end": 48, "start": 0, "text": "• Hold the pen with the needle pointing upwards.", "truncated": false}, "before_length": 48, "before_sha256": "128fba2ea3c4165f782f8287ebcdda6bb8165d619c9c9033c2f7827102383d37", "change_kind": "content", "change_operations": [{"after_end": 8, "after_start": 0, "before_end": 1, "before_start": 0, "kind": "replace"}, {"after_end": 128, "after_start": 53, "before_end": 46, "before_start": 46, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 83}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0612d7d268b5a80299d18398", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2016}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "nordics@mundipharma.dk", "truncated": false}, "before_length": 22, "before_sha256": "f439d81e92f339fb15af44387dc1531c6265af6c724b25a05f18a5ab6acd0f1e", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 22, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 22, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-061ff19b8a2f81935ed06175", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1146}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 9, "start": 0, "text": "Slovenija", "truncated": false}, "before_length": 9, "before_sha256": "fa267dd198bd52b588eff3ae1ccd7c7ea1ac67b4d621fd44e50742c91809cac3", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 9, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 9, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0630421ea6090756b91459d2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1116}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 12, "start": 0, "text": "info@egis.lt", "truncated": false}, "before_length": 12, "before_sha256": "a1afeca2989077e067a8190ee7f5e0ec0812d2073e4555a1b4185de53eea1a0a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 12, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 12, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0676341c6536ee89ea867a3a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1021}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 43, "start": 0, "text": "The vaccine comes ready to use once thawed.", "truncated": false}, "before_length": 43, "before_sha256": "a4f540004da2311077aa0ae1cd291686425e5d1fb0dbdf3f249e9192732dcfc9", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 43, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 43, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-067ba032c34cdb3ab4189c38", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6380}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Tel: +353 1 206 3800", "truncated": false}, "before_length": 20, "before_sha256": "b76fef5190d612d91d8ee1c3f52c40e30fcc7f25541faffe2a0c00e33c8cb7c1", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 20, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 20, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-069010ffdef7677a10d0b362", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1118}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 7, "start": 0, "text": "Danmark", "truncated": false}, "before_length": 7, "before_sha256": "b2bebaaf55198f3166a7d7089112d30e245d6cf4a3249ae87b597fa988e7f1be", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 7, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-06977bfd58d71f9d0175154c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1057}
{"after": {"end": 119, "start": 0, "text": "Un étui intérieur de cartouche Terrosa (contenant 1 cartouche) et un étui intérieur de Terrosa Pen (contenant 1 stylo).", "truncated": false}, "after_length": 119, "after_sha256": "dd34bb1b8d84df14a030cbde68642d5fefdb0d70a85196aa0e049cfbb605c33f", "annex": "I", "before": {"end": 121, "start": 0, "text": "Un étui intérieur de cartouche Terrosa (contenant 1 cartouche) et un étui intérieur de stylo Terrosa (contenant 1 stylo).", "truncated": false}, "before_length": 121, "before_sha256": "7571acc748a63cb986a7d093107b3f29a6dd500738530321f6ba8e9a893c67fc", "change_kind": "content", "change_operations": [{"after_end": 87, "after_start": 87, "before_end": 93, "before_start": 87, "kind": "delete"}, {"after_end": 98, "after_start": 94, "before_end": 100, "before_start": 100, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-06b0704f7fbb2266d4bc9fdd", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "Terrosa 20 microgrammes/80 microlitres solution injectable", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.5", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 459}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 37, "start": 0, "text": "nausea, vomiting such as granisetron.", "truncated": false}, "before_length": 37, "before_sha256": "3b2a9217d93f10feb0f615225268d54ae08fcbdfc92aefa170d87ea742960f09", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 37, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 37, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0715b1b1c7b020b2c6c05c8a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3212}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 33, "start": 0, "text": "United Kingdom (Northern Ireland)", "truncated": false}, "before_length": 33, "before_sha256": "9379d82927cdb505cfb186e912177065e56a1314de3a2b914ebbb8b5fe21525a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 33, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 33, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-077178128d106e452d7ddf55", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1132}
{"after": {"end": 19, "start": 0, "text": "Sími: +354 535 7000", "truncated": false}, "after_length": 19, "after_sha256": "4147b258aaf4f6d0d9b2ae441e0fa1eb5f0dadfd4e4fea070a7673c7133bf389", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Sími: + 354 535 7000", "truncated": false}, "before_length": 20, "before_sha256": "66fcdd056ccfbc5ba6d0c26580292977898106c90655c78208bc87c3d941892c", "change_kind": "content", "change_operations": [{"after_end": 7, "after_start": 7, "before_end": 8, "before_start": 7, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-07e532aac3d63609c78e6909", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3169}
{"after": {"end": 385, "start": 0, "text": "There have been postmarketing cases of intentional and accidental overdose. Reported doses of perampanel were up to approximately 50 mg in paediatric patients and up to 300 mg in adult patients. The adverse reactions observed included altered mental status, agitation, aggressive behaviour, vomiting, coma, and depressed level of consciousness. The patients recovered without sequelae.", "truncated": false}, "after_length": 385, "after_sha256": "6e07c6334ef8479da1ec43ef216e237f6491e05f5402850708586a25a6092b55", "annex": "I", "before": {"end": 361, "start": 0, "text": "There have been postmarketing cases of intentional and accidental overdose in paediatric patients with doses of perampanel up to 36 mg and in adult patients with doses up to 300 mg. The adverse reactions observed included altered mental status, agitation, aggressive behaviour, coma and depressed level of consciousness. The patients recovered without sequelae.", "truncated": false}, "before_length": 361, "before_sha256": "3da8de3889f1fb62e5898a784d4e4b9ebed5ad283faefe7f1d79f6cd4dea9730", "change_kind": "content", "change_operations": [{"after_end": 135, "after_start": 74, "before_end": 74, "before_start": 74, "kind": "insert"}, {"after_end": 159, "after_start": 159, "before_end": 118, "before_start": 98, "kind": "delete"}, {"after_end": 162, "after_start": 161, "before_end": 122, "before_start": 120, "kind": "replace"}, {"after_end": 172, "after_start": 170, "before_end": 131, "before_start": 130, "kind": "replace"}, {"after_end": 175, "after_start": 175, "before_end": 138, "before_start": 134, "kind": "delete"}, {"after_end": 193, "after_start": 193, "before_end": 180, "before_start": 156, "kind": "delete"}, {"after_end": 301, "after_start": 291, "before_end": 278, "before_start": 278, "kind": "insert"}, {"after_end": 306, "after_start": 305, "before_end": 282, "before_start": 282, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 51, "chars_inserted": 75}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-07e6f3519320c45d8e2b8173", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "Fycompa 0.5 mg/ml oral suspension", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.9", "section_type": "overdose", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1315}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 268, "start": 0, "text": "The MAH shall ensure that in each Member State where etanercept is marketed, all healthcare professionals who are expected to prescribe etanercept and all patients who are expected to use etanercept have access to/are provided with the following educational materials:", "truncated": false}, "before_length": 268, "before_sha256": "fa60c85a994ba18d8e1407894e470ab6031ea190d712b5a326d33a056085f372", "change_kind": "unassigned", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 268, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 268, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-07fe9c3bbc4b65d9a450f460", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6572}
{"after": {"end": 97, "start": 0, "text": "pression sanguine basse (hypotension) (très fréquent : pouvant concerner plus de 1 enfant sur 10)", "truncated": false}, "after_length": 97, "after_sha256": "c2909a775f518544fbcf7cc51dadfeef1fa56d5ee78ca7dcc6ba6918c5637e4d", "annex": "IIIA", "before": {"end": 97, "start": 0, "text": "pression sanguine basse (hypotension) (Très fréquent : pouvant concerner plus de 1 enfant sur 10)", "truncated": false}, "before_length": 97, "before_sha256": "795e4cf10fa8969fa8e52d908cd4ad13cba0d6794f59c83ac380b5998f1f9baf", "change_kind": "content", "change_operations": [{"after_end": 40, "after_start": 39, "before_end": 40, "before_start": 39, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-08090c0adbc97ecb6b2d95d0", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2983}
{"after": {"end": 37, "start": 0, "text": "Survie Sans Progression (SSP)^ (mois)", "truncated": false}, "after_length": 37, "after_sha256": "b1a3a86b4ac1e19c7e18776e4763beeb6be6dc6a6ca96af8331783fc78424852", "annex": "I", "before": {"end": 37, "start": 0, "text": "Survie Sans Progression (PFS)^ (mois)", "truncated": false}, "before_length": 37, "before_sha256": "e133289c55904e124dd43e50d23942c7039f423cb65aff49e19db6781dbd7b0c", "change_kind": "content", "change_operations": [{"after_end": 27, "after_start": 25, "before_end": 25, "before_start": 25, "kind": "insert"}, {"after_end": 28, "after_start": 28, "before_end": 28, "before_start": 26, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0814dab9d985326c24e33347", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1591}
{"after": {"end": 49, "start": 0, "text": "Pas d’exigences particulières pour l’élimination.", "truncated": false}, "after_length": 49, "after_sha256": "e8b5619a1cf1c51f05bd9661472863b95514334a3fad7acb81f4c2e0822ccb36", "annex": "I", "before": {"end": 30, "start": 0, "text": "Pas d’exigences particulières.", "truncated": false}, "before_length": 30, "before_sha256": "301e954ede8fa0b7074ef1039e0aecbf1707ba81774e008d2454f13f8871e846", "change_kind": "content", "change_operations": [{"after_end": 48, "after_start": 29, "before_end": 29, "before_start": 29, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 19}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-083079257c9782d29143e62e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:32:00Z", "pipeline_version": "2.0.0", "presentation_label": "Fycompa 2 mg comprimés pelliculés Fycompa 4 mg comprimés pelliculés Fycompa 6 mg comprimés pelliculés Fycompa 8 mg comprimés pelliculés Fycompa 10 mg comprimés pelliculés Fycompa 12 mg comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "3ff8cd4d67d22ba799aa348aeda944d6d896a16dcf54b030db101cbc095fc8ad", "source_snapshot_id": "source-a79a7cba8bf5dbc72fd40574", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 828}
{"after": {"end": 43, "start": 0, "text": "4 seringues pré-remplies de 1 mL de solvant", "truncated": false}, "after_length": 43, "after_sha256": "ebfac950c9aa338c1bc77c45d525865d556881a25922995ef6d475cc5a6772b6", "annex": "IIIA", "before": {"end": 43, "start": 0, "text": "4 seringues pré-remplies de 1 ml de solvant", "truncated": false}, "before_length": 43, "before_sha256": "339c013aec71992a822e6c84710fe78715830580515f79c89b045d4f714eacdf", "change_kind": "content", "change_operations": [{"after_end": 32, "after_start": 31, "before_end": 32, "before_start": 31, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-08385d5d4d47b9a3152c7fc8", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 7590}
{"after": {"end": 8, "start": 0, "text": "Pays-Bas", "truncated": false}, "after_length": 8, "after_sha256": "2f1d512c96e61c1e31319fc9326840a0ea9ab221bba6bbdca327b162ac12fa51", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 8, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0844f9c370877b2fffd511af", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1025}
{"after": {"end": 72, "start": 0, "text": "Medicines that can change the level of Adempas in the blood, for example", "truncated": false}, "after_length": 72, "after_sha256": "9a68e5dde529571b769db702358a8f94c7e0ef480f831e6d1ce1f35f856588cc", "annex": "IIIA", "before": {"end": 111, "start": 0, "text": "The following medicines can increase the level of Adempas in the blood which increases the risk of side effects", "truncated": false}, "before_length": 111, "before_sha256": "ecfa7fa01702f3b681434e7b066b8460f7bb0e702287121c85f0e64a5956f978", "change_kind": "content", "change_operations": [{"after_end": 1, "after_start": 0, "before_end": 15, "before_start": 0, "kind": "replace"}, {"after_end": 15, "after_start": 10, "before_end": 24, "before_start": 24, "kind": "insert"}, {"after_end": 22, "after_start": 19, "before_end": 29, "before_start": 28, "kind": "replace"}, {"after_end": 24, "after_start": 23, "before_end": 35, "before_start": 30, "kind": "replace"}, {"after_end": 60, "after_start": 59, "before_end": 70, "before_start": 70, "kind": "insert"}, {"after_end": 63, "after_start": 61, "before_end": 80, "before_start": 71, "kind": "replace"}, {"after_end": 64, "after_start": 64, "before_end": 103, "before_start": 81, "kind": "delete"}, {"after_end": 71, "after_start": 66, "before_end": 107, "before_start": 105, "kind": "replace"}, {"after_end": 72, "after_start": 72, "before_end": 111, "before_start": 108, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 57, "chars_inserted": 18}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0871e7ee0458fcd268e7df70", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2775}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 27, "start": 0, "text": "Mundipharma Ges.m.b.H.-o.z.", "truncated": false}, "before_length": 27, "before_sha256": "9029483ca33dfc6da671293b2cd5f39021da794ad7ae13578dd56a22e674b430", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 27, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 27, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0881871d5f41f9d31a53ec49", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1127}
{"after": {"end": 12, "start": 0, "text": "MSD Α.Φ.Ε.Ε.", "truncated": false}, "after_length": 12, "after_sha256": "2920f5081525207a4790665fb26df902fdae978fe29baab6a51bbb705bb0115e", "annex": "IIIA", "before": {"end": 11, "start": 0, "text": "MSD Α.Φ.Ε.Ε", "truncated": false}, "before_length": 11, "before_sha256": "59152f94c242dd20eb3ac511729a3bc6beb5b7295232b77ad5bd9aa45afa4c63", "change_kind": "content", "change_operations": [{"after_end": 12, "after_start": 11, "before_end": 11, "before_start": 11, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0888d4e274e8eb2d9173775e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3433}
{"after": {"end": 52, "start": 0, "text": "le millepertuis, utilisé pour traiter la dépression.", "truncated": false}, "after_length": 52, "after_sha256": "d07cd097c53bd3ab4869753c049529d3d83be39dc2674eb80a40f98958778754", "annex": "IIIA", "before": {"end": 42, "start": 0, "text": "de la dépression tels que le millepertuis.", "truncated": false}, "before_length": 42, "before_sha256": "7d82720f9f8eab55abf64d5d1a94d3b4209c8fd15beff345943423cb2fae10e6", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 26, "before_start": 0, "kind": "delete"}, {"after_end": 51, "after_start": 15, "before_end": 41, "before_start": 41, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 26, "chars_inserted": 36}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0889c066bd58c51d0b390a8f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3301}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 11, "start": 0, "text": "Takeda GmbH", "truncated": false}, "before_length": 11, "before_sha256": "94e4e4fc81542d4a8a0deb904c666e74cf300a1075af4d0d2e564a29e287bafb", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 11, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 11, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-088b63f4617fdd52251dfb7d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1337}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 6, "start": 0, "text": "France", "truncated": false}, "before_length": 6, "before_sha256": "7a1ca4ef7515f7276bae7230545829c27810c9d9e98ab2c06066bee6270d5153", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 6, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-088fa1769f18a25829c72a20", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1103}
{"after": {"end": 6, "start": 0, "text": "0,5 mL", "truncated": false}, "after_length": 6, "after_sha256": "6747c863b8991251bf2c34b31d5018ab9386dcebc36ccb0be76b65a0200e9060", "annex": "IIIA", "before": {"end": 6, "start": 0, "text": "0,5 ml", "truncated": false}, "before_length": 6, "before_sha256": "c18cd45fd905f6425dfb832ecbebc2d4c02cc790a770677e8ffa360c6d4854fb", "change_kind": "content", "change_operations": [{"after_end": 6, "after_start": 5, "before_end": 6, "before_start": 5, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-08a326dafeaca27f36512c5e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 8176}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 248, "start": 0, "text": "de la pression sanguine élevée ou des maladies du cœur comme les dérivés nitrés et le nitrite d’amyle, ou un autre médicament stimulateur de la guanylate cyclase soluble tel que le vériciguat. Ne prenez pas ces médicaments en même temps qu’Adempas.", "truncated": false}, "before_length": 248, "before_sha256": "f47c994b5b974276c1a7e1cb3bae0def5ee190d893399351de30d9c311a88002", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 248, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 248, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-08b0d5e3732ba0ed2bcffedb", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2853}
{"after": {"end": 41, "start": 0, "text": "GlaxoSmithKline Pharmaceuticals s.a./n.v.", "truncated": false}, "after_length": 41, "after_sha256": "78a50ede7f6f749aad8e46d5c904e76d599a24803810e6aa82ac2a4623d14d3b", "annex": "IIIA", "before": {"end": 37, "start": 0, "text": "GlaxoSmithKline Pharmaceuticals SA/NV", "truncated": false}, "before_length": 37, "before_sha256": "76a8c323880ceb0f3084587deeb6993db7df1bb7006480e529e3b2bdcc2fb11c", "change_kind": "content", "change_operations": [{"after_end": 36, "after_start": 32, "before_end": 34, "before_start": 32, "kind": "replace"}, {"after_end": 41, "after_start": 37, "before_end": 37, "before_start": 35, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-08e9962e2df5c53754cfc68e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000112", "medicine_name": "Twinrix Adult", "medicine_slug": "twinrix-adult", "observed_at": "2026-10-12T13:29:23Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "cfad5fb0086c9b5d6a36b454f3f546373def1f56cded73e0652b498d02d68e41", "source_snapshot_id": "source-17627897b0874bf1160c7372", "source_updated_at": "2026-08-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/twinrix-adult-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 911}
{"after": {"end": 13, "start": 0, "text": "Leusderend 16", "truncated": false}, "after_length": 13, "after_sha256": "af1e1fecef744f092123851cb8459b03d91077081e50b99a8caaeae83326dc44", "annex": "II", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 13}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-08f69a8d462578f1194ae2de", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 534}
{"after": {"end": 2, "start": 0, "text": "SC", "truncated": false}, "after_length": 2, "after_sha256": "32da6721804f1dd3226c0551970304ebf1059ec19a27451426541027861c9388", "annex": "IIIA", "before": {"end": 17, "start": 0, "text": "Voie sous-cutanée", "truncated": false}, "before_length": 17, "before_sha256": "2c39e73e194fa4f0fa51aa54d98a94765b3fcf21e9faf5848d5728b740ab316d", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 0, "before_end": 17, "before_start": 0, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 17, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-08f885ea8858c3e2da5be018", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 7891}
{"after": {"end": 43, "start": 0, "text": "Pfizer Healthcare Ireland Unlimited Company", "truncated": false}, "after_length": 43, "after_sha256": "1f203777a0ec6fed9c840d52631b6a74c7e25b5d318485d8147e2404f52dc981", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "Pfizer Healthcare Ireland", "truncated": false}, "before_length": 25, "before_sha256": "4beeea9b6d0c491f03a9511d9f9576b9c75cbcdcfd736e4934f768fdded936f5", "change_kind": "content", "change_operations": [{"after_end": 43, "after_start": 25, "before_end": 25, "before_start": 25, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 18}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0942ba22e80ee54ce136cc14", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 10136}
{"after": {"end": 215, "start": 0, "text": "Les données obtenues après le mois 60 et le mois 12 de l’étude AADC-010 et de l’étude AADC-011, respectivement, ont été recueillies dans le cadre de l’étude de suivi à long terme AADC-1602, comme indiqué ci-dessous.", "truncated": false}, "after_length": 215, "after_sha256": "c89e860fefb77d85afb67f6c286da3bc4c8027273e14b4f12bb7b2219d7f5279", "annex": "I", "before": {"end": 283, "start": 0, "text": "Les données obtenues après le mois 60 et le mois 12 de l’étude AADC-010 et de l’étude AADC-011, respectivement, ont été recueillies dans le cadre de l’étude de suivi à long terme AADC-1602, comme indiqué ci-dessous, avec une date d’arrêt de recueil des données fixée au 16 juin 2023.", "truncated": false}, "before_length": 283, "before_sha256": "c84debe63efab8fb852c7a8755bedd4b951359d5143349341b469658c34b50c7", "change_kind": "content", "change_operations": [{"after_end": 214, "after_start": 214, "before_end": 282, "before_start": 214, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 68, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-095a21b778cf771092f6951c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005352", "medicine_name": "Upstaza", "medicine_slug": "upstaza", "observed_at": "2026-10-12T13:36:09Z", "pipeline_version": "2.0.0", "presentation_label": "Upstaza 2,8 × 1011 génomes de vecteur (vg)/0,5 mL, solution pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "42d7861913c7c415a9acf1067eeb3f9f1287a4e4718affc1402af95754bd6fed", "source_snapshot_id": "source-1e1e567efddae34509b5de34", "source_updated_at": "2026-06-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/upstaza-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 315}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 8, "start": 0, "text": "Portugal", "truncated": false}, "before_length": 8, "before_sha256": "4c7de2c3da6dc0ae8f9d13b107718a913859359bd30166d077c867577953865d", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 8, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 8, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-09ae1581ca73f700775ae392", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1108}
{"after": {"end": 119, "start": 0, "text": "Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu", "truncated": false}, "after_length": 119, "after_sha256": "0f2b81ab8009e1a279ca008eb6e21bdb2e532de63aef52b62bdac980c49555d4", "annex": "IIIA", "before": {"end": 118, "start": 0, "text": "Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu", "truncated": false}, "before_length": 118, "before_sha256": "d114210a3c6f4b6710e22609ee80410ff17f5efd93b30ab72728a60b65635068", "change_kind": "technical", "change_operations": [{"after_end": 99, "after_start": 98, "before_end": 98, "before_start": 98, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-09d510223a9bf81d0e6dfc4b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 10029}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "Tél: +33 1 40 65 29 29", "truncated": false}, "before_length": 22, "before_sha256": "80f8b635bfd20be9b4f761a79c7cf6d1a5a2894b709f54f7104b9cc6382753ad", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 22, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 22, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-09df2fdcf776dd2a160b17d5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1105}
{"after": {"end": 6, "start": 0, "text": "7 (32)", "truncated": false}, "after_length": 6, "after_sha256": "5381cf2caeeb0c444d378826e402319e8afb7abc2f842250a25d2f9e776cc61e", "annex": "I", "before": {"end": 6, "start": 0, "text": "6 (27)", "truncated": false}, "before_length": 6, "before_sha256": "b4a07d9e9e064b339d669cda25ac2c21b7c726287abca68cf2167d70363ed749", "change_kind": "content", "change_operations": [{"after_end": 1, "after_start": 0, "before_end": 1, "before_start": 0, "kind": "replace"}, {"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}, {"after_end": 5, "after_start": 5, "before_end": 5, "before_start": 4, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-09efd899c46752cd49ba530a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005352", "medicine_name": "Upstaza", "medicine_slug": "upstaza", "observed_at": "2026-10-12T13:36:09Z", "pipeline_version": "2.0.0", "presentation_label": "Upstaza 2,8 × 1011 génomes de vecteur (vg)/0,5 mL, solution pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "42d7861913c7c415a9acf1067eeb3f9f1287a4e4718affc1402af95754bd6fed", "source_snapshot_id": "source-1e1e567efddae34509b5de34", "source_updated_at": "2026-06-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/upstaza-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 346}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 6, "start": 0, "text": "Ελλάδα", "truncated": false}, "before_length": 6, "before_sha256": "e6f7401e81c9b2a3c1f082d0c9a0183287a6f7b4ecded4f4d3ac5e1efefa9ce5", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 6, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0a4c9ee19ea0a68bcab9713d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1070}
{"after": {"end": 7, "start": 0, "text": "17 (77)", "truncated": false}, "after_length": 7, "after_sha256": "95d4e49ee1812236931bb91218f01c09f1e0fe34a5eec20fd88a457f2a1a80d0", "annex": "I", "before": {"end": 7, "start": 0, "text": "16 (73)", "truncated": false}, "before_length": 7, "before_sha256": "436e980a2c225ff8334b0ed687ee08af099979fdb3666e58b8fcbff2b9172d6f", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 1, "before_end": 2, "before_start": 1, "kind": "replace"}, {"after_end": 6, "after_start": 5, "before_end": 6, "before_start": 5, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0a89e6c18c98f90baed09fad", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005352", "medicine_name": "Upstaza", "medicine_slug": "upstaza", "observed_at": "2026-10-12T13:36:09Z", "pipeline_version": "2.0.0", "presentation_label": "Upstaza 2,8 × 1011 génomes de vecteur (vg)/0,5 mL, solution pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "42d7861913c7c415a9acf1067eeb3f9f1287a4e4718affc1402af95754bd6fed", "source_snapshot_id": "source-1e1e567efddae34509b5de34", "source_updated_at": "2026-06-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/upstaza-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 335}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 31, "start": 0, "text": "Mundipharma Pharmaceuticals Ltd", "truncated": false}, "before_length": 31, "before_sha256": "16a6c553b8ef125dae7ad452aab0e5f569dfcb615e35e199efe424dd624ea758", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 31, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 31, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0ab6e19956d4c5b046d097a6", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1140}
{"after": {"end": 20, "start": 0, "text": "Tlf.: +45 44 201 100", "truncated": false}, "after_length": 20, "after_sha256": "a342c892cb893e888e9b98929ab7ba413528a3b19847cefc774fcc7b2c91291e", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "Tlf: +45 44 201 100", "truncated": false}, "before_length": 19, "before_sha256": "c639c1fe70f9701d8cecb70d89ff79995abd4e41911073143438fc69a41a0363", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0abd5d85dbe6f5a6643ca0a2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 10460}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 33, "start": 0, "text": "United Kingdom (Northern Ireland)", "truncated": false}, "before_length": 33, "before_sha256": "9379d82927cdb505cfb186e912177065e56a1314de3a2b914ebbb8b5fe21525a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 33, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 33, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0af0f78ed0964d6f951563a1", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11748}
{"after": {"end": 71, "start": 0, "text": "la ciclosporine, utilisée pour prévenir le rejet des greffes d’organes.", "truncated": false}, "after_length": 71, "after_sha256": "e3d3b57620f52899cdb330890a071521119758530576ca0cc2ff7105b82fd69f", "annex": "IIIA", "before": {"end": 73, "start": 0, "text": "de la prévention du rejet des greffes d’organes tels que la ciclosporine.", "truncated": false}, "before_length": 73, "before_sha256": "06cac6b07ec9d1485c3382e7a22a8128c9bab05c622042350ec741cdc5c14777", "change_kind": "content", "change_operations": [{"after_end": 24, "after_start": 0, "before_end": 1, "before_start": 0, "kind": "replace"}, {"after_end": 30, "after_start": 26, "before_end": 5, "before_start": 3, "kind": "replace"}, {"after_end": 37, "after_start": 37, "before_end": 13, "before_start": 12, "kind": "delete"}, {"after_end": 39, "after_start": 38, "before_end": 16, "before_start": 14, "kind": "replace"}, {"after_end": 42, "after_start": 40, "before_end": 19, "before_start": 17, "kind": "replace"}, {"after_end": 70, "after_start": 70, "before_end": 72, "before_start": 47, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 33, "chars_inserted": 31}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0b1b9014c75fbca09e1c18ba", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2861}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "II", "before": {"end": 4, "start": 0, "text": "Date", "truncated": false}, "before_length": 4, "before_sha256": "99c40ab405926cb5ad1def9cff4d7ce624f8f8abfff4e85f655347fcb949d08e", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 4, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0b38a4afe08de23370aa96be", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 472}
{"after": {"end": 205, "start": 0, "text": "Le critère principal d’évaluation était la survie sans progression et les critères secondaires incluaient le taux de réponse objective et la survie globale. Les résultats sont présentés dans le tableau 23.", "truncated": false}, "after_length": 205, "after_sha256": "7dfe8831c2943ef11b3aa88ddddf686abc8f86c5f710ec4c3e6185590d953627", "annex": "I", "before": {"end": 192, "start": 0, "text": "Le critère principal était la survie sans progression et les critères secondaires incluaient le taux de réponse objective et la survie globale. Les résultats sont présentés dans le tableau 23.", "truncated": false}, "before_length": 192, "before_sha256": "7878f410973e2c5d409ec0a6356e275259907248f5ede4635210042614829399", "change_kind": "content", "change_operations": [{"after_end": 34, "after_start": 21, "before_end": 21, "before_start": 21, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 13}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0b5829c3e6276bcd2845b12a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2139}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 43, "start": 0, "text": "Single-dose 0.5 mL vial (blue flip-off cap)", "truncated": false}, "before_length": 43, "before_sha256": "2dd10b4f0a0f0b56d712ccde12047f7aeb83ea54db787d737df32c44fb976eeb", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 43, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 43, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0b98942dd1c91157a144c3c0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "2", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5430}
{"after": {"end": 18, "start": 0, "text": "dpoccyprus@msd.com", "truncated": false}, "after_length": 18, "after_sha256": "492fae7e6db021703bcb80e4b139bc2be78a7e6cf4c6056a9314c70cfe643716", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "malta_info@merck.com", "truncated": false}, "before_length": 20, "before_sha256": "d0529053ac5f753b95c76e02b64d46efbc0d61183bea7de30faa0abc218a9e1c", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 0, "before_end": 9, "before_start": 0, "kind": "replace"}, {"after_end": 10, "after_start": 3, "before_end": 10, "before_start": 10, "kind": "insert"}, {"after_end": 14, "after_start": 12, "before_end": 16, "before_start": 12, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 13, "chars_inserted": 11}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0bbbafea1f8244a93c989692", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3410}
{"after": {"end": 69, "start": 0, "text": "Comment conserver Nyxoid 1,8 mg, solution pour pulvérisation nasale ?", "truncated": false}, "after_length": 69, "after_sha256": "3d430d6e5594e626963f6434b582d4d22b579d1f4e36de25200aec8014eb4e29", "annex": "IIIA", "before": {"end": 67, "start": 0, "text": "Comment conserver Nyxoid 1,8 mg, solution pour pulvérisation nasale", "truncated": false}, "before_length": 67, "before_sha256": "d0924dedf7abeac10d0bdc92965bed84c17286df08136d1ee8690a0a9cd8ff9b", "change_kind": "content", "change_operations": [{"after_end": 69, "after_start": 67, "before_end": 67, "before_start": 67, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0bcf34a9c501d686fdf21f0a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 748}
{"after": {"end": 20, "start": 0, "text": "Tlf.: +45 44 201 100", "truncated": false}, "after_length": 20, "after_sha256": "a342c892cb893e888e9b98929ab7ba413528a3b19847cefc774fcc7b2c91291e", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "Tlf: +45 44 201 100", "truncated": false}, "before_length": 19, "before_sha256": "c639c1fe70f9701d8cecb70d89ff79995abd4e41911073143438fc69a41a0363", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0c35657bf0b991e58f171b44", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11658}
{"after": {"end": 11, "start": 0, "text": "Voie orale.", "truncated": false}, "after_length": 11, "after_sha256": "dd303ff5eaeb3946adedda2cb1cc0525b4d6b7561b2450d515addd890456afe9", "annex": "IIIA", "before": {"end": 10, "start": 0, "text": "Voie orale", "truncated": false}, "before_length": 10, "before_sha256": "b21e8d51c5cf6ffc46ec58c52f7fd9782e18be932f51e39153050c410cb9b1b2", "change_kind": "content", "change_operations": [{"after_end": 11, "after_start": 10, "before_end": 10, "before_start": 10, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0c646c83fd49e9eb72ac9532", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:32:00Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3ff8cd4d67d22ba799aa348aeda944d6d896a16dcf54b030db101cbc095fc8ad", "source_snapshot_id": "source-a79a7cba8bf5dbc72fd40574", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2147}
{"after": {"end": 15, "start": 0, "text": "3832 RC Leusden", "truncated": false}, "after_length": 15, "after_sha256": "ba405ef0bf36eca0b0c6d25a5c566d076892169d711c353d3632e2a334a18c52", "annex": "II", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 15, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 15}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0c980ec422cc8fed2a288603", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 544}
{"after": {"end": 105, "start": 0, "text": "Lire la notice des cartouches Terrosa et les Instructions d’utilisation de Terrosa Pen avant utilisation.", "truncated": false}, "after_length": 105, "after_sha256": "efa9a61503a919ca1ad8a378b5df5c73dd09d022db803768d5698ef7e2e1229a", "annex": "IIIA", "before": {"end": 107, "start": 0, "text": "Lire la notice des cartouches Terrosa et les Instructions d’utilisation du stylo Terrosa avant utilisation.", "truncated": false}, "before_length": 107, "before_sha256": "53850563958a3b1f95c5829eeb37aa5e7bc931b1e8a222e09e70d15f195a2160", "change_kind": "content", "change_operations": [{"after_end": 74, "after_start": 73, "before_end": 80, "before_start": 73, "kind": "replace"}, {"after_end": 86, "after_start": 82, "before_end": 88, "before_start": 88, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 5}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0c9e91e119e4a235770c9720", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1268}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IV", "before": {"end": 241, "start": 0, "text": "On the basis of the scientific conclusions for tremelimumab the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing tremelimumab is unchanged subject to the proposed changes to the product information.", "truncated": false}, "before_length": 241, "before_sha256": "bf8efe83d7011ee2cd979b83a56f1f90a0a4cea5ebc35b0df6a7c141451d2881", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 241, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 241, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0ca1d37df27255a8addd5d71", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2534}
{"after": {"end": 416, "start": 0, "text": "Les instructions pour les professionnels de santé : fournir au patient/soignant la carte d’information du patient, s’assurer que les patients/soignants savent qu’ils peuvent également visionner une vidéo de formation sur le site nyxoid.com et les encourager à lire la notice incluse dans le conditionnement primaire du médicament et le guide d’initiation rapide (GIR) sur le conditionnement primaire de la plaquette.", "truncated": false}, "after_length": 416, "after_sha256": "462989bc73fc84acfee1f6d7396716e1718f88d0c2b6801cf8ae183285fd7661", "annex": "II", "before": {"end": 363, "start": 0, "text": "Les instructions pour les professionnels de santé : fournir au patient/soignant la carte d’information du patient, s’assurer que les patients/soignants auront accès à la vidéo (soit par la carte d’information du patient ou la clé USB) et les encourager à lire le guide d’initiation rapide (GIR) et la notice incluse dans le conditionnement primaire du médicament.", "truncated": false}, "before_length": 363, "before_sha256": "7ab1a63dd8deb70877ad34ca84f4f8da36c59f80336767d989dd679683268768", "change_kind": "content", "change_operations": [{"after_end": 153, "after_start": 152, "before_end": 152, "before_start": 152, "kind": "insert"}, {"after_end": 156, "after_start": 154, "before_end": 156, "before_start": 153, "kind": "replace"}, {"after_end": 164, "after_start": 159, "before_end": 163, "before_start": 159, "kind": "replace"}, {"after_end": 173, "after_start": 166, "before_end": 166, "before_start": 165, "kind": "replace"}, {"after_end": 177, "after_start": 174, "before_end": 167, "before_start": 167, "kind": "insert"}, {"after_end": 197, "after_start": 178, "before_end": 169, "before_start": 168, "kind": "replace"}, {"after_end": 205, "after_start": 204, "before_end": 193, "before_start": 176, "kind": "replace"}, {"after_end": 207, "after_start": 207, "before_end": 199, "before_start": 195, "kind": "delete"}, {"after_end": 218, "after_start": 217, "before_end": 210, "before_start": 209, "kind": "replace"}, {"after_end": 220, "after_start": 219, "before_end": 222, "before_start": 211, "kind": "replace"}, {"after_end": 223, "after_start": 222, "before_end": 225, "before_start": 224, "kind": "replace"}, {"after_end": 236, "after_start": 224, "before_end": 226, "before_start": 226, "kind": "insert"}, {"after_end": 239, "after_start": 237, "before_end": 234, "before_start": 227, "kind": "replace"}, {"after_end": 264, "after_start": 264, "before_end": 297, "before_start": 259, "kind": "delete"}, {"after_end": 415, "after_start": 329, "before_end": 362, "before_start": 362, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 88, "chars_inserted": 141}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0d111aabd9e189e5656b2b1e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 436}
{"after": {"end": 2, "start": 0, "text": "SC", "truncated": false}, "after_length": 2, "after_sha256": "32da6721804f1dd3226c0551970304ebf1059ec19a27451426541027861c9388", "annex": "IIIA", "before": {"end": 16, "start": 0, "text": "Subcutaneous use", "truncated": false}, "before_length": 16, "before_sha256": "363fd22613abec178143cdac0b1a34f04ee8ccdaa7d6988b3722fa7540374cde", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 1, "before_end": 16, "before_start": 1, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 15, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0d1b26fc3fb51c4e7e894893", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 7649}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 14, "start": 0, "text": "Mundipharma Oy", "truncated": false}, "before_length": 14, "before_sha256": "28b7df80a5f9916e0ed8cfdc9a679cf8d1a386e6b8194ccb23b30136da9e9cd5", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0d307d8ccb9e13521eb19a17", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1144}
{"after": {"end": 50, "start": 0, "text": "headache (common: may affect up to 1 in 10 people)", "truncated": false}, "after_length": 50, "after_sha256": "64d18a1d2bf47f4db419d1ae049891a70bdb1dbb78571f933493535e7732527e", "annex": "IIIA", "before": {"end": 50, "start": 0, "text": "headache (Common: may affect up to 1 in 10 people)", "truncated": false}, "before_length": 50, "before_sha256": "473df29f950beda2ccef8c40e5bbef54d095a29cc6640578e4e77ec4c9373a02", "change_kind": "content", "change_operations": [{"after_end": 11, "after_start": 10, "before_end": 11, "before_start": 10, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0d30bc24f301e82977df36ba", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2901}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 26, "start": 0, "text": "Tel: + 385 (0) 1 230 34 46", "truncated": false}, "before_length": 26, "before_sha256": "6619ab5d144eee4d434c704be01e6c2c45b7995dba9dc48588a036bbe5033fa8", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 26, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 26, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0d6fad97d86c294305f694a3", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1114}
{"after": {"end": 13, "start": 0, "text": "Carte Patient", "truncated": false}, "after_length": 13, "after_sha256": "553c2099e8e0089c27222d14a714bdbeab3b7852e613d201f2630411e16d5020", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 13, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 13}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0db7d0f99cff53d06b85c2db", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6659}
{"after": {"end": 463, "start": 0, "text": "Si vous présentez une réaction allergique, informez-en immédiatement votre médecin ou un membre de l’équipe médicale. Les signes peuvent inclure : une difficulté à respirer ou une douleur thoracique. Vous pouvez également présenter des rougeurs de la peau ou des bouffées de chaleurs ou une éruption cutanée, des frissons et tremblements, des nausées ou des vomissements, un gonflement (œdème), des étourdissements, un pouls accéléré et une perte de connaissance.", "truncated": false}, "after_length": 463, "after_sha256": "2d9a11fd6d0b90997ec5452561c9d8612838d02642a0fe1271b7929f399c0e1c", "annex": "IIIA", "before": {"end": 467, "start": 0, "text": "Si vous présentez une réaction allergique, informez-en immédiatement votre médecin ou un membre de l’équipe médicale. Les signes peuvent inclure : une difficulté à respirer ou une douleur thoracique. Vous pouvez également présenter des rougeurs de la peau ou des bouffées de chaleurs ou une éruption transitoire, des frissons et tremblements, des nausées ou des vomissements, un gonflement (œdème), des étourdissements, un pouls accéléré et une perte de connaissance.", "truncated": false}, "before_length": 467, "before_sha256": "94b89f72c5b8a04513829284ee8f2656f0276e635a03e02f070169b01b6d5a49", "change_kind": "content", "change_operations": [{"after_end": 302, "after_start": 300, "before_end": 300, "before_start": 300, "kind": "insert"}, {"after_end": 303, "after_start": 303, "before_end": 302, "before_start": 301, "kind": "delete"}, {"after_end": 306, "after_start": 305, "before_end": 310, "before_start": 304, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 3}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0de5b09c2348e63d4e8b09f7", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3105}
{"after": {"end": 20, "start": 0, "text": "dpoc_austria@msd.com", "truncated": false}, "after_length": 20, "after_sha256": "fffcced0c5785d318bead68b726572c8df5f6a7f283341dbbaa2c0e000b9f45e", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "dpoc_austria@merck.com", "truncated": false}, "before_length": 22, "before_sha256": "24a76a21b822b2b605efa994eaf3b0998f214621c2a7d0ab97cd100c212f6bc9", "change_kind": "content", "change_operations": [{"after_end": 16, "after_start": 14, "before_end": 18, "before_start": 14, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0dfa8ab1511dfa66c49b24cf", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3536}
{"after": {"end": 13, "start": 0, "text": "Leusderend 16", "truncated": false}, "after_length": 13, "after_sha256": "af1e1fecef744f092123851cb8459b03d91077081e50b99a8caaeae83326dc44", "annex": "II", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 13}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0e43474e85cf1a29672cecc7", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 543}
{"after": {"end": 147, "start": 0, "text": "If a child has received one prior dose of any Spikevax vaccine, one dose of Spikevax LP.8.1 should be administered to complete the two-dose series.", "truncated": false}, "after_length": 147, "after_sha256": "0d19ffa07e82c529802336035f730371e5c12e85cbf4ede1192315c0ed0fcd2a", "annex": "I", "before": {"end": 145, "start": 0, "text": "If a child has received one prior dose of any Spikevax vaccine, one dose of Spikevax JN.1 should be administered to complete the two-dose series.", "truncated": false}, "before_length": 145, "before_sha256": "c2602c92ab3fe8252041d2d1d4f0c9a12ec19dae440c1ca5e6b6f60ae3840f3c", "change_kind": "administrative", "change_operations": [{"after_end": 89, "after_start": 85, "before_end": 87, "before_start": 85, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0e64cd98388d4c9bf3464ff1", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12702}
{"after": {"end": 23, "start": 0, "text": "Tél/Tel: +32(0)27766211", "truncated": false}, "after_length": 23, "after_sha256": "310414d79c9777caccca375508ba76843df9171e9155179f4e97323d11721dd0", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "Tel/Tél: +32(0)27766211", "truncated": false}, "before_length": 23, "before_sha256": "82d40bdddb183e889f9263d7731dc3a0880c8dc29905ebd8ad88a6249c7e7dba", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 1, "before_end": 2, "before_start": 1, "kind": "replace"}, {"after_end": 6, "after_start": 5, "before_end": 6, "before_start": 5, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0e6ce3c977dc3d3e399cdda7", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3485}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 10, "start": 0, "text": "45 minutes", "truncated": false}, "before_length": 10, "before_sha256": "bc54807d7df55abaf214d21aef97ce35c150ce5c072cf6f287d6c790c72ab265", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 10, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 10, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0ee2d30ada84c3696d64857a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6399}
{"after": {"end": 175, "start": 0, "text": "ne commencez pas Adempas avant au moins 24 heures après votre dernière dose de sildénafil et au moins 72 heures après votre dernière dose de tadalafil, si vous êtes un enfant.", "truncated": false}, "after_length": 175, "after_sha256": "fa9d0cdf8cf27d8dc2a6c5e2ccfa094f62d31de51bdedfed53ba0c9763894898", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 175, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 175}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0f0729922d1d32f0e0dae234", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2939}
{"after": {"end": 99, "start": 0, "text": "Pour plus d’informations ou pour visionner la vidéo, scannez le code QR ou consultez www.nyxoid.com", "truncated": false}, "after_length": 99, "after_sha256": "894e2775e5bbc00ce225479e758908c6ae84f6573d564a1a627cd26a898044f2", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 99, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 99}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0f0d84c929ba407f3d1a7a76", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 899}
{"after": {"end": 28, "start": 0, "text": "Tél/Tel: + 32 (0)10 85 52 00", "truncated": false}, "after_length": 28, "after_sha256": "21991020d31ee1ff18b7e886e60c72625978ff6aaf6b37b3b94d159c09e80017", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "Tél/Tel: + 32 10 85 52 00", "truncated": false}, "before_length": 25, "before_sha256": "0a43db96a0eb6a17e821e1b2c7fb04323930ea184ab3ecb536a9297f8de45db1", "change_kind": "content", "change_operations": [{"after_end": 17, "after_start": 14, "before_end": 14, "before_start": 14, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 3}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0f2a5481db4c20c303ce70e6", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000112", "medicine_name": "Twinrix Adult", "medicine_slug": "twinrix-adult", "observed_at": "2026-10-12T13:29:23Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "cfad5fb0086c9b5d6a36b454f3f546373def1f56cded73e0652b498d02d68e41", "source_snapshot_id": "source-17627897b0874bf1160c7372", "source_updated_at": "2026-08-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/twinrix-adult-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 923}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 26, "start": 0, "text": "mundipharma@mundipharma.sk", "truncated": false}, "before_length": 26, "before_sha256": "4424124df62454025b9a7894fddc50e29858aaba98931eb68c3e6ef2c2e49693", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 26, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 26, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0f58d937a0553d272c232359", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1138}
{"after": {"end": 152, "start": 0, "text": "• Screw the pen needle clockwise onto the cartridge sleeve. Make sure that the pen needle is attached correctly and sits firmly on the cartridge sleeve.", "truncated": false}, "after_length": 152, "after_sha256": "e9c01684c6a528445d45af24485235ce475d40c6f96c4fc2e04c959ca7c00ea5", "annex": "IIIA", "before": {"end": 152, "start": 0, "text": "• Screw the pen needle clockwise onto the cartridge holder. Make sure that the pen needle is attached correctly and sits firmly on the cartridge holder.", "truncated": false}, "before_length": 152, "before_sha256": "c7e67de3b0544ab199fc5a7f0a4f3cb7bfc23a7fac0d1c93e40138198a30ce3c", "change_kind": "content", "change_operations": [{"after_end": 53, "after_start": 52, "before_end": 54, "before_start": 52, "kind": "replace"}, {"after_end": 54, "after_start": 54, "before_end": 56, "before_start": 55, "kind": "delete"}, {"after_end": 58, "after_start": 55, "before_end": 58, "before_start": 57, "kind": "replace"}, {"after_end": 146, "after_start": 145, "before_end": 147, "before_start": 145, "kind": "replace"}, {"after_end": 147, "after_start": 147, "before_end": 149, "before_start": 148, "kind": "delete"}, {"after_end": 151, "after_start": 148, "before_end": 151, "before_start": 150, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 8, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0fce7284d425b009f9e3f956", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2003}
{"after": {"end": 604, "start": 0, "text": "L’etanercept est absorbé lentement depuis le site d’injection sous-cutanée, atteignant une concentration maximale environ 48 heures après administration unique. La biodisponibilité absolue est de 76 %. Avec deux doses par semaine, on peut s’attendre à ce que les concentrations à l’état d’équilibre représentent environ deux fois celles que l’on mesure après administration unique. Après l’administration unique, par voie sous-cutanée, de 25 mg d’Enbrel, la concentration sérique maximale moyenne observée chez les volontaires sains était de 1,65 0,66 g/mL, l’aire sous la courbe étant de 235 96,6 gh/mL.", "truncated": false}, "after_length": 604, "after_sha256": "6f40ddbb33800058afb763e3202115e0356ab1fbfa07ceaf21c15a552d5c4836", "annex": "I", "before": {"end": 604, "start": 0, "text": "L’etanercept est absorbé lentement depuis le site d’injection sous-cutanée, atteignant une concentration maximale environ 48 heures après administration unique. La biodisponibilité absolue est de 76 %. Avec deux doses par semaine, on peut s’attendre à ce que les concentrations à l’état d’équilibre représentent environ deux fois celles que l’on mesure après administration unique. Après l’administration unique, par voie sous-cutanée, de 25 mg d’Enbrel, la concentration sérique maximale moyenne observée chez les volontaires sains était de 1,65 0,66 g/ml, l’aire sous la courbe étant de 235 96,6 gh/ml.", "truncated": false}, "before_length": 604, "before_sha256": "5d4f40654f407d6f697d5385a203da2afc4d7a966ce1dde15c489f8a85003f89", "change_kind": "content", "change_operations": [{"after_end": 556, "after_start": 555, "before_end": 556, "before_start": 555, "kind": "replace"}, {"after_end": 603, "after_start": 602, "before_end": 603, "before_start": 602, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0ff234b918865772e8486096", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg, solution injectable en cartouche distributrice de dose Enbrel 50 mg, solution injectable en cartouche distributrice de dose", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6448}
{"after": {"end": 92, "start": 0, "text": "1 Les investigateurs ont évalué l’analyse de la SSP à la date du 30 novembre 2010 (cut-off).", "truncated": false}, "after_length": 92, "after_sha256": "c7978297b477d2b587b9f0543558bce93d939dcdc37416c0ef4817c45abd3aa8", "annex": "I", "before": {"end": 92, "start": 0, "text": "1 Les investigateurs ont évalué l’analyse de la PFS à la date du 30 novembre 2010 (cut-off).", "truncated": false}, "before_length": 92, "before_sha256": "4c6fab8b650e6d5d35639e60fdd8132a56adf50fa85a0aec137ddcd7ee37e611", "change_kind": "content", "change_operations": [{"after_end": 50, "after_start": 48, "before_end": 48, "before_start": 48, "kind": "insert"}, {"after_end": 51, "after_start": 51, "before_end": 51, "before_start": 49, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-0ff638dd01b7ad2512bb1fd7", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1949}
{"after": {"end": 7, "start": 0, "text": "17 (77)", "truncated": false}, "after_length": 7, "after_sha256": "95d4e49ee1812236931bb91218f01c09f1e0fe34a5eec20fd88a457f2a1a80d0", "annex": "I", "before": {"end": 7, "start": 0, "text": "16 (73)", "truncated": false}, "before_length": 7, "before_sha256": "436e980a2c225ff8334b0ed687ee08af099979fdb3666e58b8fcbff2b9172d6f", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 1, "before_end": 2, "before_start": 1, "kind": "replace"}, {"after_end": 6, "after_start": 5, "before_end": 6, "before_start": 5, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-10084141b861767a71084031", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005352", "medicine_name": "Upstaza", "medicine_slug": "upstaza", "observed_at": "2026-10-12T13:36:07Z", "pipeline_version": "2.0.0", "presentation_label": "Upstaza 2.8 × 1011 vector genomes (vg)/0.5 mL solution for infusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8561a0c5aed752dd415d30acef76bf620ad205d702080a0bca765e086873fe20", "source_snapshot_id": "source-4b712d5f9e4e2e8cd620aa93", "source_updated_at": "2026-06-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/upstaza-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 303}
{"after": {"end": 78, "start": 0, "text": "d’autres stimulateurs de la guanylate cyclase soluble, tels que le vériciguat.", "truncated": false}, "after_length": 78, "after_sha256": "059958cf15d8017283a6ca168e2980976c8fc984ded0844928869b4986562cb6", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 78, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 78}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1027a071432b47bce2fcace3", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2852}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 6, "start": 0, "text": "Carton", "truncated": false}, "before_length": 6, "before_sha256": "debaef418bf153ff447599c58fc07da46f8c6bdacf576da1e2129b4de5a44dd3", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 6, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-106cc7c387c1cac474ebd557", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13098}
{"after": {"end": 20, "start": 0, "text": "Tel: +385 1 6611 333", "truncated": false}, "after_length": 20, "after_sha256": "ac17f5de7a55b551146b4e13e2e182c0c768e2407d11ada47b7ea50ccc88e7a9", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tel: + 385 1 6611 333", "truncated": false}, "before_length": 21, "before_sha256": "832fb9e4a0309ac207ea1cddc7b0f0d314eb5cd3eac51bc4ad14b8ef55b1e935", "change_kind": "content", "change_operations": [{"after_end": 6, "after_start": 6, "before_end": 7, "before_start": 6, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-10866fc86babf0365f0d213c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3062}
{"after": {"end": 48, "start": 0, "text": "Do not take the following medicines with Adempas", "truncated": false}, "after_length": 48, "after_sha256": "bddcdac4dfa438c949a610ee79758d3e1231ab93d08bf3c7d25e9c60377d3e27", "annex": "IIIA", "before": {"end": 30, "start": 0, "text": "Do not take medicines used for", "truncated": false}, "before_length": 30, "before_sha256": "d596261e10c1143a295defa398637159897eb0f74ecbd056b340d8c950c356c2", "change_kind": "content", "change_operations": [{"after_end": 26, "after_start": 12, "before_end": 12, "before_start": 12, "kind": "insert"}, {"after_end": 47, "after_start": 36, "before_end": 23, "before_start": 22, "kind": "replace"}, {"after_end": 48, "after_start": 48, "before_end": 30, "before_start": 24, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 25}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1093f43b91179b38c29a9a0f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2768}
{"after": {"end": 105, "start": 0, "text": "Conclusions scientifiques et motifs de la modification des termes des autorisations de mise sur le marché", "truncated": false}, "after_length": 105, "after_sha256": "2fbff61239d3eb69b65aa53210e4e3eae2173ae57f3f1864f8e30c5c3821d522", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 105, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 105}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-10c7d8541af3a8b0962669a9", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "9ac80b0d56ebad4970f7a8335a177613af59ef25517bcd0bdd3397c207cc1bac", "source_snapshot_id": "source-c11aa9e32420f125a88005bc", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2713}
{"after": {"end": 18, "start": 0, "text": "Tel: +370 80000334", "truncated": false}, "after_length": 18, "after_sha256": "070182b732687ebecc53ca52625433b3770e4308764e233923df1e0a7c41a74f", "annex": "IIIA", "before": {"end": 18, "start": 0, "text": "Tel. +370 80000334", "truncated": false}, "before_length": 18, "before_sha256": "4314c1144c8dfc9482f2713af5a057f582377362046ebe71b893a47f80699370", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 4, "before_start": 3, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-10cbc9f02274f61911c9fe65", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000112", "medicine_name": "Twinrix Adult", "medicine_slug": "twinrix-adult", "observed_at": "2026-10-12T13:29:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "bc8ba3adecfe04d3079e5b502251cec982d6197257fe3b7ec3a22dc5f2ace654", "source_snapshot_id": "source-8439a1a319b62d1bd67256a4", "source_updated_at": "2026-08-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/twinrix-adult-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 884}
{"after": {"end": 103, "start": 0, "text": "La tolérance et l’efficacité d’Avastin chez les enfants âgés de moins de 18 ans n’ont pas été établies.", "truncated": false}, "after_length": 103, "after_sha256": "f0f4dfe261b8b619274c4eaaf2d743ca2095af787bd4f23a47ca11d4b3271347", "annex": "I", "before": {"end": 100, "start": 0, "text": "La tolérance et l’efficacité d’Avastin chez les enfants âgés de moins de 18 ans n’a pas été établie.", "truncated": false}, "before_length": 100, "before_sha256": "672375d8b25770e01f3a8d6c27c8f2723fbbcec048c8044e53a481c9568bdc50", "change_kind": "content", "change_operations": [{"after_end": 85, "after_start": 82, "before_end": 83, "before_start": 82, "kind": "replace"}, {"after_end": 102, "after_start": 101, "before_end": 99, "before_start": 99, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-10d3a3bad8653d4a0752b97f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 847}
{"after": {"end": 2, "start": 0, "text": "SC", "truncated": false}, "after_length": 2, "after_sha256": "32da6721804f1dd3226c0551970304ebf1059ec19a27451426541027861c9388", "annex": "IIIA", "before": {"end": 16, "start": 0, "text": "Subcutaneous use", "truncated": false}, "before_length": 16, "before_sha256": "363fd22613abec178143cdac0b1a34f04ee8ccdaa7d6988b3722fa7540374cde", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 1, "before_end": 16, "before_start": 1, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 15, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-10f36b5dd73c4aa4ad508af9", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 7165}
{"after": {"end": 44, "start": 0, "text": "l’erlotinib, utilisé pour traiter le cancer.", "truncated": false}, "after_length": 44, "after_sha256": "7e871719fc2070b82c0d9b2bf2dad1ef9e0e4f664681fcaadb1ec0f16b51edd8", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 44, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 44}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-114bedec8126f8c1c9c2f7d1", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3311}
{"after": {"end": 43, "start": 0, "text": "Pfizer Healthcare Ireland Unlimited Company", "truncated": false}, "after_length": 43, "after_sha256": "1f203777a0ec6fed9c840d52631b6a74c7e25b5d318485d8147e2404f52dc981", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "Pfizer Healthcare Ireland", "truncated": false}, "before_length": 25, "before_sha256": "4beeea9b6d0c491f03a9511d9f9576b9c75cbcdcfd736e4934f768fdded936f5", "change_kind": "content", "change_operations": [{"after_end": 43, "after_start": 25, "before_end": 25, "before_start": 25, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 18}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1184ee9f0f31544b34e80333", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12271}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 17, "start": 0, "text": "Byk-Gulden-Str. 2", "truncated": false}, "before_length": 17, "before_sha256": "5dc95d013d793b6958719e5db82aa51cd0c1864e2e8bc9bfcf2cfded1a05eba6", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 17, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 17, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1193cc4c0c7b970d5f14f2d4", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2173}
{"after": {"end": 16, "start": 0, "text": "EU/1/20/1507/033", "truncated": false}, "after_length": 16, "after_sha256": "158d8315e9befab5018ce5820e416fd7a0179743f82cdd0d2a8e65ad8e27c484", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "administrative", "change_operations": [{"after_end": 16, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 16}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-11a10e4035c82fc10c10420d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "8", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6486}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 11, "start": 0, "text": "Deutschland", "truncated": false}, "before_length": 11, "before_sha256": "af6e56aacd8097c3fb7597b08ecb3d87a040f6ab58067a4b8ff9f5b747adb9be", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 11, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 11, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-11d9460ea88edeee7aaa0873", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1050}
{"after": {"end": 46, "start": 0, "text": "Do not use this pen, contact customer service.", "truncated": false}, "after_length": 46, "after_sha256": "d0eef22a61843e8e1ba634fd308a0fab81f33e175e22fac3fb7bd5e32b6704d9", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Do not use this pen.", "truncated": false}, "before_length": 20, "before_sha256": "01b905053879eaea7fdc5aab942d257a461128b493d86ee78d47a1001b9513bf", "change_kind": "content", "change_operations": [{"after_end": 45, "after_start": 19, "before_end": 19, "before_start": 19, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 26}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-11dd91bcf11840f52beb407f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2132}
{"after": {"end": 76, "start": 0, "text": "Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe", "truncated": false}, "after_length": 76, "after_sha256": "6c7ff1bbd2f6d8c84f1254cce87065dac51505e1edd888622047a746e34551e6", "annex": "I", "before": {"end": 74, "start": 0, "text": "Spikevax JN.1 50 micrograms dispersion for injection in pre-filled syringe", "truncated": false}, "before_length": 74, "before_sha256": "ebe036d056b86be90e582dc3803425dce3820674579f962bd2fc8976b65c292a", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-11de542d5d947e24ecee0e98", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.4", "section_type": "storage", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6300}
{"after": {"end": 363, "start": 0, "text": "You have been prescribed Adempas granules for oral suspension. For PAH patients of 6 years and older that weigh 50 kg and more, Adempas is also available as tablets. Patients may be switched between granules for oral suspension and tablets during therapy due to body weight changes. Efficacy and safety have not been shown in the following paediatric populations:", "truncated": false}, "after_length": 363, "after_sha256": "84ee050297514e81454ad77d4ac1dd6527f3239f0f1136beb3bab3c4b344905a", "annex": "IIIA", "before": {"end": 364, "start": 0, "text": "Your have been prescribed Adempas granules for oral suspension. For PAH patients of 6 years and older that weigh 50 kg and more, Adempas is also available as tablets. Patients may be switched between granules for oral suspension and tablets during therapy due to body weight changes. Efficacy and safety have not been shown in the following paediatric populations:", "truncated": false}, "before_length": 364, "before_sha256": "9dda6a3ffe51515aacb68339a332ff2c70887f0cadcd1922657b69875333f8ce", "change_kind": "content", "change_operations": [{"after_end": 3, "after_start": 3, "before_end": 4, "before_start": 3, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-11e1e038e7b2e6185be8320c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3191}
{"after": {"end": 241, "start": 0, "text": "On the basis of the scientific conclusions for tremelimumab the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing tremelimumab is unchanged subject to the proposed changes to the product information.", "truncated": false}, "after_length": 241, "after_sha256": "bf8efe83d7011ee2cd979b83a56f1f90a0a4cea5ebc35b0df6a7c141451d2881", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 241, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 241}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-12156735d023fd0fb24e0314", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2546}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IV", "before": {"end": 86, "start": 0, "text": "The CHMP recommends that the terms of the marketing authorisation(s) should be varied.", "truncated": false}, "before_length": 86, "before_sha256": "58ed8da449860435afd7d26d286a000f65c5901b49253a30ae46cbbcbca82784", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 86, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 86, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-122e7679c7734535cee1ff88", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2535}
{"after": {"end": 128, "start": 0, "text": "Taking into account the PRAC Assessment Report on the PSUR(s) for perampanel, the scientific conclusions of PRAC are as follows:", "truncated": false}, "after_length": 128, "after_sha256": "eb9e541e37836a0936330111ea2fcb6fd1b5f69d8a2efa9b5d83d133a993ad0b", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 128, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 128}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-12479e45a9f04c42df10ce4e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3442}
{"after": {"end": 142, "start": 0, "text": "Pour plus d’informations, voir le site web de l’Agence européenne des médicaments: https://www.ema.europa.eu/en/medicines/human/EPAR/novorapid", "truncated": false}, "after_length": 142, "after_sha256": "08dc669e21ad041899a1585594dad2203080838b6945babac941d421740e34fc", "annex": "", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 142, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 142}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1296c2ec058a7dc0e1dbc4b2", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000258", "medicine_name": "NovoRapid", "medicine_slug": "novorapid", "observed_at": "2026-10-12T19:05:20Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "7a2e275dc85e326e218371029d27a1433946e84b3ea473376b27254ac744b108", "source_snapshot_id": "source-a7dd2dd81f4bb5f7de078b9c", "source_updated_at": "2025-10-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/novorapid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 18, "start": 0, "text": "medis.hu@medis.com", "truncated": false}, "before_length": 18, "before_sha256": "cef2304db43cba5f54fe3172d255c50ce282b9e19214c53b510003d3b94a344d", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 18, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 18, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-12afe02920027d166664280d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1041}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 18, "start": 0, "text": "organizační složka", "truncated": false}, "before_length": 18, "before_sha256": "ea36ce099264fdab294e69d74c985f3b15bc858dbf7ace60b68b6ec5844f892f", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 18, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 18, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-12b8ba877aebc1ee25367f83", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1035}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 17, "start": 0, "text": "Byk-Gulden-Str. 2", "truncated": false}, "before_length": 17, "before_sha256": "5dc95d013d793b6958719e5db82aa51cd0c1864e2e8bc9bfcf2cfded1a05eba6", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 17, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 17, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-12cf39820348449b7cb219f8", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2180}
{"after": {"end": 20, "start": 0, "text": "Tlf. +45 45 17 48 00", "truncated": false}, "after_length": 20, "after_sha256": "67b288680491a1d528179a2d435c44abca139afef48fda220fd7248c69d054e7", "annex": "IIIA", "before": {"end": 16, "start": 0, "text": "Tlf. 45 17 48 00", "truncated": false}, "before_length": 16, "before_sha256": "2c753979d855ade591464b5a15bb9d48b8bd926cbc650fac958308a656578a91", "change_kind": "content", "change_operations": [{"after_end": 9, "after_start": 5, "before_end": 5, "before_start": 5, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-13093eb620e1bcae5748046e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:33Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "21d66bf1e9a74479f577de09da3cf8517d65c1ce1b1d8bbdfe4bc38f79410def", "source_snapshot_id": "source-2c39c998fdaf05159687c016", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 980}
{"after": {"end": 12, "start": 0, "text": "25 mg/0,5 mL", "truncated": false}, "after_length": 12, "after_sha256": "46e5380e927990cf15221f8049ebcf74c4b711d4516f6c2e7e82c8518c127d25", "annex": "IIIA", "before": {"end": 12, "start": 0, "text": "25 mg/0,5 ml", "truncated": false}, "before_length": 12, "before_sha256": "80b887636c832cc7740bd32b98c07488f5022cb3920ced1a54bd52030d2ad71d", "change_kind": "content", "change_operations": [{"after_end": 12, "after_start": 11, "before_end": 12, "before_start": 11, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-131f1645257c0cea0bc48522", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11765}
{"after": {"end": 147, "start": 0, "text": "Si vous prenez ces médicaments, vous pourriez présenter davantage d’effets indésirables ou Adempas pourrait ne pas fonctionner comme il le devrait.", "truncated": false}, "after_length": 147, "after_sha256": "df9f9a30684e1cb28bca8d44598158614396f705c8795c551f97a7f79e05e7f6", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 147, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 147}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-133d1f25277dc2e2ebf66901", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3308}
{"after": {"end": 90, "start": 0, "text": "If you are taking these medicines, ask your doctor whether their doses need to be changed.", "truncated": false}, "after_length": 90, "after_sha256": "3898554d9d5a1e13fe88506cfde9addb53ce036936a77cf7b57b26ebc11d194a", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 90, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 90}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-134d535c5617ae448fda2096", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3218}
{"after": {"end": 143, "start": 0, "text": "arrêtez d’utiliser Adempas au moins 24 heures avant de commencer à utiliser le sildénafil ou le tadalafil, si vous êtes un adulte ou un enfant.", "truncated": false}, "after_length": 143, "after_sha256": "53d6bfb08aa7a8741cf71cb5cf0530876c64747272a4a1d1158da78822175e80", "annex": "IIIA", "before": {"end": 107, "start": 0, "text": "arrêtez d’utiliser Adempas au moins 24 heures avant de commencer à utiliser le sildénafil ou le tadalafil .", "truncated": false}, "before_length": 107, "before_sha256": "1bedd928766ddb7f499a03e10669a282bd5457bafd42c8ea72e4cabdf8d2fb28", "change_kind": "content", "change_operations": [{"after_end": 106, "after_start": 105, "before_end": 105, "before_start": 105, "kind": "insert"}, {"after_end": 142, "after_start": 107, "before_end": 106, "before_start": 106, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 36}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1378fdc3b4b6a21571d31399", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2942}
{"after": {"end": 397, "start": 0, "text": "Pour les pays où Nyxoid n’est pas sur le marché et où aucun matériel de formation n’a été approuvé, le site nyxoid.com le précisera sous le lien correspondant au pays et fournira un lien vers la notice destinée au patient pour ce pays, qui contient également les informations importantes présentées dans le matériel de formation sur la manière d’identifier un surdosage et comment utiliser Nyxoid.", "truncated": false}, "after_length": 397, "after_sha256": "d6bc033e3b66d97a717903df37a4ea4820a046c9a87298f32c68b4849bc242ab", "annex": "II", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 397, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 397}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1380fa37f92d1de88e4052a9", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 464}
{"after": {"end": 379, "start": 0, "text": "Au vu des données disponibles sur la pseudopolyarthrite rhizomélique , le PRAC considère qu'une relation de cause à effet entre le trémélimumab en association avec le durvalumab et la pseudopolyarthrite rhizomélique est au moins une possibilité raisonnable. Le PRAC a conclu que les informations sur les produits contenant du trémélimumab devraient être modifiées en conséquence.", "truncated": false}, "after_length": 379, "after_sha256": "b821c1f77cc43b1253e36da0b8f56eb22a3a99af347b029274fe7e6a4cf3e4a0", "annex": "IV", "before": {"end": 352, "start": 0, "text": "Au vu des données disponibles sur la myélite transverse, le PRAC considère qu'une relation de cause à effet entre le trémélimumab en association avec le durvalumab et la myélite transverse est au moins une possibilité raisonnable. Le PRAC a conclu que les informations sur les produits contenant du trémélimumab devraient être modifiées en conséquence.", "truncated": false}, "before_length": 352, "before_sha256": "02be6516911ec44b53a7ad5fb5a5c0a89ebb614b2bda7dee71c38ea6338a7067", "change_kind": "content", "change_operations": [{"after_end": 46, "after_start": 37, "before_end": 38, "before_start": 37, "kind": "replace"}, {"after_end": 52, "after_start": 47, "before_end": 41, "before_start": 39, "kind": "replace"}, {"after_end": 56, "after_start": 56, "before_end": 46, "before_start": 45, "kind": "delete"}, {"after_end": 67, "after_start": 57, "before_end": 51, "before_start": 47, "kind": "replace"}, {"after_end": 69, "after_start": 68, "before_end": 55, "before_start": 52, "kind": "replace"}, {"after_end": 193, "after_start": 184, "before_end": 171, "before_start": 170, "kind": "replace"}, {"after_end": 199, "after_start": 194, "before_end": 174, "before_start": 172, "kind": "replace"}, {"after_end": 203, "after_start": 203, "before_end": 179, "before_start": 178, "kind": "delete"}, {"after_end": 214, "after_start": 204, "before_end": 187, "before_start": 180, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 22, "chars_inserted": 49}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1394017b6e5943f34b595658", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:18Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "2437ab76633f46c9eee5e002e5c7a7caba6367f59567d750be0eb67c74d1db4e", "source_snapshot_id": "source-7f4d129b0a0fd2d3684d27c5", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2517}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Tel: +40 744 777 258", "truncated": false}, "before_length": 20, "before_sha256": "2f8518807aac1374d3d8dd7c6368398c16e4c209bdb5c605dcdf3de7b1a6874f", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 20, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 20, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-13b232c080daebb3c410898c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1113}
{"after": {"end": 26, "start": 0, "text": "Puh/Tel: +358 (0)9 804 650", "truncated": false}, "after_length": 26, "after_sha256": "4e4ce567ad8fc5ce4a995dfaa7487af0a3a8e51db5041ab103d4f16252c66e4f", "annex": "IIIA", "before": {"end": 26, "start": 0, "text": "Puh/Tel: + 358 (0)9 804650", "truncated": false}, "before_length": 26, "before_sha256": "4d337eb78e05cdda3f51c0741cb1f1396cf637a24baad8faad372b206b668352", "change_kind": "content", "change_operations": [{"after_end": 10, "after_start": 10, "before_end": 11, "before_start": 10, "kind": "delete"}, {"after_end": 23, "after_start": 22, "before_end": 23, "before_start": 23, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-13f5913ad86de50f02e798c3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3096}
{"after": {"end": 67, "start": 0, "text": "maux de tête (fréquent : pouvant concerner jusqu’à 1 enfant sur 10)", "truncated": false}, "after_length": 67, "after_sha256": "4ebd315f41ae78663ee4589726eb34299d1b460434a142e7947659d8bf91b00a", "annex": "IIIA", "before": {"end": 67, "start": 0, "text": "maux de tête (Fréquent : pouvant concerner jusqu’à 1 enfant sur 10)", "truncated": false}, "before_length": 67, "before_sha256": "befe7ca7737b555a369408413b8016ddd8bd2b382194538cface06d969b08b97", "change_kind": "content", "change_operations": [{"after_end": 15, "after_start": 14, "before_end": 15, "before_start": 14, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-140d3cee58d1c5c5748df566", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2984}
{"after": {"end": 269, "start": 0, "text": "Le titulaire de l’autorisation de mise sur le marché réalisera les activités et interventions requises décrites dans le PGR adopté et présenté dans le module 1.8.2 de l’autorisation de mise sur le marché, ainsi que toutes les actualisations ultérieures adoptées du PGR.", "truncated": false}, "after_length": 269, "after_sha256": "a3adafaf5c92500cc4702e6bcda26c53c3045a0752f1760cdb1eff195e91a8fc", "annex": "II", "before": {"end": 265, "start": 0, "text": "Le titulaire de l’autorisation de mise sur le marché réalisera les activités et interventions requises décrites dans le PGR adopté et présenté dans le Module 1.8.2 de l’autorisation de mise sur le marché, ainsi que toutes actualisations ultérieures adoptées du PGR.", "truncated": false}, "before_length": 265, "before_sha256": "a18ec8910e8d62d806ece76926f2662681f511ee63bdf3329705db3fcb876d06", "change_kind": "administrative", "change_operations": [{"after_end": 152, "after_start": 151, "before_end": 152, "before_start": 151, "kind": "replace"}, {"after_end": 223, "after_start": 219, "before_end": 219, "before_start": 219, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 5}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-14118cebe470e4774c795a4a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 402}
{"after": {"end": 192, "start": 0, "text": "Le critère principal d’efficacité était la survie globale. Le critère secondaire principal d’efficacité était la survie sans progression (SSP). Les résultats sont présentés dans le tableau 22.", "truncated": false}, "after_length": 192, "after_sha256": "8dfb48f5411422f20e751344a55f66475b6ad23bf6b8f955020847c82000e674", "annex": "I", "before": {"end": 192, "start": 0, "text": "Le critère principal d’efficacité était la survie globale. Le critère secondaire principal d’efficacité était la survie sans progression (PFS). Les résultats sont présentés dans le tableau 22.", "truncated": false}, "before_length": 192, "before_sha256": "91f4689d51cf369f6664942522fb2b18bdebebb6ebbbc89ba1bfbed42cf9126f", "change_kind": "content", "change_operations": [{"after_end": 140, "after_start": 138, "before_end": 138, "before_start": 138, "kind": "insert"}, {"after_end": 141, "after_start": 141, "before_end": 141, "before_start": 139, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-143ece6555c91c08d5ab7cea", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2086}
{"after": {"end": 20, "start": 0, "text": "msd.slovenia@msd.com", "truncated": false}, "after_length": 20, "after_sha256": "32f245e2e4036e3b467769cde309d09f05bcdd6f4f0f06a8cc91d81e4a082213", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "msd.slovenia@merck.com", "truncated": false}, "before_length": 22, "before_sha256": "fde9163edb7de43fa3b79d2f1f0c2a3195d3f29d316528e4141d99f1f940d448", "change_kind": "content", "change_operations": [{"after_end": 16, "after_start": 14, "before_end": 18, "before_start": 14, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-14655314378e2ba59fccfd4a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3479}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 33, "start": 0, "text": "United Kingdom (Northern Ireland)", "truncated": false}, "before_length": 33, "before_sha256": "9379d82927cdb505cfb186e912177065e56a1314de3a2b914ebbb8b5fe21525a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 33, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 33, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-147f0f3ba22cb3c4b686466f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000112", "medicine_name": "Twinrix Adult", "medicine_slug": "twinrix-adult", "observed_at": "2026-10-12T13:29:23Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "cfad5fb0086c9b5d6a36b454f3f546373def1f56cded73e0652b498d02d68e41", "source_snapshot_id": "source-17627897b0874bf1160c7372", "source_updated_at": "2026-08-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/twinrix-adult-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1031}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 18, "start": 0, "text": "medis.hr@medis.com", "truncated": false}, "before_length": 18, "before_sha256": "8544591a2cde06226d45116ff621fd59cca137bb8ddd85c10baaa55da94c1172", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 18, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 18, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1498725e78248907becd4975", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1103}
{"after": {"end": 190, "start": 0, "text": "présentez une augmentation de la pression sanguine dans vos poumons associée à une formation de tissu cicatriciel dans les poumons de cause inconnue, appelée fibrose pulmonaire idiopathique.", "truncated": false}, "after_length": 190, "after_sha256": "2725c7a1fa7b8d8d0e2fe59929f41a8e67789773b186cdd7a2f71dc799e256a3", "annex": "IIIA", "before": {"end": 190, "start": 0, "text": "présentez une augmentation de la pression sanguine dans les poumons associée à une formation de tissu cicatriciel dans les poumons de cause inconnue, appelée fibrose pulmonaire idiopathique.", "truncated": false}, "before_length": 190, "before_sha256": "30dc9725bef1733632a0e70cb98dcb512d164bdd1f021e9088ce97fe170f3f2a", "change_kind": "content", "change_operations": [{"after_end": 58, "after_start": 56, "before_end": 58, "before_start": 56, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-14a4d8f7f17c9b3456a9b18b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2816}
{"after": {"end": 498, "start": 0, "text": "Spikevax LP.8.1 stimulates the body’s natural defences (immune system). The vaccine works by causing the body to produce protection (antibodies) against the virus that causes COVID-19. Spikevax LP.8.1 uses a substance called messenger ribonucleic acid (mRNA) to carry instructions that cells in the body can use to make the spike protein that is also on the virus. The cells then make antibodies against the spike protein to help fight off the virus. This will help to protect you against COVID-19.", "truncated": false}, "after_length": 498, "after_sha256": "f2bf7d305e3916b619c7ac574ed596439cac02b20aab6f3ae0ce07c11bfd7b56", "annex": "I", "before": {"end": 494, "start": 0, "text": "Spikevax JN.1 stimulates the body’s natural defences (immune system). The vaccine works by causing the body to produce protection (antibodies) against the virus that causes COVID-19. Spikevax JN.1 uses a substance called messenger ribonucleic acid (mRNA) to carry instructions that cells in the body can use to make the spike protein that is also on the virus. The cells then make antibodies against the spike protein to help fight off the virus. This will help to protect you against COVID-19.", "truncated": false}, "before_length": 494, "before_sha256": "87fcd770e3e2e206e062a3846a1555d4fd8304df3005304854ecc3c4a212089f", "change_kind": "administrative", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}, {"after_end": 198, "after_start": 194, "before_end": 194, "before_start": 192, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-15949bf3f7f4a48364e46158", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12630}
{"after": {"end": 17, "start": 0, "text": "inform_pt@msd.com", "truncated": false}, "after_length": 17, "after_sha256": "80ea8d7772d76b760ca402228980572f0cf6dc451b408386454eb84cec35e7c8", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "inform_pt@merck.com", "truncated": false}, "before_length": 19, "before_sha256": "417a4e56160e131fb045d4a98431bae78237c04f6d71f4a97656e8299c0b43d2", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 11, "before_end": 15, "before_start": 11, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-15bd19b3e3a2f58007c302b4", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3058}
{"after": {"end": 270, "start": 0, "text": "Conditionnement de cartouche et Terrosa Pen : une boîte de cartouche Terrosa emballée dans une barquette en plastique fermée par un opercule en aluminium et emballée dans un étui intérieur en carton, et une boîte de Terrosa Pen emballée dans un étui intérieur en carton.", "truncated": false}, "after_length": 270, "after_sha256": "909d9d2c8e54098e67712458fcbb267ca64cf7d98f64c21e9bb5d408855072b7", "annex": "IIIA", "before": {"end": 274, "start": 0, "text": "Conditionnement de cartouche et stylo Terrosa : une boîte de cartouche Terrosa emballée dans une barquette en plastique fermée par un opercule en aluminium et emballée dans un étui intérieur en carton, et une boîte de stylo Terrosa emballée dans un étui intérieur en carton.", "truncated": false}, "before_length": 274, "before_sha256": "4a19bc2b9ea09d1a892d14d3102ec9b17bf4771962d2aa71094a28b8f5569ec4", "change_kind": "content", "change_operations": [{"after_end": 32, "after_start": 32, "before_end": 38, "before_start": 32, "kind": "delete"}, {"after_end": 43, "after_start": 39, "before_end": 45, "before_start": 45, "kind": "insert"}, {"after_end": 216, "after_start": 216, "before_end": 224, "before_start": 218, "kind": "delete"}, {"after_end": 227, "after_start": 223, "before_end": 231, "before_start": 231, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 12, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-15dfe9cb18420e3c18a238d6", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1908}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 32, "start": 0, "text": "ТП„Мундифарма Гезелшафт м.б.Х. “", "truncated": false}, "before_length": 32, "before_sha256": "2e86a38d985f693398dd7b19a3d568a256beb6a4ef38bdf87621ccd9f8d30a27", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 32, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 32, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1639d2c29c4d44e550c4cb36", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1040}
{"after": {"end": 20, "start": 0, "text": "Tel: +385 1 6611 333", "truncated": false}, "after_length": 20, "after_sha256": "ac17f5de7a55b551146b4e13e2e182c0c768e2407d11ada47b7ea50ccc88e7a9", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tel: + 385 1 6611 333", "truncated": false}, "before_length": 21, "before_sha256": "832fb9e4a0309ac207ea1cddc7b0f0d314eb5cd3eac51bc4ad14b8ef55b1e935", "change_kind": "content", "change_operations": [{"after_end": 6, "after_start": 6, "before_end": 7, "before_start": 6, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-165c50e394f6676b82304b8c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3463}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Tel: +353 1 206 3800", "truncated": false}, "before_length": 20, "before_sha256": "b76fef5190d612d91d8ee1c3f52c40e30fcc7f25541faffe2a0c00e33c8cb7c1", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 20, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 20, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1705a71eb3eb0ea7962c3856", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1048}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 72, "start": 0, "text": "Spikevax JN.1 50 micrograms dispersion for injection (single-dose vials)", "truncated": false}, "before_length": 72, "before_sha256": "41ccaa4784373a30743e6194685d229de5b4a64699df21c150e5a91151740b4d", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 72, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 72, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-170e84361082c2f8a8792341", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6378}
{"after": {"end": 274, "start": 0, "text": "D: Push the threaded rod with your finger carefully back into the housing, as far as it will go. The threaded rod cannot be pushed back entirely into the pen housing. This step is not necessary when the rod is already in the starting position, such as at the very first use.", "truncated": false}, "after_length": 274, "after_sha256": "9b59aa3a317b88106ece9eaea4330a2dde79053fd63192e38ff226411ed835d4", "annex": "IIIA", "before": {"end": 273, "start": 0, "text": "D: Push back the threaded rod carefully with your finger, in a straight line and as far as it will go. This is not necessary when the rod is already in the starting position, such as at the very first use. The threaded rod cannot be pushed back to the pen housing entirely.", "truncated": false}, "before_length": 273, "before_sha256": "7487dc2a279c11f12ddf93079a3db3c3d99bdf07f3f45e643df7fe931894fd5b", "change_kind": "content", "change_operations": [{"after_end": 8, "after_start": 8, "before_end": 13, "before_start": 8, "kind": "delete"}, {"after_end": 25, "after_start": 25, "before_end": 40, "before_start": 30, "kind": "delete"}, {"after_end": 56, "after_start": 41, "before_end": 57, "before_start": 56, "kind": "replace"}, {"after_end": 61, "after_start": 59, "before_end": 60, "before_start": 60, "kind": "insert"}, {"after_end": 65, "after_start": 62, "before_end": 62, "before_start": 61, "kind": "replace"}, {"after_end": 69, "after_start": 66, "before_end": 63, "before_start": 63, "kind": "insert"}, {"after_end": 70, "after_start": 70, "before_end": 73, "before_start": 64, "kind": "delete"}, {"after_end": 74, "after_start": 72, "before_end": 80, "before_start": 75, "kind": "replace"}, {"after_end": 169, "after_start": 99, "before_end": 105, "before_start": 105, "kind": "insert"}, {"after_end": 176, "after_start": 171, "before_end": 107, "before_start": 107, "kind": "insert"}, {"after_end": 273, "after_start": 273, "before_end": 272, "before_start": 204, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 99, "chars_inserted": 100}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-171b1d700299053019b95b05", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1995}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "II", "before": {"end": 7, "start": 0, "text": "Q4 2024", "truncated": false}, "before_length": 7, "before_sha256": "451c4f238ae40a7c57c2c1ff4f11ff90d5c90c28278489fb86170fd56ee2dde8", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 7, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1725dae19d748f889af94106", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:33Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "21d66bf1e9a74479f577de09da3cf8517d65c1ce1b1d8bbdfe4bc38f79410def", "source_snapshot_id": "source-2c39c998fdaf05159687c016", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 473}
{"after": {"end": 352, "start": 0, "text": "Materials approved by the local authority will be posted on the non-promotional website nyxoid.com from where they can be freely downloaded as needed. A QR code on the package and in the patient information leaflet links to nyxoid.com to ensure the site can be reached quickly in case of “just in time” retraining at the time of witnessing an overdose.", "truncated": false}, "after_length": 352, "after_sha256": "606c0edc2f8b64a8d119a5af89265f3980dff7ab62fd5f30834a35032424f2ce", "annex": "II", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 352, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 352}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-172a3ecce904b0a1e9d42256", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:33Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "21d66bf1e9a74479f577de09da3cf8517d65c1ce1b1d8bbdfe4bc38f79410def", "source_snapshot_id": "source-2c39c998fdaf05159687c016", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 411}
{"after": {"end": 734, "start": 0, "text": "Enbrel 25 mg est reconstitué avec 1 mL d’eau pour préparations injectables avant utilisation, et administration de l’injection sous-cutanée. Enbrel ne contient aucun agent conservateur antibactérien, et les solutions préparées avec de l’eau pour préparations injectables doivent donc être administrées le plus vite possible, au plus tard dans les six heures qui suivent la reconstitution. La solution doit être limpide et incolore à jaune pâle ou brun pâle, sans amas, flocons ou particules visibles. Il se peut que de la mousse reste dans le flacon – c’est normal. Enbrel ne doit pas être utilisé si toute la poudre du flacon ne s’est pas dissoute dans les 10 minutes. Si tel est le cas, recommencez l’opération avec un autre flacon.", "truncated": false}, "after_length": 734, "after_sha256": "35ff2805e807a65eeea4a461584569e681530ea60cc7ae2d2d072651febfda35", "annex": "I", "before": {"end": 734, "start": 0, "text": "Enbrel 25 mg est reconstitué avec 1 ml d’eau pour préparations injectables avant utilisation, et administration de l’injection sous-cutanée. Enbrel ne contient aucun agent conservateur antibactérien, et les solutions préparées avec de l’eau pour préparations injectables doivent donc être administrées le plus vite possible, au plus tard dans les six heures qui suivent la reconstitution. La solution doit être limpide et incolore à jaune pâle ou brun pâle, sans amas, flocons ou particules visibles. Il se peut que de la mousse reste dans le flacon – c’est normal. Enbrel ne doit pas être utilisé si toute la poudre du flacon ne s’est pas dissoute dans les 10 minutes. Si tel est le cas, recommencez l’opération avec un autre flacon.", "truncated": false}, "before_length": 734, "before_sha256": "e93f724b5cd18bca79a2acb1856fe1c60fda757517b0ad2dd5baddaf7a773f3e", "change_kind": "content", "change_operations": [{"after_end": 38, "after_start": 37, "before_end": 38, "before_start": 37, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1759f648628a33eb4aa0ccc3", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg poudre pour solution injectable", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1113}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 399, "start": 0, "text": "de la pression sanguine élevée dans les artères des poumons, puisque vous ne devez pas prendre certains médicaments comme le sildénafil et le tadalafil en même temps qu’Adempas. D’autres médicaments utilisés pour le traitement de la pression sanguine élevée dans les artères des poumons, comme le bosentan et l’iloprost, peuvent être utilisés avec Adempas, mais vous devez en informer votre médecin.", "truncated": false}, "before_length": 399, "before_sha256": "2bd739a7be6101aa67e0225aaf6a8c3f0a37217165927305e4af9a7e35a21d20", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 399, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 399, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-176258f0a1a9f3bc68e12bd5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2854}
{"after": {"end": 265, "start": 0, "text": "The reusable Terrosa Pen is intended to assist adult patients with osteoporosis, healthcare professionals, caregivers and third parties with the delivery of once-daily subcutaneous injections of Terrosa either in a clinical environment or self-administered at home.", "truncated": false}, "after_length": 265, "after_sha256": "b990898ee1290dec640285a391fc672f67034f2f1e5edcfc5015a92646e64c19", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 265, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 265}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-17634d57b2e4ee8b345236f4", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1946}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 114, "start": 0, "text": "erectile dysfunction such as sildenafil, tadalafil, vardenafil. Do not take these medicines together with Adempas.", "truncated": false}, "before_length": 114, "before_sha256": "5ba69ab6c42999b4230d535819f792de6116d4223c1fa84337d67919bead0dc1", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 114, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 114, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-176f0dd5ff3351feba5d9b93", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2774}
{"after": {"end": 2, "start": 0, "text": "SC", "truncated": false}, "after_length": 2, "after_sha256": "32da6721804f1dd3226c0551970304ebf1059ec19a27451426541027861c9388", "annex": "IIIA", "before": {"end": 16, "start": 0, "text": "Subcutaneous use", "truncated": false}, "before_length": 16, "before_sha256": "363fd22613abec178143cdac0b1a34f04ee8ccdaa7d6988b3722fa7540374cde", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 1, "before_end": 16, "before_start": 1, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 15, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-17c0f4e6a3f5006ed0cc9646", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6758}
{"after": {"end": 16, "start": 0, "text": "EU/1/20/1507/031", "truncated": false}, "after_length": 16, "after_sha256": "ef0de028a6460d04dced37c7e0b71c87537a7bc63e3b6feca5c6dc32dfb8d011", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "administrative", "change_operations": [{"after_end": 16, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 16}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-17d9b1a3acdd195a893feb62", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "8", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6484}
{"after": {"end": 81, "start": 0, "text": "Do not use the pen if the cartridge is cloudy, discoloured or contains particles.", "truncated": false}, "after_length": 81, "after_sha256": "046bb913395f51e6bf4c6343f07eab5e628ae8bc009d7a6e8238900962568ce1", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 81, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 81}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-17f2798711e6039fd57dcb8c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1975}
{"after": {"end": 54, "start": 0, "text": "Takeda Pharmaceuticals International AG Ireland Branch", "truncated": false}, "after_length": 54, "after_sha256": "81709515d3af1f0e4041ce3c760d8fc81fefa358805810b0b53a84e121d5efa6", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 54, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 54}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-184f25f57d12619cdd413efb", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1210}
{"after": {"end": 9, "start": 0, "text": "ANNEXE IV", "truncated": false}, "after_length": 9, "after_sha256": "5623d2bfc35b28c1d982ab389e6c5fa37f50e40d0b9b737593e164d081c1191d", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 9, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 9}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-187fbbeb52466d4ad6a4bda8", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:32:00Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "3ff8cd4d67d22ba799aa348aeda944d6d896a16dcf54b030db101cbc095fc8ad", "source_snapshot_id": "source-a79a7cba8bf5dbc72fd40574", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3511}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 11, "start": 0, "text": "Takeda GmbH", "truncated": false}, "before_length": 11, "before_sha256": "94e4e4fc81542d4a8a0deb904c666e74cf300a1075af4d0d2e564a29e287bafb", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 11, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 11, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1894118d2490eba4dce5306d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1336}
{"after": {"end": 225, "start": 0, "text": "1 Les investigateurs ont évalué l’analyse de la SSP spécifiée au protocole GOG (données de progression CA 125 et traitements hors protocole avant progression de la maladie non censurés) à la date du 25 février 2010 (cut-off).", "truncated": false}, "after_length": 225, "after_sha256": "08def08db9043c10589700843d60741e618bb09867aa7c6c147f8033543feab0", "annex": "I", "before": {"end": 225, "start": 0, "text": "1 Les investigateurs ont évalué l’analyse de la PFS spécifiée au protocole GOG (données de progression CA 125 et traitements hors protocole avant progression de la maladie non censurés) à la date du 25 février 2010 (cut-off).", "truncated": false}, "before_length": 225, "before_sha256": "387bac484598daee2f6d7e2b3bc512ed2b444d21b255fd3de3f7e419970ca866", "change_kind": "content", "change_operations": [{"after_end": 50, "after_start": 48, "before_end": 48, "before_start": 48, "kind": "insert"}, {"after_end": 51, "after_start": 51, "before_end": 51, "before_start": 49, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-189abfdba95d5d73f9010e35", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1777}
{"after": {"end": 60, "start": 0, "text": "•Rubrique 4 : Quels sont les effets indésirables éventuels ?", "truncated": false}, "after_length": 60, "after_sha256": "324fbcba3fa2b743c0ac5866ae6c48d0ede218bbcc7960a3edf7ccdbd7dbfa42", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 60, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 60}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-18ae8a19cdca693a458b62f8", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "9ac80b0d56ebad4970f7a8335a177613af59ef25517bcd0bdd3397c207cc1bac", "source_snapshot_id": "source-c11aa9e32420f125a88005bc", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2737}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IV", "before": {"end": 587, "start": 0, "text": "Compte tenu des 18 cas de troubles psychotiques provenant des essais cliniques, dont 10 cas présentant un déchallenge positif, de la littérature (2 études de cas), des rapports spontanés, dont 10 cas avec une relation temporelle étroite, 6 cas avec un déchallenge positif et 1 cas avec rechallenge, le PRAC considère qu’une relation de cause à effet entre le pérampanel et les troubles psychotiques constitue au minimum une possibilité raisonnable. Le PRAC a conclu que les informations sur le produit relatives aux produits contenant du pérampanel doivent être modifiées en conséquence.", "truncated": false}, "before_length": 587, "before_sha256": "f732e082e550efce7f80fc9f14097f84272585f5a487913cf6fa375c52294cc3", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 587, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 587, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-18d8b37ef20991001ec0c9e1", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:32:00Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "3ff8cd4d67d22ba799aa348aeda944d6d896a16dcf54b030db101cbc095fc8ad", "source_snapshot_id": "source-a79a7cba8bf5dbc72fd40574", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3520}
{"after": {"end": 22, "start": 0, "text": "Tlf.: + 45 36 35 91 00", "truncated": false}, "after_length": 22, "after_sha256": "ee5cfc7acaf9dfe8868ac7e8cd8079d0cb8f85922089533a08d33e515be7aea6", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tlf: + 45 36 35 91 00", "truncated": false}, "before_length": 21, "before_sha256": "18d8cf6a57f2048255a4474230a78ae1192c8bd63af3a4aa0c409cccfeafcba9", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-18e6cc2b7e072d78a8c2df70", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000112", "medicine_name": "Twinrix Adult", "medicine_slug": "twinrix-adult", "observed_at": "2026-10-12T13:29:23Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "cfad5fb0086c9b5d6a36b454f3f546373def1f56cded73e0652b498d02d68e41", "source_snapshot_id": "source-17627897b0874bf1160c7372", "source_updated_at": "2026-08-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/twinrix-adult-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 936}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 13, "start": 0, "text": "Suomi/Finland", "truncated": false}, "before_length": 13, "before_sha256": "5bea43a11ae0d0e9706443422f6eb9b6107624ceb18d16ec89005011c62699dd", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 13, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 13, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-191e1bcd22be55fbe2802863", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1134}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 7, "start": 0, "text": "Germany", "truncated": false}, "before_length": 7, "before_sha256": "80db4ccdca106d37b920206331fcfe3e9e50a9e763d89b54ce3ad5ac8cf30f03", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 7, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-191f55f08534078056dc89ab", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "Qdenga powder and solvent for solution for injection Qdenga powder and solvent for solution for injection in pre-filled syringe Dengue tetravalent vaccine (live, attenuated)", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 972}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 191, "start": 0, "text": "high blood pressure or heart disease such as nitrates and amyl nitrite, or another soluble guanylate cyclase stimulators such as vericiguat. Do not take these medicines together with Adempas.", "truncated": false}, "before_length": 191, "before_sha256": "3181119bcb3e48131944a4bf57e277a690b8694b268691ba86174edfe824517a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 191, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 191, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-194dc774613cc1296c91e874", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2772}
{"after": {"end": 19, "start": 0, "text": "hungary_msd@msd.com", "truncated": false}, "after_length": 19, "after_sha256": "4ffcdd5eaf215819b6063b291e957577af48205584cf794ece9fd17a4802c6e1", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "hungary_msd@merck.com", "truncated": false}, "before_length": 21, "before_sha256": "da92e6e80d6625405a462b85c1135580d63c6c4a9e76a7c5be0eef07e90aee85", "change_kind": "content", "change_operations": [{"after_end": 15, "after_start": 13, "before_end": 17, "before_start": 13, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-195d5393dd62ba2a90362a99", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3400}
{"after": {"end": 85, "start": 0, "text": "Purple, round, biconvex tablet, engraved with E295 on one side and ‘8’ on other side.", "truncated": false}, "after_length": 85, "after_sha256": "d7843499f139ee573d924db1a9b1693b84c6bcf25a8ff2671714004d0592e8eb", "annex": "I", "before": {"end": 84, "start": 0, "text": "Purple, round, biconvex tablet, engraved with E295 on one side and ‘8’ on other side", "truncated": false}, "before_length": 84, "before_sha256": "01544034c916d0b079c6623d0cb34e1fd78a492d4a970074857e8e07c1647303", "change_kind": "content", "change_operations": [{"after_end": 85, "after_start": 84, "before_end": 84, "before_start": 84, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-197954fe8b6fb1da16ec9dca", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "Fycompa 2 mg filmcoated tablets Fycompa 4 mg filmcoated tablets Fycompa 6 mg filmcoated tablets Fycompa 8 mg filmcoated tablets Fycompa 10 mg filmcoated tablets Fycompa 12 mg filmcoated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "3", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 103}
{"after": {"end": 43, "start": 0, "text": "Pfizer Healthcare Ireland Unlimited Company", "truncated": false}, "after_length": 43, "after_sha256": "1f203777a0ec6fed9c840d52631b6a74c7e25b5d318485d8147e2404f52dc981", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "Pfizer Healthcare Ireland", "truncated": false}, "before_length": 25, "before_sha256": "4beeea9b6d0c491f03a9511d9f9576b9c75cbcdcfd736e4934f768fdded936f5", "change_kind": "content", "change_operations": [{"after_end": 43, "after_start": 25, "before_end": 25, "before_start": 25, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 18}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-199f8c3360220253eba10fb1", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 10522}
{"after": {"end": 494, "start": 0, "text": "b Les termes représentent des groupes d’évènements indésirables décrivant un concept médical plutôt qu’une condition particulière ou terme privilégié MedDRA (Medical Dictionary for Regulatory Activities). Ce groupe de termes médicaux peut impliquer la même physiopathologie sous-jacente (ex : les effets thromboemboliques artériels incluent les accidents vasculaires cérébraux, les infarctus du myocarde, les accidents ischémiques transitoires et les autres effets thromboemboliques artériels).", "truncated": false}, "after_length": 494, "after_sha256": "e5b6e3ef94f21d1c344db741f13b80bb788333855cf241d4884422e2837d7a4d", "annex": "I", "before": {"end": 494, "start": 0, "text": "b Les termes représentent des groupes d’évènements indésirables décrivant un concept médical plutôt qu’une condition particulière ou terme privilégié MedDRA (Medical Dictionnay for Regulatory Activities). Ce groupe de termes médicaux peut impliquer la même physiopathologie sous-jacente (ex : les effets thromboemboliques artériels incluent les accidents vasculaires cérébraux, les infarctus du myocarde, les accidents ischémiques transitoires et les autres effets thromboemboliques artériels).", "truncated": false}, "before_length": 494, "before_sha256": "eb6127b7a5245b3be6f4926bb0fbe9df60b169c0fa1d30b68df86887bccd1725", "change_kind": "content", "change_operations": [{"after_end": 173, "after_start": 173, "before_end": 174, "before_start": 173, "kind": "delete"}, {"after_end": 175, "after_start": 174, "before_end": 175, "before_start": 175, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-19dcddab52b0b4208b970eb6", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 535}
{"after": {"end": 475, "start": 0, "text": "Il a été rarement rapporté que des patients traités par Avastin développent des signes et symptômes compatibles avec un SEPR, un trouble neurologique rare. Sa survenue peut inclure des convulsions, céphalées, état mental altéré, troubles de la vision, cécité corticale, avec ou sans hypertension associée. Le tableau clinique d’un SEPR est souvent non spécifique et par conséquent le diagnostic de SEPR requiert une confirmation par imagerie cérébrale, de préférence une IRM.", "truncated": false}, "after_length": 475, "after_sha256": "19a5e68af0686f6564fd4acc7069c3a7d99aa57da3ab5ce8561b1c7ff9b8e929", "annex": "I", "before": {"end": 472, "start": 0, "text": "Il a été rarement rapporté que des patients traités par Avastin développent des signes et symptômes compatibles avec un SEPR, un trouble neurologique rare. Sa survenue peut inclure des attaques, céphalées, état mental altéré, troubles de la vision, cécité corticale, avec ou sans hypertension associée. Le tableau clinique d’un SEPR est souvent non spécifique et par conséquent le diagnostic de SEPR requiert une confirmation par imagerie cérébrale, de préférence une IRM.", "truncated": false}, "before_length": 472, "before_sha256": "e842b473cf36cd6f266931173fc4120bf3c0c12ae6babe0b0a24d42722724d23", "change_kind": "content", "change_operations": [{"after_end": 189, "after_start": 185, "before_end": 190, "before_start": 185, "kind": "replace"}, {"after_end": 195, "after_start": 190, "before_end": 192, "before_start": 191, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 9}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1abd28d074a870dbb1b1a8dc", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 763}
{"after": {"end": 9, "start": 0, "text": "Oral use.", "truncated": false}, "after_length": 9, "after_sha256": "3cb600334d66cfc50b70bcea280eaeb9fc125e589d372d56f3fae261332b8ee9", "annex": "IIIA", "before": {"end": 8, "start": 0, "text": "Oral use", "truncated": false}, "before_length": 8, "before_sha256": "1a1f6c65b762e8cde9480afdbb709dcfb59c2d46c38f5d3112c9f605bcbdf25f", "change_kind": "content", "change_operations": [{"after_end": 9, "after_start": 8, "before_end": 8, "before_start": 8, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1add21eb3b201f81826f9b55", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1695}
{"after": {"end": 4, "start": 0, "text": "1 mL", "truncated": false}, "after_length": 4, "after_sha256": "af7727a32f7da2545262756526dd30894df734889f01f15bae043a9c9443b45c", "annex": "IIIA", "before": {"end": 4, "start": 0, "text": "1 ml", "truncated": false}, "before_length": 4, "before_sha256": "4103eeeca6e2548f11a7718ff403283afec588e4fb6e5622d0ed558b3d903b7b", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 4, "before_start": 3, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1b0ab8e7ee744074b0898c1d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 8177}
{"after": {"end": 59, "start": 0, "text": "l’erlotinib, le géfitinib, utilisés pour traiter le cancer.", "truncated": false}, "after_length": 59, "after_sha256": "c90290125bf01fb5021f2497797f33b3d52068fe8bebc5487344502cc3790e9e", "annex": "IIIA", "before": {"end": 42, "start": 0, "text": "du cancer comme l’erlotinib, le géfitinib.", "truncated": false}, "before_length": 42, "before_sha256": "f3567bfd0c8f279021bdd5ce8944e8549faf966d1951191c11456e76da8c1286", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 16, "before_start": 0, "kind": "delete"}, {"after_end": 58, "after_start": 25, "before_end": 41, "before_start": 41, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 16, "chars_inserted": 33}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1b6373ae4785aefbab38948c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2862}
{"after": {"end": 38, "start": 0, "text": "Résumé des caractéristiques du produit", "truncated": false}, "after_length": 38, "after_sha256": "54c9baacddcb198bd7c106217b7e31a980478250f75aee45c3edc0467f5151cb", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 38, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 38}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1b75b36e454a49a5ee4a9ed9", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "9ac80b0d56ebad4970f7a8335a177613af59ef25517bcd0bdd3397c207cc1bac", "source_snapshot_id": "source-c11aa9e32420f125a88005bc", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2721}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "office@mundipharma.pl", "truncated": false}, "before_length": 21, "before_sha256": "81c5ffb99abd461b2b46bd9426bde7f8bc683221226fbaf15a52f3407e427ad3", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 21, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 21, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1ba21a4653c591ae42501705", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1101}
{"after": {"end": 67, "start": 0, "text": "Table 3. Spikevax LP.8.1 posology for immunocompromised individuals", "truncated": false}, "after_length": 67, "after_sha256": "1c45d4ca4fd6ac6f9cbf9586972cc054dca285b25c92ff6f0efa43226ac91561", "annex": "I", "before": {"end": 65, "start": 0, "text": "Table 3. Spikevax JN.1 posology for immunocompromised individuals", "truncated": false}, "before_length": 65, "before_sha256": "38ca7e70683b9a14c792ae76f21c301a93342da4364fe6bfd0ba6d52a4041b1d", "change_kind": "content", "change_operations": [{"after_end": 22, "after_start": 18, "before_end": 20, "before_start": 18, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1bc76056b27e7f240141a5b3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5503}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "Tel: + 370 68735006", "truncated": false}, "before_length": 19, "before_sha256": "0b71bb823ba1803c0344337fdda95e0fb541d57f42a05bdf33012e3406feabf1", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 19, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 19, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1c2b38ae827da8dc84ff6e90", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1160}
{"after": {"end": 25, "start": 0, "text": "Intended user population:", "truncated": false}, "after_length": 25, "after_sha256": "5976bef08b803409f2c301fca13b5c266ecb0d6ea7b712849f92e795228c579e", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 25, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 25}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1c3db16f290a4579d476ddac", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1953}
{"after": {"end": 2, "start": 0, "text": "ou", "truncated": false}, "after_length": 2, "after_sha256": "fc74181ece96ac0d3a8d14da85058f9a336cab3ea77d797cfbb9fadcf49e86d0", "annex": "III", "before": {"end": 53, "start": 0, "text": "6, boulevard de l’Europe, F-21800 Quétigny, France ou", "truncated": false}, "before_length": 53, "before_sha256": "3f72606e6412202334dfd6fdf9c16813900db83c349694ce9bb1d91d6168461a", "change_kind": "unassigned", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 51, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 51, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1c77c90f5b81c6b3ac6bb9c7", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000174", "medicine_name": "Plavix", "medicine_slug": "plavix", "observed_at": "2026-10-12T19:26:25Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "8d1630f20e7a86728cac32eaccf248b0a0e88d4d9a2a9cfa6e6429b883e20247", "source_snapshot_id": "source-77d6cc5bd19bd71f20e22a8e", "source_updated_at": "2025-07-14", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/plavix-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1550}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 11, "start": 0, "text": "Takeda GmbH", "truncated": false}, "before_length": 11, "before_sha256": "94e4e4fc81542d4a8a0deb904c666e74cf300a1075af4d0d2e564a29e287bafb", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 11, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 11, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1c7d1f36d7fd1a1813cf2f19", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1206}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "II", "before": {"end": 7, "start": 0, "text": "T4 2024", "truncated": false}, "before_length": 7, "before_sha256": "e7084594f4a09b4fdd5d421ddb18d0b7d1bb8429726e1ac62652aab1aa32bd19", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 7, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1cadbc112b974a399a4ec455", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 475}
{"after": {"end": 532, "start": 0, "text": "Ces effets indésirables, cliniquement significatifs, ont été rapportés dans les essais cliniques mais les effets de grade 3-5 n’ont pas atteint le seuil d’une différence d’au moins 2 % par rapport au groupe témoin. Le tableau 2 inclut également les effets indésirables cliniquement significatifs, observés depuis la commercialisation uniquement. Par conséquent, la fréquence et le grade NCI-CTCAE ne sont pas connus. Ces effets cliniquement significatifs ont ainsi été inclus dans la colonne « fréquence indéterminée » du tableau 2.", "truncated": false}, "after_length": 532, "after_sha256": "28e05c777e5d32383b27d50331a640748907abda0720fe29fdf845e4e258af6e", "annex": "I", "before": {"end": 529, "start": 0, "text": "Ces effets indésirables, cliniquement significatifs, ont été rapportés dans les essais cliniques mais les effets de grade 3-5 n’ont pas atteint le seuil d’une différence d’au moins 2 % par rapport au groupe témoin. Le tableau 2 inclut également les effets indésirables cliniquement significatifs, observés depuis la commercialisation uniquement. Par conséquent, la fréquence et le grade NCI-CTCAE n’est pas connu. Ces effets cliniquement significatifs ont ainsi été inclus dans la colonne « fréquence indéterminée » du tableau 2.", "truncated": false}, "before_length": 529, "before_sha256": "32269f2169af321ca954a9362f556bf9fc5f884387b4567382d376f5eaea7086", "change_kind": "content", "change_operations": [{"after_end": 398, "after_start": 398, "before_end": 399, "before_start": 398, "kind": "delete"}, {"after_end": 400, "after_start": 399, "before_end": 400, "before_start": 400, "kind": "insert"}, {"after_end": 403, "after_start": 401, "before_end": 401, "before_start": 401, "kind": "insert"}, {"after_end": 415, "after_start": 414, "before_end": 412, "before_start": 412, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1cbf7531c2ff1b4291d0ca2e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 709}
{"after": {"end": 131, "start": 0, "text": "Les signes ou symptômes relatifs à ce problème de sécurité et le moment auquel l’avis d’un professionnel de santé doit être demandé", "truncated": false}, "after_length": 131, "after_sha256": "4f5cb43b7d8c02e6d75d9470fad13b1489c0005fdd56c63fe146a3cf54b94e12", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 131, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 131}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1cda9927347489daa19deef8", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6662}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "Tel: +43 (0)1 523 25 05", "truncated": false}, "before_length": 23, "before_sha256": "1c871405cc2b2c04561b63ec0520ec0b01c5f9571be60e896ddbf90186d9c8da", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 23, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 23, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1cfda600d41721687546e54d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1091}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 1, "start": 0, "text": "8", "truncated": false}, "before_length": 1, "before_sha256": "2c624232cdd221771294dfbb310aca000a0df6ac8b66b696d90ef06fdefb64a3", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 1, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1d0182d4b603143ad4642b12", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005352", "medicine_name": "Upstaza", "medicine_slug": "upstaza", "observed_at": "2026-10-12T13:36:07Z", "pipeline_version": "2.0.0", "presentation_label": "Upstaza 2.8 × 1011 vector genomes (vg)/0.5 mL solution for infusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8561a0c5aed752dd415d30acef76bf620ad205d702080a0bca765e086873fe20", "source_snapshot_id": "source-4b712d5f9e4e2e8cd620aa93", "source_updated_at": "2026-06-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/upstaza-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 339}
{"after": {"end": 332, "start": 0, "text": "Les effets indésirables mentionnés dans cette rubrique font partie des groupes de fréquence suivants : très fréquent (≥ 1/10), fréquent (≥ 1 /100, < 1/10), peu fréquent : (≥ 1 /1 000, < 1 /100), rare (≥ 1 /10 000, < 1/1 000), très rare (< 1/10 000), fréquence indéterminée (ne peut être estimée sur la base des données disponibles).", "truncated": false}, "after_length": 332, "after_sha256": "cbd310b1d213f3e76ea38a3623624862d35a3fa64d531f128f03363be1a5842a", "annex": "I", "before": {"end": 335, "start": 0, "text": "Les effets indésirables mentionnés dans cette rubrique font partie des groupes de fréquence suivants : très fréquent (≥ 1/10), fréquent (≥ 1 /100 - < 1/10), peu fréquent : (≥ 1 /1 000 à < 1 /100), rare (≥ 1 /10 000 à < 1/1 000), très rare (< 1/10 000), fréquence indéterminée (ne peut être estimée sur la base des données disponibles).", "truncated": false}, "before_length": 335, "before_sha256": "90b98f6ee2e513c987354984516de5cc1dccecf0d511326c07458607a1ccd48b", "change_kind": "content", "change_operations": [{"after_end": 146, "after_start": 145, "before_end": 147, "before_start": 145, "kind": "replace"}, {"after_end": 183, "after_start": 182, "before_end": 185, "before_start": 183, "kind": "replace"}, {"after_end": 213, "after_start": 212, "before_end": 216, "before_start": 214, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 3}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1d16bd97f796789b692ac82b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 322}
{"after": {"end": 99, "start": 0, "text": "SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S)", "truncated": false}, "after_length": 99, "after_sha256": "4d43e1a4109e8a776bcf1a5f90e9a1bc3b91d0b8306edf4d773e154de56fdd42", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 99, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 99}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1d660098cedf51c76133adff", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:30Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "35ab6716aa09492c14ac6849111486ec47235c0bc65ef055350de950f316c5e6", "source_snapshot_id": "source-f20a60110d1f8fef5225317d", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2335}
{"after": {"end": 49, "start": 0, "text": "4. Quels sont les effets indésirables éventuels ?", "truncated": false}, "after_length": 49, "after_sha256": "80a31a89fa4d8dc9fa3b4c7fe95808e57595f8420ddcda64fd9007734a4f703b", "annex": "IIIA", "before": {"end": 47, "start": 0, "text": "4. Quels sont les effets indésirables éventuels", "truncated": false}, "before_length": 47, "before_sha256": "b082704e47b8525a5d217e2a505cc93111cbd284b5eeb162a812afb7952a6b31", "change_kind": "content", "change_operations": [{"after_end": 49, "after_start": 47, "before_end": 47, "before_start": 47, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1d78e47523b5b55a64640ec3", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2949}
{"after": {"end": 167, "start": 0, "text": "Insuffisance cardiaque (pouvant inclure des symptômes tels qu’un essoufflement, une sensation de fatigue, un évanouissement, un gonflement des chevilles et des jambes)", "truncated": false}, "after_length": 167, "after_sha256": "20a2ed75c8c50c3fde1a0984e39bc226b01348824288a86ad42138c78975d8c5", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 167, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 167}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1d889bbd6fd0661d9cf3f2af", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002640", "medicine_name": "Cometriq", "medicine_slug": "cometriq", "observed_at": "2026-10-12T19:00:55Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c7f8aa8da9127064263770c4aed5506128bacd0c40693b863c48a757d735203e", "source_snapshot_id": "source-e4fa0b9c95a2e427d4c95a33", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/cometriq-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1995}
{"after": {"end": 47, "start": 0, "text": "Lire attentivement la notice avant utilisation.", "truncated": false}, "after_length": 47, "after_sha256": "92b25b6479aa954112f3920fb26bac5473eb5d609d2e65194b217a27c9179a76", "annex": "IIIA", "before": {"end": 46, "start": 0, "text": "Lire attentivement la notice avant utilisation", "truncated": false}, "before_length": 46, "before_sha256": "e7a9c9bbbbbd81b1435363adef4e03485578bc1b0be14283e02ee118124c65e7", "change_kind": "content", "change_operations": [{"after_end": 47, "after_start": 46, "before_end": 46, "before_start": 46, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1d9c2008c6742e5cb623bab0", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 7390}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 33, "start": 0, "text": "United Kingdom (Northern Ireland)", "truncated": false}, "before_length": 33, "before_sha256": "9379d82927cdb505cfb186e912177065e56a1314de3a2b914ebbb8b5fe21525a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 33, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 33, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1da2c17e042de9fdcfb9868f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9097}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 15, "start": 0, "text": "Česká republika", "truncated": false}, "before_length": 15, "before_sha256": "c768c215f215c71e7ffcbffe06cb1a66fa3c379a86285d5da65cef3c627bc09d", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 15, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 15, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1e2a1dff58d05793c413b4db", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1048}
{"after": {"end": 6, "start": 0, "text": "7 (32)", "truncated": false}, "after_length": 6, "after_sha256": "5381cf2caeeb0c444d378826e402319e8afb7abc2f842250a25d2f9e776cc61e", "annex": "I", "before": {"end": 6, "start": 0, "text": "6 (27)", "truncated": false}, "before_length": 6, "before_sha256": "b4a07d9e9e064b339d669cda25ac2c21b7c726287abca68cf2167d70363ed749", "change_kind": "content", "change_operations": [{"after_end": 1, "after_start": 0, "before_end": 1, "before_start": 0, "kind": "replace"}, {"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}, {"after_end": 5, "after_start": 5, "before_end": 5, "before_start": 4, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1e665170086624ae9ca952c2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005352", "medicine_name": "Upstaza", "medicine_slug": "upstaza", "observed_at": "2026-10-12T13:36:07Z", "pipeline_version": "2.0.0", "presentation_label": "Upstaza 2.8 × 1011 vector genomes (vg)/0.5 mL solution for infusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8561a0c5aed752dd415d30acef76bf620ad205d702080a0bca765e086873fe20", "source_snapshot_id": "source-4b712d5f9e4e2e8cd620aa93", "source_updated_at": "2026-06-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/upstaza-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 315}
{"after": {"end": 51, "start": 0, "text": "Ne prenez pas les médicaments suivants avec Adempas", "truncated": false}, "after_length": 51, "after_sha256": "b45702508d12ba9265bea5c9651094dd13251090c705d9e265642a3a86d7c5aa", "annex": "IIIA", "before": {"end": 56, "start": 0, "text": "Ne prenez pas de médicaments utilisés pour le traitement", "truncated": false}, "before_length": 56, "before_sha256": "449bb64bd12b29ef09bcff7eac43c566251d2e74bd7a4151e7137043d2ce8d74", "change_kind": "content", "change_operations": [{"after_end": 15, "after_start": 14, "before_end": 15, "before_start": 14, "kind": "replace"}, {"after_end": 17, "after_start": 16, "before_end": 16, "before_start": 16, "kind": "insert"}, {"after_end": 31, "after_start": 30, "before_end": 29, "before_start": 29, "kind": "insert"}, {"after_end": 36, "after_start": 32, "before_end": 30, "before_start": 30, "kind": "insert"}, {"after_end": 37, "after_start": 37, "before_end": 36, "before_start": 31, "kind": "delete"}, {"after_end": 43, "after_start": 39, "before_end": 42, "before_start": 38, "kind": "replace"}, {"after_end": 46, "after_start": 44, "before_end": 51, "before_start": 43, "kind": "replace"}, {"after_end": 51, "after_start": 48, "before_end": 56, "before_start": 53, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 21, "chars_inserted": 16}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1e73e04527576bff6a3362b5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2849}
{"after": {"end": 530, "start": 0, "text": "The safety information was observed in 3 open-label clinical studies in which eladocagene exuparvovec was administered to 30 AADC-deficient patients aged 19 months to 8.5 years at the time of dosing. Patients were followed for a median duration of 59.3 months (minimum of 11.8 months to a maximum of 5.7 years). Twenty-seven patients treated in the clinical studies enrolled in a long-term follow-up study. The duration of follow-up from the time of gene therapy ranged from 51.6 to 126.5 months (approximately 4.3 to 10.5 years).", "truncated": false}, "after_length": 530, "after_sha256": "c8878c8c3d4af73b32330edda898b4a1b7ccccdd390f97f87b128df04683e6fd", "annex": "I", "before": {"end": 526, "start": 0, "text": "The safety information was observed in 3 open-label clinical studies in which eladocagene exuparvovec was administered to 30 AADC-deficient patients aged 19 months to 8.5 years at the time of dosing. Patients were followed for a median duration of 59.3 months (minimum of 11.8 months to a maximum of 5.7 years). Twenty-six patients treated in the clinical studies enrolled in a long-term follow-up study. The duration of follow-up from the time of gene therapy ranged from 27.2 to 126.5 months (approximately 2 to 10.5 years).", "truncated": false}, "before_length": 526, "before_sha256": "717257ecca3594f8cda175a746aac6a30be190585cdba300ae23fa3f778e225c", "change_kind": "content", "change_operations": [{"after_end": 324, "after_start": 320, "before_end": 322, "before_start": 320, "kind": "replace"}, {"after_end": 477, "after_start": 475, "before_end": 475, "before_start": 473, "kind": "replace"}, {"after_end": 479, "after_start": 478, "before_end": 477, "before_start": 476, "kind": "replace"}, {"after_end": 514, "after_start": 511, "before_end": 510, "before_start": 509, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 10}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1e8223cb2612f036ba7d67ef", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005352", "medicine_name": "Upstaza", "medicine_slug": "upstaza", "observed_at": "2026-10-12T13:36:07Z", "pipeline_version": "2.0.0", "presentation_label": "Upstaza 2.8 × 1011 vector genomes (vg)/0.5 mL solution for infusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "8561a0c5aed752dd415d30acef76bf620ad205d702080a0bca765e086873fe20", "source_snapshot_id": "source-4b712d5f9e4e2e8cd620aa93", "source_updated_at": "2026-06-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/upstaza-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 159}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IV", "before": {"end": 84, "start": 0, "text": "Motifs de la modification des termes de la/des autorisation(s) de mise sur le marché", "truncated": false}, "before_length": 84, "before_sha256": "4ae2391ae7d822fcc157b2047bb5fc98dea0742b977efc28a87cde01dda2e02a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 84, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 84, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1ed182cc2419f110d87a7fbe", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:32:00Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "3ff8cd4d67d22ba799aa348aeda944d6d896a16dcf54b030db101cbc095fc8ad", "source_snapshot_id": "source-a79a7cba8bf5dbc72fd40574", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3524}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "nordics@mundipharma.dk", "truncated": false}, "before_length": 22, "before_sha256": "f439d81e92f339fb15af44387dc1531c6265af6c724b25a05f18a5ab6acd0f1e", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 22, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 22, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1edda70784e214973b6f4396", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1083}
{"after": {"end": 18, "start": 0, "text": "Tel: +372 614 4200", "truncated": false}, "after_length": 18, "after_sha256": "7d3522618730b1de908f19c99d5ea234b90d83a5325dd2ec72bca1ef54fabcae", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "Tel: + 372 614 4200", "truncated": false}, "before_length": 19, "before_sha256": "6c17b65f6dae7b7eb8a66b70911f988e73da3c441a896be83003ab51482ef3fd", "change_kind": "content", "change_operations": [{"after_end": 6, "after_start": 6, "before_end": 7, "before_start": 6, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1f05123c0e32320d001e3a25", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3520}
{"after": {"end": 8, "start": 0, "text": "Pays-Bas", "truncated": false}, "after_length": 8, "after_sha256": "2f1d512c96e61c1e31319fc9326840a0ea9ab221bba6bbdca327b162ac12fa51", "annex": "II", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 8, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1f30d1399375036f68445eb1", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 545}
{"after": {"end": 169, "start": 0, "text": "• Press the push button fully in. Hold it pressed in until the dose indication has turned back to the start position. Some medicine must be expelled from the needle tip.", "truncated": false}, "after_length": 169, "after_sha256": "14dbee33eeedb004076c4a7a6b6c4d1ddc8bd3a563f139a63ee5237bcc884be4", "annex": "IIIA", "before": {"end": 178, "start": 0, "text": "• Press the push button fully in. Hold it pressed in until the dose indication has turned back to the start position. Some drops of medicine must be expelled from the needle tip.", "truncated": false}, "before_length": 178, "before_sha256": "f8db0fff893fb5b32434de0fc3f97cdf4b2ec18121b63cd6f0642f0ce0772282", "change_kind": "content", "change_operations": [{"after_end": 123, "after_start": 123, "before_end": 132, "before_start": 123, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 9, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1f457e84443056ef54c834cf", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2018}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "Tel.: + (48 22) 3824850", "truncated": false}, "before_length": 23, "before_sha256": "2c455292fbe8258120ef5ec846952b728b3dff75a9a64145d2a25b23af2e3a60", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 23, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 23, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1f87c2ce5c24a3298a4957a3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1087}
{"after": {"end": 102, "start": 0, "text": "Suivez toujours les instructions fournies ci-dessous et au verso lors de l’utilisation du Terrosa Pen.", "truncated": false}, "after_length": 102, "after_sha256": "261ea093853463216d8940e0630a2a7abbc7686599e3a56367556c09d9c442ba", "annex": "IIIA", "before": {"end": 104, "start": 0, "text": "Suivez toujours les instructions fournies ci-dessous et au verso lors de l’utilisation du stylo Terrosa.", "truncated": false}, "before_length": 104, "before_sha256": "cdbbf78be06e75891c857b544d1fe4d26b850c3b1337ed72858c9c2de71d776a", "change_kind": "content", "change_operations": [{"after_end": 90, "after_start": 90, "before_end": 96, "before_start": 90, "kind": "delete"}, {"after_end": 101, "after_start": 97, "before_end": 103, "before_start": 103, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-1f9d1d862ad17159aa4205f3", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1945}
{"after": {"end": 54, "start": 0, "text": "Each ml of oral suspension contains 0.5 mg perampanel.", "truncated": false}, "after_length": 54, "after_sha256": "eb42be99f3d1d6c60f59cccc5902172c55551b3a904c5e73bc02b5cb6615fc3e", "annex": "I", "before": {"end": 53, "start": 0, "text": "Each ml of oral suspension contains 0.5 mg perampanel", "truncated": false}, "before_length": 53, "before_sha256": "6ec0e36d4b2f4111163bebb45b194a68ae5d10aea4d9d654558e92ddb56ab232", "change_kind": "content", "change_operations": [{"after_end": 54, "after_start": 53, "before_end": 53, "before_start": 53, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2004c1518a275b1ad50cf842", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "Fycompa 0.5 mg/ml oral suspension", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "2", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 857}
{"after": {"end": 29, "start": 0, "text": "Survie sans progression (SSP)", "truncated": false}, "after_length": 29, "after_sha256": "617193974d6682c85a8af219a6f2b06ff66ff3e0e9b29cabebd5d5998461e7d8", "annex": "I", "before": {"end": 29, "start": 0, "text": "Survie sans progression (PFS)", "truncated": false}, "before_length": 29, "before_sha256": "8f5b37d99ddf529df1ca72d62d3cc355e8dee70624f1335d36a06a6f71013027", "change_kind": "content", "change_operations": [{"after_end": 27, "after_start": 25, "before_end": 25, "before_start": 25, "kind": "insert"}, {"after_end": 28, "after_start": 28, "before_end": 28, "before_start": 26, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-20362df8ffaf72d6fbb2e800", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1535}
{"after": {"end": 80, "start": 0, "text": "have symptoms of low blood pressure like dizziness, lightheadedness or fainting,", "truncated": false}, "after_length": 80, "after_sha256": "855f9d47d97b7c5421092a7ffaba1d00847b46014921cf3639baa82783219041", "annex": "IIIA", "before": {"end": 83, "start": 0, "text": "have symptoms of low blood pressure like dizziness, lightheadedness or fainting, or", "truncated": false}, "before_length": 83, "before_sha256": "cc0b709d3b013229f35b337db8941c5f8d579d29035df10cc67670d02f39f208", "change_kind": "content", "change_operations": [{"after_end": 80, "after_start": 80, "before_end": 83, "before_start": 80, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 3, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-20374ad062b321d1ebb78fcd", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2745}
{"after": {"end": 8, "start": 0, "text": "ANNEX IV", "truncated": false}, "after_length": 8, "after_sha256": "29972ab77d4b1358a0bdb16d438bcde59007e95356d1f5f9ee2f7045597f9574", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 8, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-203c69a08c35a8afc4044ba8", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3436}
{"after": {"end": 325, "start": 0, "text": "In view of available data on polymyalgia rheumatica, the PRAC considers a causal relationship between tremelimumab in combination with durvalumab and polymyalgia rheumatica is at least a reasonable possibility. The PRAC concluded that the product information of products containing tremelimumab should be amended accordingly.", "truncated": false}, "after_length": 325, "after_sha256": "85e78d79b56f3a2467ae6391220ed52f5d2c64aef48e12979df9c38ba81f39cf", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 325, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 325}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-204fa487c782094a233b0bd0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2540}
{"after": {"end": 56, "start": 0, "text": "Uncommon side effects (may affect up to 1 in 100 people)", "truncated": false}, "after_length": 56, "after_sha256": "097994ea97aad54ece5a69680f688335da9efccab6fc855f5d56021bd4f6d711", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 56, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 56}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-20a5fbf649b85340c2295643", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:30Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "35ab6716aa09492c14ac6849111486ec47235c0bc65ef055350de950f316c5e6", "source_snapshot_id": "source-f20a60110d1f8fef5225317d", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2367}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 103, "start": 0, "text": "Within this period, singledose vials may be transported up to 36 hours at 2°C to 8°C (see section 6.4).", "truncated": false}, "before_length": 103, "before_sha256": "f01da0cc23014af6fc3526831d1da91e1d3d908e1a76cf394a0b05dc52f6fecc", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 103, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 103, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-20acd090ba58a8d4e968a8aa", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.3", "section_type": "storage", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6253}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 6, "start": 0, "text": "España", "truncated": false}, "before_length": 6, "before_sha256": "f85c9fe36948469b69f31fb5026694619ce4dc122757ece67c8584ff8f2ac008", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 6, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-20af5896ff59f8ebe95e5001", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1080}
{"after": {"end": 222, "start": 0, "text": "Users are persons with sufficient visual, manual and tactile skills to operate the Terrosa Pen according to the instructions for use (IFU). In case of impairments, a consultation with the prescribing physician is required.", "truncated": false}, "after_length": 222, "after_sha256": "f4f0ea0602044e9cfe3b515805170d0b8edb1fa1517499dc97505ddb21f67dbd", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 222, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 222}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-21034bd0c59bc6efe5826c15", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1954}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 31, "start": 0, "text": "ТП„Мундифарма Гезелшафт м.б.Х.“", "truncated": false}, "before_length": 31, "before_sha256": "49dd41fdb39cb7e04d6b411179b3a1fa9c315294e03fb9900237a3962f3dc273", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 31, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 31, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-213cb9af1ccf95351993112e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1024}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 33, "start": 0, "text": "United Kingdom (Northern Ireland)", "truncated": false}, "before_length": 33, "before_sha256": "9379d82927cdb505cfb186e912177065e56a1314de3a2b914ebbb8b5fe21525a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 33, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 33, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-216e5b4e9479807e28a55809", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12299}
{"after": {"end": 50, "start": 0, "text": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection", "truncated": false}, "after_length": 50, "after_sha256": "8c0d5490a68da1e449c0490ed0defe0da9d9d8c2d6ae11271b883fa7dfd5a64a", "annex": "IIIA", "before": {"end": 48, "start": 0, "text": "Spikevax JN.1 0.1 mg/mL dispersion for injection", "truncated": false}, "before_length": 48, "before_sha256": "f251c20d6a11d153458ca69aaf22627ccbe0cce3064c14f8eb27faf9c2c0f105", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2184a87e4fb8e0e0a187845f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9159}
{"after": {"end": 92, "start": 0, "text": "Table 5. Thawing instructions for Spikevax LP.8.1 pre-filled syringes and cartons before use", "truncated": false}, "after_length": 92, "after_sha256": "23296eacb800c29762deea796132c4b73a30f4761201f71e4c888c4dba51c90a", "annex": "I", "before": {"end": 90, "start": 0, "text": "Table 6. Thawing instructions for Spikevax JN.1 pre-filled syringes and cartons before use", "truncated": false}, "before_length": 90, "before_sha256": "464f0d720ce6e11fe7db300f700a90211f92d04ff279c26a0336147b3c08cd74", "change_kind": "administrative", "change_operations": [{"after_end": 7, "after_start": 6, "before_end": 7, "before_start": 6, "kind": "replace"}, {"after_end": 47, "after_start": 43, "before_end": 45, "before_start": 43, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 3, "chars_inserted": 5}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-21afd1143e695077ef2d83c3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13124}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 14, "start": 0, "text": "Pfizer Limited", "truncated": false}, "before_length": 14, "before_sha256": "faadd350d247ecbb0e8edac0805fa3d4cdbf449fbb9a1a9614eee6624274a2f6", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-21d068f94d830b1b05d7a318", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9098}
{"after": {"end": 38, "start": 0, "text": "The Patient Information Card includes:", "truncated": false}, "after_length": 38, "after_sha256": "005b8c4cc471e8db582d960f7c535d2bb87c0248b24a79e1d63d847f379190f6", "annex": "II", "before": {"end": 44, "start": 0, "text": "The Patient Information Card should include:", "truncated": false}, "before_length": 44, "before_sha256": "f732c386a7ba3a3d9f281490b3b982f233d8368adb45b24ad96f61ecb667e14e", "change_kind": "content", "change_operations": [{"after_end": 29, "after_start": 29, "before_end": 36, "before_start": 29, "kind": "delete"}, {"after_end": 37, "after_start": 36, "before_end": 43, "before_start": 43, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-21d09bc1fbdff065ac7c4eef", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:33Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "21d66bf1e9a74479f577de09da3cf8517d65c1ce1b1d8bbdfe4bc38f79410def", "source_snapshot_id": "source-2c39c998fdaf05159687c016", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 435}
{"after": {"end": 141, "start": 0, "text": "Pour plus d’informations, voir le site web de l’Agence européenne des médicaments: https://www.ema.europa.eu/en/medicines/human/EPAR/cometriq", "truncated": false}, "after_length": 141, "after_sha256": "df166bdd6469d295a03e5e45b6dfbfdc61539ce9ffea31d7aacd3b77c91f4faf", "annex": "", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 141, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 141}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-21da218314050f82131bd31c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002640", "medicine_name": "Cometriq", "medicine_slug": "cometriq", "observed_at": "2026-10-12T19:00:55Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "c7f8aa8da9127064263770c4aed5506128bacd0c40693b863c48a757d735203e", "source_snapshot_id": "source-e4fa0b9c95a2e427d4c95a33", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/cometriq-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "Tel: +44 (0)1304 616161", "truncated": false}, "before_length": 23, "before_sha256": "eba81e6ccdbae471c024a5ba77d9ec9e0617a3c443fd22205a626861e87fbd8c", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 23, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 23, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-21dad803e2ad23b290dc1cd0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 10020}
{"after": {"end": 1, "start": 0, "text": "-", "truncated": false}, "after_length": 1, "after_sha256": "3973e022e93220f9212c18d0d0c543ae7c309e46640da93a4a0314de999f5112", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 1, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-21e92c8896d07f6152feaa24", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:18Z", "pipeline_version": "2.0.0", "presentation_label": "IMJUDO 20 mg/ml, solution à diluer pour perfusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "2437ab76633f46c9eee5e002e5c7a7caba6367f59567d750be0eb67c74d1db4e", "source_snapshot_id": "source-7f4d129b0a0fd2d3684d27c5", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 832}
{"after": {"end": 15, "start": 0, "text": "3832 RC Leusden", "truncated": false}, "after_length": 15, "after_sha256": "ba405ef0bf36eca0b0c6d25a5c566d076892169d711c353d3632e2a334a18c52", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 15, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 15}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-22266bc2c4341ba2add6cc21", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1024}
{"after": {"end": 19, "start": 0, "text": "Mundipharma DC B.V.", "truncated": false}, "after_length": 19, "after_sha256": "e3293d50ef13895d680c96110997100aa9ea415c79a538edde8c542ffb4f7ce6", "annex": "II", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 19, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 19}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-22a8444d3c49178176cdcde9", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 542}
{"after": {"end": 59, "start": 0, "text": "l’erlotinib, le géfitinib, utilisés pour traiter le cancer.", "truncated": false}, "after_length": 59, "after_sha256": "c90290125bf01fb5021f2497797f33b3d52068fe8bebc5487344502cc3790e9e", "annex": "IIIA", "before": {"end": 42, "start": 0, "text": "du cancer comme l’erlotinib, le géfitinib.", "truncated": false}, "before_length": 42, "before_sha256": "f3567bfd0c8f279021bdd5ce8944e8549faf966d1951191c11456e76da8c1286", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 16, "before_start": 0, "kind": "delete"}, {"after_end": 58, "after_start": 25, "before_end": 41, "before_start": 41, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 16, "chars_inserted": 33}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-22bfa32e30a7a633c159d3d3", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3303}
{"after": {"end": 113, "start": 0, "text": "2. Quelles sont les informations à connaître avant d’utiliser Nyxoid 1,8 mg, solution pour pulvérisation nasale ?", "truncated": false}, "after_length": 113, "after_sha256": "30da97fe83201916a10fd111c4c126ead9909276bbf3c77885844f03fd8d3d03", "annex": "IIIA", "before": {"end": 111, "start": 0, "text": "2. Quelles sont les informations à connaître avant d’utiliser Nyxoid 1,8 mg, solution pour pulvérisation nasale", "truncated": false}, "before_length": 111, "before_sha256": "7526c0c574fc8df9ea186f6daf050aad7a3871511aa4573b4bdf7ccf20b54a23", "change_kind": "content", "change_operations": [{"after_end": 113, "after_start": 111, "before_end": 111, "before_start": 111, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-22f2f10660be50817103f1e2", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 766}
{"after": {"end": 367, "start": 0, "text": "For countries where Nyxoid is not on the market and no educational materials have been approved, nyxoid.com will indicate this under the country link and will provide a link to the approved patient information leaflet for that country which also contains the key information presented in the educational materials on how to identify an overdose and how to use Nyxoid.", "truncated": false}, "after_length": 367, "after_sha256": "4cd5b6bc8d2e6dc50ca5153d221c4940bf0cc2cb33a07fdec85e2dbd02f25c83", "annex": "II", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 367, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 367}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-231f92ef3ab2d52163fb217c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:33Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "21d66bf1e9a74479f577de09da3cf8517d65c1ce1b1d8bbdfe4bc38f79410def", "source_snapshot_id": "source-2c39c998fdaf05159687c016", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 462}
{"after": {"end": 727, "start": 0, "text": "However, a large amount of observational data from pregnant women vaccinated with Spikevax (original) during the second and third trimester has not shown an increase in adverse pregnancy outcomes. While data on pregnancy outcomes following vaccination during the first trimester are presently limited, no increased risk for miscarriage has been seen. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development (see section 5.3). Since differences between products are confined to the spike protein sequence, and there are no clinically meaningful differences in reactogenicity, SARSCoV2 LP.8.1 mRNA can be used during pregnancy.", "truncated": false}, "after_length": 727, "after_sha256": "0d50bb3acf4fd274cfc102e556757f0d3e8d97878774b153452de247f81c2643", "annex": "I", "before": {"end": 725, "start": 0, "text": "However, a large amount of observational data from pregnant women vaccinated with Spikevax (original) during the second and third trimester has not shown an increase in adverse pregnancy outcomes. While data on pregnancy outcomes following vaccination during the first trimester are presently limited, no increased risk for miscarriage has been seen. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development (see section 5.3). Since differences between products are confined to the spike protein sequence, and there are no clinically meaningful differences in reactogenicity, SARSCoV2 JN.1 mRNA can be used during pregnancy.", "truncated": false}, "before_length": 725, "before_sha256": "1b4f8ac3e09bed86c33fb7f45c1c957fcee6b8269f6fb3b4ee2bfa02072e828c", "change_kind": "content", "change_operations": [{"after_end": 690, "after_start": 686, "before_end": 688, "before_start": 686, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2347c92eba1a38b1457506cc", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.6", "section_type": "pregnancy", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5619}
{"after": {"end": 13, "start": 0, "text": "1932 Zaventem", "truncated": false}, "after_length": 13, "after_sha256": "cffe4475a5de91da7a3a6363a4d41ccfd1405766d95ae182d89bf39b29686221", "annex": "IIIA", "before": {"end": 13, "start": 0, "text": "1930 Zaventem", "truncated": false}, "before_length": 13, "before_sha256": "ed9ea9385e3e50f6278214da5d7483a8543c36d1261df263d35022c5936c74db", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 4, "before_start": 3, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-23941a5f4bf1bf78225a99df", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004310", "medicine_name": "Daptomycin Hospira", "medicine_slug": "daptomycin-hospira", "observed_at": "2026-10-12T19:09:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e544a64f1681af82ba143ddd0cfa7cca4ef0de691ed43076b92bb75f66ec7f7b", "source_snapshot_id": "source-a214fce23bf43c3222026b3d", "source_updated_at": "2025-09-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/daptomycin-hospira-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1600}
{"after": {"end": 197, "start": 0, "text": "nitrates or nitric oxide donors such as amyl nitrite. These are medicines often used to treat high blood pressure, chest pain or heart disease. This also includes recreational drugs called poppers.", "truncated": false}, "after_length": 197, "after_sha256": "f2bdb81182b6b32853cffa30263faf6b158b7636a20027e7bae70d9670396d71", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 197, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 197}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-23947016f7dce78057ccf491", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2770}
{"after": {"end": 12, "start": 0, "text": "MSD Α.Φ.Ε.Ε.", "truncated": false}, "after_length": 12, "after_sha256": "2920f5081525207a4790665fb26df902fdae978fe29baab6a51bbb705bb0115e", "annex": "IIIA", "before": {"end": 11, "start": 0, "text": "MSD Α.Φ.Ε.Ε", "truncated": false}, "before_length": 11, "before_sha256": "59152f94c242dd20eb3ac511729a3bc6beb5b7295232b77ad5bd9aa45afa4c63", "change_kind": "content", "change_operations": [{"after_end": 12, "after_start": 11, "before_end": 11, "before_start": 11, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-23b2d408d743a5089316cd5f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3119}
{"after": {"end": 1, "start": 0, "text": "-", "truncated": false}, "after_length": 1, "after_sha256": "3973e022e93220f9212c18d0d0c543ae7c309e46640da93a4a0314de999f5112", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 1, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-23e35ae8dac514824b79022d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:18Z", "pipeline_version": "2.0.0", "presentation_label": "IMJUDO 20 mg/ml, solution à diluer pour perfusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "2437ab76633f46c9eee5e002e5c7a7caba6367f59567d750be0eb67c74d1db4e", "source_snapshot_id": "source-7f4d129b0a0fd2d3684d27c5", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 833}
{"after": {"end": 21, "start": 0, "text": "Block 2 Miesian Plaza", "truncated": false}, "after_length": 21, "after_sha256": "99b504ac4fff9020da29e00aeb786f0975177380626e2b3347bd3fbd75afeeba", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 21, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 21}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-23eae0feab68fa759cf19cfd", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1211}
{"after": {"end": 20, "start": 0, "text": "Tel. +370 5 2780 247", "truncated": false}, "after_length": 20, "after_sha256": "be9916884a39997d225e35a54dcbad608c2f1450d383ed91a2b2c37447acf059", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tel: + 370 5 2780 247", "truncated": false}, "before_length": 21, "before_sha256": "faa31f75401420bbf0ff6f06d92fff41d82385ffc387084762acc731facfdedc", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 4, "before_start": 3, "kind": "replace"}, {"after_end": 6, "after_start": 6, "before_end": 7, "before_start": 6, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2467e4a3e58e01574a86470d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3065}
{"after": {"end": 55, "start": 0, "text": "Do not remove the needle cap until instructed to do so.", "truncated": false}, "after_length": 55, "after_sha256": "31e19a488e6bcba148e42b0432b26c21723ca81297fb6ae98b737e5f2bbe22b0", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 55, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 55}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-24733ea37f97dadf8797d993", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11695}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "Tel.: + (48 22) 3824850", "truncated": false}, "before_length": 23, "before_sha256": "2c455292fbe8258120ef5ec846952b728b3dff75a9a64145d2a25b23af2e3a60", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 23, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 23, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-24b0eb9b466c00800e9fc309", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1100}
{"after": {"end": 205, "start": 0, "text": "• Un chiffon humide suffit pour nettoyer votre stylo. N’utilisez pas d’alcool, d’autres solvants ou de produits de nettoyage. N’immergez jamais votre Terrosa Pen dans l’eau, car cela pourrait l’endommager.", "truncated": false}, "after_length": 205, "after_sha256": "59a9ecfe060ff1a9b3ce4310aafa10df87e90f365f271153a506d7758ec85b49", "annex": "IIIA", "before": {"end": 207, "start": 0, "text": "• Un chiffon humide suffit pour nettoyer votre stylo. N’utilisez pas d’alcool, d’autres solvants ou de produits de nettoyage. N’immergez jamais votre stylo Terrosa dans l’eau, car cela pourrait l’endommager.", "truncated": false}, "before_length": 207, "before_sha256": "c6c2f2f2b585733d3ef8fea7008422323502824a4891fc273f38c4792201dfe6", "change_kind": "content", "change_operations": [{"after_end": 150, "after_start": 150, "before_end": 156, "before_start": 150, "kind": "delete"}, {"after_end": 161, "after_start": 157, "before_end": 163, "before_start": 163, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-24b5ca2f60b330cb7424c9ea", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2090}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 95, "start": 0, "text": "If the vaccine is received at 2°C to 8°C, it should be stored at 2°C to 8°C. The expiry date on", "truncated": false}, "before_length": 95, "before_sha256": "4db24e7c68722f05450cc8ab4b3981bc76c9f42afa8f0ea5654957f7abc3bb89", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 95, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 95, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-24e3ec7397ac6947c0b16cb5", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13104}
{"after": {"end": 167, "start": 0, "text": "If you see blood at the injection site after the needle is removed, gently apply pressure on your skin by using a cotton pad or similar. Do not rub the injection site.", "truncated": false}, "after_length": 167, "after_sha256": "fb44c1be61a0b38772f78de6dfb7c9e7b45e15d5ff2ec9a314278d24e518cb38", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 167, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 167}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-24e7345fb48d86ff1dd5de2b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2089}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "nordics@mundipharma.dk", "truncated": false}, "before_length": 22, "before_sha256": "f439d81e92f339fb15af44387dc1531c6265af6c724b25a05f18a5ab6acd0f1e", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 22, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 22, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-24f85c85d99af2e21a02af02", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1137}
{"after": {"end": 18, "start": 0, "text": "info-msdbg@msd.com", "truncated": false}, "after_length": 18, "after_sha256": "a9564ace7f83680b30d249e1267cfecfc6de3252d14464719ba30061fb8124b8", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "info-msdbg@merck.com", "truncated": false}, "before_length": 20, "before_sha256": "0b46e48b14b2f549da86787bd2d27cc0b14ced470375af44415dc160418b8ba4", "change_kind": "content", "change_operations": [{"after_end": 14, "after_start": 12, "before_end": 16, "before_start": 12, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-251641632052b39ed3485356", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3481}
{"after": {"end": 321, "start": 0, "text": "Mise à jour de la rubrique 4.4 du RCP afin de modifier la mise en garde actuelle portant sur les « Affections psychiatriques », et mise à jour de la rubrique 4.8 du RCP afin d’ajouter les effets indésirables « anxiété » et « humeur modifiée » avec une fréquence « peu fréquent ». La notice est mise à jour en conséquence.", "truncated": false}, "after_length": 321, "after_sha256": "526db5fdeb009afc2778658998fea5318809a8ea2db2a47402437f02d4893842", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 321, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 321}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-251f0a83fe20b836dbd2af4e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "9ac80b0d56ebad4970f7a8335a177613af59ef25517bcd0bdd3397c207cc1bac", "source_snapshot_id": "source-c11aa9e32420f125a88005bc", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2717}
{"after": {"end": 50, "start": 0, "text": "DES TERMES DES AUTORISATIONS DE MISE SUR LE MARCHÉ", "truncated": false}, "after_length": 50, "after_sha256": "903bb45a1b7886b51dc795eb5d870ef367f3f6b04c33c742569a6e4ed036ed7c", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 50, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 50}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-25534d4658089574408be6b1", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3397}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "Tel: +351 21 901 31 62", "truncated": false}, "before_length": 22, "before_sha256": "4fed4b1633437ec1d2d291235f0428ccd51ae54dd7bf54f0dfd0a7def72a4a1d", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 22, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 22, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-255a351b1995a669f405fea6", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1110}
{"after": {"end": 20, "start": 0, "text": "Tel.: +36 1 888 5300", "truncated": false}, "after_length": 20, "after_sha256": "b83b25ec254a4166b3f210dedbd33d8e207b4ceaadec1095ccd49882767eb509", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tel.: + 36 1 888 5300", "truncated": false}, "before_length": 21, "before_sha256": "e840a2e7dcac912eac697222649c523cf85354b94f2ef4174a7e446b7bf36b6f", "change_kind": "content", "change_operations": [{"after_end": 7, "after_start": 7, "before_end": 8, "before_start": 7, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2567c160f7627cf083a5e83e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3399}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 35, "start": 0, "text": "Mundipharma Pharmaceuticals Limited", "truncated": false}, "before_length": 35, "before_sha256": "c9f3bc818698700e6aea923854537c9e902c0d2d4a55bc83c3346f2abbcfd880", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 35, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 35, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-256c4ae44e0df2b65438f32a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1117}
{"after": {"end": 283, "start": 0, "text": "les inhibiteurs de la PDE-5 tels que le sildénafil, le tadalafil ou le vardénafil. Ces médicaments sont utilisés pour traiter l’hypertension artérielle pulmonaire (pression sanguine élevée dans les artères des poumons) ou pour traiter les problèmes d’érection (dysfonction érectile).", "truncated": false}, "after_length": 283, "after_sha256": "279d99a9cef605f0dbd56cc664a400ea4471714a54e094b6f3df8b90f95cde2c", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 283, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 283}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-258c6563a2dc550895e3d134", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2850}
{"after": {"end": 119, "start": 0, "text": "Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu", "truncated": false}, "after_length": 119, "after_sha256": "0f2b81ab8009e1a279ca008eb6e21bdb2e532de63aef52b62bdac980c49555d4", "annex": "IIIA", "before": {"end": 118, "start": 0, "text": "Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu", "truncated": false}, "before_length": 118, "before_sha256": "d114210a3c6f4b6710e22609ee80410ff17f5efd93b30ab72728a60b65635068", "change_kind": "technical", "change_operations": [{"after_end": 99, "after_start": 98, "before_end": 98, "before_start": 98, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2593f7bb8172f2f50a571ee2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11069}
{"after": {"end": 54, "start": 0, "text": "ee Includes oedema peripheral and peripheral swelling.", "truncated": false}, "after_length": 54, "after_sha256": "c61ef5163e245023a1eb0e6a0785aef1e35645d29b8a88517bd14cd153826de1", "annex": "I", "before": {"end": 54, "start": 0, "text": "dd Includes oedema peripheral and peripheral swelling.", "truncated": false}, "before_length": 54, "before_sha256": "8da3affff0227b6f63363170a401813b508c899214811fa49b49cf79f39a6fc3", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 0, "before_end": 2, "before_start": 0, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-25975b46edabf12acd001220", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "IMJUDO 20 mg/ml concentrate for solution for infusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 934}
{"after": {"end": 19, "start": 0, "text": "Tel.: +371 67025300", "truncated": false}, "after_length": 19, "after_sha256": "9d56d23b23e1cc8fe2e91dfd2c53e6e0d7c450088c854b2bc903cc7de0211cce", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Tel.: + 371 67025300", "truncated": false}, "before_length": 20, "before_sha256": "4827747deaf690f224c8bd3d87c76b9541304a06d0d293efd223d7eb4b6cb8df", "change_kind": "content", "change_operations": [{"after_end": 7, "after_start": 7, "before_end": 8, "before_start": 7, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-25baf66f8fa7435364971a7b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3512}
{"after": {"end": 134, "start": 0, "text": "do not start Adempas for at least 24 hours after your last dose of sildenafil and at least 72 hours after your last dose of tadalafil.", "truncated": false}, "after_length": 134, "after_sha256": "5e6d76f0ace445ef090105fc574a9e4d5972057867fb147ef5d9aca2f01aa748", "annex": "IIIA", "before": {"end": 134, "start": 0, "text": "do not start Adempas for at least 24 hours after your last dose of sildenafil and at least 48 hours after your last dose of tadalafil.", "truncated": false}, "before_length": 134, "before_sha256": "76e7cef14aefd617bf2d2b3345b9a219917d1b227f6449e3fa445110ba4108bd", "change_kind": "content", "change_operations": [{"after_end": 93, "after_start": 91, "before_end": 93, "before_start": 91, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-25c79efbf01bd539dd1160a3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3282}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 24, "start": 0, "text": "Tél/Tel: +32 2 358 54 68", "truncated": false}, "before_length": 24, "before_sha256": "41a8515e0ad87e2db6e34f58a5b4db10b75995776214e98d6be98b1aa31eee38", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 24, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 24, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-25d00759585dc624926f0a85", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1031}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 6, "start": 0, "text": "Polska", "truncated": false}, "before_length": 6, "before_sha256": "d1974e0e3e575b6dadb40f080dae05025f574cb23e5cababcac0f50cf2619549", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 6, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2604c3d5e28f316dde114a08", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1085}
{"after": {"end": 54, "start": 0, "text": "Takeda Pharmaceuticals International AG Ireland Branch", "truncated": false}, "after_length": 54, "after_sha256": "81709515d3af1f0e4041ce3c760d8fc81fefa358805810b0b53a84e121d5efa6", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "administrative", "change_operations": [{"after_end": 54, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 54}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-260fcba101025f1da3d528eb", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "Qdenga poudre et solvant pour solution injectable. Qdenga poudre et solvant pour solution injectable en seringue pré-remplie Vaccin tétravalent contre la dengue (vivant, atténué)", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 974}
{"after": {"end": 12, "start": 0, "text": "Patient Card", "truncated": false}, "after_length": 12, "after_sha256": "b9f1d23d52aa92d0440f2d945975d6472a399b8df54492030bc43eea79e2edc1", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 12, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 12}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-264982fccac8d64b649e1b18", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6573}
{"after": {"end": 638, "start": 0, "text": "Les caractéristiques des concentrations sériques moyennes à l’état d’équilibre chez les patients atteints de PR étaient une Cmax de 2,4 mg/l vs 2,6 mg/l, une Cmin de 1,2 mg/l vs 1,4 mg/l, et une ASC partielle (ASC) de 297 mgh/l vs 316 mgh/l pour la dose de 50 mg d’Enbrel une fois par semaine (n = 21) vs 25 mg d’Enbrel deux fois par semaine (n = 16) respectivement. Dans une étude en ouvert, croisée, avec administration unique de deux posologies différentes chez des volontaires sains, il a été démontré que l’administration d’une injection unique de 50 mg/mL d’etanercept était bioéquivalente à deux injections simultanées de 25 mg/mL.", "truncated": false}, "after_length": 638, "after_sha256": "125202bcbbeb6f972668bd417fafddcda94679e6db54c2450d6888c848504361", "annex": "I", "before": {"end": 638, "start": 0, "text": "Les caractéristiques des concentrations sériques moyennes à l’état d’équilibre chez les patients atteints de PR étaient une Cmax de 2,4 mg/l vs 2,6 mg/l, une Cmin de 1,2 mg/l vs 1,4 mg/l, et une ASC partielle (ASC) de 297 mgh/l vs 316 mgh/l pour la dose de 50 mg d’Enbrel une fois par semaine (n = 21) vs 25 mg d’Enbrel deux fois par semaine (n = 16) respectivement. Dans une étude en ouvert, croisée, avec administration unique de deux posologies différentes chez des volontaires sains, il a été démontré que l’administration d’une injection unique de 50 mg/ml d’etanercept était bioéquivalente à deux injections simultanées de 25 mg/ml.", "truncated": false}, "before_length": 638, "before_sha256": "2906ee17feb86d0ae479b293432455aea9200347d9a0446bc4aa4fef7411eac9", "change_kind": "content", "change_operations": [{"after_end": 561, "after_start": 560, "before_end": 561, "before_start": 560, "kind": "replace"}, {"after_end": 637, "after_start": 636, "before_end": 637, "before_start": 636, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-26fc25f0a21ca382d87fb0c6", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg solution injectable en seringue pré-remplie Enbrel 50 mg solution injectable en seringue pré-remplie", "presentation_occurrence": 3, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3283}
{"after": {"end": 22, "start": 0, "text": "Τηλ: +30 210 98 97 300", "truncated": false}, "after_length": 22, "after_sha256": "dd162db651d0bb933c67abbcfedf7247ba30b74281375422519823d66107bf57", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "Τηλ: + 30 210 98 97 300", "truncated": false}, "before_length": 23, "before_sha256": "1997a91a04dae627a7812e41999545eae97ed698432b9af730eba8006d8fde42", "change_kind": "content", "change_operations": [{"after_end": 6, "after_start": 6, "before_end": 7, "before_start": 6, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-271c504ae92562dcad54948f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3530}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "II", "before": {"end": 14, "start": 0, "text": "Delpharm Dijon", "truncated": false}, "before_length": 14, "before_sha256": "488aa9484cf024ead28202226d4252020932466c3441a2c99248d9d96918b046", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-272de145b2ec5f46be1beec9", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000174", "medicine_name": "Plavix", "medicine_slug": "plavix", "observed_at": "2026-10-12T19:27:50Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "3818c2e3c9979bf5f8be3f164dfce187fccfccf62bbd1e3227c64ca7c00ad02f", "source_snapshot_id": "source-4aff1b64c7cf58337d33ecfa", "source_updated_at": "2025-07-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/plavix-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 787}
{"after": {"end": 22, "start": 0, "text": "Tel.: +48 22 549 51 00", "truncated": false}, "after_length": 22, "after_sha256": "b4f3ff473cb9a7a642bf71f33b5b5948d208175e4d85b587f2a38e81caf1a4cb", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tel: +48 22 549 51 00", "truncated": false}, "before_length": 21, "before_sha256": "222e9a202ca5b1cde4fca3b2b78aaf332f0c1aa8b98e03455889987c3316067a", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-27354c932ec817a12cdb3d00", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3048}
{"after": {"end": 554, "start": 0, "text": "En l’absence de données sur l’excrétion de la naloxone dans le lait maternel, l’effet de la naloxone chez le nourrisson allaité n’a pas été établi. Cependant, la biodisponibilité de la naloxone par voie orale étant très faible, l’effet chez un nourrisson allaité est négligeable. La prudence est de rigueur lorsque la naloxone est administrée à une mère allaitante, mais il n’est pas nécessaire d’arrêter l’allaitement. Les bébés allaités par une mère traitée par Nyxoid doivent être étroitement surveillés afin de vérifier la sédation et l’irritabilité.", "truncated": false}, "after_length": 554, "after_sha256": "6fc70f1509f394c1c540e0f829a210e5f868bc519c7ee5c7c3e6029eef34483b", "annex": "I", "before": {"end": 554, "start": 0, "text": "En l’absence de données sur l’excrétion de la naloxone dans le lait maternel, l’effet de la naloxone chez le nourrisson allaité n’a pas été établi. Cependant, la biodisponibilité de la naloxone par voie orale étant très faible, l’effet chez un nourrisson allaité est négligeable. La prudence est de rigueur lorsque la naloxone est administrée à une mère allaitante, mais il n’est pas nécessaire d’arrêter l’allaitement. Les bébés allaités par une mère traités par Nyxoid doivent être étroitement surveillés afin de vérifier la sédation et l’irritabilité.", "truncated": false}, "before_length": 554, "before_sha256": "63c87338d03018ab093a01f085292ab0eb98047300589e400f5b3a0a558d9f1f", "change_kind": "content", "change_operations": [{"after_end": 459, "after_start": 458, "before_end": 459, "before_start": 458, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-278ca8fe3916e29ab42d24a1", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "Nyxoid 1,8 mg, solution pour pulvérisation nasale en récipient unidose", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.6", "section_type": "pregnancy", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 134}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 14, "start": 0, "text": "Mundipharma BV", "truncated": false}, "before_length": 14, "before_sha256": "aa43c52e5bcfdc7b36232711c5dd25de9255fafdc355d6d9a2d1955654fe4598", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-27aaa0a7ef95fc425ae6755e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1045}
{"after": {"end": 50, "start": 0, "text": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection", "truncated": false}, "after_length": 50, "after_sha256": "8c0d5490a68da1e449c0490ed0defe0da9d9d8c2d6ae11271b883fa7dfd5a64a", "annex": "IIIA", "before": {"end": 48, "start": 0, "text": "Spikevax JN.1 0.1 mg/mL dispersion for injection", "truncated": false}, "before_length": 48, "before_sha256": "f251c20d6a11d153458ca69aaf22627ccbe0cce3064c14f8eb27faf9c2c0f105", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-281aa6405dea44585f1173ef", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9056}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 15, "start": 0, "text": "Česká republika", "truncated": false}, "before_length": 15, "before_sha256": "c768c215f215c71e7ffcbffe06cb1a66fa3c379a86285d5da65cef3c627bc09d", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 15, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 15, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-285eaeac7ae44389942b4d11", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1033}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 10, "start": 0, "text": "45 minutes", "truncated": false}, "before_length": 10, "before_sha256": "bc54807d7df55abaf214d21aef97ce35c150ce5c072cf6f287d6c790c72ab265", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 10, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 10, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-28a4acd7bf3a92b30694de00", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13095}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 33, "start": 0, "text": "United Kingdom (Northern Ireland)", "truncated": false}, "before_length": 33, "before_sha256": "9379d82927cdb505cfb186e912177065e56a1314de3a2b914ebbb8b5fe21525a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 33, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 33, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-28db849491063df758952161", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11058}
{"after": {"end": 92, "start": 0, "text": "Table 9. Thawing instructions for Spikevax LP.8.1 pre-filled syringes and cartons before use", "truncated": false}, "after_length": 92, "after_sha256": "1cef03b055e8f6da727e505e83b37d6ab4956e5149697548063f1139223d401b", "annex": "I", "before": {"end": 91, "start": 0, "text": "Table 10. Thawing instructions for Spikevax JN.1 pre-filled syringes and cartons before use", "truncated": false}, "before_length": 91, "before_sha256": "2a9874dcf169593622769ed2db769d5239bbd304f833d1f58178caf9be554817", "change_kind": "content", "change_operations": [{"after_end": 7, "after_start": 6, "before_end": 8, "before_start": 6, "kind": "replace"}, {"after_end": 47, "after_start": 43, "before_end": 46, "before_start": 44, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 5}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-28e859bad39177693e7b3f9e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6427}
{"after": {"end": 108, "start": 0, "text": "Vous aurez aussi besoin d’1 mL d’eau pour préparations injectables et d’une seringue pour administrer Enbrel", "truncated": false}, "after_length": 108, "after_sha256": "c401fbec1602ca338ccd9d88277cd1e10b7645258079550cdf880766606b2034", "annex": "IIIA", "before": {"end": 108, "start": 0, "text": "Vous aurez aussi besoin d’1 ml d’eau pour préparations injectables et d’une seringue pour administrer Enbrel", "truncated": false}, "before_length": 108, "before_sha256": "c7df10994694a2f8c8a074058eedbfe4872c011db5e44fc1f6d41c0bc9946b29", "change_kind": "content", "change_operations": [{"after_end": 30, "after_start": 29, "before_end": 30, "before_start": 29, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2907248a45889daecb20056e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6810}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 248, "start": 0, "text": "Write down the first injection date of each new cartridge. This helps you to know when the 28 daily doses per cartridge are used (see section 2 “Warnings and precautions” and section 3 “Preparing the pen for use” in the Package leaflet of Terrosa).", "truncated": false}, "before_length": 248, "before_sha256": "e695a0b58631990d9976ce7a8e389811e88d8a2dd88d89052a43ca0855e723f4", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 248, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 248, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2915011563a311ea6a09be3a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1979}
{"after": {"end": 740, "start": 0, "text": "Le cabozantinib a été associé à un risque accru d’insuffisance cardiaque. Ce risque peut être exacerbé par des effets indésirables fréquents du cabozantinib (par exemple, hypertension, hypothyroïdie et événements thrombotiques artériels), qui peuvent entraîner une insuffisance cardiaque. Les patients doivent être surveillés tout au long du traitement afin de détecter tout signe et symptôme d’insuffisance cardiaque. Ces effets indésirables doivent être pris en charge rapidement, une interruption du traitement et/ou une adaptation de la dose doivent être envisagées si nécessaire (voir rubrique 4.2) et le traitement par inhibiteur de tyrosine kinase doit être arrêté chez les patients qui développent une insuffisance cardiaque sévère.", "truncated": false}, "after_length": 740, "after_sha256": "ebed773d2c44a09f5134e38e96f19d98e5082eb837de6091898e868713fff81e", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 740, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 740}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-294bdc37a6262b4a40829bd5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002640", "medicine_name": "Cometriq", "medicine_slug": "cometriq", "observed_at": "2026-10-12T19:00:55Z", "pipeline_version": "2.0.0", "presentation_label": "COMETRIQ 20 mg, gélules COMETRIQ 80 mg, gélules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "c7f8aa8da9127064263770c4aed5506128bacd0c40693b863c48a757d735203e", "source_snapshot_id": "source-e4fa0b9c95a2e427d4c95a33", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/cometriq-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 144}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 6, "start": 0, "text": "España", "truncated": false}, "before_length": 6, "before_sha256": "f85c9fe36948469b69f31fb5026694619ce4dc122757ece67c8584ff8f2ac008", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 6, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2987c7e48dfd9d991242b7e4", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1094}
{"after": {"end": 66, "start": 0, "text": "Do not remove your Cartridge needle cap until instructed to do so.", "truncated": false}, "after_length": 66, "after_sha256": "5f44ff5490f870fad33f2b50b532b02a5e5205ddaf7d4ee09777ad6f91bdcde2", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 66, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 66}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-299424c541f377ed36b92446", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11645}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 10, "start": 0, "text": "45 minutes", "truncated": false}, "before_length": 10, "before_sha256": "bc54807d7df55abaf214d21aef97ce35c150ce5c072cf6f287d6c790c72ab265", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 10, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 10, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-29a71ec7cad3aed0388a7af7", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13102}
{"after": {"end": 118, "start": 0, "text": "Avastin peut entraîner une altération de la fertilité chez la femme. Contactez votre médecin pour plus d’informations.", "truncated": false}, "after_length": 118, "after_sha256": "a51efca6c50215aa5280881a7b106fceb7ecc53a191d5a9dd2f7965037ff888b", "annex": "IIIA", "before": {"end": 104, "start": 0, "text": "Avastin peut entraîner une altération de la fertilité. Contactez votre médecin pour plus d’informations.", "truncated": false}, "before_length": 104, "before_sha256": "5ae95026c8cf04a4ec07ff48bdfc00439a05ddee1991938212cf4e54ff3d8b25", "change_kind": "content", "change_operations": [{"after_end": 67, "after_start": 53, "before_end": 53, "before_start": 53, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 14}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-29adc792cc1c9ced18f63974", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3048}
{"after": {"end": 9, "start": 0, "text": "Oral use.", "truncated": false}, "after_length": 9, "after_sha256": "3cb600334d66cfc50b70bcea280eaeb9fc125e589d372d56f3fae261332b8ee9", "annex": "IIIA", "before": {"end": 8, "start": 0, "text": "Oral use", "truncated": false}, "before_length": 8, "before_sha256": "1a1f6c65b762e8cde9480afdbb709dcfb59c2d46c38f5d3112c9f605bcbdf25f", "change_kind": "content", "change_operations": [{"after_end": 9, "after_start": 8, "before_end": 8, "before_start": 8, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-29ee703ac8f725dad318eadd", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1821}
{"after": {"end": 72, "start": 0, "text": "Grounds for the variation to the terms of the marketing authorisation(s)", "truncated": false}, "after_length": 72, "after_sha256": "3186bdadc3d2480c65b477145e6ff994610239d4243371f493c1f2ab110ec5da", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 72, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 72}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-29ef5f02738e3cf767068db5", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3448}
{"after": {"end": 134, "start": 0, "text": "The safety and efficacy of Spikevax LP.8.1 in children less than 6 months of age have not yet been established. No data are available.", "truncated": false}, "after_length": 134, "after_sha256": "b5ab9b3a2c13fb9ade988988760deae373ff21d7e715c0f7b2e2eb307ab518f5", "annex": "I", "before": {"end": 132, "start": 0, "text": "The safety and efficacy of Spikevax JN.1 in children less than 6 months of age have not yet been established. No data are available.", "truncated": false}, "before_length": 132, "before_sha256": "bdbeb82e98a129829b04b3da61ab1e1a2556637973335e1010912e0bacf952f6", "change_kind": "content", "change_operations": [{"after_end": 40, "after_start": 36, "before_end": 38, "before_start": 36, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2a705b4b518bfbfaad45b844", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5532}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 14, "start": 0, "text": "Pfizer Limited", "truncated": false}, "before_length": 14, "before_sha256": "faadd350d247ecbb0e8edac0805fa3d4cdbf449fbb9a1a9614eee6624274a2f6", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2a7f5855f0097bfeeadbd3c4", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9576}
{"after": {"end": 225, "start": 0, "text": "Le récipient primaire comprend une ampoule en verre de type I contenant un bouchon en chlorobutyle siliconé contenant 0,1 mL de solution. L’emballage secondaire (actionneur) est composé de polypropylène et d’acier inoxydable.", "truncated": false}, "after_length": 225, "after_sha256": "02a23f78a0e70ba9f28f0135e9775c43effa41dd6f9adc1480a1962f683d13e4", "annex": "I", "before": {"end": 225, "start": 0, "text": "Le récipient primaire comprend une ampoule en verre de type I contenant un bouchon en chlorobutyle siliconé contenant 0,1 ml de solution. L’emballage secondaire (actionneur) est composé de polypropylène et d’acier inoxydable.", "truncated": false}, "before_length": 225, "before_sha256": "1147a737ab005c452693959cd84d945f0092bf4469baec5ff71deeae439d4de8", "change_kind": "content", "change_operations": [{"after_end": 124, "after_start": 123, "before_end": 124, "before_start": 123, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2abb4344241b423ef9a77233", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "Nyxoid 1,8 mg, solution pour pulvérisation nasale en récipient unidose", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.5", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 308}
{"after": {"end": 241, "start": 0, "text": "Ce document constitue les informations sur le produit approuvées pour Cometriq, les modifications apportées depuis la procédure précédente qui ont une incidence sur les informations sur le produit (EMA/VR/0000263255) étant mises en évidence.", "truncated": false}, "after_length": 241, "after_sha256": "22b74d76e80e5b4257c54e93ea57d2fd89de6038cf4de636424678548eee3f09", "annex": "", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 241, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 241}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2ad52b4466ef9c49d16a493b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002640", "medicine_name": "Cometriq", "medicine_slug": "cometriq", "observed_at": "2026-10-12T19:00:55Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "c7f8aa8da9127064263770c4aed5506128bacd0c40693b863c48a757d735203e", "source_snapshot_id": "source-e4fa0b9c95a2e427d4c95a33", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/cometriq-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 0}
{"after": {"end": 72, "start": 0, "text": "Grounds for the variation to the terms of the marketing authorisation(s)", "truncated": false}, "after_length": 72, "after_sha256": "3186bdadc3d2480c65b477145e6ff994610239d4243371f493c1f2ab110ec5da", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 72, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 72}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2ae05f27939854a04b7793ef", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2544}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 9, "start": 0, "text": "Slovenija", "truncated": false}, "before_length": 9, "before_sha256": "fa267dd198bd52b588eff3ae1ccd7c7ea1ac67b4d621fd44e50742c91809cac3", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 9, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 9, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2afd45cc9dd1bedc4eca7948", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1125}
{"after": {"end": 18, "start": 0, "text": "dpoccyprus@msd.com", "truncated": false}, "after_length": 18, "after_sha256": "492fae7e6db021703bcb80e4b139bc2be78a7e6cf4c6056a9314c70cfe643716", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "cyprus_info@merck.com", "truncated": false}, "before_length": 21, "before_sha256": "a6a31d0f7dc84283ce751c4e4d77e632a879da9a362680e26db9aa73403f7008", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}, {"after_end": 10, "after_start": 10, "before_end": 11, "before_start": 6, "kind": "delete"}, {"after_end": 14, "after_start": 12, "before_end": 17, "before_start": 13, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 9, "chars_inserted": 6}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2b0ce6bfd3883b80b6c01350", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3102}
{"after": {"end": 64, "start": 0, "text": "other soluble guanylate cyclase stimulators, such as vericiguat.", "truncated": false}, "after_length": 64, "after_sha256": "97aed5e38797a1c8c1bff120afcf015dfe8a74ff1508175b54788dc9956179b0", "annex": "IIIA", "before": {"end": 191, "start": 0, "text": "high blood pressure or heart disease such as nitrates and amyl nitrite, or another soluble guanylate cyclase stimulators such as vericiguat. Do not take these medicines together with Adempas.", "truncated": false}, "before_length": 191, "before_sha256": "3181119bcb3e48131944a4bf57e277a690b8694b268691ba86174edfe824517a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 77, "before_start": 0, "kind": "delete"}, {"after_end": 44, "after_start": 43, "before_end": 120, "before_start": 120, "kind": "insert"}, {"after_end": 63, "after_start": 63, "before_end": 190, "before_start": 139, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 128, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2b142bdaa06c95140eca8594", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3199}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "info@mundipharma.at", "truncated": false}, "before_length": 19, "before_sha256": "7b20dc8f57783374adb30e55d582211b3496a4f85781e5658eaffb383009893c", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 19, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 19, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2b1836f5a8a1cf5861b01a9b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1092}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tel.:+ 370 5 231 4658", "truncated": false}, "before_length": 21, "before_sha256": "f51302598bfdf813db86b99fb01306c70f457c7d688d0fda55807ca1140935db", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 21, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 21, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2b1ed08ecca516f884e5572d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1036}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 14, "start": 0, "text": "Mundipharma BV", "truncated": false}, "before_length": 14, "before_sha256": "aa43c52e5bcfdc7b36232711c5dd25de9255fafdc355d6d9a2d1955654fe4598", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2b259459751efe1fea878f7c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1030}
{"after": {"end": 161, "start": 0, "text": "PDE5 inhibitors such as sildenafil, tadalafil, or vardenafil. These are medicines to treat high blood pressure in lung arteries or to treat erectile dysfunction.", "truncated": false}, "after_length": 161, "after_sha256": "a431cc12ade8f1e770ba66c20970471f6b4114ec0ff7b9d86f291b27b7dbe463", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 161, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 161}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2b365b4a60ff0213610a4d14", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2769}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 16, "start": 0, "text": "Mundipharma GmbH", "truncated": false}, "before_length": 16, "before_sha256": "2de27f129414a5929fea0d2e4e89e1533c2f6c526e876dc36d57a357db32188a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 16, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 16, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2b5f91916533e3299fe467be", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1067}
{"after": {"end": 307, "start": 0, "text": "Dans une analyse pharmacocinétique de population chez des patients atteints de spondylarthrite ankylosante, les ASC de l’etanercept à l’état d’équilibre ont été de 466 gh/mL et de 474 gh/mL respectivement pour Enbrel 50 mg une fois par semaine (n = 154) et pour Enbrel 25 mg deux fois par semaine (n = 148).", "truncated": false}, "after_length": 307, "after_sha256": "1c43c823b021ca355a70ce91caf9457501b150b77ff3824f2ada9508e781e74b", "annex": "I", "before": {"end": 307, "start": 0, "text": "Dans une analyse pharmacocinétique de population chez des patients atteints de spondylarthrite ankylosante, les ASC de l’etanercept à l’état d’équilibre ont été de 466 gh/ml et de 474 gh/ml respectivement pour Enbrel 50 mg une fois par semaine (n = 154) et pour Enbrel 25 mg deux fois par semaine (n = 148).", "truncated": false}, "before_length": 307, "before_sha256": "5d8df1dfa3590f8cd7f05f183c4a37b7abc74223db55f470f360af9b806b6cab", "change_kind": "content", "change_operations": [{"after_end": 173, "after_start": 172, "before_end": 173, "before_start": 172, "kind": "replace"}, {"after_end": 189, "after_start": 188, "before_end": 189, "before_start": 188, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2b6e7e924fc2fe88f3684652", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg solution injectable en seringue pré-remplie Enbrel 50 mg solution injectable en seringue pré-remplie", "presentation_occurrence": 3, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3285}
{"after": {"end": 154, "start": 0, "text": "• Clean the injection site with an alcohol swab. Let the area air dry before you inject. Do not blow on the disinfected site to accelerate drying process.", "truncated": false}, "after_length": 154, "after_sha256": "91e3e598b20a0e54e2962c057b1bbf827e8b6a78f982d6305fa6db546897e4cf", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 154, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 154}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2b721bfcd79d3fa8bf8fcaf1", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2060}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Τηλ: + 353 1 206 3800", "truncated": false}, "before_length": 21, "before_sha256": "a050297c9d1beab810fdcd5ebcd16258aacb90bdf1ac91dea393687126595109", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 21, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 21, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2b76fddd93a84390f6553585", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1087}
{"after": {"end": 22, "start": 0, "text": "Τηλ: +30 210 98 97 300", "truncated": false}, "after_length": 22, "after_sha256": "dd162db651d0bb933c67abbcfedf7247ba30b74281375422519823d66107bf57", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "Τηλ: + 30 210 98 97 300", "truncated": false}, "before_length": 23, "before_sha256": "1997a91a04dae627a7812e41999545eae97ed698432b9af730eba8006d8fde42", "change_kind": "content", "change_operations": [{"after_end": 6, "after_start": 6, "before_end": 7, "before_start": 6, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2b9c3ebd54588de97b14aecb", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3434}
{"after": {"end": 43, "start": 0, "text": "Pfizer Healthcare Ireland Unlimited Company", "truncated": false}, "after_length": 43, "after_sha256": "1f203777a0ec6fed9c840d52631b6a74c7e25b5d318485d8147e2404f52dc981", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "Pfizer Healthcare Ireland", "truncated": false}, "before_length": 25, "before_sha256": "4beeea9b6d0c491f03a9511d9f9576b9c75cbcdcfd736e4934f768fdded936f5", "change_kind": "content", "change_operations": [{"after_end": 43, "after_start": 25, "before_end": 25, "before_start": 25, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 18}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2bb8319f4271d315861af09e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11145}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 17, "start": 0, "text": "Byk-Gulden-Str. 2", "truncated": false}, "before_length": 17, "before_sha256": "5dc95d013d793b6958719e5db82aa51cd0c1864e2e8bc9bfcf2cfded1a05eba6", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 17, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 17, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2c110add956d65473baf3ff4", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1337}
{"after": {"end": 44, "start": 0, "text": "l’erlotinib, utilisé pour traiter le cancer.", "truncated": false}, "after_length": 44, "after_sha256": "7e871719fc2070b82c0d9b2bf2dad1ef9e0e4f664681fcaadb1ec0f16b51edd8", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 44, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 44}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2c1c85177e6761e1bde9746f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2870}
{"after": {"end": 8, "start": 0, "text": "Dublin 2", "truncated": false}, "after_length": 8, "after_sha256": "b9d41e7d3be3ec3e12457949fb5c2f7be98290b5d2919e8b974df9c98fab02b9", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "administrative", "change_operations": [{"after_end": 8, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2c3af62931bc31c5bdabb88b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "Qdenga powder and solvent for solution for injection Qdenga powder and solvent for solution for injection in pre-filled syringe Dengue tetravalent vaccine (live, attenuated)", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 976}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 82, "start": 0, "text": "Do not shake or dilute. Swirl the vial gently after thawing and before withdrawal.", "truncated": false}, "before_length": 82, "before_sha256": "3bb837cece84c3915e889590ec4b81fff9fd0027a19fcfcb8995398702a7d3f8", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 82, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 82, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2c65587c150fc19ecb80ed81", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6382}
{"after": {"end": 24, "start": 0, "text": "dpoc_czechslovak@msd.com", "truncated": false}, "after_length": 24, "after_sha256": "337ee03ecaecb8e917a1c5d342c556aebf19918c2dc3ac63cf08adeafa748373", "annex": "IIIA", "before": {"end": 26, "start": 0, "text": "dpoc_czechslovak@merck.com", "truncated": false}, "before_length": 26, "before_sha256": "a4642d78bee1d644f5eed542e84f756d52a7869d19900b6efa351b35ef1062c2", "change_kind": "content", "change_operations": [{"after_end": 20, "after_start": 18, "before_end": 22, "before_start": 18, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2c9c683b2598c10c865538ca", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3491}
{"after": {"end": 20, "start": 0, "text": "Tlf.: +45 44 201 100", "truncated": false}, "after_length": 20, "after_sha256": "a342c892cb893e888e9b98929ab7ba413528a3b19847cefc774fcc7b2c91291e", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "Tlf: +45 44 201 100", "truncated": false}, "before_length": 19, "before_sha256": "c639c1fe70f9701d8cecb70d89ff79995abd4e41911073143438fc69a41a0363", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2cb670d526e7908837d8bd77", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 10074}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 33, "start": 0, "text": "United Kingdom (Northern Ireland)", "truncated": false}, "before_length": 33, "before_sha256": "9379d82927cdb505cfb186e912177065e56a1314de3a2b914ebbb8b5fe21525a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 33, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 33, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2cc240e42888bebea0147dbc", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 10164}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "II", "before": {"end": 72, "start": 0, "text": "The MAH shall complete, within the stated timeframe, the below measures:", "truncated": false}, "before_length": 72, "before_sha256": "5db574a1b578f5d04b78424769c40890f39d3a93820bf7efddc9080e96dde428", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 72, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 72, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2ccc0d9d4c11e571ef93ead3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:33Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "21d66bf1e9a74479f577de09da3cf8517d65c1ce1b1d8bbdfe4bc38f79410def", "source_snapshot_id": "source-2c39c998fdaf05159687c016", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 467}
{"after": {"end": 43, "start": 0, "text": "nurse before you are given Spikevax LP.8.1.", "truncated": false}, "after_length": 43, "after_sha256": "077ae905ea92636e1ed879288b42e228e94bf7590ad6b6c388c04456506f14e2", "annex": "I", "before": {"end": 41, "start": 0, "text": "nurse before you are given Spikevax JN.1.", "truncated": false}, "before_length": 41, "before_sha256": "2007dd2e6b9aa525fe87436a09c1c881520e5f81791f281169c63289b03b88ed", "change_kind": "administrative", "change_operations": [{"after_end": 40, "after_start": 36, "before_end": 38, "before_start": 36, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2d0cdc8ad9ddcfd9daa2d8d6", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12658}
{"after": {"end": 45, "start": 0, "text": "90 mmHg or more if you are 6 to 11 years old,", "truncated": false}, "after_length": 45, "after_sha256": "310abe146eeaa2989c4655608923df18aafa96a607535276fe984ca2f2c375c2", "annex": "IIIA", "before": {"end": 54, "start": 0, "text": "90 mmHg or more if your age is between 6 and 12 years,", "truncated": false}, "before_length": 54, "before_sha256": "9128e5d9cd864b5ced5ad3e6613cf8d89493c9196199047f89901fb89d845f9a", "change_kind": "content", "change_operations": [{"after_end": 22, "after_start": 22, "before_end": 23, "before_start": 22, "kind": "delete"}, {"after_end": 25, "after_start": 24, "before_end": 26, "before_start": 25, "kind": "replace"}, {"after_end": 26, "after_start": 26, "before_end": 38, "before_start": 27, "kind": "delete"}, {"after_end": 31, "after_start": 29, "before_end": 44, "before_start": 41, "kind": "replace"}, {"after_end": 34, "after_start": 33, "before_end": 47, "before_start": 46, "kind": "replace"}, {"after_end": 44, "after_start": 40, "before_end": 53, "before_start": 53, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 17, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2d220dc6f905243c77bb7c18", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3165}
{"after": {"end": 247, "start": 0, "text": "Suivez les instructions chaque fois que vous insérez une nouvelle cartouche Terrosa dans votre Terrosa Pen. Ne répétez pas cette étape avant chaque injection quotidienne, sinon vous n’aurez pas suffisamment de Terrosa pour une période de 28 jours.", "truncated": false}, "after_length": 247, "after_sha256": "5e59e94a640f7833f02fddd380b16004d7d9b6db4b1fd8849c49a1a2b42b27df", "annex": "IIIA", "before": {"end": 249, "start": 0, "text": "Suivez les instructions chaque fois que vous insérez une nouvelle cartouche Terrosa dans votre stylo Terrosa. Ne répétez pas cette étape avant chaque injection quotidienne, sinon vous n’aurez pas suffisamment de Terrosa pour une période de 28 jours.", "truncated": false}, "before_length": 249, "before_sha256": "5f7359e4b094e0e0a214ddf6b02efc73dc559bd9ad9bd3b48a079cc2fb7acb53", "change_kind": "content", "change_operations": [{"after_end": 95, "after_start": 95, "before_end": 101, "before_start": 95, "kind": "delete"}, {"after_end": 106, "after_start": 102, "before_end": 108, "before_start": 108, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2d46ad62cbd6dee488387cfc", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1964}
{"after": {"end": 17, "start": 0, "text": "msdpolska@msd.com", "truncated": false}, "after_length": 17, "after_sha256": "1b250a519a0f233f4e354eb6c7114ba65293ff16c0041901602d11e2c6c3498c", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "msdpolska@merck.com", "truncated": false}, "before_length": 19, "before_sha256": "5690867ba2de57367aef5787dfb5119647492569c1acc32aee4d6aec5daced2d", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 11, "before_end": 15, "before_start": 11, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2d4a61ea71aff4defc480a7a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3450}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "II", "before": {"end": 57, "start": 0, "text": "Obligation de mise en place de mesures post-autorisation.", "truncated": false}, "before_length": 57, "before_sha256": "0cf5090215642666d9a86d266314dea751cf95b21ee33ad1ddcc912ec3b57ad3", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 57, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 57, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2d4b3d8e29216ac05fb10ed5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 467}
{"after": {"end": 101, "start": 0, "text": "Si vous prenez ces médicaments, demandez à votre médecin s’il est nécessaire de modifier leurs doses.", "truncated": false}, "after_length": 101, "after_sha256": "e000fe02fa43ba1cbdf38919b8b55a81dd96a8aacbb80810eb04586c675d2725", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 101, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 101}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2d5ba4100b60c732b915bdde", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2872}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 121, "start": 0, "text": "Le traitement par etanercept peut augmenter le risque d’infection et d’insuffisance cardiaque congestive chez les adultes", "truncated": false}, "before_length": 121, "before_sha256": "42cc8603ea2593f93ecd8687e7d9d3777cbb4492a6c6707ff4af84836d4055fb", "change_kind": "unassigned", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 121, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 121, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2da6958a2f6484b9c513744c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6667}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 79, "start": 0, "text": "are older than 65 years as low blood pressure is more likely in this age group.", "truncated": false}, "before_length": 79, "before_sha256": "2b2fdae5d801dcb6caf4c121791515ed6e1125f8a7a26ee526e78c379247ff23", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 79, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 79, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2db947083def094604cc15fc", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3180}
{"after": {"end": 63, "start": 0, "text": "dd Includes autoimmune nephritis and immune-mediated nephritis.", "truncated": false}, "after_length": 63, "after_sha256": "c3937dbe8b356363976044c7f0dc840a71716532d35ae571acf8a82737877563", "annex": "I", "before": {"end": 63, "start": 0, "text": "cc Includes autoimmune nephritis and immune-mediated nephritis.", "truncated": false}, "before_length": 63, "before_sha256": "1fa38dca4f6a5f7f82b523bf77a508b1dad73bac0e8187c4f265e33d4b18c7bc", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 0, "before_end": 2, "before_start": 0, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2dbb13d1670d409849e2e797", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "IMJUDO 20 mg/ml concentrate for solution for infusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 933}
{"after": {"end": 80, "start": 0, "text": "have symptoms of low blood pressure like dizziness, lightheadedness or fainting,", "truncated": false}, "after_length": 80, "after_sha256": "855f9d47d97b7c5421092a7ffaba1d00847b46014921cf3639baa82783219041", "annex": "IIIA", "before": {"end": 83, "start": 0, "text": "have symptoms of low blood pressure like dizziness, lightheadedness or fainting, or", "truncated": false}, "before_length": 83, "before_sha256": "cc0b709d3b013229f35b337db8941c5f8d579d29035df10cc67670d02f39f208", "change_kind": "content", "change_operations": [{"after_end": 80, "after_start": 80, "before_end": 83, "before_start": 80, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 3, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2dbca5bb44048288e502902c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3177}
{"after": {"end": 145, "start": 0, "text": "• Screw the pen needle clockwise onto the cartridge sleeve. Make sure that the pen needle is attached correctly and sits firmly on the cartridge.", "truncated": false}, "after_length": 145, "after_sha256": "bd56e45962c6d31894e12f04eca780dc712196632cffdbf8eaec832224100c07", "annex": "IIIA", "before": {"end": 152, "start": 0, "text": "• Screw the pen needle clockwise onto the cartridge holder. Make sure that the pen needle is attached correctly and sits firmly on the cartridge holder.", "truncated": false}, "before_length": 152, "before_sha256": "c7e67de3b0544ab199fc5a7f0a4f3cb7bfc23a7fac0d1c93e40138198a30ce3c", "change_kind": "content", "change_operations": [{"after_end": 53, "after_start": 52, "before_end": 54, "before_start": 52, "kind": "replace"}, {"after_end": 54, "after_start": 54, "before_end": 56, "before_start": 55, "kind": "delete"}, {"after_end": 58, "after_start": 55, "before_end": 58, "before_start": 57, "kind": "replace"}, {"after_end": 144, "after_start": 144, "before_end": 151, "before_start": 144, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 11, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2e0a21e01d8280433d972e2f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2042}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 17, "start": 0, "text": "Byk-Gulden-Str. 2", "truncated": false}, "before_length": 17, "before_sha256": "5dc95d013d793b6958719e5db82aa51cd0c1864e2e8bc9bfcf2cfded1a05eba6", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 17, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 17, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2e37ec556b50fab48e8d0d8d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1712}
{"after": {"end": 63, "start": 0, "text": "Ne retirez pas le capuchon de l’aiguille avant d’y être invité.", "truncated": false}, "after_length": 63, "after_sha256": "4253650414791f649d08c88334e3aadafc33845e6bee35c68a21ef936df907a2", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 63, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 63}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2e3d95833b154f91be1da086", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12378}
{"after": {"end": 8, "start": 0, "text": "Dublin 2", "truncated": false}, "after_length": 8, "after_sha256": "b9d41e7d3be3ec3e12457949fb5c2f7be98290b5d2919e8b974df9c98fab02b9", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 8, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2e78e59849e3ecbe1f4141b0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1213}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 30, "start": 0, "text": "GlaxoSmithKline Biologicals SA", "truncated": false}, "before_length": 30, "before_sha256": "9076f81d6649169dd6b3c0ca008f09f07b0f4fddd6f63a0eb13693ea63527328", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 30, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 30, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2e9c4fc53f9b8ad025ed0437", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000112", "medicine_name": "Twinrix Adult", "medicine_slug": "twinrix-adult", "observed_at": "2026-10-12T13:29:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "bc8ba3adecfe04d3079e5b502251cec982d6197257fe3b7ec3a22dc5f2ace654", "source_snapshot_id": "source-8439a1a319b62d1bd67256a4", "source_updated_at": "2026-08-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/twinrix-adult-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1005}
{"after": {"end": 144, "start": 0, "text": "benefit-risk balance of the medicinal product(s) containing bevacizumab is unchanged subject to the proposed changes to the product information.", "truncated": false}, "after_length": 144, "after_sha256": "162076d720e1753ae7eaec4b4cc81f4202254d35e7b0cb2169b555b4e4c5c346", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 144, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 144}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2ea33018ce301d5728d4a5d5", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:18Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "89a938df5e41f86548301270084e3d1ecf171802e24b5429f62e3bede7ee32dd", "source_snapshot_id": "source-b71aeee5a07abebc34c02e28", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3435}
{"after": {"end": 191, "start": 0, "text": "If you have taken more Fycompa than you should, contact your doctor straight away. You may experience confusion, agitation, aggressive behaviour, vomiting, and reduced level of consciousness.", "truncated": false}, "after_length": 191, "after_sha256": "c5d2248c805383a83f7d35d055b32f8169c8826eecef95aa090a57c57e144016", "annex": "IIIA", "before": {"end": 180, "start": 0, "text": "If you have taken more Fycompa than you should contact your doctor straight away. You may experience confusion, agitation, aggressive behaviourand depressed level of consciousness.", "truncated": false}, "before_length": 180, "before_sha256": "ba0e2c6e097bd76f30aac5bbc0a4c0572bd101c612ac083063eceee2eb68de4d", "change_kind": "content", "change_operations": [{"after_end": 47, "after_start": 46, "before_end": 46, "before_start": 46, "kind": "insert"}, {"after_end": 156, "after_start": 144, "before_end": 143, "before_start": 143, "kind": "insert"}, {"after_end": 160, "after_start": 160, "before_end": 150, "before_start": 147, "kind": "delete"}, {"after_end": 165, "after_start": 162, "before_end": 154, "before_start": 152, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 5, "chars_inserted": 16}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2ebc0b56d43325c1608de48d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2719}
{"after": {"end": 71, "start": 0, "text": "For more information or video, scan the QR code or visit www.nyxoid.com", "truncated": false}, "after_length": 71, "after_sha256": "bb049acce416a81ba9d230ecc0beb75ddcd55f06259618b14309ddcdc6c9c81e", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 71, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 71}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2ed22f1519adafaf3a4fd360", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:33Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "21d66bf1e9a74479f577de09da3cf8517d65c1ce1b1d8bbdfe4bc38f79410def", "source_snapshot_id": "source-2c39c998fdaf05159687c016", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 861}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "België/Belgique/Belgien", "truncated": false}, "before_length": 23, "before_sha256": "4646bb1028d1508f87afd915f6c144536b764795c7df5858f4eaa35881bb797d", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 23, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 23, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2ed30825eb1da802e51b7b2a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1029}
{"after": {"end": 31, "start": 0, "text": "3. How Spikevax LP.8.1 is given", "truncated": false}, "after_length": 31, "after_sha256": "a850200a729417ff45e4adbfea120385ae05f7c4b7b417627b61e3d41901761a", "annex": "I", "before": {"end": 29, "start": 0, "text": "3. How Spikevax JN.1 is given", "truncated": false}, "before_length": 29, "before_sha256": "250387d956f2e384674d1027f02135813ceb4f58888e0b55b544ad8ab5178821", "change_kind": "administrative", "change_operations": [{"after_end": 20, "after_start": 16, "before_end": 18, "before_start": 16, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2ef6f73523f74e5de8dc8836", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12617}
{"after": {"end": 8, "start": 0, "text": "Dublin 2", "truncated": false}, "after_length": 8, "after_sha256": "b9d41e7d3be3ec3e12457949fb5c2f7be98290b5d2919e8b974df9c98fab02b9", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 8, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2f4fd921bd7bb78c9cbae007", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1718}
{"after": {"end": 25, "start": 0, "text": "50-58 Baggot Street Lower", "truncated": false}, "after_length": 25, "after_sha256": "2b6052bef6a7051ce20b776d1525055c417fc02e59b9e559cd21b7aa4c7859f0", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 25, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 25}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2f6cf9d971a654a604157c84", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1212}
{"after": {"end": 86, "start": 0, "text": "The CHMP recommends that the terms of the marketing authorisation(s) should be varied.", "truncated": false}, "after_length": 86, "after_sha256": "58ed8da449860435afd7d26d286a000f65c5901b49253a30ae46cbbcbca82784", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 86, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 86}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2fc3e5f12f9c13a27e341235", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3452}
{"after": {"end": 54, "start": 0, "text": "Allongez la personne. Inclinez sa tête vers l’arrière.", "truncated": false}, "after_length": 54, "after_sha256": "1adb6f5be097a9ea40d29515a0a81249ba86638e5bf24338dd5e91437e5dd390", "annex": "IIIA", "before": {"end": 58, "start": 0, "text": "Allonger la personne. Lui incliner la tête vers l’arrière.", "truncated": false}, "before_length": 58, "before_sha256": "fa1930a5447de15078e124631216a80c1c8424ff1475fe3687c9c9b80cdf1e85", "change_kind": "content", "change_operations": [{"after_end": 8, "after_start": 7, "before_end": 8, "before_start": 7, "kind": "replace"}, {"after_end": 23, "after_start": 22, "before_end": 27, "before_start": 22, "kind": "replace"}, {"after_end": 30, "after_start": 29, "before_end": 34, "before_start": 33, "kind": "replace"}, {"after_end": 32, "after_start": 31, "before_end": 36, "before_start": 35, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 8, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2fe9c4a86c409c3474ee8692", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 667}
{"after": {"end": 284, "start": 0, "text": "Carboplatine (ASC 4, Jour 1) et gemcitabine (1000 mg/m², les jours 1 et 8) en association à un placebo, administrés toutes les 3 semaines pendant 6 cycles, et jusqu’à 10 cycles, suivis du placebo (toutes les 3 semaines) seul jusqu’à progression de la maladie ou toxicité inacceptable.", "truncated": false}, "after_length": 284, "after_sha256": "fa06a5daac3339da421b7b0145e6ad3f61053b7214225140fb4378dfd1f368ad", "annex": "I", "before": {"end": 257, "start": 0, "text": "Carboplatine (ASC 4, Jour 1) et gemcitabine (1000 mg/m², Jours 1 et 8) suivis du placebo toutes les 3 semaines pendant 6 cycles, et jusqu’à 10 cycles, suivis du placebo (toutes les 3 semaines) seul jusqu’à progression de la maladie ou toxicité inacceptable.", "truncated": false}, "before_length": 257, "before_sha256": "cd3012e798ea310fe304fae6022b5995b079ba90bc7fa574b0b3a7458b70b71a", "change_kind": "content", "change_operations": [{"after_end": 62, "after_start": 57, "before_end": 58, "before_start": 57, "kind": "replace"}, {"after_end": 79, "after_start": 75, "before_end": 71, "before_start": 71, "kind": "insert"}, {"after_end": 92, "after_start": 80, "before_end": 72, "before_start": 72, "kind": "insert"}, {"after_end": 94, "after_start": 93, "before_end": 80, "before_start": 73, "kind": "replace"}, {"after_end": 115, "after_start": 102, "before_end": 88, "before_start": 88, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 8, "chars_inserted": 35}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-2fee809ad9bd31fc7dc4ba80", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1968}
{"after": {"end": 20, "start": 0, "text": "changements d’humeur", "truncated": false}, "after_length": 20, "after_sha256": "3e49245c143c3acf5ae9419a2bf54b114cd0731a2d2a09a7a1c3e5fee0ae63ef", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 20, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 20}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-301a06091a1cf3465f0a17e6", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "9ac80b0d56ebad4970f7a8335a177613af59ef25517bcd0bdd3397c207cc1bac", "source_snapshot_id": "source-c11aa9e32420f125a88005bc", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2742}
{"after": {"end": 11, "start": 0, "text": "Nephritisdd", "truncated": false}, "after_length": 11, "after_sha256": "8d9df509eb3e153cc3395743ede2d6b4f41e86ae4582e7b247d019c363a66d6a", "annex": "I", "before": {"end": 11, "start": 0, "text": "Nephritiscc", "truncated": false}, "before_length": 11, "before_sha256": "5c2735a120bb91c7e572eef55bb3419a82a7d01e53140333b4552f2eef459a23", "change_kind": "content", "change_operations": [{"after_end": 11, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-305f62d0d6f2a154099b9257", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "IMJUDO 20 mg/ml concentrate for solution for infusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 860}
{"after": {"end": 17, "start": 0, "text": "inform_pt@msd.com", "truncated": false}, "after_length": 17, "after_sha256": "80ea8d7772d76b760ca402228980572f0cf6dc451b408386454eb84cec35e7c8", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "inform_pt@merck.com", "truncated": false}, "before_length": 19, "before_sha256": "417a4e56160e131fb045d4a98431bae78237c04f6d71f4a97656e8299c0b43d2", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 11, "before_end": 15, "before_start": 11, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-307c8e1e706a6c58de1b17c3", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3145}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 13, "start": 0, "text": "Thaw duration", "truncated": false}, "before_length": 13, "before_sha256": "1192f885dc2df1a806d7eec521b69a527d874ceba16591d76aabb6dbb7166424", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 13, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 13, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-30a2b2c65254812f0f1307c2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6396}
{"after": {"end": 126, "start": 0, "text": "La substance active d’Enbrel est etanercept. Chaque seringue pré-remplie contient 0,5 mL de solution, soit 25 mg d’etanercept.", "truncated": false}, "after_length": 126, "after_sha256": "35b1efc81f77d43d3c79408f7c5ae072ba42cc4164d6d2ca1ea32ba7ed3ce9ec", "annex": "IIIA", "before": {"end": 126, "start": 0, "text": "La substance active d’Enbrel est etanercept. Chaque seringue pré-remplie contient 0,5 ml de solution, soit 25 mg d’etanercept.", "truncated": false}, "before_length": 126, "before_sha256": "53f98068e078c3e277172798237e9c2a9d0a6f6e7ba863d4fe7edffdf7b367d6", "change_kind": "content", "change_operations": [{"after_end": 88, "after_start": 87, "before_end": 88, "before_start": 87, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-30ba990c730ad6d537b12dbf", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9538}
{"after": {"end": 18, "start": 0, "text": "info-msdbg@msd.com", "truncated": false}, "after_length": 18, "after_sha256": "a9564ace7f83680b30d249e1267cfecfc6de3252d14464719ba30061fb8124b8", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "info-msdbg@merck.com", "truncated": false}, "before_length": 20, "before_sha256": "0b46e48b14b2f549da86787bd2d27cc0b14ced470375af44415dc160418b8ba4", "change_kind": "content", "change_operations": [{"after_end": 14, "after_start": 12, "before_end": 16, "before_start": 12, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-30e6dfb5ddb3e3053773038a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3385}
{"after": {"end": 185, "start": 0, "text": "The physician should prescribe the most appropriate formulation and strength according to weight and dose. Alternate formulations of perampanel are available, including oral suspension.", "truncated": false}, "after_length": 185, "after_sha256": "d69b1c1ccfde57105eeaa8d1be9c355fbc5883bfbdb59ba581fa1b28091e8191", "annex": "I", "before": {"end": 184, "start": 0, "text": "The physician should prescribe the most appropriate formulation and strength according to weight and dose. Alternate formulations of perampanel are available, including oral suspension", "truncated": false}, "before_length": 184, "before_sha256": "f6e25a761ed3e92744538b423b5e902d5b9cb5ca8d41c0956f4a415b54f99531", "change_kind": "content", "change_operations": [{"after_end": 185, "after_start": 184, "before_end": 184, "before_start": 184, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-30f56f516242b3b567d7ce05", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "Fycompa 2 mg filmcoated tablets Fycompa 4 mg filmcoated tablets Fycompa 6 mg filmcoated tablets Fycompa 8 mg filmcoated tablets Fycompa 10 mg filmcoated tablets Fycompa 12 mg filmcoated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 128}
{"after": {"end": 118, "start": 0, "text": "If the display still does not return to start position after injection, do not use this pen, contact customer service.", "truncated": false}, "after_length": 118, "after_sha256": "60dd6b9b9fbee79af3abaa3f4c65142e2146f7f01a92b389c023dc23dea6f5e0", "annex": "IIIA", "before": {"end": 92, "start": 0, "text": "If the display still does not return to start position after injection, do not use this pen.", "truncated": false}, "before_length": 92, "before_sha256": "c9c5b30ec16940df784befff6904609aded7a78b2558e5e992298e630a3fa627", "change_kind": "content", "change_operations": [{"after_end": 117, "after_start": 91, "before_end": 91, "before_start": 91, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 26}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-31435520f46c25d36c78f962", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2142}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 333, "start": 0, "text": "Verify that the vial has a blue flip-off cap and the product name is Spikevax JN.1. If the vial has a blue flip-off cap and the product name is Spikevax bivalent Original/Omicron BA.1, Spikevax bivalent Original/Omicron BA.4-5 or Spikevax XBB.1.5, please make reference to the Summary of Product Characteristics for that formulation.", "truncated": false}, "before_length": 333, "before_sha256": "ff4fa1ac48ce1e8f1173e4441b0879c17039c7cc41b5ca20406a7c08630e7105", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 333, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 333, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3177a2b9a6aa7a5e5ca12f9e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6384}
{"after": {"end": 49, "start": 0, "text": "Each bottle of 340 ml contains 170 mg perampanel.", "truncated": false}, "after_length": 49, "after_sha256": "e182d3be3891478db681851754e3987247df7d19465fa2ac9a94d205c73cb87a", "annex": "I", "before": {"end": 48, "start": 0, "text": "Each bottle of 340 ml contains 170 mg perampanel", "truncated": false}, "before_length": 48, "before_sha256": "42ef89e1fdb4f63b37ba147d3b82e2a72c40f0403757ca7b38d57673f7dfd96b", "change_kind": "content", "change_operations": [{"after_end": 49, "after_start": 48, "before_end": 48, "before_start": 48, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-31b06edde93fd19644060059", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "Fycompa 0.5 mg/ml oral suspension", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "2", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 859}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 95, "start": 0, "text": "Instructions to record the brand name and batch number of the medication to ensure traceability", "truncated": false}, "before_length": 95, "before_sha256": "61670d4f4bc4995607c615b0cc2a31208cea23447738a86c87f2de0cd671bb02", "change_kind": "unassigned", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 95, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 95, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-31c4ebae4e27d2674c5dc2a0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6584}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 5, "start": 0, "text": "Month", "truncated": false}, "before_length": 5, "before_sha256": "310ca503ef36f177ddbc760463fcaec1edc6eca12bfd590ad7bb244b31e59543", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 5, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 5, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-31cc65b808ae29ca8d51afbf", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005352", "medicine_name": "Upstaza", "medicine_slug": "upstaza", "observed_at": "2026-10-12T13:36:07Z", "pipeline_version": "2.0.0", "presentation_label": "Upstaza 2.8 × 1011 vector genomes (vg)/0.5 mL solution for infusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8561a0c5aed752dd415d30acef76bf620ad205d702080a0bca765e086873fe20", "source_snapshot_id": "source-4b712d5f9e4e2e8cd620aa93", "source_updated_at": "2026-06-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/upstaza-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 349}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 70, "start": 0, "text": "Wash your hands carefully with soap to minimise the risk of infection.", "truncated": false}, "before_length": 70, "before_sha256": "36ac5d80cccb711cb8b7b4abf3eaa3a505ef4d59890c0a4e1971bb9b23dca7f0", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 70, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 70, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-31dc07da8639ea51b60e828a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2029}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 33, "start": 0, "text": "United Kingdom (Northern Ireland)", "truncated": false}, "before_length": 33, "before_sha256": "9379d82927cdb505cfb186e912177065e56a1314de3a2b914ebbb8b5fe21525a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 33, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 33, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-31e6ba854bf819a4939fa002", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 10018}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 35, "start": 0, "text": "Not all pack sizes may be marketed.", "truncated": false}, "before_length": 35, "before_sha256": "be81359d16e6600d35fa2d803b9d851ff31cc7a1c48b622e9a0a7f0395154682", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 35, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 35, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-31f6b998ce6a994d66ecb38f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12890}
{"after": {"end": 181, "start": 0, "text": "Le Terrosa Pen fait partie d’un ensemble d’éléments comprenant le stylo lui-même, une cartouche et une aiguille. La cartouche et les aiguilles ne sont pas fournies dans l'emballage.", "truncated": false}, "after_length": 181, "after_sha256": "f6fe6e2bdc81f622f7a00d5f70015af69b01171399f8b23466890f75da411ee1", "annex": "IIIA", "before": {"end": 183, "start": 0, "text": "Le stylo Terrosa fait partie d’un ensemble d’éléments comprenant le stylo lui-même, une cartouche et une aiguille. La cartouche et les aiguilles ne sont pas fournies dans l'emballage.", "truncated": false}, "before_length": 183, "before_sha256": "28154d859b9c8257054dbf0106d1ca4cd55525f4541fd680ec597d99a621f9fb", "change_kind": "content", "change_operations": [{"after_end": 3, "after_start": 3, "before_end": 9, "before_start": 3, "kind": "delete"}, {"after_end": 14, "after_start": 10, "before_end": 16, "before_start": 16, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-32229f6d9d96e7406ddc780a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1937}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 7, "start": 0, "text": "Lietuva", "truncated": false}, "before_length": 7, "before_sha256": "5109820f748796128b8bafd3806d05511bc89ad77fc3cda960facf37a639bc7f", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 7, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-326bc9385b16648e6ea7218e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1018}
{"after": {"end": 97, "start": 0, "text": "Qu’est-ce que Nyxoid 1,8 mg, solution pour pulvérisation nasale et dans quels cas est-il utilisé?", "truncated": false}, "after_length": 97, "after_sha256": "72647788c7b6532d6c731d1dda5eb2e88547fb3ad67d6555b4abc8e5ae9d02c7", "annex": "IIIA", "before": {"end": 96, "start": 0, "text": "Qu’est-ce que Nyxoid 1,8 mg, solution pour pulvérisation nasale et dans quels cas est-il utilisé", "truncated": false}, "before_length": 96, "before_sha256": "b65b91ffe60322737e5758f34642eeb6af65f750671cebd4838c84ddb4aa1d6e", "change_kind": "content", "change_operations": [{"after_end": 97, "after_start": 96, "before_end": 96, "before_start": 96, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-32c44250d3c904d25ae6092e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 744}
{"after": {"end": 326, "start": 0, "text": "Verify that the product name of the pre-filled syringe is Spikevax LP.8.1. If the product name is Spikevax 50 micrograms, Spikevax bivalent Original/Omicron BA.1, Spikevax bivalent Original/Omicron BA.4-5, Spikevax XBB.1.5 or Spikevax JN.1, please make reference to the Summary of Product Characteristics for that formulation.", "truncated": false}, "after_length": 326, "after_sha256": "10fcb18e1faecdc5010e19cd2827989b6bf204cbdd4a362d50b022a01f7b57f5", "annex": "I", "before": {"end": 309, "start": 0, "text": "Verify that the product name of the pre-filled syringe is Spikevax JN.1. If the product name is Spikevax 50 micrograms, Spikevax bivalent Original/Omicron BA.1, Spikevax bivalent Original/Omicron BA.4-5 or Spikevax XBB.1.5, please make reference to the Summary of Product Characteristics for that formulation.", "truncated": false}, "before_length": 309, "before_sha256": "f8df2d454faac8c0c1f7a471f5680b03801d6b65c664b4f03dd434a972a06a24", "change_kind": "administrative", "change_operations": [{"after_end": 71, "after_start": 67, "before_end": 69, "before_start": 67, "kind": "replace"}, {"after_end": 205, "after_start": 204, "before_end": 205, "before_start": 202, "kind": "replace"}, {"after_end": 239, "after_start": 222, "before_end": 222, "before_start": 222, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 5, "chars_inserted": 22}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3306f7a0e4e4b80bcaaee4d1", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13149}
{"after": {"end": 45, "start": 0, "text": "Conditionnement de cartouche et Terrosa Pen :", "truncated": false}, "after_length": 45, "after_sha256": "02a15ff781fc0718edf0b06ef5d1922b5985d3658f3b459d381c8f1057f41955", "annex": "I", "before": {"end": 47, "start": 0, "text": "Conditionnement de cartouche et stylo Terrosa :", "truncated": false}, "before_length": 47, "before_sha256": "3fe9ab6c6ab15b9dfaacd9a32ace8bf0d4a6114d0926ef9e1ebb6ea3e6457266", "change_kind": "content", "change_operations": [{"after_end": 32, "after_start": 32, "before_end": 38, "before_start": 32, "kind": "delete"}, {"after_end": 43, "after_start": 39, "before_end": 45, "before_start": 45, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-336438674d528e32c0eeb285", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "Terrosa 20 microgrammes/80 microlitres solution injectable", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.5", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 458}
{"after": {"end": 64, "start": 0, "text": "take medicines to lower blood pressure or to increase urination,", "truncated": false}, "after_length": 64, "after_sha256": "e4ae8bd07b4e6d2bd99ee651a79c695cfc033498eab8844f8b5bd192f696efce", "annex": "IIIA", "before": {"end": 67, "start": 0, "text": "take medicines to lower blood pressure or to increase urination, or", "truncated": false}, "before_length": 67, "before_sha256": "bb76682fd671d13030ede85158c6a3d951897d7c064d87675b743ef35ce2493c", "change_kind": "content", "change_operations": [{"after_end": 64, "after_start": 64, "before_end": 67, "before_start": 64, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 3, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-33815462eaff19070ef31e75", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2746}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 6, "start": 0, "text": "Ísland", "truncated": false}, "before_length": 6, "before_sha256": "5801902efe8b92c2ace1332f4cca2ea1fcb704712e2fe7ca66654d2a826e8451", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 6, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-33a3a1880e2993ac2f293854", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1121}
{"after": {"end": 24, "start": 0, "text": "dpoc_czechslovak@msd.com", "truncated": false}, "after_length": 24, "after_sha256": "337ee03ecaecb8e917a1c5d342c556aebf19918c2dc3ac63cf08adeafa748373", "annex": "IIIA", "before": {"end": 26, "start": 0, "text": "dpoc_czechslovak@merck.com", "truncated": false}, "before_length": 26, "before_sha256": "a4642d78bee1d644f5eed542e84f756d52a7869d19900b6efa351b35ef1062c2", "change_kind": "content", "change_operations": [{"after_end": 20, "after_start": 18, "before_end": 22, "before_start": 18, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-33c5fb783d35942b88bea995", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3081}
{"after": {"end": 112, "start": 0, "text": "• N’utilisez pas votre Terrosa Pen s’il est endommagé ou si vous avez des doutes quant à son bon fonctionnement.", "truncated": false}, "after_length": 112, "after_sha256": "9a0eaa7139832942231de1b1185ff145d708f71c8613624e492eb4b3e117a262", "annex": "IIIA", "before": {"end": 114, "start": 0, "text": "• N’utilisez pas votre stylo Terrosa s’il est endommagé ou si vous avez des doutes quant à son bon fonctionnement.", "truncated": false}, "before_length": 114, "before_sha256": "6fe92ccf38e1a87bf5d12db3f564e39a3ca844645512d45cc31b6805a60f1bfe", "change_kind": "content", "change_operations": [{"after_end": 23, "after_start": 23, "before_end": 29, "before_start": 23, "kind": "delete"}, {"after_end": 34, "after_start": 30, "before_end": 36, "before_start": 36, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-33d7c364d4839c7fc09f1672", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2091}
{"after": {"end": 128, "start": 0, "text": "La substance active d’Enbrel est l’etanercept. Chaque seringue pré-remplie contient 1,0 mL de solution, soit 50 mg d’etanercept.", "truncated": false}, "after_length": 128, "after_sha256": "2df9f15f024b87c8888355300b843249dcc45c8c4b50fbcff7d3be8a9907c8e4", "annex": "IIIA", "before": {"end": 128, "start": 0, "text": "La substance active d’Enbrel est l’etanercept. Chaque seringue pré-remplie contient 1,0 ml de solution, soit 50 mg d’etanercept.", "truncated": false}, "before_length": 128, "before_sha256": "121e401024a80e318ee85bbe39872e619cc09e8d9fd7f2a1df2e1cceee0aacf8", "change_kind": "content", "change_operations": [{"after_end": 90, "after_start": 89, "before_end": 90, "before_start": 89, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-341ab7ef7f5d6870e53ef429", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9541}
{"after": {"end": 21, "start": 0, "text": "Tel.: +351 21 4465700", "truncated": false}, "after_length": 21, "after_sha256": "81a4c4002df1418d2222d806783560055518461831297fdd2d0c5bfb5f673696", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Tel: + 351 214465700", "truncated": false}, "before_length": 20, "before_sha256": "4a3d7a7c5925473eef92c2cd7a2e616c5dd3e20a042ab127910a184d9dfd503d", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}, {"after_end": 7, "after_start": 7, "before_end": 7, "before_start": 6, "kind": "delete"}, {"after_end": 14, "after_start": 13, "before_end": 13, "before_start": 13, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-342858a8bdef4c71435dee5d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3554}
{"after": {"end": 603, "start": 0, "text": "L’etanercept est absorbé lentement depuis le site d’injection sous-cutanée, atteignant une concentration maximale environ 48 heures après administration unique. La biodisponibilité absolue est de 76 %. Avec deux doses par semaine, on peut s’attendre à ce que les concentrations à l’état d’équilibre représentent environ deux fois celles que l’on mesure après administration unique. Après l’administration unique, par voie sous-cutanée de 25 mg d’Enbrel, la concentration sérique maximale moyenne observée chez les volontaires sains était de 1,65 0,66 g/mL, l’aire sous la courbe étant de 235 96,6 gh/mL.", "truncated": false}, "after_length": 603, "after_sha256": "a3899248927bc8edd5cd7b5d18ec0aacfc388b6da6aa8f8eb72766129d901ab5", "annex": "I", "before": {"end": 603, "start": 0, "text": "L’etanercept est absorbé lentement depuis le site d’injection sous-cutanée, atteignant une concentration maximale environ 48 heures après administration unique. La biodisponibilité absolue est de 76 %. Avec deux doses par semaine, on peut s’attendre à ce que les concentrations à l’état d’équilibre représentent environ deux fois celles que l’on mesure après administration unique. Après l’administration unique, par voie sous-cutanée de 25 mg d’Enbrel, la concentration sérique maximale moyenne observée chez les volontaires sains était de 1,65 0,66 g/ml, l’aire sous la courbe étant de 235 96,6 gh/ml.", "truncated": false}, "before_length": 603, "before_sha256": "de76b6f58f9f89d1b0d8c974fdf2da8956536c6458e7b2763effd3b6c00620ec", "change_kind": "content", "change_operations": [{"after_end": 555, "after_start": 554, "before_end": 555, "before_start": 554, "kind": "replace"}, {"after_end": 602, "after_start": 601, "before_end": 602, "before_start": 601, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3458574d38f353a627a70fb8", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg solution injectable en stylo pré-rempli Enbrel 50 mg solution injectable en stylo pré-rempli", "presentation_occurrence": 4, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 4425}
{"after": {"end": 26, "start": 0, "text": "Puh/Tel: +358 (0)9 804 650", "truncated": false}, "after_length": 26, "after_sha256": "4e4ce567ad8fc5ce4a995dfaa7487af0a3a8e51db5041ab103d4f16252c66e4f", "annex": "IIIA", "before": {"end": 26, "start": 0, "text": "Puh/Tel: + 358 (0)9 804650", "truncated": false}, "before_length": 26, "before_sha256": "4d337eb78e05cdda3f51c0741cb1f1396cf637a24baad8faad372b206b668352", "change_kind": "content", "change_operations": [{"after_end": 10, "after_start": 10, "before_end": 11, "before_start": 10, "kind": "delete"}, {"after_end": 23, "after_start": 22, "before_end": 23, "before_start": 23, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-34989b865df665e794fa8c62", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3593}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 29, "start": 0, "text": "Puh/Tel: + 358 (0)9 8520 2065", "truncated": false}, "before_length": 29, "before_sha256": "18eaa0a9ec1bb9b7b1d51c6daf02e6bb688d8af44de55f4a319e425bea49457c", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 29, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 29, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-34d1b3de93ae36bf121afe6a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1136}
{"after": {"end": 84, "start": 0, "text": "Blue, round, biconvex tablet, engraved with E297 on one side and ‘12’ on other side.", "truncated": false}, "after_length": 84, "after_sha256": "2dcad32acc10598aa0b1f64f03489fceaa31da8f3aab8504b4f8432eb96af080", "annex": "I", "before": {"end": 83, "start": 0, "text": "Blue, round, biconvex tablet, engraved with E297 on one side and ‘12’ on other side", "truncated": false}, "before_length": 83, "before_sha256": "beaaeecc879f81dd82e8b7b99a53b9114582f9ee752ec375925708eb9e306828", "change_kind": "content", "change_operations": [{"after_end": 84, "after_start": 83, "before_end": 83, "before_start": 83, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-34d39c7837fd817840d4b880", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "Fycompa 2 mg filmcoated tablets Fycompa 4 mg filmcoated tablets Fycompa 6 mg filmcoated tablets Fycompa 8 mg filmcoated tablets Fycompa 10 mg filmcoated tablets Fycompa 12 mg filmcoated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "3", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 111}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IV", "before": {"end": 130, "start": 0, "text": "Taking into account the PRAC Assessment Report on the PSUR(s) for tremelimumab, the scientific conclusions of PRAC are as follows:", "truncated": false}, "before_length": 130, "before_sha256": "805dcbe6c7135261b9b9ce03543f00323496ae1660a9cc77d53fd49b32e2627a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 130, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 130, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3541c54f7e006505d3227bc2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2529}
{"after": {"end": 603, "start": 0, "text": "L’etanercept est absorbé lentement depuis le site d’injection sous-cutanée, atteignant une concentration maximale environ 48 heures après administration unique. La biodisponibilité absolue est de 76 %. Avec deux doses par semaine, on peut s’attendre à ce que les concentrations à l’état d’équilibre représentent environ deux fois celles que l’on mesure après administration unique. Après l’administration unique, par voie sous-cutanée de 25 mg d’Enbrel, la concentration sérique maximale moyenne observée chez les volontaires sains était de 1,65 0,66 g/mL, l’aire sous la courbe étant de 235 96,6 gh/mL.", "truncated": false}, "after_length": 603, "after_sha256": "a3899248927bc8edd5cd7b5d18ec0aacfc388b6da6aa8f8eb72766129d901ab5", "annex": "I", "before": {"end": 603, "start": 0, "text": "L’etanercept est absorbé lentement depuis le site d’injection sous-cutanée, atteignant une concentration maximale environ 48 heures après administration unique. La biodisponibilité absolue est de 76 %. Avec deux doses par semaine, on peut s’attendre à ce que les concentrations à l’état d’équilibre représentent environ deux fois celles que l’on mesure après administration unique. Après l’administration unique, par voie sous-cutanée de 25 mg d’Enbrel, la concentration sérique maximale moyenne observée chez les volontaires sains était de 1,65 0,66 g/ml, l’aire sous la courbe étant de 235 96,6 gh/ml.", "truncated": false}, "before_length": 603, "before_sha256": "de76b6f58f9f89d1b0d8c974fdf2da8956536c6458e7b2763effd3b6c00620ec", "change_kind": "content", "change_operations": [{"after_end": 555, "after_start": 554, "before_end": 555, "before_start": 554, "kind": "replace"}, {"after_end": 602, "after_start": 601, "before_end": 602, "before_start": 601, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3570ee0ca0a6d9ff9f5af463", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg poudre et solvant pour solution injectable", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2145}
{"after": {"end": 575, "start": 0, "text": "Cabozantinib has been associated with an increased risk of cardiac failure. This risk may be exacerbated by common adverse drug reactions of cabozantinib (e.g. hypertension, hypothyroidism and arterial thrombotic events), which can lead to cardiac failure. Patients should be monitored for signs and symptoms of cardiac failure throughout treatment. These adverse events should be managed promptly, dose interruptions and/or adjustments should be considered if necessary (see section 4.2) and TKI therapy should be discontinued in patients who develop severe cardiac failure.", "truncated": false}, "after_length": 575, "after_sha256": "4a97aaf33e3a31d908c66323a3519b02e2e6bd7072c1dec69d03427ab56ee243", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 575, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 575}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-35877da51988dad2089ef19b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002640", "medicine_name": "Cometriq", "medicine_slug": "cometriq", "observed_at": "2026-10-12T19:00:48Z", "pipeline_version": "2.0.0", "presentation_label": "COMETRIQ 20 mg hard capsules COMETRIQ 80 mg hard capsules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "9a013f64c372a20a7dfcfd0a30d84c365e558413e28c71df200098486d1db15b", "source_snapshot_id": "source-a2dc64012a0e2142a7477fbb", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/cometriq-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 143}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tlf: + 45 45 17 48 00", "truncated": false}, "before_length": 21, "before_sha256": "4e4f97da713bcb120d3c0c35a877cad54bf9ee7e912dac4610c730c24fe928a3", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 21, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 21, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3595c51846dba53de4463435", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1044}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 54, "start": 0, "text": "For storage conditions after thawing, see section 6.3.", "truncated": false}, "before_length": 54, "before_sha256": "1cec7d15146834e6c590136e3f09c556110e7ebf462b11fced690ee7f5c4c732", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 54, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 54, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-35e0785ce2a36c4f5138e50c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.4", "section_type": "storage", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6295}
{"after": {"end": 13, "start": 0, "text": "Hermeslaan 11", "truncated": false}, "after_length": 13, "after_sha256": "6426889eacea87c88f1e0405aad54515d8a889ca0f1b2ab39e2039040651e7d3", "annex": "II", "before": {"end": 11, "start": 0, "text": "Hoge Wei 10", "truncated": false}, "before_length": 11, "before_sha256": "ba5c0cab58e83e9dc6ec41e55e6acc00077e1be63c8a1ed970723221f2f12ba4", "change_kind": "content", "change_operations": [{"after_end": 1, "after_start": 1, "before_end": 3, "before_start": 1, "kind": "delete"}, {"after_end": 4, "after_start": 2, "before_end": 6, "before_start": 4, "kind": "replace"}, {"after_end": 10, "after_start": 5, "before_end": 8, "before_start": 7, "kind": "replace"}, {"after_end": 13, "after_start": 12, "before_end": 11, "before_start": 10, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-36272ecebbe614e822d2db53", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004310", "medicine_name": "Daptomycin Hospira", "medicine_slug": "daptomycin-hospira", "observed_at": "2026-10-12T19:09:33Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "3242bb93d94dc3b7e86b89af5160c6986e8caa2e4f8d73bf8a634a557420452a", "source_snapshot_id": "source-dd7a18b7c210239223fa10ad", "source_updated_at": "2025-09-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/daptomycin-hospira-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1016}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 15, "start": 0, "text": "Medis RO S.R.L.", "truncated": false}, "before_length": 15, "before_sha256": "1caf96d7205ab5e6dbca0d3ca067e94bb07d3dafc2838cd6702bac4b82047b6a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 15, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 15, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3633a98ff7ab16ced47d7d24", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1121}
{"after": {"end": 8, "start": 0, "text": "D02 HW68", "truncated": false}, "after_length": 8, "after_sha256": "1ed87437489fcb80b59bfa5d17082f438d78a8aff5deaac6125946420fbf0992", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "administrative", "change_operations": [{"after_end": 8, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-366e03c0ffe9e5f4589dc10a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "Qdenga poudre et solvant pour solution injectable. Qdenga poudre et solvant pour solution injectable en seringue pré-remplie Vaccin tétravalent contre la dengue (vivant, atténué)", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 978}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 33, "start": 0, "text": "United Kingdom (Northern Ireland)", "truncated": false}, "before_length": 33, "before_sha256": "9379d82927cdb505cfb186e912177065e56a1314de3a2b914ebbb8b5fe21525a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 33, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 33, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-36c2dc41a9ca49dca422d7e6", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:33Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "21d66bf1e9a74479f577de09da3cf8517d65c1ce1b1d8bbdfe4bc38f79410def", "source_snapshot_id": "source-2c39c998fdaf05159687c016", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1086}
{"after": {"end": 76, "start": 0, "text": "Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe", "truncated": false}, "after_length": 76, "after_sha256": "6c7ff1bbd2f6d8c84f1254cce87065dac51505e1edd888622047a746e34551e6", "annex": "I", "before": {"end": 74, "start": 0, "text": "Spikevax JN.1 50 micrograms dispersion for injection in pre-filled syringe", "truncated": false}, "before_length": 74, "before_sha256": "ebe036d056b86be90e582dc3803425dce3820674579f962bd2fc8976b65c292a", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-370b7321ccf7fe3839571eae", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.5", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6329}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 105, "start": 0, "text": "Single-dose vials may be stored at 8°C to 25°C up to 24 hours after removal from refrigerated conditions.", "truncated": false}, "before_length": 105, "before_sha256": "d1baa9ee6b615f5d1ae412ca26e444c4245645826b4d065e6523429c115091d9", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 105, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 105, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-37249ec7be4cc0b7f3fe9c4f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.3", "section_type": "storage", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6257}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 37, "start": 0, "text": "Store in a freezer at -50ºC to -15ºC.", "truncated": false}, "before_length": 37, "before_sha256": "fb408eef60126ff57332a0595bf115bbbda4d791aa1c278707d4b848787538cb", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 37, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 37, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-373291c149e80cafacf19b46", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.4", "section_type": "storage", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6292}
{"after": {"end": 800, "start": 0, "text": "Les patients atteints de psoriasis en plaques pédiatrique (âgés de 4 à 17 ans) ont reçu 0,8 mg/kg (jusqu’à une dose maximale de 50 mg par semaine) d’etanercept une fois par semaine jusqu’à 48 semaines. Les concentrations sériques moyennes à l’état d’équilibre ont varié de 1,6 à 2,1 g/mL aux semaines 12, 24 et 48. Ces concentrations moyennes chez les patients atteints de psoriasis en plaques pédiatrique ont été similaires aux concentrations observées chez les patients atteints d’arthrite juvénile idiopathique (traités par 0,4 mg/kg d’etanercept deux fois par semaine, jusqu’à une dose maximale de 50 mg par semaine). Ces concentrations moyennes étaient similaires à celles observées chez les patients adultes atteints de psoriasis en plaques traités par 25 mg d’etanercept deux fois par semaine.", "truncated": false}, "after_length": 800, "after_sha256": "45cec5f493545419a45e5abbb1dd4ac0a9e852e76d7b20b526414eed5d33951b", "annex": "I", "before": {"end": 800, "start": 0, "text": "Les patients atteints de psoriasis en plaques pédiatrique (âgés de 4 à 17 ans) ont reçu 0,8 mg/kg (jusqu’à une dose maximale de 50 mg par semaine) d’etanercept une fois par semaine jusqu’à 48 semaines. Les concentrations sériques moyennes à l’état d’équilibre ont varié de 1,6 à 2,1 g/ml aux semaines 12, 24 et 48. Ces concentrations moyennes chez les patients atteints de psoriasis en plaques pédiatrique ont été similaires aux concentrations observées chez les patients atteints d’arthrite juvénile idiopathique (traités par 0,4 mg/kg d’etanercept deux fois par semaine, jusqu’à une dose maximale de 50 mg par semaine). Ces concentrations moyennes étaient similaires à celles observées chez les patients adultes atteints de psoriasis en plaques traités par 25 mg d’etanercept deux fois par semaine.", "truncated": false}, "before_length": 800, "before_sha256": "fe7d3d907bc892858ed04c3fdbb1d64ae7c6b7ed8a81004a623298b1197fad7e", "change_kind": "content", "change_operations": [{"after_end": 287, "after_start": 286, "before_end": 287, "before_start": 286, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3762d898e3aa1a61a29c70c9", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg poudre pour solution injectable", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1068}
{"after": {"end": 146, "start": 0, "text": "One dose (0.25 mL) contains 25 micrograms of SARSCoV2 LP.8.1 mRNA, a COVID19 mRNA Vaccine (nucleoside modified) (embedded in lipid nanoparticles).", "truncated": false}, "after_length": 146, "after_sha256": "0df0fc864f7ce507846e06d35b6ac05b17454894d6804e70e3edd785bb839529", "annex": "I", "before": {"end": 144, "start": 0, "text": "One dose (0.25 mL) contains 25 micrograms of SARSCoV2 JN.1 mRNA, a COVID19 mRNA Vaccine (nucleoside modified) (embedded in lipid nanoparticles).", "truncated": false}, "before_length": 144, "before_sha256": "804c1ad539df74127d120ff4d28c93fa77c4c697a123af1bfd2a1220ff8517d4", "change_kind": "content", "change_operations": [{"after_end": 58, "after_start": 54, "before_end": 56, "before_start": 54, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-379584fb6127685a792d2583", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "2", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5426}
{"after": {"end": 801, "start": 0, "text": "Les patients atteints de psoriasis en plaques pédiatrique (âgés de 4 à 17 ans) ont reçu 0,8 mg/kg (jusqu’à une dose maximale de 50 mg par semaine) d’etanercept une fois par semaine jusqu’à 48 semaines. Les concentrations sériques moyennes à l’état d’équilibre ont varié de 1,6 à 2,1 µg/mL aux semaines 12, 24 et 48. Ces concentrations moyennes chez les patients atteints de psoriasis en plaques pédiatrique ont été similaires aux concentrations observées chez les patients atteints d’arthrite juvénile idiopathique (traités par 0,4 mg/kg d’etanercept deux fois par semaine, jusqu’à une dose maximale de 50 mg par semaine). Ces concentrations moyennes étaient similaires à celles observées chez les patients adultes atteints de psoriasis en plaques traités par 25 mg d’etanercept deux fois par semaine.", "truncated": false}, "after_length": 801, "after_sha256": "5a9241299de0d00b1671784d63ea5f655e0be460780fb99d66c6810b9d4f53a0", "annex": "I", "before": {"end": 801, "start": 0, "text": "Les patients atteints de psoriasis en plaques pédiatrique (âgés de 4 à 17 ans) ont reçu 0,8 mg/kg (jusqu’à une dose maximale de 50 mg par semaine) d’etanercept une fois par semaine jusqu’à 48 semaines. Les concentrations sériques moyennes à l’état d’équilibre ont varié de 1,6 à 2,1 µg/ml aux semaines 12, 24 et 48. Ces concentrations moyennes chez les patients atteints de psoriasis en plaques pédiatrique ont été similaires aux concentrations observées chez les patients atteints d’arthrite juvénile idiopathique (traités par 0,4 mg/kg d’etanercept deux fois par semaine, jusqu’à une dose maximale de 50 mg par semaine). Ces concentrations moyennes étaient similaires à celles observées chez les patients adultes atteints de psoriasis en plaques traités par 25 mg d’etanercept deux fois par semaine.", "truncated": false}, "before_length": 801, "before_sha256": "e3a1c3d746033394d20349032e06f24add85b50a6b5f7606cd2db2e64c818637", "change_kind": "content", "change_operations": [{"after_end": 288, "after_start": 287, "before_end": 288, "before_start": 287, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-37b7ca939c71d12b8b2475b2", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg poudre et solvant pour solution injectable", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2182}
{"after": {"end": 223, "start": 0, "text": "Des analyses de la SSP en sous-groupe, par stade de la maladie et statut de l’exérèse, sont résumées dans le Tableau 17. Ces résultats démontrent une robustesse de l’analyse de la SSP telle que présentée dans le Tableau 16.", "truncated": false}, "after_length": 223, "after_sha256": "4c6948cd79f879ec7f1d898296f31859935f9e51fb180ecdefb2e7491a63d95f", "annex": "I", "before": {"end": 223, "start": 0, "text": "Des analyses de la PFS en sous-groupe, par stade de la maladie et statut de l’exérèse, sont résumées dans le Tableau 17. Ces résultats démontrent une robustesse de l’analyse de la PFS telle que présentée dans le Tableau 16.", "truncated": false}, "before_length": 223, "before_sha256": "00908b1c0b1409350d4e2216e3e387e2c1094e5b804788f4134a3645631f3699", "change_kind": "content", "change_operations": [{"after_end": 21, "after_start": 19, "before_end": 19, "before_start": 19, "kind": "insert"}, {"after_end": 22, "after_start": 22, "before_end": 22, "before_start": 20, "kind": "delete"}, {"after_end": 182, "after_start": 180, "before_end": 180, "before_start": 180, "kind": "insert"}, {"after_end": 183, "after_start": 183, "before_end": 183, "before_start": 181, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-37e554c8ea9c43370a67c43c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1790}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 30, "start": 0, "text": "Thaw instructions and duration", "truncated": false}, "before_length": 30, "before_sha256": "21e0f3dbd79a3786de0e170003075169ee12d311bd543dea304ec6546f9af6b9", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 30, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 30, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-38165bce29999f8e769e5e80", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6391}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "II", "before": {"end": 6, "start": 0, "text": "France", "truncated": false}, "before_length": 6, "before_sha256": "7a1ca4ef7515f7276bae7230545829c27810c9d9e98ab2c06066bee6270d5153", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 6, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-38356e35be6160a2e1249b3a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000174", "medicine_name": "Plavix", "medicine_slug": "plavix", "observed_at": "2026-10-12T19:27:50Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "3818c2e3c9979bf5f8be3f164dfce187fccfccf62bbd1e3227c64ca7c00ad02f", "source_snapshot_id": "source-4aff1b64c7cf58337d33ecfa", "source_updated_at": "2025-07-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/plavix-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 790}
{"after": {"end": 21, "start": 0, "text": "Oedème périphériqueee", "truncated": false}, "after_length": 21, "after_sha256": "a116262cc6e134abf4b9a9d74f6579a7258de62b511a5b0616ee28d47891f233", "annex": "I", "before": {"end": 21, "start": 0, "text": "Oedème périphériquedd", "truncated": false}, "before_length": 21, "before_sha256": "c7bd3c8a1df603f09587bc8cf8ab1e55fe125bfc4d164a076567e5a93ebae472", "change_kind": "content", "change_operations": [{"after_end": 21, "after_start": 19, "before_end": 21, "before_start": 19, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-383cbc29b98d61e0cd86f4f8", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:18Z", "pipeline_version": "2.0.0", "presentation_label": "IMJUDO 20 mg/ml, solution à diluer pour perfusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "2437ab76633f46c9eee5e002e5c7a7caba6367f59567d750be0eb67c74d1db4e", "source_snapshot_id": "source-7f4d129b0a0fd2d3684d27c5", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 881}
{"after": {"end": 124, "start": 0, "text": "Le programme éducationnel vise à réduire le risque d’infections graves et à assurer la traçabilité du médicament etanercept.", "truncated": false}, "after_length": 124, "after_sha256": "72ec8c88c534c576c91f230c896c995c686a2d0820a90714e7ec53a733930b5b", "annex": "I", "before": {"end": 163, "start": 0, "text": "Le programme éducationnel vise à réduire le risque d’infections graves et d’insuffisance cardiaque congestive et à assurer la traçabilité du médicament etanercept.", "truncated": false}, "before_length": 163, "before_sha256": "cd428657896bc0a6e9e130748a3cbacc2de2afc16af4ca046f30df5108d26168", "change_kind": "unassigned", "change_operations": [{"after_end": 74, "after_start": 74, "before_end": 113, "before_start": 74, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 39, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-38581786954ed2dc0c55a403", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6656}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "II", "before": {"end": 11, "start": 0, "text": "Hoge Wei 10", "truncated": false}, "before_length": 11, "before_sha256": "ba5c0cab58e83e9dc6ec41e55e6acc00077e1be63c8a1ed970723221f2f12ba4", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 11, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 11, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-385bf9600c908da37cb0f5fe", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004310", "medicine_name": "Daptomycin Hospira", "medicine_slug": "daptomycin-hospira", "observed_at": "2026-10-12T19:09:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "e544a64f1681af82ba143ddd0cfa7cca4ef0de691ed43076b92bb75f66ec7f7b", "source_snapshot_id": "source-a214fce23bf43c3222026b3d", "source_updated_at": "2025-09-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/daptomycin-hospira-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1022}
{"after": {"end": 129, "start": 0, "text": "Les évènements indésirables d’intensité sévère pouvant être rares (peuvent affecter jusqu’à une personne sur 1 000) comprennent :", "truncated": false}, "after_length": 129, "after_sha256": "71de61b7db4ff89cb7817372cd09c2947e8681b06140b1628e2df8f705d87711", "annex": "IIIA", "before": {"end": 125, "start": 0, "text": "Les évènements indésirables d’intensité sévère pouvant être rare (peut affecter jusqu’à une personne sur 1 000) comprennent :", "truncated": false}, "before_length": 125, "before_sha256": "4a843725ba7ddf05ca161e47ae771b7e80787abb86f4d1a95d9b94435c5516ec", "change_kind": "content", "change_operations": [{"after_end": 65, "after_start": 64, "before_end": 64, "before_start": 64, "kind": "insert"}, {"after_end": 73, "after_start": 70, "before_end": 69, "before_start": 69, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-388a61eb292354ae5d81f707", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3148}
{"after": {"end": 159, "start": 0, "text": "Enbrel est administré par injection sous-cutanée. Enbrel poudre pour solution doit être reconstitué dans 1 mL de solvant avant utilisation (voir rubrique 6.6).", "truncated": false}, "after_length": 159, "after_sha256": "3d0d44b91970adc1b5b3d2dd8ae762a7bc927db50c2b08e3e78fec74b820f95d", "annex": "I", "before": {"end": 159, "start": 0, "text": "Enbrel est administré par injection sous-cutanée. Enbrel poudre pour solution doit être reconstitué dans 1 ml de solvant avant utilisation (voir rubrique 6.6).", "truncated": false}, "before_length": 159, "before_sha256": "73b86fa43e0c145ad8a03fe62e43f66d84765c1ab06ff54055a2952b316ad4dd", "change_kind": "content", "change_operations": [{"after_end": 109, "after_start": 108, "before_end": 109, "before_start": 108, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-38afe97257681c4a683e7dd0", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 10 mg poudre et solvant pour solution injectable pour usage pédiatrique", "presentation_occurrence": 5, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 4626}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 192, "start": 0, "text": "Votre médecin vous remettra également une Carte Patient qui comportera des informations importantes de sécurité d’emploi que vous devez connaître, avant et pendant votre traitement par Enbrel.", "truncated": false}, "before_length": 192, "before_sha256": "a9b61621aee7f348e503c6ef13da6f1d4dc6f2a4d953f840016b3daaebeecd6a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 192, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 192, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-38da773696fa2c158deb0aa5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 8727}
{"after": {"end": 126, "start": 0, "text": "For more information, see the European Medicines Agency’s website: https://www.ema.europa.eu/en/medicines/human/EPAR/novorapid", "truncated": false}, "after_length": 126, "after_sha256": "0434cf7f6976e1606728a58ee667461643ae50b0c1669b7f34de657c75c2b221", "annex": "", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 126, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 126}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-391d7a503b84debddae642dc", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000258", "medicine_name": "NovoRapid", "medicine_slug": "novorapid", "observed_at": "2026-10-12T19:05:17Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "1f523a448c243ca0c7f4a7a256aecf542f6d2937ca52c9e9a8051cbe652ac962", "source_snapshot_id": "source-a33d4e91086c5c029de837c3", "source_updated_at": "2025-10-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/novorapid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5}
{"after": {"end": 15, "start": 0, "text": "The Netherlands", "truncated": false}, "after_length": 15, "after_sha256": "91729ff7107ee698fe168dc62d5b2020678fcfcf55b4ea9065982ce1d071ba31", "annex": "II", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 15, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 15}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-391f7158de1231a5f83ec0ad", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 536}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 33, "start": 0, "text": "United Kingdom (Northern Ireland)", "truncated": false}, "before_length": 33, "before_sha256": "9379d82927cdb505cfb186e912177065e56a1314de3a2b914ebbb8b5fe21525a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 33, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 33, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-397ec1dc4cf67c67cf137fa0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9013}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 12, "start": 0, "text": "15°C to 25°C", "truncated": false}, "before_length": 12, "before_sha256": "b57c2b618e71e3e42c038965c231cecdb8049c3d82d00aa02012ac70ea91f351", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 12, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 12, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3a18d0a65c6ecb0145299547", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13101}
{"after": {"end": 125, "start": 0, "text": "Caution: The pen must be primed and tested after inserting a new cartridge and prior the first injection from each cartridge.", "truncated": false}, "after_length": 125, "after_sha256": "04dec92b1bdd1b0625c62715a071f06e954e80da05a379cc47be3e72a66ad404", "annex": "IIIA", "before": {"end": 116, "start": 0, "text": "The pen must be primed and tested after inserting a new cartridge and prior the first injection from each cartridge.", "truncated": false}, "before_length": 116, "before_sha256": "05e97e4f857c6f214b57c52eeae037eb58b1bc31501928cdbc85a3868bd6d3f0", "change_kind": "content", "change_operations": [{"after_end": 9, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 9}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3a2965fec8d733d93240c45a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2012}
{"after": {"end": 93, "start": 0, "text": "Use another needle instead. Contact customer service if the second needle cannot be attached.", "truncated": false}, "after_length": 93, "after_sha256": "36fc6edb9f1d53f4c76afab2261704b31c5158fcc605c6023e367ecc7ab24f26", "annex": "IIIA", "before": {"end": 27, "start": 0, "text": "Use another needle instead.", "truncated": false}, "before_length": 27, "before_sha256": "4dae911f9b06a532c5b130d7c970177e98bcec203852b7485fa97d195d2e6c15", "change_kind": "content", "change_operations": [{"after_end": 93, "after_start": 27, "before_end": 27, "before_start": 27, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 66}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3a5d251e0187cc43b3b941d7", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2128}
{"after": {"end": 135, "start": 0, "text": "The educational programme is aimed at reducing the risk of serious infections and ensuring the traceability of etanercept drug product.", "truncated": false}, "after_length": 135, "after_sha256": "c67e2d0696894c717ce0ace196029238358a31275f80cf0ae1cff812e923dba2", "annex": "I", "before": {"end": 164, "start": 0, "text": "The educational programme is aimed at reducing the risk of serious infections and congestive heart failure and ensuring the traceability of etanercept drug product.", "truncated": false}, "before_length": 164, "before_sha256": "b46ce966a7d11229eba392d781622e7d6865aa31e9c8f840b07e68dcbcd8d81f", "change_kind": "unassigned", "change_operations": [{"after_end": 82, "after_start": 82, "before_end": 111, "before_start": 82, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 29, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3a714fc922630e92bcbfb6b9", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6567}
{"after": {"end": 22, "start": 0, "text": "Teл.: +359 2 819 37 37", "truncated": false}, "after_length": 22, "after_sha256": "f99d9da7522776c9e193c3d902a0bfac1449878008698e67a70066d46f048b40", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "Teл.: + 359 2 819 37 37", "truncated": false}, "before_length": 23, "before_sha256": "c607221a5f8b9a53eea2b30c436402b48449ce353ad88bc41c01cdb4f8bb48e8", "change_kind": "content", "change_operations": [{"after_end": 7, "after_start": 7, "before_end": 8, "before_start": 7, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3aba2e38a3c83f9de6151bd1", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3480}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "customercontactuk@gsk.com", "truncated": false}, "before_length": 25, "before_sha256": "73834f2ec2786ba4565d1820e07d2bb38952e8214867b143e05286042d58b0b0", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 25, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 25, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3af5f2c3228ba681e1eabd1d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000112", "medicine_name": "Twinrix Adult", "medicine_slug": "twinrix-adult", "observed_at": "2026-10-12T13:29:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "bc8ba3adecfe04d3079e5b502251cec982d6197257fe3b7ec3a22dc5f2ace654", "source_snapshot_id": "source-8439a1a319b62d1bd67256a4", "source_updated_at": "2026-08-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/twinrix-adult-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1007}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IV", "before": {"end": 98, "start": 0, "text": "Le CHMP recommande que les termes de la/des autorisation(s) de mise sur le marché soient modifiés.", "truncated": false}, "before_length": 98, "before_sha256": "814445cd01b1f96232572044ddd66f4350cafdd933e820b4d83b946474ffc969", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 98, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 98, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3b637d5bc211dd4b50ba81b6", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:32:00Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "3ff8cd4d67d22ba799aa348aeda944d6d896a16dcf54b030db101cbc095fc8ad", "source_snapshot_id": "source-a79a7cba8bf5dbc72fd40574", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3528}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 10, "start": 0, "text": "Österreich", "truncated": false}, "before_length": 10, "before_sha256": "b1b763860d4f30c2e1feafdcd57b714a1422b4fbc1a93d94969118a0faa65288", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 10, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 10, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3b673fc316094a8d9e44064a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1075}
{"after": {"end": 18, "start": 0, "text": "dpoccyprus@msd.com", "truncated": false}, "after_length": 18, "after_sha256": "492fae7e6db021703bcb80e4b139bc2be78a7e6cf4c6056a9314c70cfe643716", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "cyprus_info@merck.com", "truncated": false}, "before_length": 21, "before_sha256": "a6a31d0f7dc84283ce751c4e4d77e632a879da9a362680e26db9aa73403f7008", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}, {"after_end": 10, "after_start": 10, "before_end": 11, "before_start": 6, "kind": "delete"}, {"after_end": 14, "after_start": 12, "before_end": 17, "before_start": 13, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 9, "chars_inserted": 6}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3b8d58b073a11bed6235f409", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3599}
{"after": {"end": 2, "start": 0, "text": "SC", "truncated": false}, "after_length": 2, "after_sha256": "32da6721804f1dd3226c0551970304ebf1059ec19a27451426541027861c9388", "annex": "IIIA", "before": {"end": 17, "start": 0, "text": "Voie sous-cutanée", "truncated": false}, "before_length": 17, "before_sha256": "2c39e73e194fa4f0fa51aa54d98a94765b3fcf21e9faf5848d5728b740ab316d", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 0, "before_end": 17, "before_start": 0, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 17, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3b9afa67a74299fd65c2cd7e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 7021}
{"after": {"end": 192, "start": 0, "text": "Votre médecin vous remettra également une Carte Patient qui comportera des informations importantes de sécurité d’emploi que vous devez connaître, avant et pendant votre traitement par Enbrel.", "truncated": false}, "after_length": 192, "after_sha256": "a9b61621aee7f348e503c6ef13da6f1d4dc6f2a4d953f840016b3daaebeecd6a", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 192, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 192}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3bb4538ee077ec5c2de18d7b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11925}
{"after": {"end": 20, "start": 0, "text": "Tlf.: +45 44 201 100", "truncated": false}, "after_length": 20, "after_sha256": "a342c892cb893e888e9b98929ab7ba413528a3b19847cefc774fcc7b2c91291e", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "Tlf: +45 44 201 100", "truncated": false}, "before_length": 19, "before_sha256": "c639c1fe70f9701d8cecb70d89ff79995abd4e41911073143438fc69a41a0363", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3c17400757fc07680ab36c37", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9485}
{"after": {"end": 196, "start": 0, "text": "l’abacavir, l’atazanavir, le cobicistat, le darunavir, le dolutégravir, l’éfavirenz, l’elvitégravir, l’emtricitabine, la rilpivirine, le ritonavir, utilisés pour traiter les infections par le VIH.", "truncated": false}, "after_length": 196, "after_sha256": "bdc7a3372558da5d604284f4481702f7e55287d6546bbf60710e1180ef43c1ed", "annex": "IIIA", "before": {"end": 179, "start": 0, "text": "de l’infection par le VIH comme l’abacavir, l’atazanavir, le cobicistat, le darunavir, le dolutégravir, l’éfavirenz, l’elvitégravir, l’emtricitabine, la rilpivirine, le ritonavir.", "truncated": false}, "before_length": 179, "before_sha256": "f1448576a1c856772836bafb89d35875a01686034dcb0b89d85c4dc5cdf5e0a4", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 32, "before_start": 0, "kind": "delete"}, {"after_end": 195, "after_start": 146, "before_end": 178, "before_start": 178, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 32, "chars_inserted": 49}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3c467e3c44b5622f6861eff7", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3299}
{"after": {"end": 7, "start": 0, "text": "Ireland", "truncated": false}, "after_length": 7, "after_sha256": "02bf1dfa9a0365a86223f0e4ac9eaa0517b06b2e9273790f719feda656a247ae", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 7, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 7}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3c56b70facc70b5215342be2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1345}
{"after": {"end": 27, "start": 0, "text": "erlotinib, to treat cancer.", "truncated": false}, "after_length": 27, "after_sha256": "a999d7283f966898d2be9a537bb4297108bfa5217d31f6fdd0090d1cd65584be", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 27, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 27}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3c6572492ad71bc2daa7d92f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3217}
{"after": {"end": 1, "start": 0, "text": "-", "truncated": false}, "after_length": 1, "after_sha256": "3973e022e93220f9212c18d0d0c543ae7c309e46640da93a4a0314de999f5112", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 1, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3c7437a2270d566efbe4cd3e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "IMJUDO 20 mg/ml concentrate for solution for infusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 841}
{"after": {"end": 69, "start": 0, "text": "ketoconazole, posaconazole, itraconazole, to treat fungal infections.", "truncated": false}, "after_length": 69, "after_sha256": "42d7d0bd4b0caa8c0b4650a4f0bd7296721223e220be20c6c140f10f6c8575e2", "annex": "IIIA", "before": {"end": 67, "start": 0, "text": "fungal infections such as ketoconazole, posaconazole, itraconazole.", "truncated": false}, "before_length": 67, "before_sha256": "e37e7e1b0744d11e9f6ffc90f1618e885bbe55720c10347853278995ef1ee095", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 26, "before_start": 0, "kind": "delete"}, {"after_end": 68, "after_start": 40, "before_end": 66, "before_start": 66, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 26, "chars_inserted": 28}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3c7543b0b30e8f699f61adeb", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3203}
{"after": {"end": 7, "start": 0, "text": "Irlande", "truncated": false}, "after_length": 7, "after_sha256": "a8cdfff5dbbda1b070a2acb339b6f0aa20b6230d9b5500c9ce066eaa89bc9a64", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 7, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 7}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3c75f864f60c2090790f7bc9", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2181}
{"after": {"end": 98, "start": 0, "text": "Le CHMP recommande que les termes de la/des autorisation(s) de mise sur le marché soient modifiés.", "truncated": false}, "after_length": 98, "after_sha256": "814445cd01b1f96232572044ddd66f4350cafdd933e820b4d83b946474ffc969", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 98, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 98}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3c87336a8812567f3f0e3931", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:32:00Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "3ff8cd4d67d22ba799aa348aeda944d6d896a16dcf54b030db101cbc095fc8ad", "source_snapshot_id": "source-a79a7cba8bf5dbc72fd40574", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3541}
{"after": {"end": 76, "start": 0, "text": "Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe", "truncated": false}, "after_length": 76, "after_sha256": "6c7ff1bbd2f6d8c84f1254cce87065dac51505e1edd888622047a746e34551e6", "annex": "I", "before": {"end": 74, "start": 0, "text": "Spikevax JN.1 50 micrograms dispersion for injection in pre-filled syringe", "truncated": false}, "before_length": 74, "before_sha256": "ebe036d056b86be90e582dc3803425dce3820674579f962bd2fc8976b65c292a", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3cbd1ef94a0242bef9f718db", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "2", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5437}
{"after": {"end": 813, "start": 0, "text": "La sécurité et l’efficacité d’Enbrel à la dose de 50 mg (deux injections de 25 mg par voie SC) administrée une fois par semaine ont été évaluées au cours d’une étude en double aveugle, contrôlée contre placebo chez 420 patients atteints de PR active. Dans cette étude, 53 patients ont reçu du placebo, 214 patients ont reçu 50 mg d’Enbrel une fois par semaine et 153 patients ont reçu 25 mg d’Enbrel deux fois par semaine. Les profils d’efficacité et de sécurité des deux schémas posologiques d’Enbrel ont été similaires à la semaine 8 sur les signes et symptômes de la PR ; à la semaine 16, la comparabilité (non-infériorité) entre les deux schémas posologiques n’a pas été démontrée. Il a été démontré qu’une injection unique d’etanercept 50 mg/mL était bioéquivalente à deux injections simultanées de 25 mg/mL.", "truncated": false}, "after_length": 813, "after_sha256": "bf6acd4d1f720d0147769cdfc5f20aba9d97e9cf4aa5fde51b3d73d428d9d0c6", "annex": "I", "before": {"end": 813, "start": 0, "text": "La sécurité et l’efficacité d’Enbrel à la dose de 50 mg (deux injections de 25 mg par voie SC) administrée une fois par semaine ont été évaluées au cours d’une étude en double aveugle, contrôlée contre placebo chez 420 patients atteints de PR active. Dans cette étude, 53 patients ont reçu du placebo, 214 patients ont reçu 50 mg d’Enbrel une fois par semaine et 153 patients ont reçu 25 mg d’Enbrel deux fois par semaine. Les profils d’efficacité et de sécurité des deux schémas posologiques d’Enbrel ont été similaires à la semaine 8 sur les signes et symptômes de la PR ; à la semaine 16, la comparabilité (non-infériorité) entre les deux schémas posologiques n’a pas été démontrée. Il a été démontré qu’une injection unique d’etanercept 50 mg/ml était bioéquivalente à deux injections simultanées de 25 mg/ml.", "truncated": false}, "before_length": 813, "before_sha256": "a39d8fb65b6826fb5127f59247ce6a498c71542a9c8361bff2ca3e75db049558", "change_kind": "content", "change_operations": [{"after_end": 749, "after_start": 748, "before_end": 749, "before_start": 748, "kind": "replace"}, {"after_end": 812, "after_start": 811, "before_end": 812, "before_start": 811, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3cf8b52ac6e6112fb32434ab", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg solution injectable en stylo pré-rempli Enbrel 50 mg solution injectable en stylo pré-rempli", "presentation_occurrence": 4, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 4039}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "II", "before": {"end": 8, "start": 0, "text": "Due date", "truncated": false}, "before_length": 8, "before_sha256": "e1cb6d30fa3f17ee1e50b2bcf1967374467748ba3b8acd64be2df8a70c2ddc46", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 8, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 8, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3d0d88b6b8db4727dbabb266", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:33Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "21d66bf1e9a74479f577de09da3cf8517d65c1ce1b1d8bbdfe4bc38f79410def", "source_snapshot_id": "source-2c39c998fdaf05159687c016", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 470}
{"after": {"end": 116, "start": 0, "text": "ARMYDA-6 MI (The Antiplatelet therapy for Reduction of Myocardial Damage during Angioplasty - Myocardial Infarction)", "truncated": false}, "after_length": 116, "after_sha256": "8bb3261fcfa522e34c31501418939189735bb44a89baad4495ecfb7761e731a3", "annex": "I", "before": {"end": 116, "start": 0, "text": "ARMYDA-6 MI (The Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty - Myocardial Infarction)", "truncated": false}, "before_length": 116, "before_sha256": "842ac6d62bb9a517d951fcc1abe8d139cd4b8a62aa03e9560395746f496561fd", "change_kind": "content", "change_operations": [{"after_end": 57, "after_start": 56, "before_end": 57, "before_start": 56, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3d3625efbad1210f7d939e58", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000174", "medicine_name": "Plavix", "medicine_slug": "plavix", "observed_at": "2026-10-12T19:27:50Z", "pipeline_version": "2.0.0", "presentation_label": "Plavix 75 mg filmcoated tablets Plavix 300 mg filmcoated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "3818c2e3c9979bf5f8be3f164dfce187fccfccf62bbd1e3227c64ca7c00ad02f", "source_snapshot_id": "source-4aff1b64c7cf58337d33ecfa", "source_updated_at": "2025-07-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/plavix-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 456}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 14, "start": 0, "text": "Pfizer Limited", "truncated": false}, "before_length": 14, "before_sha256": "faadd350d247ecbb0e8edac0805fa3d4cdbf449fbb9a1a9614eee6624274a2f6", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3d451a74f1dfa5000d06a976", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11059}
{"after": {"end": 114, "start": 0, "text": "prenez des médicaments pour abaisser votre pression sanguine ou pour augmenter la production d’urine (diurétique),", "truncated": false}, "after_length": 114, "after_sha256": "ff2566bfc824f5e400fa32dc9f89e289d05cdb73c477ffc926758956f5832cba", "annex": "IIIA", "before": {"end": 117, "start": 0, "text": "prenez des médicaments pour abaisser votre pression sanguine ou pour augmenter la production d’urine (diurétique), ou", "truncated": false}, "before_length": 117, "before_sha256": "2066c871e150c875923154995c90dde08efb0077d53defddf47611c1cf363ce1", "change_kind": "content", "change_operations": [{"after_end": 114, "after_start": 114, "before_end": 117, "before_start": 114, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 3, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3d61570e7019f38291e228db", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2828}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 192, "start": 0, "text": "Votre médecin vous remettra également une Carte Patient qui comportera des informations importantes de sécurité d’emploi que vous devez connaître, avant et pendant votre traitement par Enbrel.", "truncated": false}, "before_length": 192, "before_sha256": "a9b61621aee7f348e503c6ef13da6f1d4dc6f2a4d953f840016b3daaebeecd6a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 192, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 192, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3d7770e4126fec9f9143b866", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 10302}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 9, "start": 0, "text": "Allemagne", "truncated": false}, "before_length": 9, "before_sha256": "6b58dbd6a994339b48d8446597da22402857b3409613459c7e3a293788fbe66a", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 9, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 9, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3d7bc3585b4dc7764284587a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "Qdenga poudre et solvant pour solution injectable. Qdenga poudre et solvant pour solution injectable en seringue pré-remplie Vaccin tétravalent contre la dengue (vivant, atténué)", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 973}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 35, "start": 0, "text": "Mundipharma Pharmaceuticals Limited", "truncated": false}, "before_length": 35, "before_sha256": "c9f3bc818698700e6aea923854537c9e902c0d2d4a55bc83c3346f2abbcfd880", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 35, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 35, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3d7c89e1d120b9d8c0e0347f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:33Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "21d66bf1e9a74479f577de09da3cf8517d65c1ce1b1d8bbdfe4bc38f79410def", "source_snapshot_id": "source-2c39c998fdaf05159687c016", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1087}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 14, "start": 0, "text": "Mundipharma AS", "truncated": false}, "before_length": 14, "before_sha256": "d225185bff45a7cac37b15c1c4f727bba36274dd9de05d7963fb65498b07991d", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3d8e3e3fe97201bdb39bd0e5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1081}
{"after": {"end": 28, "start": 0, "text": "Tél/Tel: + 32 (0)10 85 52 00", "truncated": false}, "after_length": 28, "after_sha256": "21991020d31ee1ff18b7e886e60c72625978ff6aaf6b37b3b94d159c09e80017", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "Tél/Tel: + 32 10 85 52 00", "truncated": false}, "before_length": 25, "before_sha256": "0a43db96a0eb6a17e821e1b2c7fb04323930ea184ab3ecb536a9297f8de45db1", "change_kind": "content", "change_operations": [{"after_end": 17, "after_start": 14, "before_end": 14, "before_start": 14, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 3}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3d9e7dd30302e4b6925e6eb5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000112", "medicine_name": "Twinrix Adult", "medicine_slug": "twinrix-adult", "observed_at": "2026-10-12T13:29:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "bc8ba3adecfe04d3079e5b502251cec982d6197257fe3b7ec3a22dc5f2ace654", "source_snapshot_id": "source-8439a1a319b62d1bd67256a4", "source_updated_at": "2026-08-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/twinrix-adult-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 880}
{"after": {"end": 57, "start": 0, "text": "ciclosporin, to prevent rejection of transplanted organs.", "truncated": false}, "after_length": 57, "after_sha256": "1b858c8c9d864d5e6d9e84c3f129509cb9d49327e4ba2105b189a3f3772c037b", "annex": "IIIA", "before": {"end": 64, "start": 0, "text": "preventing rejection of transplanted organs such as ciclosporin.", "truncated": false}, "before_length": 64, "before_sha256": "e1aa0190f123ffdd65a9578c00537d3cac3b18ee3f16dcee643c6a902d1f2003", "change_kind": "content", "change_operations": [{"after_end": 16, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}, {"after_end": 23, "after_start": 23, "before_end": 10, "before_start": 7, "kind": "delete"}, {"after_end": 56, "after_start": 56, "before_end": 63, "before_start": 43, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 23, "chars_inserted": 16}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3defe966292c62f855b903e9", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2780}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 72, "start": 0, "text": "Spikevax JN.1 50 micrograms dispersion for injection (single-dose vials)", "truncated": false}, "before_length": 72, "before_sha256": "41ccaa4784373a30743e6194685d229de5b4a64699df21c150e5a91151740b4d", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 72, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 72, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3e05d2983060114a3c055409", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13073}
{"after": {"end": 121, "start": 0, "text": "Attention : Le Terrosa Pen a une durée de vie de deux ans. N’utilisez pas le Terrosa Pen après la fin de sa durée de vie.", "truncated": false}, "after_length": 121, "after_sha256": "ca3dfd114f00bcb5367e5662de550cc16ec7281b78677ee09132a914a1ba17ce", "annex": "IIIA", "before": {"end": 125, "start": 0, "text": "Attention : Le stylo Terrosa a une durée de vie de deux ans. N’utilisez pas le stylo Terrosa après la fin de sa durée de vie.", "truncated": false}, "before_length": 125, "before_sha256": "ca5c9400eff630dd635507a3ef0ffdb77e99e44f1fd3cd7d5eb9c4846170a22f", "change_kind": "content", "change_operations": [{"after_end": 15, "after_start": 15, "before_end": 21, "before_start": 15, "kind": "delete"}, {"after_end": 26, "after_start": 22, "before_end": 28, "before_start": 28, "kind": "insert"}, {"after_end": 77, "after_start": 77, "before_end": 85, "before_start": 79, "kind": "delete"}, {"after_end": 88, "after_start": 84, "before_end": 92, "before_start": 92, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 12, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3e0ccef8ba09bb3ac819c363", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2097}
{"after": {"end": 25, "start": 0, "text": "Conclusions scientifiques", "truncated": false}, "after_length": 25, "after_sha256": "b9dba41fa3c9d3b642cfe755c989781c6765c2e1667b80c2d6fb1f02a6cb6463", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 25, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 25}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3e16e8a394fb4a9e9926eaf6", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:32:00Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "3ff8cd4d67d22ba799aa348aeda944d6d896a16dcf54b030db101cbc095fc8ad", "source_snapshot_id": "source-a79a7cba8bf5dbc72fd40574", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3529}
{"after": {"end": 8, "start": 0, "text": "D02 HW68", "truncated": false}, "after_length": 8, "after_sha256": "1ed87437489fcb80b59bfa5d17082f438d78a8aff5deaac6125946420fbf0992", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 8, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3e1a839c34040469502799fe", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1214}
{"after": {"end": 21, "start": 0, "text": "Tel.: +421 2 58282010", "truncated": false}, "after_length": 21, "after_sha256": "32c933770f90d44663e373be0c519eb7428907366f1868c6a270ab7f76ac5d6c", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tel: + 421 2 58282010", "truncated": false}, "before_length": 21, "before_sha256": "90cacf7d3ec61fa882ae694eb785acb84b5a4d5dc4e01a35b7899e1f2403cc28", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}, {"after_end": 7, "after_start": 7, "before_end": 7, "before_start": 6, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3e30e37f8ef8de89ff5036a7", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3487}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 129, "start": 0, "text": "Warning: Ensure the use of the correct medicine. Check the label of the cartridge before its insertion into the cartridge holder.", "truncated": false}, "before_length": 129, "before_sha256": "9122ad9fc201fd25827a369100aef99e17c8820f5dac4e93f2effc1b0d035bb7", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 129, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 129, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3e37010f1d2dda29caf21182", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2052}
{"after": {"end": 802, "start": 0, "text": "Les patients atteints de psoriasis en plaques pédiatriques (âgés de 4 à 17 ans) ont reçu 0,8 mg/kg (jusqu’à une dose maximale de 50 mg par semaine) d’etanercept une fois par semaine jusqu’à 48 semaines. Les concentrations sériques moyennes à l’état d’équilibre ont varié de 1,6 à 2,1 g/mL aux semaines 12, 24 et 48. Ces concentrations moyennes chez les patients atteints de psoriasis en plaques pédiatriques ont été similaires aux concentrations observées chez les patients atteints d’arthrite juvénile idiopathique (traités par 0,4 mg/kg d’etanercept deux fois par semaine, jusqu’à une dose maximale de 50 mg par semaine). Ces concentrations moyennes étaient similaires à celles observées chez les patients adultes atteints de psoriasis en plaques traités par 25 mg d’etanercept deux fois par semaine.", "truncated": false}, "after_length": 802, "after_sha256": "ca5c7c3e555ab392f8c67fbb745448c12b6b08f293c9e20def58d272460ceaf1", "annex": "I", "before": {"end": 802, "start": 0, "text": "Les patients atteints de psoriasis en plaques pédiatriques (âgés de 4 à 17 ans) ont reçu 0,8 mg/kg (jusqu’à une dose maximale de 50 mg par semaine) d’etanercept une fois par semaine jusqu’à 48 semaines. Les concentrations sériques moyennes à l’état d’équilibre ont varié de 1,6 à 2,1 g/ml aux semaines 12, 24 et 48. Ces concentrations moyennes chez les patients atteints de psoriasis en plaques pédiatriques ont été similaires aux concentrations observées chez les patients atteints d’arthrite juvénile idiopathique (traités par 0,4 mg/kg d’etanercept deux fois par semaine, jusqu’à une dose maximale de 50 mg par semaine). Ces concentrations moyennes étaient similaires à celles observées chez les patients adultes atteints de psoriasis en plaques traités par 25 mg d’etanercept deux fois par semaine.", "truncated": false}, "before_length": 802, "before_sha256": "d4455d52b7180305231ad26b80345ca5187b6e1b8f4a48a51dcc2df4f0bc7fc6", "change_kind": "content", "change_operations": [{"after_end": 288, "after_start": 287, "before_end": 288, "before_start": 287, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3e4261334ea6622e526d96c2", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 10 mg poudre et solvant pour solution injectable pour usage pédiatrique", "presentation_occurrence": 5, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5340}
{"after": {"end": 252, "start": 0, "text": "prenez des inhibiteurs de la PDE-5 tels que le sildénafil, le tadalafil, le vardénafil. Ces médicaments sont utilisés pour traiter la pression sanguine élevée dans les artères des poumons ou pour traiter les problèmes d’érection (dysfonction érectile).", "truncated": false}, "after_length": 252, "after_sha256": "a25e8de5c277dfae1dfac44a37c2e92c3bbc06968c9909f816bba1df0939b62f", "annex": "IIIA", "before": {"end": 239, "start": 0, "text": "prenez des inhibiteurs de la PDE-5 tels que le sildénafil, le tadalafil, le vardénafil. Ces médicaments sont utilisés pour traiter la pression sanguine élevée dans les artères des poumons ou les problèmes d’érection (dysfonction érectile).", "truncated": false}, "before_length": 239, "before_sha256": "92b3a945c92b569949830ff52142dccc3444f0557c9af3d9133aef3e3ae696ec", "change_kind": "content", "change_operations": [{"after_end": 204, "after_start": 191, "before_end": 191, "before_start": 191, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 13}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3e4f50689c85bd711d0c93d1", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2807}
{"after": {"end": 129, "start": 0, "text": "Taking into account the PRAC Assessment Report on the PSUR(s) for bevacizumab, the scientific conclusions of PRAC are as follows:", "truncated": false}, "after_length": 129, "after_sha256": "0b11e2fa146669716da0e097b7c018e65c36b3f9e63c9b699854913753faa9d7", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 129, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 129}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3ead97940e3229c3a77e0885", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:18Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "89a938df5e41f86548301270084e3d1ecf171802e24b5429f62e3bede7ee32dd", "source_snapshot_id": "source-b71aeee5a07abebc34c02e28", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3426}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 17, "start": 0, "text": "1 hour 45 minutes", "truncated": false}, "before_length": 17, "before_sha256": "91cdd6a52d7d436f49753a82ebbf2f903deeae52be8c0c29e2c10f042b87c186", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 17, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 17, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3eccf63153f3ca4b157f05d9", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6404}
{"after": {"end": 22, "start": 0, "text": "Scientific conclusions", "truncated": false}, "after_length": 22, "after_sha256": "48a176450b72da083aae0c461d4b9485bc052767229342ad7b9f3b91fb4b3641", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 22, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 22}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3efb2d8ec5d6e3b78cdf4fff", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3440}
{"after": {"end": 306, "start": 0, "text": "La déclaration des effets indésirables suspectés après autorisation du médicament est importante. Elle permet une surveillance continue du rapport bénéfice-risque du médicament. Les professionnels de santé déclarent tout effet indésirable suspecté via le système national de déclaration décrit en Annexe V.", "truncated": false}, "after_length": 306, "after_sha256": "452bc131151fe3718829a27fe4a102af949a8c9167b7442f3e5c02b09ad0be48", "annex": "I", "before": {"end": 466, "start": 0, "text": "La déclaration des effets indésirables suspectés après autorisation du médicament est importante. Elle permet une surveillance continue du rapport bénéfice-risque du médicament. Les professionnels de santé déclarent tout effet indésirable suspecté via le système national de déclaration : Agence nationale de sécurité du médicament et des produits de santé (ANSM) et réseau des Centres Régionaux de Pharmacovigilance - Site internet : www.signalement-sante.gouv.fr..", "truncated": false}, "before_length": 466, "before_sha256": "dfdf4592a0e6e05077f1b657de85e5f66cbe7aa770bff64637412b25db20d3b0", "change_kind": "content", "change_operations": [{"after_end": 287, "after_start": 287, "before_end": 306, "before_start": 287, "kind": "delete"}, {"after_end": 288, "after_start": 288, "before_end": 310, "before_start": 307, "kind": "delete"}, {"after_end": 290, "after_start": 290, "before_end": 313, "before_start": 312, "kind": "delete"}, {"after_end": 293, "after_start": 293, "before_end": 317, "before_start": 316, "kind": "delete"}, {"after_end": 294, "after_start": 294, "before_end": 328, "before_start": 318, "kind": "delete"}, {"after_end": 296, "after_start": 296, "before_end": 331, "before_start": 330, "kind": "delete"}, {"after_end": 300, "after_start": 297, "before_end": 332, "before_start": 332, "kind": "insert"}, {"after_end": 302, "after_start": 301, "before_end": 349, "before_start": 333, "kind": "replace"}, {"after_end": 305, "after_start": 304, "before_end": 465, "before_start": 351, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 165, "chars_inserted": 5}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3f231895e807a08f3a1a4451", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "Nyxoid 1,8 mg, solution pour pulvérisation nasale en récipient unidose", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 226}
{"after": {"end": 632, "start": 0, "text": "Les caractéristiques des concentrations sériques moyennes à l’état d’équilibre chez les patients atteints de PR étaient une Cmax de 2,4 mg/l vs 2,6 mg/l, une Cmin de 1,2 mg/l vs 1,4 mg/l, et une ASC partielle de 297 mgh/l vs 316 mgh/l pour la dose de 50 mg d’Enbrel une fois par semaine (n = 21) vs 25 mg d’Enbrel deux fois par semaine (n = 16) respectivement. Dans une étude en ouvert, croisée, avec administration unique de deux posologies différentes chez des volontaires sains, il a été démontré que l’administration d’une injection unique de 50 mg/mL d’etanercept était bioéquivalente à deux injections simultanées de 25 mg/mL.", "truncated": false}, "after_length": 632, "after_sha256": "a314719d36f9cbee570762008a9dbbdc562da2fa0fcbf7079b1f1d65515aa5c9", "annex": "I", "before": {"end": 632, "start": 0, "text": "Les caractéristiques des concentrations sériques moyennes à l’état d’équilibre chez les patients atteints de PR étaient une Cmax de 2,4 mg/l vs 2,6 mg/l, une Cmin de 1,2 mg/l vs 1,4 mg/l, et une ASC partielle de 297 mgh/l vs 316 mgh/l pour la dose de 50 mg d’Enbrel une fois par semaine (n = 21) vs 25 mg d’Enbrel deux fois par semaine (n = 16) respectivement. Dans une étude en ouvert, croisée, avec administration unique de deux posologies différentes chez des volontaires sains, il a été démontré que l’administration d’une injection unique de 50 mg/ml d’etanercept était bioéquivalente à deux injections simultanées de 25 mg/ml.", "truncated": false}, "before_length": 632, "before_sha256": "8c065fd129119e22879a2173b5d388342b9c02f7cde21405d481a9d61753f047", "change_kind": "content", "change_operations": [{"after_end": 555, "after_start": 554, "before_end": 555, "before_start": 554, "kind": "replace"}, {"after_end": 631, "after_start": 630, "before_end": 631, "before_start": 630, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3f57c192072a0b300dae7be3", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg poudre et solvant pour solution injectable", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2147}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "icepharma@icepharma.is", "truncated": false}, "before_length": 22, "before_sha256": "1d615bc2c915498be3f3e7960f34d5af0bec545d614ea24eba34ab7ead4041e7", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 22, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 22, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3f5a4cad737fb5aed3884803", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1124}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "info@mundipharma.be", "truncated": false}, "before_length": 19, "before_sha256": "fc5e5b98df902cc2264e183a9bf7b097d1330cde86581ebd0467522133fb8584", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 19, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 19, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3f76b215839985833e6166d3", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1047}
{"after": {"end": 308, "start": 0, "text": "Avant de jeter le Terrosa Pen, retirez toujours l’aiguille pour stylo et la cartouche. Les aiguilles et les cartouches usagées doivent être éliminées séparément et en toute sécurité. Le Terrosa Pen peut être éliminé conformément à la réglementation locale en matière de déchets ou avec les ordures ménagères.", "truncated": false}, "after_length": 308, "after_sha256": "890c82dc4dea49744b3119d5d78cde1ded82cd2e85060c22341eed11fe6d4e28", "annex": "IIIA", "before": {"end": 312, "start": 0, "text": "Avant de jeter le stylo Terrosa, retirez toujours l’aiguille pour stylo et la cartouche. Les aiguilles et les cartouches usagées doivent être éliminées séparément et en toute sécurité. Le stylo Terrosa peut être éliminé conformément à la réglementation locale en matière de déchets ou avec les ordures ménagères.", "truncated": false}, "before_length": 312, "before_sha256": "6df716047fb1960f1f9e4accb549fe62cca26bc9d4ced6fe337c03a6a3b9c9a0", "change_kind": "content", "change_operations": [{"after_end": 18, "after_start": 18, "before_end": 24, "before_start": 18, "kind": "delete"}, {"after_end": 29, "after_start": 25, "before_end": 31, "before_start": 31, "kind": "insert"}, {"after_end": 186, "after_start": 186, "before_end": 194, "before_start": 188, "kind": "delete"}, {"after_end": 197, "after_start": 193, "before_end": 201, "before_start": 201, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 12, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3fb5af08ea64fe5da14969b2", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2099}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 11, "start": 0, "text": "Takeda GmbH", "truncated": false}, "before_length": 11, "before_sha256": "94e4e4fc81542d4a8a0deb904c666e74cf300a1075af4d0d2e564a29e287bafb", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 11, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 11, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3fd56f3693d871dafba2c62b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "Qdenga poudre et solvant pour solution injectable. Qdenga poudre et solvant pour solution injectable en seringue pré-remplie Vaccin tétravalent contre la dengue (vivant, atténué)", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 970}
{"after": {"end": 6, "start": 0, "text": "5 ans.", "truncated": false}, "after_length": 6, "after_sha256": "e56b7643b0b02580f0067499b1f2db3ee28088620bb2fed55dfc14e8d21d7104", "annex": "I", "before": {"end": 5, "start": 0, "text": "5 ans", "truncated": false}, "before_length": 5, "before_sha256": "7c2168471c65c1fbdb42748b93ff536f9061f087771fcdb9e55dd456606e12b1", "change_kind": "content", "change_operations": [{"after_end": 6, "after_start": 5, "before_end": 5, "before_start": 5, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-3ff24d7e2d79a2cc1c2cd836", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:32:00Z", "pipeline_version": "2.0.0", "presentation_label": "Fycompa 2 mg comprimés pelliculés Fycompa 4 mg comprimés pelliculés Fycompa 6 mg comprimés pelliculés Fycompa 8 mg comprimés pelliculés Fycompa 10 mg comprimés pelliculés Fycompa 12 mg comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.3", "section_type": "storage", "source_provider": "European Medicines Agency", "source_sha256": "3ff8cd4d67d22ba799aa348aeda944d6d896a16dcf54b030db101cbc095fc8ad", "source_snapshot_id": "source-a79a7cba8bf5dbc72fd40574", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 796}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 8, "start": 0, "text": "Portugal", "truncated": false}, "before_length": 8, "before_sha256": "4c7de2c3da6dc0ae8f9d13b107718a913859359bd30166d077c867577953865d", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 8, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 8, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4003f9c790405e3460694749", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1096}
{"after": {"end": 8, "start": 0, "text": "ANNEX IV", "truncated": false}, "after_length": 8, "after_sha256": "29972ab77d4b1358a0bdb16d438bcde59007e95356d1f5f9ee2f7045597f9574", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 8, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-40199f0b691e3290fc1d6d48", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:18Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "89a938df5e41f86548301270084e3d1ecf171802e24b5429f62e3bede7ee32dd", "source_snapshot_id": "source-b71aeee5a07abebc34c02e28", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3420}
{"after": {"end": 20, "start": 0, "text": "Tel: +386 1 520 4201", "truncated": false}, "after_length": 20, "after_sha256": "4bc9aa9751d0ed5412a51f1a97aa4bd5b6851a9385ea852b8e407689ba7fe597", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Tel: + 386 1 5204201", "truncated": false}, "before_length": 20, "before_sha256": "03fc8248ffd9e4d5d179a7355c42c921061db83dc6ab440084c3885eeef938e0", "change_kind": "content", "change_operations": [{"after_end": 6, "after_start": 6, "before_end": 7, "before_start": 6, "kind": "delete"}, {"after_end": 16, "after_start": 15, "before_end": 16, "before_start": 16, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-403c5a780524217122d3b2bd", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3478}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "II", "before": {"end": 11, "start": 0, "text": "Description", "truncated": false}, "before_length": 11, "before_sha256": "526e0087cc3f254d9f86f6c7d8e23d954c4dfda2b312efc29194ae8a860106ba", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 11, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 11, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4053d47db7a81b578d038fae", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 471}
{"after": {"end": 11, "start": 0, "text": "Section 4.8", "truncated": false}, "after_length": 11, "after_sha256": "13379a103dd3ab9b7c3d8baf6c76ab3bea735dd4c4b3e79f646ef24f9ca952d9", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 11, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 11}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-40750d446bc80e99e21b8e26", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:30Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "35ab6716aa09492c14ac6849111486ec47235c0bc65ef055350de950f316c5e6", "source_snapshot_id": "source-f20a60110d1f8fef5225317d", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2359}
{"after": {"end": 129, "start": 0, "text": "Après examen de la recommandation du PRAC, le CHMP approuve les conclusions générales du PRAC et les motifs de sa recommandation.", "truncated": false}, "after_length": 129, "after_sha256": "7f742dd4d84dfcd3eaee344b865d2447706c76828f7b7aeaa1db7fa5791f3aec", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 129, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 129}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-409e52e3cada613ec4c659d5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3404}
{"after": {"end": 22, "start": 0, "text": "Tel: + 420 296 188 338", "truncated": false}, "after_length": 22, "after_sha256": "cade761d1991183690c5d39848f424472df61dbad0bc430b6f01fef8e76b3e31", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "Tel: + 420 222 318 221", "truncated": false}, "before_length": 22, "before_sha256": "bb97657d5fa1378aa53d1991199309e2efe0a292f06fc3bf2e0ab4b83ac0c8eb", "change_kind": "content", "change_operations": [{"after_end": 18, "after_start": 12, "before_end": 14, "before_start": 12, "kind": "replace"}, {"after_end": 21, "after_start": 20, "before_end": 17, "before_start": 16, "kind": "replace"}, {"after_end": 22, "after_start": 22, "before_end": 22, "before_start": 18, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 7}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-40d18e6533b31b8f0afe865e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:33Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "21d66bf1e9a74479f577de09da3cf8517d65c1ce1b1d8bbdfe4bc38f79410def", "source_snapshot_id": "source-2c39c998fdaf05159687c016", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 971}
{"after": {"end": 387, "start": 0, "text": "L’analyse primaire de la SSP évaluée par les investigateurs (données de progression CA 125 et traitements hors protocole censurés) a montré un risque relatif stratifié de 0,62 (IC 95 % : 0,52-0,75, valeur de p du test du log-rank unilatéral < 0,0001) quand le bras CPB15+ est comparé au bras CPP, avec une médiane de SSP de 12,0 mois dans le bras CPP et de 18,2 mois dans le bras CPB15+.", "truncated": false}, "after_length": 387, "after_sha256": "51b34e7fc4e6991518d69fbef397f45214d55ac110945b9c5788f45e35a6f983", "annex": "I", "before": {"end": 387, "start": 0, "text": "L’analyse primaire de la PFS évaluée par les investigateurs (données de progression CA 125 et traitements hors protocole censurés) a montré un risque relatif stratifié de 0,62 (IC 95 % : 0,52-0,75, valeur de p du test du log-rank unilatéral < 0,0001) quand le bras CPB15+ est comparé au bras CPP, avec une médiane de PFS de 12,0 mois dans le bras CPP et de 18,2 mois dans le bras CPB15+.", "truncated": false}, "before_length": 387, "before_sha256": "7b3dd84d80bf811c0f93e9a3b5827c011332a7621279987b95eb01420eb3544e", "change_kind": "content", "change_operations": [{"after_end": 27, "after_start": 25, "before_end": 25, "before_start": 25, "kind": "insert"}, {"after_end": 28, "after_start": 28, "before_end": 28, "before_start": 26, "kind": "delete"}, {"after_end": 319, "after_start": 317, "before_end": 317, "before_start": 317, "kind": "insert"}, {"after_end": 320, "after_start": 320, "before_end": 320, "before_start": 318, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-40eec3814eb1874b7a7bd9de", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1787}
{"after": {"end": 43, "start": 0, "text": "Pfizer Healthcare Ireland Unlimited Company", "truncated": false}, "after_length": 43, "after_sha256": "1f203777a0ec6fed9c840d52631b6a74c7e25b5d318485d8147e2404f52dc981", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "Pfizer Healthcare Ireland", "truncated": false}, "before_length": 25, "before_sha256": "4beeea9b6d0c491f03a9511d9f9576b9c75cbcdcfd736e4934f768fdded936f5", "change_kind": "content", "change_operations": [{"after_end": 43, "after_start": 25, "before_end": 25, "before_start": 25, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 18}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-40fc35b38118ca330b54565c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12134}
{"after": {"end": 109, "start": 0, "text": "If you are taking these medicines, you may experience more side effects, or Adempas may not work as expected.", "truncated": false}, "after_length": 109, "after_sha256": "03696b91bbb3d0f21a713249836c659207436a01347f784537618316f06d5d05", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 109, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 109}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-40fe7d904dd698fa8efd21e5", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3214}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 143, "start": 0, "text": "One dose (0.5 mL) contains 50 micrograms of SARSCoV2 JN.1 mRNA, a COVID19 mRNA Vaccine (nucleoside modified) (embedded in lipid nanoparticles).", "truncated": false}, "before_length": 143, "before_sha256": "59aec4ee6835dd582a93dffc8976603649dfe92fb8f9cfefbbdb72454c4dc65a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 143, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 143, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4185f4574d3b0480dcbd53b8", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "2", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5434}
{"after": {"end": 71, "start": 0, "text": "le bosentan, utilisé pour traiter l’hypertension artérielle pulmonaire.", "truncated": false}, "after_length": 71, "after_sha256": "2d214745467c14c815d7d04973792b27eca1894b9440fd8f23acc519a3d2b545", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 71, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 71}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4186c5eb1df6d7fc9b5ff911", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3304}
{"after": {"end": 2, "start": 0, "text": "SC", "truncated": false}, "after_length": 2, "after_sha256": "32da6721804f1dd3226c0551970304ebf1059ec19a27451426541027861c9388", "annex": "IIIA", "before": {"end": 17, "start": 0, "text": "Voie sous-cutanée", "truncated": false}, "before_length": 17, "before_sha256": "2c39e73e194fa4f0fa51aa54d98a94765b3fcf21e9faf5848d5728b740ab316d", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 0, "before_end": 17, "before_start": 0, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 17, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-41bea4671c00b56644275c36", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 7681}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tel: + 4212 6381 1611", "truncated": false}, "before_length": 21, "before_sha256": "81bd347adb468135c4f9a20c3656db9d98eed722c50566c9f514fa504d3a8608", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 21, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 21, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-41e0623eaf6720a692cd78d8", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1128}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "info@mundipharma.de", "truncated": false}, "before_length": 19, "before_sha256": "7352e6d7ce28cc7bc279a48fb87c85d0a241093368a041e0a8e1ef75be4fce99", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 19, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 19, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-41f5241c11707dc7da9cae71", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1053}
{"after": {"end": 20, "start": 0, "text": "dpoc.croatia@msd.com", "truncated": false}, "after_length": 20, "after_sha256": "e6060fe9f944bc26788eae6c6fde884372f9d1fb19a754bedfaa7c027a1b33e8", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "croatia_info@merck.com", "truncated": false}, "before_length": 22, "before_sha256": "759280e179a26a0343b8a3e77f7b95e8375fadcd491da4367ac6580767a10fbf", "change_kind": "content", "change_operations": [{"after_end": 5, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}, {"after_end": 12, "after_start": 12, "before_end": 12, "before_start": 7, "kind": "delete"}, {"after_end": 16, "after_start": 14, "before_end": 18, "before_start": 14, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 9, "chars_inserted": 7}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-420730655e813c1aaeb35f94", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3560}
{"after": {"end": 20, "start": 0, "text": "Tlf: +47 32 20 73 00", "truncated": false}, "after_length": 20, "after_sha256": "554d3014d2516702d0c22a89fb65d9c24ed800d14c36df4bf39ee1ecab71c124", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tlf: + 47 32 20 73 00", "truncated": false}, "before_length": 21, "before_sha256": "e1f6d02c8ded918450f2e8f65b84556d21d9f9644984ce9e4a7da61d7a6ac88f", "change_kind": "content", "change_operations": [{"after_end": 6, "after_start": 6, "before_end": 7, "before_start": 6, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-424adfc69b11a2fde9bf1e89", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3525}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "II", "before": {"end": 14, "start": 0, "text": "Delpharm Dijon", "truncated": false}, "before_length": 14, "before_sha256": "488aa9484cf024ead28202226d4252020932466c3441a2c99248d9d96918b046", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-426397a4f01b2009eaf24c8f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000174", "medicine_name": "Plavix", "medicine_slug": "plavix", "observed_at": "2026-10-12T19:26:25Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "8d1630f20e7a86728cac32eaccf248b0a0e88d4d9a2a9cfa6e6429b883e20247", "source_snapshot_id": "source-77d6cc5bd19bd71f20e22a8e", "source_updated_at": "2025-07-14", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/plavix-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 882}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "infomed@mundipharma.es", "truncated": false}, "before_length": 22, "before_sha256": "b804f6d6d90771ef4472b0befaaa07ffaa6334b73b084d8dd8578760f78b2dc5", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 22, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 22, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-427895a1708a9493dfb0ed8c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1097}
{"after": {"end": 646, "start": 0, "text": "Dans l’étude E2100, les patients étaient traités jusqu’à progression de la maladie. Dans les cas où un arrêt prématuré de la chimiothérapie était nécessaire, le traitement par Avastin en monothérapie était poursuivi jusqu’à progression de la maladie. Les caractéristiques des patients étaient similaires dans les deux bras de traitement. L’objectif principal de l’étude était la survie sans progression (SSP), selon une évaluation de la progression de la maladie faite par les investigateurs de l’étude. De plus, une revue indépendante du critère principal a également été réalisée. Les résultats de cette étude sont présentés dans le tableau 10.", "truncated": false}, "after_length": 646, "after_sha256": "5564ae5fd17c929a1390c89b637f71a5285eb59860f89e31318c98cb09510923", "annex": "I", "before": {"end": 646, "start": 0, "text": "Dans l’étude E2100, les patients étaient traités jusqu’à progression de la maladie. Dans les cas où un arrêt prématuré de la chimiothérapie était nécessaire, le traitement par Avastin en monothérapie était poursuivi jusqu’à progression de la maladie. Les caractéristiques des patients étaient similaires dans les deux bras de traitement. L’objectif principal de l’étude était la survie sans progression (PFS), selon une évaluation de la progression de la maladie faite par les investigateurs de l’étude. De plus, une revue indépendante du critère principal a également été réalisée. Les résultats de cette étude sont présentés dans le tableau 10.", "truncated": false}, "before_length": 646, "before_sha256": "e1e97d876a2f37398f1cc593295acd5bf4ce7a4bf9400b75ffa544cb28d9f233", "change_kind": "content", "change_operations": [{"after_end": 406, "after_start": 404, "before_end": 404, "before_start": 404, "kind": "insert"}, {"after_end": 407, "after_start": 407, "before_end": 407, "before_start": 405, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4291667974210b65423e7bb1", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1328}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 10, "start": 0, "text": "45 minutes", "truncated": false}, "before_length": 10, "before_sha256": "bc54807d7df55abaf214d21aef97ce35c150ce5c072cf6f287d6c790c72ab265", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 10, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 10, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-42b201a06c208006c4889815", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6406}
{"after": {"end": 51, "start": 0, "text": "Ne prenez pas les médicaments suivants avec Adempas", "truncated": false}, "after_length": 51, "after_sha256": "b45702508d12ba9265bea5c9651094dd13251090c705d9e265642a3a86d7c5aa", "annex": "IIIA", "before": {"end": 56, "start": 0, "text": "Ne prenez pas de médicaments utilisés pour le traitement", "truncated": false}, "before_length": 56, "before_sha256": "449bb64bd12b29ef09bcff7eac43c566251d2e74bd7a4151e7137043d2ce8d74", "change_kind": "content", "change_operations": [{"after_end": 15, "after_start": 14, "before_end": 15, "before_start": 14, "kind": "replace"}, {"after_end": 17, "after_start": 16, "before_end": 16, "before_start": 16, "kind": "insert"}, {"after_end": 31, "after_start": 30, "before_end": 29, "before_start": 29, "kind": "insert"}, {"after_end": 36, "after_start": 32, "before_end": 30, "before_start": 30, "kind": "insert"}, {"after_end": 37, "after_start": 37, "before_end": 36, "before_start": 31, "kind": "delete"}, {"after_end": 43, "after_start": 39, "before_end": 42, "before_start": 38, "kind": "replace"}, {"after_end": 46, "after_start": 44, "before_end": 51, "before_start": 43, "kind": "replace"}, {"after_end": 51, "after_start": 48, "before_end": 56, "before_start": 53, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 21, "chars_inserted": 16}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-42b86f1810e96c431b5701c1", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3290}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 16, "start": 0, "text": "EU/1/20/1507/022", "truncated": false}, "before_length": 16, "before_sha256": "47582a0cb1b0c52edc670829bf737073718f2ac3da744334b096c9e0a9a3c204", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 16, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 16, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-42bf2367a5ede2da32b326d2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "8", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6479}
{"after": {"end": 19, "start": 0, "text": "Tel: +46 77 5700488", "truncated": false}, "after_length": 19, "after_sha256": "a968f6c96e435fb9594d06eee9f260814621b5e791fe61e1569bed42d6c801a6", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Tel: + 46 77 5700488", "truncated": false}, "before_length": 20, "before_sha256": "cb17614fcd82c944ba52cdd6413741cfa9e5ecd4d08eb5b092e244324255c763", "change_kind": "content", "change_operations": [{"after_end": 6, "after_start": 6, "before_end": 7, "before_start": 6, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-42d0e81b0ace572075a6c4b2", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3193}
{"after": {"end": 145, "start": 0, "text": "One dose (0.5 mL) contains 50 micrograms of SARSCoV2 LP.8.1 mRNA, a COVID19 mRNA Vaccine (nucleoside modified) (embedded in lipid nanoparticles).", "truncated": false}, "after_length": 145, "after_sha256": "7b73ed4334cf57ac73142541e7981150e2d96786f22e9ca9f81005e977b9e222", "annex": "I", "before": {"end": 143, "start": 0, "text": "One dose (0.5 mL) contains 50 micrograms of SARSCoV2 JN.1 mRNA, a COVID19 mRNA Vaccine (nucleoside modified) (embedded in lipid nanoparticles).", "truncated": false}, "before_length": 143, "before_sha256": "59aec4ee6835dd582a93dffc8976603649dfe92fb8f9cfefbbdb72454c4dc65a", "change_kind": "content", "change_operations": [{"after_end": 57, "after_start": 53, "before_end": 55, "before_start": 53, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4302cc8de3c7ae29dc1ee1eb", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "2", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5424}
{"after": {"end": 122, "start": 0, "text": "Having reviewed the PRAC recommendation, the CHMP agrees with the PRAC overall conclusions and grounds for recommendation.", "truncated": false}, "after_length": 122, "after_sha256": "095a3b724a58255112d0ae23e9c65e77959b40571fcaaf1946c9da9f699beeda", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 122, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 122}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-433729fa2cdc980706369275", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3446}
{"after": {"end": 37, "start": 0, "text": "Utiliser uniquement avec Terrosa Pen.", "truncated": false}, "after_length": 37, "after_sha256": "9e6e297962f9997271f8b6c31e0be7943e1e920118926bbc1c361dfa49c5845b", "annex": "IIIA", "before": {"end": 42, "start": 0, "text": "Utiliser uniquement avec le stylo Terrosa.", "truncated": false}, "before_length": 42, "before_sha256": "2526eb440c0d3175a80f9f79f43335fd7b304df14199869bbd12ccfe685c339a", "change_kind": "content", "change_operations": [{"after_end": 25, "after_start": 25, "before_end": 34, "before_start": 25, "kind": "delete"}, {"after_end": 36, "after_start": 32, "before_end": 41, "before_start": 41, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 9, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-43471f2301a124baa2913389", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1484}
{"after": {"end": 20, "start": 0, "text": "Tlf: +47 32 20 73 00", "truncated": false}, "after_length": 20, "after_sha256": "554d3014d2516702d0c22a89fb65d9c24ed800d14c36df4bf39ee1ecab71c124", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tlf: + 47 32 20 73 00", "truncated": false}, "before_length": 21, "before_sha256": "e1f6d02c8ded918450f2e8f65b84556d21d9f9644984ce9e4a7da61d7a6ac88f", "change_kind": "content", "change_operations": [{"after_end": 6, "after_start": 6, "before_end": 7, "before_start": 6, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4357504c4f5328d952736fc4", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3429}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 192, "start": 0, "text": "Votre médecin vous remettra également une Carte Patient qui comportera des informations importantes de sécurité d’emploi que vous devez connaître, avant et pendant votre traitement par Enbrel.", "truncated": false}, "before_length": 192, "before_sha256": "a9b61621aee7f348e503c6ef13da6f1d4dc6f2a4d953f840016b3daaebeecd6a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 192, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 192, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4358f26175ba5e3008924b5d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11376}
{"after": {"end": 172, "start": 0, "text": "The following changes to the product information of medicinal products containing apremilast are recommended (new text underlined and in bold, deleted text strike through):", "truncated": false}, "after_length": 172, "after_sha256": "8d9a9c4e2243453cac327121ba84a28a11732da2504bd9d1c748686def1d021f", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 172, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 172}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-437b39863100a352d89fcf60", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:30Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "35ab6716aa09492c14ac6849111486ec47235c0bc65ef055350de950f316c5e6", "source_snapshot_id": "source-f20a60110d1f8fef5225317d", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2347}
{"after": {"end": 54, "start": 0, "text": "Takeda Pharmaceuticals International AG Ireland Branch", "truncated": false}, "after_length": 54, "after_sha256": "81709515d3af1f0e4041ce3c760d8fc81fefa358805810b0b53a84e121d5efa6", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 54, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 54}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-43ade1dbef01777b2a05db3d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1715}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IV", "before": {"end": 128, "start": 0, "text": "Taking into account the PRAC Assessment Report on the PSUR(s) for perampanel, the scientific conclusions of CHMP are as follows:", "truncated": false}, "before_length": 128, "before_sha256": "4c4176b55d3ed891a10679fbd70b951a5a4e7932a95ec4c14b8a7799d109b315", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 128, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 128, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-43b9595c318606bf941a24e8", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3425}
{"after": {"end": 21, "start": 0, "text": "Block 2 Miesian Plaza", "truncated": false}, "after_length": 21, "after_sha256": "99b504ac4fff9020da29e00aeb786f0975177380626e2b3347bd3fbd75afeeba", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 21, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 21}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-43f4cfd47c619c5af88a579b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1716}
{"after": {"end": 178, "start": 0, "text": "This document is the approved product information for NovoRapid, with the changes since the previous procedure affecting the product information (EMEA/H/C/000258/N/0146) tracked.", "truncated": false}, "after_length": 178, "after_sha256": "e68ddf5b96d1d9bfe29e43291313a29f80e93d5c9651321e8daedac5f7fcbd71", "annex": "", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 178, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 178}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-44179e866dc8f527cc37fc5d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000258", "medicine_name": "NovoRapid", "medicine_slug": "novorapid", "observed_at": "2026-10-12T19:05:17Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "1f523a448c243ca0c7f4a7a256aecf542f6d2937ca52c9e9a8051cbe652ac962", "source_snapshot_id": "source-a33d4e91086c5c029de837c3", "source_updated_at": "2025-10-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/novorapid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 4}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tel.:+ 370 5 231 4658", "truncated": false}, "before_length": 21, "before_sha256": "f51302598bfdf813db86b99fb01306c70f457c7d688d0fda55807ca1140935db", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 21, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 21, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-442d55dccb16db376c8c4bbd", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1020}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 391, "start": 0, "text": "Chemical and physical stability has also been demonstrated for unopened single-dose vials when stored for 12 months at -50°C to -15°C provided that once thawed and stored at 2°C to 8°C, protected from light, the single-dose vial will be used up within a maximum of 14 days (instead of 30 days, when stored at -50ºC to -15ºC for 9 months), but not exceeding a total storage time of 12 months.", "truncated": false}, "before_length": 391, "before_sha256": "adc4205a753ccaf933c2359ba273d5d5a1b7b3f0977a3713cd2c6be54e29c972", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 391, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 391, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4444e651242dc16c618d8682", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.3", "section_type": "storage", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6247}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 10, "start": 0, "text": "2°C to 8°C", "truncated": false}, "before_length": 10, "before_sha256": "81d810716acbe950b41556ad0d6f83327c0c94aaaad43647bd6107d8f320a304", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 10, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 10, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-445fd97d9f6d9c62efa9906b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13094}
{"after": {"end": 199, "start": 0, "text": "Spikevax LP.8.1 is a white to off-white dispersion. It may contain white or translucent product-related particulates. Do not administer if vaccine is discoloured or contains other particulate matter.", "truncated": false}, "after_length": 199, "after_sha256": "d5b51c0205f6e67b19719fd3ff83b59baf2d8e2a3e15f3a7679a0f0cf2791794", "annex": "I", "before": {"end": 197, "start": 0, "text": "Spikevax JN.1 is a white to off-white dispersion. It may contain white or translucent product-related particulates. Do not administer if vaccine is discoloured or contains other particulate matter.", "truncated": false}, "before_length": 197, "before_sha256": "ef4d0d5157f11a38979142c01b394ea022b848da95f1c9cc7b8636bbb0ac0e52", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-44855d5d6ef89702e9afca1e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6452}
{"after": {"end": 16, "start": 0, "text": "Intended purpose", "truncated": false}, "after_length": 16, "after_sha256": "0a6ded1606d3aef39f1468221812cf1a888891e0a1383ae2a3e98b87b3d614a5", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 16, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 16}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-44a4693b6ba900bd290b461f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1943}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 215, "start": 0, "text": "Des Cartes Patient sont fournies aux médecins prescripteurs d’etanercept pour être remises aux patients recevant de l’etanercept. Cette carte fournit aux patients les informations de sécurité importantes suivantes :", "truncated": false}, "before_length": 215, "before_sha256": "da7c6d0404ffd6f1a0e8e68ca16409b0c1dc904967294cc4ba77583468a92b37", "change_kind": "unassigned", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 215, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 215, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-44e82ba29c2072f1dadb1215", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6666}
{"after": {"end": 236, "start": 0, "text": "Adempas moderately influences the ability to cycle, drive and use machines. It may cause side effects such as dizziness. You should be aware of the side effects of this medicine before cycling, driving or using machines (see section 4).", "truncated": false}, "after_length": 236, "after_sha256": "ed4a6ce649ab2bc1cce0c804d533f46b4a33c30a31ae0d32f448d8228bafbd4a", "annex": "IIIA", "before": {"end": 249, "start": 0, "text": "Adempas moderately influences the ability to cycle, drive and use machines. It may cause side effects such as dizziness. You should be aware of the side effects of this medicine before cycling, driving or using any tools or machines (see section 4).", "truncated": false}, "before_length": 249, "before_sha256": "3d6aa8958d26d057f062fdb9714debaa6c1f7127dc8112c5a62458c824f68282", "change_kind": "content", "change_operations": [{"after_end": 211, "after_start": 211, "before_end": 224, "before_start": 211, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 13, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-44ee4a311a201b736f6614d0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3230}
{"after": {"end": 68, "start": 0, "text": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection (multidose vials)", "truncated": false}, "after_length": 68, "after_sha256": "f5f1beca1e5749b2903a5e2cb2014d788c8731962a72b68f5748383bb0fce157", "annex": "I", "before": {"end": 66, "start": 0, "text": "Spikevax JN.1 0.1 mg/mL dispersion for injection (multidose vials)", "truncated": false}, "before_length": 66, "before_sha256": "6f4af5e44b1ec25d468896b61a90c845b84f703de2c49e23017c4c87baa76838", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-44fc6de5ccb557bad1dca392", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6346}
{"after": {"end": 119, "start": 0, "text": "Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu", "truncated": false}, "after_length": 119, "after_sha256": "0f2b81ab8009e1a279ca008eb6e21bdb2e532de63aef52b62bdac980c49555d4", "annex": "IIIA", "before": {"end": 93, "start": 0, "text": "Detailed information on this medicine is available on the European Medicines Agency web site:", "truncated": false}, "before_length": 93, "before_sha256": "1c2e788d78bca4cef615d8e7fe8e0268db2345fae4c6f39add7db65e179edffe", "change_kind": "content", "change_operations": [{"after_end": 119, "after_start": 93, "before_end": 93, "before_start": 93, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 26}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-45460cd33f085484db6df72c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000112", "medicine_name": "Twinrix Adult", "medicine_slug": "twinrix-adult", "observed_at": "2026-10-12T13:29:23Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "cfad5fb0086c9b5d6a36b454f3f546373def1f56cded73e0652b498d02d68e41", "source_snapshot_id": "source-17627897b0874bf1160c7372", "source_updated_at": "2026-08-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/twinrix-adult-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1042}
{"after": {"end": 80, "start": 0, "text": "If still no medicine is expelled, do not use this pen, contact customer service.", "truncated": false}, "after_length": 80, "after_sha256": "b60fc648df54a4f9ab091915be1be514c4d7eaa64e771f7cd309033f352428d7", "annex": "IIIA", "before": {"end": 54, "start": 0, "text": "If still no medicine is expelled, do not use this pen.", "truncated": false}, "before_length": 54, "before_sha256": "c25ca34c63416fc4ef0d6ff1d1b2ecbcdd265e2e6c6902bcceb45931541b5487", "change_kind": "content", "change_operations": [{"after_end": 79, "after_start": 53, "before_end": 53, "before_start": 53, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 26}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4566bd9b88e8308e3018361a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2135}
{"after": {"end": 11, "start": 0, "text": "Voie orale.", "truncated": false}, "after_length": 11, "after_sha256": "dd303ff5eaeb3946adedda2cb1cc0525b4d6b7561b2450d515addd890456afe9", "annex": "IIIA", "before": {"end": 10, "start": 0, "text": "Voie orale", "truncated": false}, "before_length": 10, "before_sha256": "b21e8d51c5cf6ffc46ec58c52f7fd9782e18be932f51e39153050c410cb9b1b2", "change_kind": "content", "change_operations": [{"after_end": 11, "after_start": 10, "before_end": 10, "before_start": 10, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4572b70272f136db5d927be7", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:32:00Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3ff8cd4d67d22ba799aa348aeda944d6d896a16dcf54b030db101cbc095fc8ad", "source_snapshot_id": "source-a79a7cba8bf5dbc72fd40574", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2017}
{"after": {"end": 159, "start": 0, "text": "Enbrel est administré par injection sous-cutanée. Enbrel poudre pour solution doit être reconstitué dans 1 mL de solvant avant utilisation (voir rubrique 6.6).", "truncated": false}, "after_length": 159, "after_sha256": "3d0d44b91970adc1b5b3d2dd8ae762a7bc927db50c2b08e3e78fec74b820f95d", "annex": "I", "before": {"end": 159, "start": 0, "text": "Enbrel est administré par injection sous-cutanée. Enbrel poudre pour solution doit être reconstitué dans 1 ml de solvant avant utilisation (voir rubrique 6.6).", "truncated": false}, "before_length": 159, "before_sha256": "73b86fa43e0c145ad8a03fe62e43f66d84765c1ab06ff54055a2952b316ad4dd", "change_kind": "content", "change_operations": [{"after_end": 109, "after_start": 108, "before_end": 109, "before_start": 108, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-45878536e8695f53307334cd", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg poudre pour solution injectable", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 137}
{"after": {"end": 21, "start": 0, "text": "Block 2 Miesian Plaza", "truncated": false}, "after_length": 21, "after_sha256": "99b504ac4fff9020da29e00aeb786f0975177380626e2b3347bd3fbd75afeeba", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 21, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 21}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-459430b0c516fae5ae203082", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1717}
{"after": {"end": 150, "start": 0, "text": "Des informations détaillées sur ce médicament sont disponibles sur le site internet de l’Agence européenne des médicaments : https://www.ema.europa.eu", "truncated": false}, "after_length": 150, "after_sha256": "e017501b5847872c1558d52561701c87c591dae3e15c4703e2daf2cb3b69868d", "annex": "IIIA", "before": {"end": 150, "start": 0, "text": "Des informations détaillées sur ce médicament sont disponibles sur le site internet de l’Agence européenne des médicaments : http://www.ema.europa.eu.", "truncated": false}, "before_length": 150, "before_sha256": "cba14846c320673c759f35d86d6c5f8913374e8c20319aa76bf242842cf27142", "change_kind": "technical", "change_operations": [{"after_end": 130, "after_start": 129, "before_end": 129, "before_start": 129, "kind": "insert"}, {"after_end": 150, "after_start": 150, "before_end": 150, "before_start": 149, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-459a8a8368317d2441b6821c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000112", "medicine_name": "Twinrix Adult", "medicine_slug": "twinrix-adult", "observed_at": "2026-10-12T13:29:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "bc8ba3adecfe04d3079e5b502251cec982d6197257fe3b7ec3a22dc5f2ace654", "source_snapshot_id": "source-8439a1a319b62d1bd67256a4", "source_updated_at": "2026-08-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/twinrix-adult-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1017}
{"after": {"end": 20, "start": 0, "text": "msd.slovenia@msd.com", "truncated": false}, "after_length": 20, "after_sha256": "32f245e2e4036e3b467769cde309d09f05bcdd6f4f0f06a8cc91d81e4a082213", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "msd.slovenia@merck.com", "truncated": false}, "before_length": 22, "before_sha256": "fde9163edb7de43fa3b79d2f1f0c2a3195d3f29d316528e4141d99f1f940d448", "change_kind": "content", "change_operations": [{"after_end": 16, "after_start": 14, "before_end": 18, "before_start": 14, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-45b52a9b2af6885bc548808c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3078}
{"after": {"end": 2, "start": 0, "text": "SC", "truncated": false}, "after_length": 2, "after_sha256": "32da6721804f1dd3226c0551970304ebf1059ec19a27451426541027861c9388", "annex": "IIIA", "before": {"end": 17, "start": 0, "text": "Voie sous-cutanée", "truncated": false}, "before_length": 17, "before_sha256": "2c39e73e194fa4f0fa51aa54d98a94765b3fcf21e9faf5848d5728b740ab316d", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 0, "before_end": 17, "before_start": 0, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 17, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-45d5f9ff9099c2ef1803b0dd", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6839}
{"after": {"end": 20, "start": 0, "text": "Tel: +386 1 520 4201", "truncated": false}, "after_length": 20, "after_sha256": "4bc9aa9751d0ed5412a51f1a97aa4bd5b6851a9385ea852b8e407689ba7fe597", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Tel: + 386 1 5204201", "truncated": false}, "before_length": 20, "before_sha256": "03fc8248ffd9e4d5d179a7355c42c921061db83dc6ab440084c3885eeef938e0", "change_kind": "content", "change_operations": [{"after_end": 6, "after_start": 6, "before_end": 7, "before_start": 6, "kind": "delete"}, {"after_end": 16, "after_start": 15, "before_end": 16, "before_start": 16, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-45d6c97a51bb9e8eac97f20b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3077}
{"after": {"end": 86, "start": 0, "text": "The CHMP recommends that the terms of the marketing authorisation(s) should be varied.", "truncated": false}, "after_length": 86, "after_sha256": "58ed8da449860435afd7d26d286a000f65c5901b49253a30ae46cbbcbca82784", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 86, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 86}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-45dacdffd93efbb1ed6a75ea", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:30Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "35ab6716aa09492c14ac6849111486ec47235c0bc65ef055350de950f316c5e6", "source_snapshot_id": "source-f20a60110d1f8fef5225317d", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2378}
{"after": {"end": 146, "start": 0, "text": "• Ne conservez pas le Terrosa Pen avec une aiguille montée car cela pourrait entraîner la formation de bulles d’air à l’intérieur de la cartouche.", "truncated": false}, "after_length": 146, "after_sha256": "06b8e3aaf72e84f41ccde5bee607892a8687bf128bade9a8a3814ef838ad1276", "annex": "IIIA", "before": {"end": 148, "start": 0, "text": "• Ne conservez pas le stylo Terrosa avec une aiguille montée car cela pourrait entraîner la formation de bulles d’air à l’intérieur de la cartouche.", "truncated": false}, "before_length": 148, "before_sha256": "5ab5c2d9903e3affa4c3c89f47211f2515291bae3a9c3aacd2b8c4bc70acb295", "change_kind": "content", "change_operations": [{"after_end": 22, "after_start": 22, "before_end": 28, "before_start": 22, "kind": "delete"}, {"after_end": 33, "after_start": 29, "before_end": 35, "before_start": 35, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-45e25a4d600faa772712d1d7", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2094}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 24, "start": 0, "text": "Tél/Tel: +32 2 358 54 68", "truncated": false}, "before_length": 24, "before_sha256": "41a8515e0ad87e2db6e34f58a5b4db10b75995776214e98d6be98b1aa31eee38", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 24, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 24, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-45e9de5dbba7166496ff9eb2", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1046}
{"after": {"end": 69, "start": 0, "text": "le granisétron, utilisé pour traiter les nausées ou les vomissements.", "truncated": false}, "after_length": 69, "after_sha256": "1598cba28776c9c26fb1a0f1177724e96bf761c7aeea405f69479d468c353e51", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 69, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 69}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-45f79fa2166f447ecd8d692f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2868}
{"after": {"end": 20, "start": 0, "text": "Tel.: +351 214465700", "truncated": false}, "after_length": 20, "after_sha256": "6171ae007b6c82d5a612a6a3443de26f3c5ee9320b52f7c4fbca51dda821fe28", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Tel: + 351 214465700", "truncated": false}, "before_length": 20, "before_sha256": "4a3d7a7c5925473eef92c2cd7a2e616c5dd3e20a042ab127910a184d9dfd503d", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}, {"after_end": 7, "after_start": 7, "before_end": 7, "before_start": 6, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-45f9e2a28d11c26987f82ff9", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3057}
{"after": {"end": 67, "start": 0, "text": "Table 7. Spikevax LP.8.1 posology for immunocompromised individuals", "truncated": false}, "after_length": 67, "after_sha256": "bbb03d18cd8382382416b0779ceba3c1cb09e8317917cb2cb2f247bd450d0368", "annex": "I", "before": {"end": 65, "start": 0, "text": "Table 8. Spikevax JN.1 posology for immunocompromised individuals", "truncated": false}, "before_length": 65, "before_sha256": "ce1babc4ff46d0e595dfd17eada74be0b18e90b4b3c9aa4b626f44ebe71988a1", "change_kind": "administrative", "change_operations": [{"after_end": 7, "after_start": 6, "before_end": 7, "before_start": 6, "kind": "replace"}, {"after_end": 22, "after_start": 18, "before_end": 20, "before_start": 18, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 3, "chars_inserted": 5}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-461031d190fcc4e52078ecfc", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13205}
{"after": {"end": 50, "start": 0, "text": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection", "truncated": false}, "after_length": 50, "after_sha256": "8c0d5490a68da1e449c0490ed0defe0da9d9d8c2d6ae11271b883fa7dfd5a64a", "annex": "I", "before": {"end": 48, "start": 0, "text": "Spikevax JN.1 0.1 mg/mL dispersion for injection", "truncated": false}, "before_length": 48, "before_sha256": "f251c20d6a11d153458ca69aaf22627ccbe0cce3064c14f8eb27faf9c2c0f105", "change_kind": "administrative", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4624ce2558ee64f91952143d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12600}
{"after": {"end": 18, "start": 0, "text": "It is available as", "truncated": false}, "after_length": 18, "after_sha256": "1e8630a93e5df44cc905cf1c8fe1f44ee81bb7fe356baa35610db157f744d9f7", "annex": "II", "before": {"end": 25, "start": 0, "text": "It should be available as", "truncated": false}, "before_length": 25, "before_sha256": "b9ec8a0d8d5f26be4730554b220566718f9a1a7dd1f48f8e88e919b931535c9c", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}, {"after_end": 5, "after_start": 5, "before_end": 12, "before_start": 4, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 8, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-464c4706fd5e743401f30bb6", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:33Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "21d66bf1e9a74479f577de09da3cf8517d65c1ce1b1d8bbdfe4bc38f79410def", "source_snapshot_id": "source-2c39c998fdaf05159687c016", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 457}
{"after": {"end": 46, "start": 0, "text": "Contenu de l’emballage et autres informations.", "truncated": false}, "after_length": 46, "after_sha256": "a3b845350856c03eeacf9c9422ac939f8d60f24ca471d72a068a0b8906cee8cf", "annex": "IIIA", "before": {"end": 45, "start": 0, "text": "Contenu de l’emballage et autres informations", "truncated": false}, "before_length": 45, "before_sha256": "88e0f10d1ff222a49631f878ae81d7d58ace92fc1346fb0d0033f7a673d6baa1", "change_kind": "content", "change_operations": [{"after_end": 46, "after_start": 45, "before_end": 45, "before_start": 45, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4662aa4f2fe7675ba37dc5dc", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 749}
{"after": {"end": 125, "start": 0, "text": "For more information, see the European Medicines Agency’s website: https://www.ema.europa.eu/en/medicines/human/epar/COMETRIQ", "truncated": false}, "after_length": 125, "after_sha256": "f9551b00f57efee9c739d6437829e2bacdca87313f5618b8427ca3309af61cb0", "annex": "", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 125, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 125}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-46ae979da54aa430b3ceffff", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002640", "medicine_name": "Cometriq", "medicine_slug": "cometriq", "observed_at": "2026-10-12T19:00:48Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "9a013f64c372a20a7dfcfd0a30d84c365e558413e28c71df200098486d1db15b", "source_snapshot_id": "source-a2dc64012a0e2142a7477fbb", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/cometriq-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "infomedica@mundipharma.it", "truncated": false}, "before_length": 25, "before_sha256": "89c9a5a4b27d88008a794269450f6c194e44699d85a48dfda4b28a0388179c52", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 25, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 25, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-46fd38e2c3e58f543f7d0ec0", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1142}
{"after": {"end": 10, "start": 0, "text": "50 mg/1 mL", "truncated": false}, "after_length": 10, "after_sha256": "a558007d4fff152f6cb4735b3ad12424e7cbc5a180e2d6aaf96494264fd38aaf", "annex": "IIIA", "before": {"end": 10, "start": 0, "text": "50 mg/1 ml", "truncated": false}, "before_length": 10, "before_sha256": "d29bca9bc6337ef8c0e27e23812ffbcfa8ebe5505134dbf116ff9f4ee101b05e", "change_kind": "content", "change_operations": [{"after_end": 10, "after_start": 9, "before_end": 10, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-476c402cbf42bc0b7afe913d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 7554}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 121, "start": 0, "text": "Upon moving the vaccine to 2°C to 8°C storage, the outer carton should be marked with the new discard date at 2°C to 8°C.", "truncated": false}, "before_length": 121, "before_sha256": "7fa17cc4bec9a0632f36d99bdb825ba5419136e8e4242e539b5c9de13593f2ac", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 121, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 121, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-478a52c3121ae51ac3abe586", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.3", "section_type": "storage", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6249}
{"after": {"end": 249, "start": 0, "text": "Sur la base des conclusions scientifiques relatives à l’aprémilast, le CHMP estime que le rapport bénéfice-risque du/des médicament(s) contenant l’aprémilast demeure inchangé, sous réserve des modifications proposées des informations sur le produit.", "truncated": false}, "after_length": 249, "after_sha256": "8857ffb559ab59e334fb72e0d4b11f91c365167b01e365099969dc77f5738cf0", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 249, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 249}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-47f6c41685ef540cbd030d4d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "9ac80b0d56ebad4970f7a8335a177613af59ef25517bcd0bdd3397c207cc1bac", "source_snapshot_id": "source-c11aa9e32420f125a88005bc", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2748}
{"after": {"end": 72, "start": 0, "text": "Grounds for the variation to the terms of the marketing authorisation(s)", "truncated": false}, "after_length": 72, "after_sha256": "3186bdadc3d2480c65b477145e6ff994610239d4243371f493c1f2ab110ec5da", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 72, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 72}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-47f8a991032b1a4086d4d592", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:18Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "89a938df5e41f86548301270084e3d1ecf171802e24b5429f62e3bede7ee32dd", "source_snapshot_id": "source-b71aeee5a07abebc34c02e28", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3432}
{"after": {"end": 26, "start": 0, "text": "Puh/Tel: +358 (0)9 804 650", "truncated": false}, "after_length": 26, "after_sha256": "4e4ce567ad8fc5ce4a995dfaa7487af0a3a8e51db5041ab103d4f16252c66e4f", "annex": "IIIA", "before": {"end": 26, "start": 0, "text": "Puh/Tel: + 358 (0)9 804650", "truncated": false}, "before_length": 26, "before_sha256": "4d337eb78e05cdda3f51c0741cb1f1396cf637a24baad8faad372b206b668352", "change_kind": "content", "change_operations": [{"after_end": 10, "after_start": 10, "before_end": 11, "before_start": 10, "kind": "delete"}, {"after_end": 23, "after_start": 22, "before_end": 23, "before_start": 23, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-48006ca3bc36ab68d28a59f1", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3497}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 63, "start": 0, "text": "Ne retirez pas le capuchon de l’aiguille avant d’y être invité.", "truncated": false}, "before_length": 63, "before_sha256": "4253650414791f649d08c88334e3aadafc33845e6bee35c68a21ef936df907a2", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 63, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 63, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4849003bdc5fb10a54881d8c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11836}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 286, "start": 0, "text": "The vaccine is shipped and supplied frozen or thawed. If the vaccine is frozen, thaw each singledose vial before use following the instructions below. Each single-dose vial or the carton containing 1 or 10 vials may be thawed either in the refrigerator or at room temperature (Table 5).", "truncated": false}, "before_length": 286, "before_sha256": "8d85b609b5544ae4b183ed913e1db4d636537fc069a0242734add8b89b31890a", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 286, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 286, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4874dd018f883bd422937fba", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13082}
{"after": {"end": 12, "start": 0, "text": "Mood changes", "truncated": false}, "after_length": 12, "after_sha256": "f19653331bff191c62a0253e1e7a194f809842486b6b565ee39bc77ecef3826c", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 12, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 12}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4885136279044e1ff14cbd35", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:30Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "35ab6716aa09492c14ac6849111486ec47235c0bc65ef055350de950f316c5e6", "source_snapshot_id": "source-f20a60110d1f8fef5225317d", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2370}
{"after": {"end": 148, "start": 0, "text": "• Pull out the pen slowly. Check if the display is at the start position as shown in the picture, to make sure that the full dose has been injected.", "truncated": false}, "after_length": 148, "after_sha256": "99a23e65e6e9179ea560d33a994a86e20490d7d55e6e9f899755cf0ca1001594", "annex": "IIIA", "before": {"end": 123, "start": 0, "text": "• Pull out the pen slowly. Check if the display is at the start position to make sure that the full dose has been injected.", "truncated": false}, "before_length": 123, "before_sha256": "ae713f74f59f474a93026f48d529e0c10399efe18d03b51941a40c80b6eadae7", "change_kind": "content", "change_operations": [{"after_end": 98, "after_start": 73, "before_end": 73, "before_start": 73, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 25}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-488d85961b6dddd638007974", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2070}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 7, "start": 0, "text": "Danmark", "truncated": false}, "before_length": 7, "before_sha256": "b2bebaaf55198f3166a7d7089112d30e245d6cf4a3249ae87b597fa988e7f1be", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 7, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-48913c217402ffb6a39c4658", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1042}
{"after": {"end": 28, "start": 0, "text": "Classe de systèmes d'organes", "truncated": false}, "after_length": 28, "after_sha256": "dc8fbd843fa829b06aa131fd2cd3fa69eab63d5f88fb5308e359f2128af90208", "annex": "I", "before": {"end": 21, "start": 0, "text": "Système Organe Classe", "truncated": false}, "before_length": 21, "before_sha256": "e5b00ff6e66604b1cc1a9f6a770e6728124c42afc2a495e9b405589962e5d1f2", "change_kind": "content", "change_operations": [{"after_end": 11, "after_start": 0, "before_end": 1, "before_start": 0, "kind": "replace"}, {"after_end": 18, "after_start": 17, "before_end": 7, "before_start": 7, "kind": "insert"}, {"after_end": 22, "after_start": 19, "before_end": 9, "before_start": 8, "kind": "replace"}, {"after_end": 27, "after_start": 27, "before_end": 18, "before_start": 14, "kind": "delete"}, {"after_end": 28, "after_start": 28, "before_end": 21, "before_start": 19, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 8, "chars_inserted": 15}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-48918e02f28c230eaf393d08", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 344}
{"after": {"end": 11, "start": 0, "text": "Voie orale.", "truncated": false}, "after_length": 11, "after_sha256": "dd303ff5eaeb3946adedda2cb1cc0525b4d6b7561b2450d515addd890456afe9", "annex": "IIIA", "before": {"end": 10, "start": 0, "text": "Voie orale", "truncated": false}, "before_length": 10, "before_sha256": "b21e8d51c5cf6ffc46ec58c52f7fd9782e18be932f51e39153050c410cb9b1b2", "change_kind": "content", "change_operations": [{"after_end": 11, "after_start": 10, "before_end": 10, "before_start": 10, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-489becaaae7ddb49e75a83ac", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:32:00Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3ff8cd4d67d22ba799aa348aeda944d6d896a16dcf54b030db101cbc095fc8ad", "source_snapshot_id": "source-a79a7cba8bf5dbc72fd40574", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2405}
{"after": {"end": 109, "start": 0, "text": "Quelles sont les informations à connaître avant d’utiliser Nyxoid 1,8 mg, solution pour pulvérisation nasale?", "truncated": false}, "after_length": 109, "after_sha256": "b661e8b23c0fcf9b6d46e30137f2739d63a2918ea11831ff8c25137e0d9acb61", "annex": "IIIA", "before": {"end": 108, "start": 0, "text": "Quelles sont les informations à connaître avant d’utiliser Nyxoid 1,8 mg, solution pour pulvérisation nasale", "truncated": false}, "before_length": 108, "before_sha256": "2cc918670db63235df0b945d3aa7a9a479e1e12eee0c997bae360e446c892b7d", "change_kind": "content", "change_operations": [{"after_end": 109, "after_start": 108, "before_end": 108, "before_start": 108, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-495bceff3ecb9d7f14632b6b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 745}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 9, "start": 0, "text": "Allemagne", "truncated": false}, "before_length": 9, "before_sha256": "6b58dbd6a994339b48d8446597da22402857b3409613459c7e3a293788fbe66a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 9, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 9, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4995720bdec27ae675591bd4", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1715}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "Slovenská republika", "truncated": false}, "before_length": 19, "before_sha256": "8667151da5d74cf45a2b263a2f7b38e944fd51f34b51e08d79151f123b8f10b2", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 19, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 19, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-49b8c465cce800b9e0ff54cd", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1135}
{"after": {"end": 43, "start": 0, "text": "Pfizer Healthcare Ireland Unlimited Company", "truncated": false}, "after_length": 43, "after_sha256": "1f203777a0ec6fed9c840d52631b6a74c7e25b5d318485d8147e2404f52dc981", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "Pfizer Healthcare Ireland", "truncated": false}, "before_length": 25, "before_sha256": "4beeea9b6d0c491f03a9511d9f9576b9c75cbcdcfd736e4934f768fdded936f5", "change_kind": "content", "change_operations": [{"after_end": 43, "after_start": 25, "before_end": 25, "before_start": 25, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 18}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4a0b1c99aff2a33a2879c114", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11030}
{"after": {"end": 192, "start": 0, "text": "Votre médecin vous remettra également une Carte Patient qui comportera des informations importantes de sécurité d’emploi que vous devez connaître, avant et pendant votre traitement par Enbrel.", "truncated": false}, "after_length": 192, "after_sha256": "a9b61621aee7f348e503c6ef13da6f1d4dc6f2a4d953f840016b3daaebeecd6a", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 192, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 192}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4a12bda2093ea3cd05358cb7", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 10823}
{"after": {"end": 26, "start": 0, "text": "Puh/Tel: +358 (0)9 804 650", "truncated": false}, "after_length": 26, "after_sha256": "4e4ce567ad8fc5ce4a995dfaa7487af0a3a8e51db5041ab103d4f16252c66e4f", "annex": "IIIA", "before": {"end": 26, "start": 0, "text": "Puh/Tel: + 358 (0)9 804650", "truncated": false}, "before_length": 26, "before_sha256": "4d337eb78e05cdda3f51c0741cb1f1396cf637a24baad8faad372b206b668352", "change_kind": "content", "change_operations": [{"after_end": 10, "after_start": 10, "before_end": 11, "before_start": 10, "kind": "delete"}, {"after_end": 23, "after_start": 22, "before_end": 23, "before_start": 23, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4a1c9afa50a450c0a036e7d4", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3183}
{"after": {"end": 105, "start": 0, "text": "Spikevax LP.8.1 should be administered at least 3 months after the most recent dose of a COVID19 vaccine.", "truncated": false}, "after_length": 105, "after_sha256": "cb920377c5c8e39d8da8bd46b2b786bee15ae3279003e504ae149a68404dcdd7", "annex": "I", "before": {"end": 103, "start": 0, "text": "Spikevax JN.1 should be administered at least 3 months after the most recent dose of a COVID19 vaccine.", "truncated": false}, "before_length": 103, "before_sha256": "1ffe43d37772f8deefe1797a49307dc26bb46874b29c0b434dbf982941e47645", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4a1e1985d6296d5f058e9b60", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5489}
{"after": {"end": 173, "start": 0, "text": "Each multidose vial contains 2.5 mL. One dose (0.5 mL) contains 50 micrograms of SARS-CoV-2 LP.8.1 mRNA. One dose (0.25 mL) contains 25 micrograms of SARS-CoV-2 LP.8.1 mRNA.", "truncated": false}, "after_length": 173, "after_sha256": "d1d2e72db596a44eed4ff1b55c58942b4b1925ce1f393359e0121d03e6ba84aa", "annex": "IIIA", "before": {"end": 169, "start": 0, "text": "Each multidose vial contains 2.5 mL. One dose (0.5 mL) contains 50 micrograms of SARS-CoV-2 JN.1 mRNA. One dose (0.25 mL) contains 25 micrograms of SARS-CoV-2 JN.1 mRNA.", "truncated": false}, "before_length": 169, "before_sha256": "bf419d07db157f5da62f4ccb51a579c7868ccf8ecea47b720f9bb754bb8a4215", "change_kind": "content", "change_operations": [{"after_end": 96, "after_start": 92, "before_end": 94, "before_start": 92, "kind": "replace"}, {"after_end": 165, "after_start": 161, "before_end": 161, "before_start": 159, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4a361e983ac65f6a1d7842b2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9062}
{"after": {"end": 25, "start": 0, "text": "50-58 Baggot Street Lower", "truncated": false}, "after_length": 25, "after_sha256": "2b6052bef6a7051ce20b776d1525055c417fc02e59b9e559cd21b7aa4c7859f0", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 25, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 25}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4a3a5459c1561bd859e8b34f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1213}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 31, "start": 0, "text": "Mundipharma Pharmaceuticals Srl", "truncated": false}, "before_length": 31, "before_sha256": "4419218cfed83a9f85981140bd12e9057539600b69b7dc2d3af8d9b505c21441", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 31, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 31, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4a9a3c856cb08db00390d829", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1140}
{"after": {"end": 20, "start": 0, "text": "Tel: +386 1 520 4201", "truncated": false}, "after_length": 20, "after_sha256": "4bc9aa9751d0ed5412a51f1a97aa4bd5b6851a9385ea852b8e407689ba7fe597", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Tel: + 386 1 5204201", "truncated": false}, "before_length": 20, "before_sha256": "03fc8248ffd9e4d5d179a7355c42c921061db83dc6ab440084c3885eeef938e0", "change_kind": "content", "change_operations": [{"after_end": 6, "after_start": 6, "before_end": 7, "before_start": 6, "kind": "delete"}, {"after_end": 16, "after_start": 15, "before_end": 16, "before_start": 16, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4abcf8e9de760283f3254156", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3164}
{"after": {"end": 274, "start": 0, "text": "Renal thrombotic microangiopathy with or without concomitant sunitinib use, and hyaline occlusive glomerular microangiopathy which may be clinically manifested as proteinuria (not known). For further information on proteinuria see section 4.4 and Proteinuria in section 4.8.", "truncated": false}, "after_length": 274, "after_sha256": "c2c68ca1b578ebc484b3b0c89fe3cfbad19c5f85c6d3c3f3856e2abaac07628b", "annex": "I", "before": {"end": 225, "start": 0, "text": "Renal thrombotic microangiopathy, which may be clinically manifested as proteinuria (not known) with or without concomitant sunitinib use. For further information on proteinuria see section 4.4 and Proteinuria in section 4.8.", "truncated": false}, "before_length": 225, "before_sha256": "534c443c05bcd65115894edc69b50cdaf8a9199c47aa08677b7d65ecc946aff3", "change_kind": "content", "change_operations": [{"after_end": 74, "after_start": 32, "before_end": 32, "before_start": 32, "kind": "insert"}, {"after_end": 124, "after_start": 75, "before_end": 33, "before_start": 33, "kind": "insert"}, {"after_end": 186, "after_start": 186, "before_end": 137, "before_start": 95, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 42, "chars_inserted": 91}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4aee5f7adb219056467df30b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:18Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml concentrate for solution for infusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "89a938df5e41f86548301270084e3d1ecf171802e24b5429f62e3bede7ee32dd", "source_snapshot_id": "source-b71aeee5a07abebc34c02e28", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 933}
{"after": {"end": 22, "start": 0, "text": "medinfo@mundipharma.pt", "truncated": false}, "after_length": 22, "after_sha256": "5459a27479d0597a7c1b1ca3825cab8fd8337cfb671df321accb79b7a7f908a8", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "med.info@mundipharma.pt", "truncated": false}, "before_length": 23, "before_sha256": "56a7f02e53b2aa0113dd2c314a8b48eba8a5d50240544c0ca4fdfae2c02a4f45", "change_kind": "content", "change_operations": [{"after_end": 3, "after_start": 3, "before_end": 4, "before_start": 3, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4b220e4aac632f695e54b013", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1080}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 14, "start": 0, "text": "78467 Konstanz", "truncated": false}, "before_length": 14, "before_sha256": "ee960a86a16086f43d4c7f3f51bd93d39025d5227fb1a6f1c825d1015754ff53", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4b4a5e16f7ef213813c75d99", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1209}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 132, "start": 0, "text": "de la dysfonction érectile comme le sildénafil, le tadalafil, le vardénafil. Ne prenez pas ces médicaments en même temps qu’Adempas.", "truncated": false}, "before_length": 132, "before_sha256": "90e13e8e581898be78e21d48541293f0ac138ca7a5b51dd2cb20d20d6103d155", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 132, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 132, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4b4f25113093c6cdfbd40a50", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3296}
{"after": {"end": 78, "start": 0, "text": "Inflammation of the muscles causing pain or stiffness (polymyalgia rheumatica)", "truncated": false}, "after_length": 78, "after_sha256": "229dc70dfa970159cf016d3e6065174409e558a2b7a84702f2b27a06e9040a9e", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 78, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 78}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4b82019ef8a7f3931bb35240", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2191}
{"after": {"end": 146, "start": 0, "text": "If a child has received one prior dose of any Spikevax vaccine, one dose of Spikevax LP.8.1 should be administered to complete the twodose series.", "truncated": false}, "after_length": 146, "after_sha256": "bcb3ff207196a1a74d05e84d2a8f8f82eff0282c90671cac5bbfbcf9f4d2accd", "annex": "I", "before": {"end": 145, "start": 0, "text": "If a child has received one prior dose of any Spikevax vaccine, one dose of Spikevax JN.1 should be administered to complete the two-dose series.", "truncated": false}, "before_length": 145, "before_sha256": "c2602c92ab3fe8252041d2d1d4f0c9a12ec19dae440c1ca5e6b6f60ae3840f3c", "change_kind": "content", "change_operations": [{"after_end": 89, "after_start": 85, "before_end": 87, "before_start": 85, "kind": "replace"}, {"after_end": 134, "after_start": 134, "before_end": 133, "before_start": 132, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 3, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4b9ce60de63bc02189be24d5", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5480}
{"after": {"end": 78, "start": 0, "text": "Les médicaments dont les effets peuvent être modifiés par Adempas, par exemple", "truncated": false}, "after_length": 78, "after_sha256": "2c128712da46e5544914c9132b3fd8a314973ee72b247151cf27a7cb6c0d2d79", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 78, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 78}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4bc0aa47b58754b28bc75198", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3309}
{"after": {"end": 78, "start": 0, "text": "Punctured multidose vials (Spikevax LP.8.1 0.1 mg/mL dispersion for injection)", "truncated": false}, "after_length": 78, "after_sha256": "9ae13e7a84f2ad94df9918b08db933ce051ad4c85b7f585509e786dd1a7a54c2", "annex": "I", "before": {"end": 76, "start": 0, "text": "Punctured multidose vials (Spikevax JN.1 0.1 mg/mL dispersion for injection)", "truncated": false}, "before_length": 76, "before_sha256": "5bf5172fa288f8b17d1ba8fd5f2054494116bf3d0aa94d253b336ca6bf6ac761", "change_kind": "content", "change_operations": [{"after_end": 40, "after_start": 36, "before_end": 38, "before_start": 36, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4c0e8b2d63eacf9722b43644", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.3", "section_type": "storage", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6237}
{"after": {"end": 633, "start": 0, "text": "Les caractéristiques des concentrations sériques moyennes à l’état d’équilibre chez les patients atteints de PR étaient une Cmax de 2,4 mg/l vs 2,6 mg/l, une Cmin de 1,2 mg/l vs 1,4 mg/l, et une ASC partielle de 297 mgh/l vs 316 mgh/l pour la dose de 50 mg d’Enbrel une fois par semaine (n = 21) vs 25 mg d’Enbrel deux fois par semaine (n = 16), respectivement. Dans une étude en ouvert, croisée, avec administration unique de deux posologies différentes chez des volontaires sains, il a été démontré que l’administration d’une injection unique de 50 mg/mL d’etanercept était bioéquivalente à deux injections simultanées de 25 mg/mL.", "truncated": false}, "after_length": 633, "after_sha256": "2072f6e9c33d4c19ff3a53287e87d8f48c620139d0a7eb3caf30c861f0fdf723", "annex": "I", "before": {"end": 633, "start": 0, "text": "Les caractéristiques des concentrations sériques moyennes à l’état d’équilibre chez les patients atteints de PR étaient une Cmax de 2,4 mg/l vs 2,6 mg/l, une Cmin de 1,2 mg/l vs 1,4 mg/l, et une ASC partielle de 297 mgh/l vs 316 mgh/l pour la dose de 50 mg d’Enbrel une fois par semaine (n = 21) vs 25 mg d’Enbrel deux fois par semaine (n = 16), respectivement. Dans une étude en ouvert, croisée, avec administration unique de deux posologies différentes chez des volontaires sains, il a été démontré que l’administration d’une injection unique de 50 mg/ml d’etanercept était bioéquivalente à deux injections simultanées de 25 mg/ml.", "truncated": false}, "before_length": 633, "before_sha256": "6d56f36d1e4ca2576eee5b9b102be2245cfd55a0ab1f7dcea577afbb44038faf", "change_kind": "content", "change_operations": [{"after_end": 556, "after_start": 555, "before_end": 556, "before_start": 555, "kind": "replace"}, {"after_end": 632, "after_start": 631, "before_end": 632, "before_start": 631, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4c3504ae1bea449ce59ecf96", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg, solution injectable en cartouche distributrice de dose Enbrel 50 mg, solution injectable en cartouche distributrice de dose", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6450}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IV", "before": {"end": 25, "start": 0, "text": "Conclusions scientifiques", "truncated": false}, "before_length": 25, "before_sha256": "b9dba41fa3c9d3b642cfe755c989781c6765c2e1667b80c2d6fb1f02a6cb6463", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 25, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 25, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4c458cb6ba343496017d0acd", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:32:00Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "3ff8cd4d67d22ba799aa348aeda944d6d896a16dcf54b030db101cbc095fc8ad", "source_snapshot_id": "source-a79a7cba8bf5dbc72fd40574", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3516}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 14, "start": 0, "text": "78467 Konstanz", "truncated": false}, "before_length": 14, "before_sha256": "ee960a86a16086f43d4c7f3f51bd93d39025d5227fb1a6f1c825d1015754ff53", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4c4a4161e9d01ffde525d017", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "Qdenga poudre et solvant pour solution injectable. Qdenga poudre et solvant pour solution injectable en seringue pré-remplie Vaccin tétravalent contre la dengue (vivant, atténué)", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 972}
{"after": {"end": 212, "start": 0, "text": "Avertissement : Les aiguilles pour stylo doivent être utilisées une seule fois, et le Terrosa Pen ne peut être utilisé que pour un seul patient, afin d’éviter tout risque de transmission de maladies infectieuses.", "truncated": false}, "after_length": 212, "after_sha256": "7c699fca54e644a50568b92ec9cf90dbb46908fff8554ddc67b77cf9b56f1f6a", "annex": "IIIA", "before": {"end": 214, "start": 0, "text": "Avertissement : Les aiguilles pour stylo doivent être utilisées une seule fois, et le stylo Terrosa ne peut être utilisé que pour un seul patient, afin d’éviter tout risque de transmission de maladies infectieuses.", "truncated": false}, "before_length": 214, "before_sha256": "0f68aa5fb2574e9dfa774ef7c3fa3be73fcb4fa71a05a41c075dd20866529e43", "change_kind": "content", "change_operations": [{"after_end": 86, "after_start": 86, "before_end": 92, "before_start": 86, "kind": "delete"}, {"after_end": 97, "after_start": 93, "before_end": 99, "before_start": 99, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4ce05bc4e33da65eb211878e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2086}
{"after": {"end": 19, "start": 0, "text": "La vidéo comprend :", "truncated": false}, "after_length": 19, "after_sha256": "53c500c8fc6680ad08433f1a67bd3faf519a8983c4897a24811c585502ce0bed", "annex": "II", "before": {"end": 26, "start": 0, "text": "La vidéo doit comprendre :", "truncated": false}, "before_length": 26, "before_sha256": "ffa511fbb74f9316d575f079b801433f0d3f06d7d733a8445f38a67ba2311bcd", "change_kind": "content", "change_operations": [{"after_end": 9, "after_start": 9, "before_end": 14, "before_start": 9, "kind": "delete"}, {"after_end": 17, "after_start": 17, "before_end": 24, "before_start": 22, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4d3e3dd728141821414c5e50", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 456}
{"after": {"end": 129, "start": 0, "text": "Make sure a cartridge is inserted. Change the needle and repeat the priming as described in pen preparation sections “F” and “G”.", "truncated": false}, "after_length": 129, "after_sha256": "008f3e1254c975cf3b3315b3d3183d073de5568e8c5f5692b617eebf0973fd35", "annex": "IIIA", "before": {"end": 94, "start": 0, "text": "Change the needle and repeat the priming as described in pen preparation sections “F” and “G”.", "truncated": false}, "before_length": 94, "before_sha256": "109ebe38ca880017cb4b233f3212810e12bd1aa74152448e4d0ae3aaee87d326", "change_kind": "content", "change_operations": [{"after_end": 35, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 35}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4d529aa186625155247f50d3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2134}
{"after": {"end": 50, "start": 0, "text": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection", "truncated": false}, "after_length": 50, "after_sha256": "8c0d5490a68da1e449c0490ed0defe0da9d9d8c2d6ae11271b883fa7dfd5a64a", "annex": "I", "before": {"end": 48, "start": 0, "text": "Spikevax JN.1 0.1 mg/mL dispersion for injection", "truncated": false}, "before_length": 48, "before_sha256": "f251c20d6a11d153458ca69aaf22627ccbe0cce3064c14f8eb27faf9c2c0f105", "change_kind": "administrative", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4d8ac0419d2517d643885e7e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12844}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 14, "start": 0, "text": "Pfizer Limited", "truncated": false}, "before_length": 14, "before_sha256": "faadd350d247ecbb0e8edac0805fa3d4cdbf449fbb9a1a9614eee6624274a2f6", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4d8ea1895b2f58aebdb78280", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12300}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 16, "start": 0, "text": "1 dose of 0.5 mL", "truncated": false}, "before_length": 16, "before_sha256": "1e83b15731626d86a57a8beccf3cef1907b37bc63878c6196c364300744551c5", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 16, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 16, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4db3bd2852c41d1f5794239a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12855}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 14, "start": 0, "text": "78467 Konstanz", "truncated": false}, "before_length": 14, "before_sha256": "ee960a86a16086f43d4c7f3f51bd93d39025d5227fb1a6f1c825d1015754ff53", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4dbd7850f80265a87e30473d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1338}
{"after": {"end": 47, "start": 0, "text": "Les coordonnées du prescripteur de l’etanercept", "truncated": false}, "after_length": 47, "after_sha256": "df97d1eb078749427f0e076143a2c3e2700cf33c35d50a56405e972141a2371f", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 47, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 47}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4e1a4699cae51443d54c5201", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6664}
{"after": {"end": 17, "start": 0, "text": "inform_pt@msd.com", "truncated": false}, "after_length": 17, "after_sha256": "80ea8d7772d76b760ca402228980572f0cf6dc451b408386454eb84cec35e7c8", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "inform_pt@merck.com", "truncated": false}, "before_length": 19, "before_sha256": "417a4e56160e131fb045d4a98431bae78237c04f6d71f4a97656e8299c0b43d2", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 11, "before_end": 15, "before_start": 11, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4ea5dd5e28be2e0fa8adcab4", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3459}
{"after": {"end": 21, "start": 0, "text": "Block 2 Miesian Plaza", "truncated": false}, "after_length": 21, "after_sha256": "99b504ac4fff9020da29e00aeb786f0975177380626e2b3347bd3fbd75afeeba", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 21, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 21}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4ed65b213e4612b18ccd5747", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2177}
{"after": {"end": 111, "start": 0, "text": "Heart failure (can include symptoms like shortness of breath, feeling tired, fainting, swollen ankles and legs)", "truncated": false}, "after_length": 111, "after_sha256": "dfe25cf9c3add7a2ee71ef191e1412cfebe1518caee99083b6567d42b08a45e4", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 111, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 111}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4ef975ea9762f09959f4ac03", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002640", "medicine_name": "Cometriq", "medicine_slug": "cometriq", "observed_at": "2026-10-12T19:00:48Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "9a013f64c372a20a7dfcfd0a30d84c365e558413e28c71df200098486d1db15b", "source_snapshot_id": "source-a2dc64012a0e2142a7477fbb", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/cometriq-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2027}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 12, "start": 0, "text": "info@egis.lt", "truncated": false}, "before_length": 12, "before_sha256": "a1afeca2989077e067a8190ee7f5e0ec0812d2073e4555a1b4185de53eea1a0a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 12, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 12, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4f006af0b19288fc4ae1f08f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1037}
{"after": {"end": 504, "start": 0, "text": "Au vu des données disponibles dans la littérature sur la microangiopathie glomérulaire occlusive hyaline, incluant dans certains cas un dé-challenge positif et en raison d’un mécanisme d'action plausible, le PRAC considère qu'une relation de cause à effet entre le bevacizumab et la microangiopathie glomérulaire occlusive hyaline constitue au moins une possibilité raisonnable. Le PRAC a conclu que les informations produit des médicaments contenant du bevacizumab doivent être modifiées en conséquence.", "truncated": false}, "after_length": 504, "after_sha256": "848a3016763dc1928ce609f47f18be8e2ed72a6fb3e00dbff3495e2d591c4511", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 504, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 504}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4f13f669e9494a57b0e2fe29", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3402}
{"after": {"end": 159, "start": 0, "text": "Enbrel est administré par injection sous-cutanée. Enbrel poudre pour solution doit être reconstitué dans 1 mL de solvant avant utilisation (voir rubrique 6.6).", "truncated": false}, "after_length": 159, "after_sha256": "3d0d44b91970adc1b5b3d2dd8ae762a7bc927db50c2b08e3e78fec74b820f95d", "annex": "I", "before": {"end": 159, "start": 0, "text": "Enbrel est administré par injection sous-cutanée. Enbrel poudre pour solution doit être reconstitué dans 1 ml de solvant avant utilisation (voir rubrique 6.6).", "truncated": false}, "before_length": 159, "before_sha256": "73b86fa43e0c145ad8a03fe62e43f66d84765c1ab06ff54055a2952b316ad4dd", "change_kind": "content", "change_operations": [{"after_end": 109, "after_start": 108, "before_end": 109, "before_start": 108, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4f206d3b0a627b1db117b9cf", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg poudre et solvant pour solution injectable", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1256}
{"after": {"end": 66, "start": 0, "text": "Fycompa (perampanel) is indicated for the adjunctive treatment of:", "truncated": false}, "after_length": 66, "after_sha256": "2bd4284b4a8bc98cc20f51cbed76c73d7f580adcb9ba888cb100ddc3e02a549b", "annex": "I", "before": {"end": 62, "start": 0, "text": "Fycompa (perampanel) is indicated for the adjunctive treatment", "truncated": false}, "before_length": 62, "before_sha256": "89830c2d2aac93606726c6f920ce20c495d1cd3c5465085c7a57699d30398526", "change_kind": "content", "change_operations": [{"after_end": 66, "after_start": 62, "before_end": 62, "before_start": 62, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4f2d36fa7755985765bdcc17", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "Fycompa 2 mg filmcoated tablets Fycompa 4 mg filmcoated tablets Fycompa 6 mg filmcoated tablets Fycompa 8 mg filmcoated tablets Fycompa 10 mg filmcoated tablets Fycompa 12 mg filmcoated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.1", "section_type": "indication", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 118}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 7, "start": 0, "text": "Germany", "truncated": false}, "before_length": 7, "before_sha256": "80db4ccdca106d37b920206331fcfe3e9e50a9e763d89b54ce3ad5ac8cf30f03", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 7, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4f4180b58f0ab53897e0f942", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1339}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "office@mundipharma.cz", "truncated": false}, "before_length": 21, "before_sha256": "502b326847805f2dbe39170c7111e402160b27e2622e4dc4d2c62c9ba45db561", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 21, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 21, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4f420d59ce084d51f52f3a6e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1052}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "II", "before": {"end": 11, "start": 0, "text": "Description", "truncated": false}, "before_length": 11, "before_sha256": "526e0087cc3f254d9f86f6c7d8e23d954c4dfda2b312efc29194ae8a860106ba", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 11, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 11, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4f537eb9df5a7fb7fc1267e9", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:33Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "21d66bf1e9a74479f577de09da3cf8517d65c1ce1b1d8bbdfe4bc38f79410def", "source_snapshot_id": "source-2c39c998fdaf05159687c016", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 469}
{"after": {"end": 2, "start": 0, "text": "SC", "truncated": false}, "after_length": 2, "after_sha256": "32da6721804f1dd3226c0551970304ebf1059ec19a27451426541027861c9388", "annex": "IIIA", "before": {"end": 17, "start": 0, "text": "Voie sous-cutanée", "truncated": false}, "before_length": 17, "before_sha256": "2c39e73e194fa4f0fa51aa54d98a94765b3fcf21e9faf5848d5728b740ab316d", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 0, "before_end": 17, "before_start": 0, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 17, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4f8a9dc32f28d32f67de15c7", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 7235}
{"after": {"end": 22, "start": 0, "text": "Polymyalgia rheumatica", "truncated": false}, "after_length": 22, "after_sha256": "b7d8fe213376ab210f8fb80757412ff6ce6ae1f8dabf5bcd0b49deea4d0b087a", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 22, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 22}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4fc68c5eaa97ac02532cac10", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "IMJUDO 20 mg/ml concentrate for solution for infusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 838}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "Tel: +44 (0)1304 616161", "truncated": false}, "before_length": 23, "before_sha256": "eba81e6ccdbae471c024a5ba77d9ec9e0617a3c443fd22205a626861e87fbd8c", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 23, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 23, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4ffa19d3c429b580b5893a93", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11060}
{"after": {"end": 236, "start": 0, "text": "On the basis of the scientific conclusions for apremilast the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing apremilast is unchanged subject to the proposed changes to the product information", "truncated": false}, "after_length": 236, "after_sha256": "e3f6ed2648d83a4b65918eadbe7b83e5e7b77a280b7ffcfb3dc44743d1cee487", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 236, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 236}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-4fffdc9426690c23f1dd54b0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:30Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "35ab6716aa09492c14ac6849111486ec47235c0bc65ef055350de950f316c5e6", "source_snapshot_id": "source-f20a60110d1f8fef5225317d", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2376}
{"after": {"end": 66, "start": 0, "text": "a 5 mg/kg toutes les 2 semaines ou 7,5 mg/kg toutes les 3 semaines", "truncated": false}, "after_length": 66, "after_sha256": "e9429b66d8bdbb073ed14601ba16430766e80ed60bc3564ef8e2618beb31527d", "annex": "I", "before": {"end": 66, "start": 0, "text": "a 5 mg/kg toutes les 2 semaines or 7,5 mg/kg toutes les 3 semaines", "truncated": false}, "before_length": 66, "before_sha256": "ca98cda56214b4315cbcb95c87b9fce1542cf5c2b376515bfc193d470bab966b", "change_kind": "content", "change_operations": [{"after_end": 34, "after_start": 33, "before_end": 34, "before_start": 33, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-50009ccb75353374dd0ce3d3", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1306}
{"after": {"end": 12, "start": 0, "text": "25 mg/0,5 mL", "truncated": false}, "after_length": 12, "after_sha256": "46e5380e927990cf15221f8049ebcf74c4b711d4516f6c2e7e82c8518c127d25", "annex": "IIIA", "before": {"end": 12, "start": 0, "text": "25 mg/0,5 ml", "truncated": false}, "before_length": 12, "before_sha256": "80b887636c832cc7740bd32b98c07488f5022cb3920ced1a54bd52030d2ad71d", "change_kind": "content", "change_operations": [{"after_end": 12, "after_start": 11, "before_end": 12, "before_start": 11, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5004e3d4e53e647a0f92c604", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 7255}
{"after": {"end": 125, "start": 0, "text": "Une formation sur la façon d’utiliser Nyxoid sera dispensée avant de vous le distribuer. Ci-dessous un guide étape par étape.", "truncated": false}, "after_length": 125, "after_sha256": "cd5ef9f852909fb87c99b2bdd7b703f1941e325d70b5e174fa7a94c911f92656", "annex": "IIIA", "before": {"end": 131, "start": 0, "text": "Une formation sur la façon d’utiliser Nyxoid sera dispensée avant de vous le distribuer. Voici ci-dessous un guide étape par étape.", "truncated": false}, "before_length": 131, "before_sha256": "1f6986798d8cfba5800c713fbced953ab9950fce496016e6c0fa2a2dc6cdafd2", "change_kind": "content", "change_operations": [{"after_end": 90, "after_start": 89, "before_end": 96, "before_start": 89, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5005f4896a35a8689c9f344c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 825}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 12, "start": 0, "text": "Magyarország", "truncated": false}, "before_length": 12, "before_sha256": "5206a7f7063a77a35861f95e022dafc37f3b3cf27ed423b1118e3fe580841b19", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 12, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 12, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5059f5ed82c2b76e04840a95", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1038}
{"after": {"end": 49, "start": 0, "text": "Une mise en garde doit être modifiée comme suit :", "truncated": false}, "after_length": 49, "after_sha256": "9642fb60a06d4d3870b408128437a0c346162c23cc9c93e890b608d742ea1ae9", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 49, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 49}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5071d0914e04b4fa89e71d04", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "9ac80b0d56ebad4970f7a8335a177613af59ef25517bcd0bdd3397c207cc1bac", "source_snapshot_id": "source-c11aa9e32420f125a88005bc", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2725}
{"after": {"end": 40, "start": 0, "text": "EU/1/20/1507/035 (paper inner tray of 1)", "truncated": false}, "after_length": 40, "after_sha256": "d69209619449d72237a4e868d36e2307d1d822777db002355b7376562eff89c3", "annex": "IIIA", "before": {"end": 40, "start": 0, "text": "EU/1/20/1507/025 (paper inner tray of 1)", "truncated": false}, "before_length": 40, "before_sha256": "da08336e9753acdff9204892d7ee5ec71d0230087a51366c8e7d2c1b9e608b37", "change_kind": "content", "change_operations": [{"after_end": 15, "after_start": 14, "before_end": 15, "before_start": 14, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-50a400a9b1dbc2654d50f8fa", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9266}
{"after": {"end": 294, "start": 0, "text": "Le bénéfice clinique d’Avastin évalué par la SSP a été retrouvé dans tous les sous-groupes testés prévus au protocole (y compris l’intervalle libre sans récidive, le nombre de sites métastatiques, un traitement antérieur par chimiothérapie adjuvante et le statut des récepteurs aux estrogènes).", "truncated": false}, "after_length": 294, "after_sha256": "61ee8c2eef863c6d6b9ddebcc2afb6819342c314e19f80a1c585abf4884098cc", "annex": "I", "before": {"end": 294, "start": 0, "text": "Le bénéfice clinique d’Avastin évalué par la PFS a été retrouvé dans tous les sous-groupes testés prévus au protocole (y compris l’intervalle libre sans récidive, le nombre de sites métastatiques, un traitement antérieur par chimiothérapie adjuvante et le statut des récepteurs aux estrogènes).", "truncated": false}, "before_length": 294, "before_sha256": "d2ea17892b7a2763172d7290e4cbbb7c8d5ff5621c9aeec2297f7fd9222436ec", "change_kind": "content", "change_operations": [{"after_end": 47, "after_start": 45, "before_end": 45, "before_start": 45, "kind": "insert"}, {"after_end": 48, "after_start": 48, "before_end": 48, "before_start": 46, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-50a5c9686a8b8e064207bb4b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1402}
{"after": {"end": 25, "start": 0, "text": "50-58 Baggot Street Lower", "truncated": false}, "after_length": 25, "after_sha256": "2b6052bef6a7051ce20b776d1525055c417fc02e59b9e559cd21b7aa4c7859f0", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 25, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 25}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-50ec9d14ec9a94400befd6c4", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2185}
{"after": {"end": 152, "start": 0, "text": "do not start Adempas for at least 24 hours after your last dose of sildenafil and at least 72 hours after your last dose of tadalafil, if you are child.", "truncated": false}, "after_length": 152, "after_sha256": "a313ea6b4614b2463c65508e9659fdd8b88c55a0143eb8ee0142d15f3a853d44", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 152, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 152}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-50f7b810c31e887c03f0f028", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2856}
{"after": {"end": 24, "start": 0, "text": "dpoc_czechslovak@msd.com", "truncated": false}, "after_length": 24, "after_sha256": "337ee03ecaecb8e917a1c5d342c556aebf19918c2dc3ac63cf08adeafa748373", "annex": "IIIA", "before": {"end": 26, "start": 0, "text": "dpoc_czechslovak@merck.com", "truncated": false}, "before_length": 26, "before_sha256": "a4642d78bee1d644f5eed542e84f756d52a7869d19900b6efa351b35ef1062c2", "change_kind": "content", "change_operations": [{"after_end": 20, "after_start": 18, "before_end": 22, "before_start": 18, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-512c86202e5016b3264f1dff", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3087}
{"after": {"end": 758, "start": 0, "text": "Avastin peut également modifier les résultats d’analyses demandées par votre médecin. Cela inclut une diminution du nombre de globules blancs dans le sang, en particulier des neutrophiles (un type de globules blancs qui aident à se protéger des infections), la présence de protéines dans l’urine, une diminution du taux de potassium, du taux de sodium, du taux de phosphore (un minéral) dans le sang, une augmentation du taux de sucre dans le sang, une augmentation des phosphatases alcalines (une enzyme) dans le sang, une augmentation de taux de créatinine sérique (une protéine mesurée par test sanguin pour voir si vos reins fonctionnent normalement), une diminution du taux d’hémoglobine (qui transporte l’oxygène dans le sang) qui peuvent être sévères.", "truncated": false}, "after_length": 758, "after_sha256": "5b90a7b2ae07b33852e9326ae26213d7ad562ea9643a0df2bc752aa8c9f1005f", "annex": "IIIA", "before": {"end": 743, "start": 0, "text": "Avastin peut également modifier les résultats d’analyses demandées par votre médecin. Cela inclut une diminution du nombre de globules blancs dans le sang, en particulier des neutrophiles (un type de globules blancs qui aident à se protéger des infections), la présence de protéines dans l’urine, une diminution du taux de potassium, du taux de sodium, du taux de phosphore (un minéral) dans le sang, une augmentation du taux de sucre dans le sang ou des phosphatases alcalines (une enzyme) dans le sang, une augmentation de taux de créatinine sérique (une protéine mesurée par test sanguin pour voir si vos reins fonctionnent normalement), une diminution du taux d’hémoglobine (qui transporte l’oxygène dans le sang) qui peuvent être sévères.", "truncated": false}, "before_length": 743, "before_sha256": "3d42cb2df0cd68cf8090218db151d8e9b59b2c30d886ee805eb3604cea9b7273", "change_kind": "content", "change_operations": [{"after_end": 448, "after_start": 447, "before_end": 447, "before_start": 447, "kind": "insert"}, {"after_end": 463, "after_start": 449, "before_end": 448, "before_start": 448, "kind": "insert"}, {"after_end": 465, "after_start": 464, "before_end": 450, "before_start": 449, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 16}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-512fd2cb074a30094bf69cba", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3192}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 14, "start": 0, "text": "Pfizer Limited", "truncated": false}, "before_length": 14, "before_sha256": "faadd350d247ecbb0e8edac0805fa3d4cdbf449fbb9a1a9614eee6624274a2f6", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5133f73607070462aff5d97b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 10682}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IV", "before": {"end": 65, "start": 0, "text": "The CHMP agrees with the scientific conclusions made by the PRAC.", "truncated": false}, "before_length": 65, "before_sha256": "94a1f6e67f2001f37ce96a58d2c36da690a2f85baa7ddba3921c28757ea2d985", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 65, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 65, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-516a04983b20687aa2ff85a5", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3429}
{"after": {"end": 25, "start": 0, "text": "Tél: +33 (0)1 80 46 40 40", "truncated": false}, "after_length": 25, "after_sha256": "8039903c80fe171d38545fabfbccd20dc939429edfd9799a4e988d97cb003cb2", "annex": "IIIA", "before": {"end": 28, "start": 0, "text": "Tél : + 33 (0) 1 80 46 40 40", "truncated": false}, "before_length": 28, "before_sha256": "f613785efd391db758f618a86bd171bd9e80b85a925313be3d64c23235cd5289", "change_kind": "content", "change_operations": [{"after_end": 3, "after_start": 3, "before_end": 4, "before_start": 3, "kind": "delete"}, {"after_end": 6, "after_start": 6, "before_end": 8, "before_start": 7, "kind": "delete"}, {"after_end": 12, "after_start": 12, "before_end": 15, "before_start": 14, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 3, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-519033eaaef0e74576cb57b1", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3454}
{"after": {"end": 19, "start": 0, "text": "Tlf.: +45 4482 4000", "truncated": false}, "after_length": 19, "after_sha256": "af0a194e29f3ab0b5fe5904b0fde60b2569357720962deb56e29ff0aaeb35cff", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Tlf.: + 45 4482 4000", "truncated": false}, "before_length": 20, "before_sha256": "f80e4dfc122f8fba0c329c1b2292f97480b856b6e047fac739f795c79bbd9711", "change_kind": "content", "change_operations": [{"after_end": 7, "after_start": 7, "before_end": 8, "before_start": 7, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-51a07d9bae4c0bdea4eb9f1c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3500}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 70, "start": 0, "text": "Once thawed, store in a refrigerator (2°C to 8°C) and do not refreeze.", "truncated": false}, "before_length": 70, "before_sha256": "86dd2800284a4756e051640a5fe467c8bbf09410372d080fc896802b28d0cd0a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 70, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 70, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-51b147ea1f87a144ad488ad2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.4", "section_type": "storage", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6293}
{"after": {"end": 36, "start": 0, "text": "idées ou comportements suicidaires ;", "truncated": false}, "after_length": 36, "after_sha256": "70eded689378b6a6c4c7b85a0828f00a6ea9b7e16f8124b1468a4d4246b8bda0", "annex": "IIIA", "before": {"end": 35, "start": 0, "text": "idées ou comportements suicidaires.", "truncated": false}, "before_length": 35, "before_sha256": "ade5510811d3352d5f4d497e06b250a2c364fbe9b699af981ee02155ec041a23", "change_kind": "content", "change_operations": [{"after_end": 36, "after_start": 34, "before_end": 35, "before_start": 34, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-51bd1ba16f49bd9a62cf0659", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "9ac80b0d56ebad4970f7a8335a177613af59ef25517bcd0bdd3397c207cc1bac", "source_snapshot_id": "source-c11aa9e32420f125a88005bc", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2474}
{"after": {"end": 74, "start": 0, "text": "* Do not use the prefilled syringe to deliver a partial volume of 0.25 mL.", "truncated": false}, "after_length": 74, "after_sha256": "75e296bff3c238176d513ed450c19057750a20263b5a3152d3b7a7c0a0d4190e", "annex": "I", "before": {"end": 94, "start": 0, "text": "* Do not use the single-dose vial or prefilled syringe to deliver a partial volume of 0.25 mL.", "truncated": false}, "before_length": 94, "before_sha256": "34a3dd6a9a278560b1c455186ca0846462be29c70b70a4dd2f194f53b65e7df3", "change_kind": "administrative", "change_operations": [{"after_end": 17, "after_start": 17, "before_end": 37, "before_start": 17, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 20, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-51fa4ded60df58431b606bbb", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12748}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 1, "start": 0, "text": "0", "truncated": false}, "before_length": 1, "before_sha256": "5feceb66ffc86f38d952786c6d696c79c2dbc239dd4e91b46729d73a27fb57e9", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 1, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-521499e2dd2543e468acf613", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005352", "medicine_name": "Upstaza", "medicine_slug": "upstaza", "observed_at": "2026-10-12T13:36:07Z", "pipeline_version": "2.0.0", "presentation_label": "Upstaza 2.8 × 1011 vector genomes (vg)/0.5 mL solution for infusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8561a0c5aed752dd415d30acef76bf620ad205d702080a0bca765e086873fe20", "source_snapshot_id": "source-4b712d5f9e4e2e8cd620aa93", "source_updated_at": "2026-06-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/upstaza-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 347}
{"after": {"end": 161, "start": 0, "text": "PDE5 inhibitors such as sildenafil, tadalafil, or vardenafil. These are medicines to treat high blood pressure in lung arteries or to treat erectile dysfunction.", "truncated": false}, "after_length": 161, "after_sha256": "a431cc12ade8f1e770ba66c20970471f6b4114ec0ff7b9d86f291b27b7dbe463", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 161, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 161}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-52908d609083cde3b5cde78f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3197}
{"after": {"end": 384, "start": 0, "text": "A few cases of capillary leak syndrome flare-ups (causing fluid leakage from small blood vessels (capillaries) resulting in rapid swelling of the arms and legs, sudden weight gain and feeling faint, low blood pressure) have been reported following vaccination with Spikevax (original). If you have previously had episodes of CLS, talk to a doctor before you are given Spikevax LP.8.1.", "truncated": false}, "after_length": 384, "after_sha256": "c63f241e0a537707a19c42e9675ebc7f4f2a6402f6f6f29bb3f425966df5ed61", "annex": "I", "before": {"end": 382, "start": 0, "text": "A few cases of capillary leak syndrome flare-ups (causing fluid leakage from small blood vessels (capillaries) resulting in rapid swelling of the arms and legs, sudden weight gain and feeling faint, low blood pressure) have been reported following vaccination with Spikevax (original). If you have previously had episodes of CLS, talk to a doctor before you are given Spikevax JN.1.", "truncated": false}, "before_length": 382, "before_sha256": "9f4c7d6f7cbeb38be0d8cacba821a23a4a5a6eb62588d1144d5bb37a12c1deb3", "change_kind": "administrative", "change_operations": [{"after_end": 381, "after_start": 377, "before_end": 379, "before_start": 377, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5291abd3050f7a32ef93e20c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12661}
{"after": {"end": 8, "start": 0, "text": "ANNEX IV", "truncated": false}, "after_length": 8, "after_sha256": "29972ab77d4b1358a0bdb16d438bcde59007e95356d1f5f9ee2f7045597f9574", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 8, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-52951d939059becb12ab516a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:30Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "35ab6716aa09492c14ac6849111486ec47235c0bc65ef055350de950f316c5e6", "source_snapshot_id": "source-f20a60110d1f8fef5225317d", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2333}
{"after": {"end": 52, "start": 0, "text": "5 Patiente ayant une maladie mesurable à l’inclusion", "truncated": false}, "after_length": 52, "after_sha256": "a1bb7d55e7e2c8a15e6fe295b6902c1705febc540dbfcf19560af900cd67674c", "annex": "I", "before": {"end": 51, "start": 0, "text": "5 Patiente ayant une maladie mesurable initialement", "truncated": false}, "before_length": 51, "before_sha256": "2340c289782ee3679ccf87edc43a1f1e554281cd8f1f5959003dfa342a3befca", "change_kind": "content", "change_operations": [{"after_end": 43, "after_start": 39, "before_end": 39, "before_start": 39, "kind": "insert"}, {"after_end": 49, "after_start": 45, "before_end": 41, "before_start": 41, "kind": "insert"}, {"after_end": 51, "after_start": 50, "before_end": 49, "before_start": 42, "kind": "replace"}, {"after_end": 52, "after_start": 52, "before_end": 51, "before_start": 50, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 8, "chars_inserted": 9}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-52be17b69afa99abceaa0147", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1781}
{"after": {"end": 141, "start": 0, "text": "Compte tenu du rapport d’évaluation du PRAC sur les PSUR concernant le pérampanel, les conclusions scientifiques du PRAC sont les suivantes :", "truncated": false}, "after_length": 141, "after_sha256": "744e7ab6178f154842e01f81b53937e33cbd454367f4f1f102d950cd408e83da", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 141, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 141}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-52d231c9acbb0231d01bbe05", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:32:00Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "3ff8cd4d67d22ba799aa348aeda944d6d896a16dcf54b030db101cbc095fc8ad", "source_snapshot_id": "source-a79a7cba8bf5dbc72fd40574", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3531}
{"after": {"end": 99, "start": 0, "text": "SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S)", "truncated": false}, "after_length": 99, "after_sha256": "4d43e1a4109e8a776bcf1a5f90e9a1bc3b91d0b8306edf4d773e154de56fdd42", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 99, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 99}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-52e713d52244c219f4e0b704", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3438}
{"after": {"end": 85, "start": 0, "text": "No data are available yet regarding the use of Spikevax LP.8.1 during breast feeding.", "truncated": false}, "after_length": 85, "after_sha256": "0d97f09dbbe8118fa9dacb762bd113a4a2a573f3f192cd85f0ae8a6a585b3006", "annex": "I", "before": {"end": 83, "start": 0, "text": "No data are available yet regarding the use of Spikevax JN.1 during breast feeding.", "truncated": false}, "before_length": 83, "before_sha256": "157a5cc5af3530cb470ca7258697f868206cb9b3e8d0dc02555a9844110d62d5", "change_kind": "administrative", "change_operations": [{"after_end": 60, "after_start": 56, "before_end": 58, "before_start": 56, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-52f4e9773e7788dc8e59721f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12678}
{"after": {"end": 134, "start": 0, "text": "Detailed information on this medicinal product is available on the website of the European Medicines Agency https://www.ema.europa.eu.", "truncated": false}, "after_length": 134, "after_sha256": "9f2a855337f11701b0cd4191c51820fa5a70b201b2e0721ba6acd34544486f89", "annex": "I", "before": {"end": 133, "start": 0, "text": "Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.", "truncated": false}, "before_length": 133, "before_sha256": "eabdb61a543e11ee016c5c43ada549964199ddf9e287a2eb3256e15d4a87fe4a", "change_kind": "technical", "change_operations": [{"after_end": 113, "after_start": 112, "before_end": 112, "before_start": 112, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-530cfd6e38f588c506f8c8b1", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg solution for injection in dose-dispenser cartridge Enbrel 50 mg solution for injection in dose-dispenser cartridge", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "10", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6487}
{"after": {"end": 8, "start": 0, "text": "D02 HW68", "truncated": false}, "after_length": 8, "after_sha256": "1ed87437489fcb80b59bfa5d17082f438d78a8aff5deaac6125946420fbf0992", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 8, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-532f7a10518e135990bc7b77", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1215}
{"after": {"end": 134, "start": 0, "text": "Detailed information on this medicinal product is available on the website of the European Medicines Agency https://www.ema.europa.eu.", "truncated": false}, "after_length": 134, "after_sha256": "9f2a855337f11701b0cd4191c51820fa5a70b201b2e0721ba6acd34544486f89", "annex": "I", "before": {"end": 133, "start": 0, "text": "Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.", "truncated": false}, "before_length": 133, "before_sha256": "eabdb61a543e11ee016c5c43ada549964199ddf9e287a2eb3256e15d4a87fe4a", "change_kind": "technical", "change_operations": [{"after_end": 113, "after_start": 112, "before_end": 112, "before_start": 112, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-53657463d333b5002315ca7c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg solution for injection in pre-filled pen Enbrel 50 mg solution for injection in pre-filled pen", "presentation_occurrence": 4, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "10", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 4492}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 33, "start": 0, "text": "United Kingdom (Northern Ireland)", "truncated": false}, "before_length": 33, "before_sha256": "9379d82927cdb505cfb186e912177065e56a1314de3a2b914ebbb8b5fe21525a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 33, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 33, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-53a3a171d9c5e43e06b6b348", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11614}
{"after": {"end": 30, "start": 0, "text": "Réaction liée à la perfusionff", "truncated": false}, "after_length": 30, "after_sha256": "5c802aa6863f99bd3fdb7eafc2ce22ff020373ff29d7df44c94ff465d7fad7e9", "annex": "I", "before": {"end": 30, "start": 0, "text": "Réaction liée à la perfusionee", "truncated": false}, "before_length": 30, "before_sha256": "aacf226881e125eedfae6b0e7e6eddcf875b9767f9c245709ecc8b20002153d9", "change_kind": "content", "change_operations": [{"after_end": 30, "after_start": 28, "before_end": 30, "before_start": 28, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-53baa6c9546297cd13930a21", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:18Z", "pipeline_version": "2.0.0", "presentation_label": "IMJUDO 20 mg/ml, solution à diluer pour perfusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "2437ab76633f46c9eee5e002e5c7a7caba6367f59567d750be0eb67c74d1db4e", "source_snapshot_id": "source-7f4d129b0a0fd2d3684d27c5", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 889}
{"after": {"end": 64, "start": 0, "text": "take medicines to lower blood pressure or to increase urination,", "truncated": false}, "after_length": 64, "after_sha256": "e4ae8bd07b4e6d2bd99ee651a79c695cfc033498eab8844f8b5bd192f696efce", "annex": "IIIA", "before": {"end": 67, "start": 0, "text": "take medicines to lower blood pressure or to increase urination, or", "truncated": false}, "before_length": 67, "before_sha256": "bb76682fd671d13030ede85158c6a3d951897d7c064d87675b743ef35ce2493c", "change_kind": "content", "change_operations": [{"after_end": 64, "after_start": 64, "before_end": 67, "before_start": 64, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 3, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-53ccbd3c7a43a92ae93a50f0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3178}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 9, "start": 0, "text": "Nederland", "truncated": false}, "before_length": 9, "before_sha256": "8a869db3fa453526573e4f2c956528743cf246af5d1b5eac4879257589776797", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 9, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 9, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-543e53e1b077cb6310100cc8", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1055}
{"after": {"end": 68, "start": 0, "text": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection (multidose vials)", "truncated": false}, "after_length": 68, "after_sha256": "f5f1beca1e5749b2903a5e2cb2014d788c8731962a72b68f5748383bb0fce157", "annex": "I", "before": {"end": 66, "start": 0, "text": "Spikevax JN.1 0.1 mg/mL dispersion for injection (multidose vials)", "truncated": false}, "before_length": 66, "before_sha256": "6f4af5e44b1ec25d468896b61a90c845b84f703de2c49e23017c4c87baa76838", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-544106cc0f3adf482462b2ed", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.4", "section_type": "storage", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6279}
{"after": {"end": 74, "start": 0, "text": "En absence d’amélioration : Après 2 à 3 min, utilisez le 2e pulvérisateur.", "truncated": false}, "after_length": 74, "after_sha256": "271935a2fb3284a028c419046ca35b3875d61ba807e117f8a08babedb228a72a", "annex": "IIIA", "before": {"end": 74, "start": 0, "text": "En absence d’amélioration : Après 2 à 3 min, utiliser le 2e pulvérisateur.", "truncated": false}, "before_length": 74, "before_sha256": "7fa7b9d0616616b5e35f7db4d53c2f29bcccde7ddb0e55d253cbfbcbf348e041", "change_kind": "content", "change_operations": [{"after_end": 53, "after_start": 52, "before_end": 53, "before_start": 52, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-544c47f3895c1586dcdbe9ad", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 675}
{"after": {"end": 5, "start": 0, "text": "BOITE", "truncated": false}, "after_length": 5, "after_sha256": "1b1d08f5410c5ffada766987117be91ac56027bdf92b1822ed66807fbaf8c3a0", "annex": "IIIA", "before": {"end": 4, "start": 0, "text": "ETUI", "truncated": false}, "before_length": 4, "before_sha256": "7b1f93054fda33f5ac26e1fcca4f88911b34102404c41298bf20bbf7f5191106", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}, {"after_end": 5, "after_start": 5, "before_end": 4, "before_start": 1, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 3, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-54dc53a0cc9f0275ecc01a3f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2636}
{"after": {"end": 22, "start": 0, "text": "Tel.: +40 21 529 29 00", "truncated": false}, "after_length": 22, "after_sha256": "c0def45751c8a6f47b191f68953f4156d333424fdfacc770cf07669eae1210a5", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "Tel: + 40 21 529 29 00", "truncated": false}, "before_length": 22, "before_sha256": "ab360a5cc3194a1966bd86bcee0a1a2cf6cc97342e9c07c5a45039ca6bac64ef", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}, {"after_end": 7, "after_start": 7, "before_end": 7, "before_start": 6, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-54f7f667ad5b6fe42d51fab3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3067}
{"after": {"end": 83, "start": 0, "text": "Pink, round, biconvex tablet, engraved with E294 on one side and ‘6’ on other side.", "truncated": false}, "after_length": 83, "after_sha256": "1de33a741cfaba5383beaa2dde703742eea3d1eea1c8921e3f83b9edd6a12a95", "annex": "I", "before": {"end": 82, "start": 0, "text": "Pink, round, biconvex tablet, engraved with E294 on one side and ‘6’ on other side", "truncated": false}, "before_length": 82, "before_sha256": "6f06398e9378373389fc05fcb5230c9459cf6e0004fb67bf2b232dfc0b3e58d8", "change_kind": "content", "change_operations": [{"after_end": 83, "after_start": 82, "before_end": 82, "before_start": 82, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-551ba315d8fbb527f2b120ab", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "Fycompa 2 mg filmcoated tablets Fycompa 4 mg filmcoated tablets Fycompa 6 mg filmcoated tablets Fycompa 8 mg filmcoated tablets Fycompa 10 mg filmcoated tablets Fycompa 12 mg filmcoated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "3", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 99}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "nordics@mundipharma.dk", "truncated": false}, "before_length": 22, "before_sha256": "f439d81e92f339fb15af44387dc1531c6265af6c724b25a05f18a5ab6acd0f1e", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 22, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 22, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-555ebc3a177ba8f427f32e8c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1156}
{"after": {"end": 7, "start": 0, "text": "Ireland", "truncated": false}, "after_length": 7, "after_sha256": "02bf1dfa9a0365a86223f0e4ac9eaa0517b06b2e9273790f719feda656a247ae", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 7, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 7}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-55a60cefe435bfc316411942", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1215}
{"after": {"end": 94, "start": 0, "text": "On the basis of the scientific conclusions for bevacizumab the CHMP is of the opinion that the", "truncated": false}, "after_length": 94, "after_sha256": "7473a25f81bc4141247f58bfa26174adc6196135daaef77c93b54156eb816a6f", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 94, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 94}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-55ee21313b0bd4f3e761925a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:18Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "89a938df5e41f86548301270084e3d1ecf171802e24b5429f62e3bede7ee32dd", "source_snapshot_id": "source-b71aeee5a07abebc34c02e28", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3434}
{"after": {"end": 20, "start": 0, "text": "Tlf.: +45 44 201 100", "truncated": false}, "after_length": 20, "after_sha256": "a342c892cb893e888e9b98929ab7ba413528a3b19847cefc774fcc7b2c91291e", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "Tlf: +45 44 201 100", "truncated": false}, "before_length": 19, "before_sha256": "c639c1fe70f9701d8cecb70d89ff79995abd4e41911073143438fc69a41a0363", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-55ee68c1e8af3d41fb7f70fa", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11524}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 44, "start": 0, "text": "BL 3 6 9 12 18 24 30 36 42 48 54 60 72 84 96", "truncated": false}, "before_length": 44, "before_sha256": "92a7c14af2c9b2abeecb09b59a2a4bac623330355d7d14ac791b895da7350a59", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 44, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 44, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5609741f9e44df089acd9b15", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005352", "medicine_name": "Upstaza", "medicine_slug": "upstaza", "observed_at": "2026-10-12T13:36:07Z", "pipeline_version": "2.0.0", "presentation_label": "Upstaza 2.8 × 1011 vector genomes (vg)/0.5 mL solution for infusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8561a0c5aed752dd415d30acef76bf620ad205d702080a0bca765e086873fe20", "source_snapshot_id": "source-4b712d5f9e4e2e8cd620aa93", "source_updated_at": "2026-06-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/upstaza-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 348}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 6, "start": 0, "text": "Ελλάδα", "truncated": false}, "before_length": 6, "before_sha256": "e6f7401e81c9b2a3c1f082d0c9a0183287a6f7b4ecded4f4d3ac5e1efefa9ce5", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 6, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5611414d2c16e8ed83a90e88", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1085}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 77, "start": 0, "text": "Keep the single-dose vial in the outer carton in order to protect from light.", "truncated": false}, "before_length": 77, "before_sha256": "6dd1869ed86f40e93bbb844b9d44f5a1810a031d848a5ff3176b6f397ba52aa4", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 77, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 77, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5627e76a5b5f75e49d956695", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.4", "section_type": "storage", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6294}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 26, "start": 0, "text": "mundipharma@mundipharma.bg", "truncated": false}, "before_length": 26, "before_sha256": "5c8cedae416243cb8959a3ac77d76d67a4127baef6c6dc6eb3c2d590f7a0241c", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 26, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 26, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-56518a0fd971dde68539208e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1026}
{"after": {"end": 800, "start": 0, "text": "Given the mechanism of action of tremelimumab in combination with durvalumab, other potential immunemediated adverse reactions may occur. The following immune-related adverse reactions have been observed in patients treated with tremelimumab in combination with durvalumab, or with durvalumab and chemotherapy: myasthenia gravis, myelitis transverse, myositis, polymyositis, rhabdomyolysis, meningitis, encephalitis, GuillainBarré syndrome, immune thrombocytopenia, cystitis noninfective, immune-mediated arthritis, uveitis and polymyalgia rheumatica (see section 4.8). Patients should be monitored for signs and symptoms and managed as recommended in section 4.2. Corticosteroids should be administered with an initial dose of 1-2 mg/kg/day prednisone or equivalent followed by taper for Grades 2-4.", "truncated": false}, "after_length": 800, "after_sha256": "acaeaea9a4c4d344d4442cd1ce5016edbcff15f8c9a956f7c9fbfcd3a3353096", "annex": "I", "before": {"end": 776, "start": 0, "text": "Given the mechanism of action of tremelimumab in combination with durvalumab, other potential immunemediated adverse reactions may occur. The following immune-related adverse reactions have been observed in patients treated with tremelimumab in combination with durvalumab, or with durvalumab and chemotherapy: myasthenia gravis, myelitis transverse, myositis, polymyositis, rhabdomyolysis, meningitis, encephalitis, GuillainBarré syndrome, immune thrombocytopenia, cystitis noninfective, immune-mediated arthritis and uveitis (see section 4.8). Patients should be monitored for signs and symptoms and managed as recommended in section 4.2. Corticosteroids should be administered with an initial dose of 1-2 mg/kg/day prednisone or equivalent followed by taper for Grades 2-4.", "truncated": false}, "before_length": 776, "before_sha256": "4ac11dd5240b8faf128e1fb1ad055d41e957f226559c74871eb7a1c551673162", "change_kind": "content", "change_operations": [{"after_end": 515, "after_start": 514, "before_end": 518, "before_start": 514, "kind": "replace"}, {"after_end": 550, "after_start": 523, "before_end": 526, "before_start": 526, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 28}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-56f4b5914951937afdbd4fb4", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "IMJUDO 20 mg/ml concentrate for solution for infusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 324}
{"after": {"end": 192, "start": 0, "text": "Votre médecin vous remettra également une Carte Patient qui comportera des informations importantes de sécurité d’emploi que vous devez connaître, avant et pendant votre traitement par Enbrel.", "truncated": false}, "after_length": 192, "after_sha256": "a9b61621aee7f348e503c6ef13da6f1d4dc6f2a4d953f840016b3daaebeecd6a", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 192, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 192}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-56fb4eb6a6615fcc16d427dd", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 10301}
{"after": {"end": 18, "start": 0, "text": "dpoccyprus@msd.com", "truncated": false}, "after_length": 18, "after_sha256": "492fae7e6db021703bcb80e4b139bc2be78a7e6cf4c6056a9314c70cfe643716", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "cyprus_info@merck.com", "truncated": false}, "before_length": 21, "before_sha256": "a6a31d0f7dc84283ce751c4e4d77e632a879da9a362680e26db9aa73403f7008", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}, {"after_end": 10, "after_start": 10, "before_end": 11, "before_start": 6, "kind": "delete"}, {"after_end": 14, "after_start": 12, "before_end": 17, "before_start": 13, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 9, "chars_inserted": 6}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-57418ad049bcf212bae6d491", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3189}
{"after": {"end": 67, "start": 0, "text": "Table 2. Spikevax LP.8.1 posology for immunocompromised individuals", "truncated": false}, "after_length": 67, "after_sha256": "2851bc22ae0e0f1a60e293324ab519599011d06fc93b53fab3a1d1fe80606a3b", "annex": "I", "before": {"end": 65, "start": 0, "text": "Table 2. Spikevax JN.1 posology for immunocompromised individuals", "truncated": false}, "before_length": 65, "before_sha256": "56d0f9008a63457a7e07f337ee9debfd38bd3f7335943bf9476aaa1f536ae8f9", "change_kind": "administrative", "change_operations": [{"after_end": 22, "after_start": 18, "before_end": 20, "before_start": 18, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5747932163435e037e974bcd", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12724}
{"after": {"end": 114, "start": 0, "text": "prenez des médicaments pour abaisser votre pression sanguine ou pour augmenter la production d’urine (diurétique),", "truncated": false}, "after_length": 114, "after_sha256": "ff2566bfc824f5e400fa32dc9f89e289d05cdb73c477ffc926758956f5832cba", "annex": "IIIA", "before": {"end": 104, "start": 0, "text": "prenez des médicaments pour abaisser votre pression sanguine ou pour augmenter la production d’urine, ou", "truncated": false}, "before_length": 104, "before_sha256": "03a070873a782c9c772a5b3be53588fecfb8f6c3b0ae0a9db893f8b8cc652a55", "change_kind": "content", "change_operations": [{"after_end": 113, "after_start": 100, "before_end": 100, "before_start": 100, "kind": "insert"}, {"after_end": 114, "after_start": 114, "before_end": 104, "before_start": 101, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 3, "chars_inserted": 13}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-574a741b8a447b9a47cdb586", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3271}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 13, "start": 0, "text": "Medis, d.o.o.", "truncated": false}, "before_length": 13, "before_sha256": "fda955bff0c409b008f998853f0a76bfdb681c029b0ff98b4bb6e9cc5ca14663", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 13, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 13, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-57640ffe66dfead475d78c7f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1126}
{"after": {"end": 20, "start": 0, "text": "Tlf: +47 32 20 73 00", "truncated": false}, "after_length": 20, "after_sha256": "554d3014d2516702d0c22a89fb65d9c24ed800d14c36df4bf39ee1ecab71c124", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tlf: + 47 32 20 73 00", "truncated": false}, "before_length": 21, "before_sha256": "e1f6d02c8ded918450f2e8f65b84556d21d9f9644984ce9e4a7da61d7a6ac88f", "change_kind": "content", "change_operations": [{"after_end": 6, "after_start": 6, "before_end": 7, "before_start": 6, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-579c7da098307b1fdcf63b54", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3115}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 95, "start": 0, "text": "If the vaccine is received at 2°C to 8°C, it should be stored at 2°C to 8°C. The expiry date on", "truncated": false}, "before_length": 95, "before_sha256": "4db24e7c68722f05450cc8ab4b3981bc76c9f42afa8f0ea5654957f7abc3bb89", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 95, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 95, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-57a6b00ea7edfbea07140b71", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.3", "section_type": "storage", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6250}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 24, "start": 0, "text": "Tél/Tel: +32 2 358 54 68", "truncated": false}, "before_length": 24, "before_sha256": "41a8515e0ad87e2db6e34f58a5b4db10b75995776214e98d6be98b1aa31eee38", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 24, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 24, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-57ad67999ee17a79028f8f9a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1031}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 49, "start": 0, "text": "des nausées et vomissements comme le granisétron.", "truncated": false}, "before_length": 49, "before_sha256": "d6dfa8c4680cda58d765ba0fd2f6b28add22868d5645bf67009241065131b734", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 49, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 49, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-587bf5feb2a9882f0623e61c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2864}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 15, "start": 0, "text": "MUNDIPHARMA SAS", "truncated": false}, "before_length": 15, "before_sha256": "7c1f6441b59573c44ce170a41d1e84818840a5210ce6359a71d9f6aa263845fe", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 15, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 15, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5898f52da0335f1f1fa82dee", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1091}
{"after": {"end": 13, "start": 0, "text": "1932 Zaventem", "truncated": false}, "after_length": 13, "after_sha256": "cffe4475a5de91da7a3a6363a4d41ccfd1405766d95ae182d89bf39b29686221", "annex": "I", "before": {"end": 13, "start": 0, "text": "1930 Zaventem", "truncated": false}, "before_length": 13, "before_sha256": "ed9ea9385e3e50f6278214da5d7483a8543c36d1261df263d35022c5936c74db", "change_kind": "administrative", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 4, "before_start": 3, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5926cbf27c347b04dfe71754", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004310", "medicine_name": "Daptomycin Hospira", "medicine_slug": "daptomycin-hospira", "observed_at": "2026-10-12T19:09:33Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "3242bb93d94dc3b7e86b89af5160c6986e8caa2e4f8d73bf8a634a557420452a", "source_snapshot_id": "source-dd7a18b7c210239223fa10ad", "source_updated_at": "2025-09-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/daptomycin-hospira-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1991}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 65, "start": 0, "text": "Delpharm Dijon 6, boulevard de l'Europe, F-21800 Quétigny, France", "truncated": false}, "before_length": 65, "before_sha256": "fd86ad8bcf2bb1986aa62f882735e0485b198090988c2558bf217db2fd846465", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 65, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 65, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5928600a8a3bda5a122c5a41", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000174", "medicine_name": "Plavix", "medicine_slug": "plavix", "observed_at": "2026-10-12T19:27:50Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3818c2e3c9979bf5f8be3f164dfce187fccfccf62bbd1e3227c64ca7c00ad02f", "source_snapshot_id": "source-4aff1b64c7cf58337d33ecfa", "source_updated_at": "2025-07-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/plavix-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1442}
{"after": {"end": 147, "start": 0, "text": "abacavir, atazanavir, cobicistat, darunavir, dolutegravir, efavirenz, elvitegravir, emtricitabine, rilpivirine, ritonavir, to treat HIV infections.", "truncated": false}, "after_length": 147, "after_sha256": "f75263e469c2e9fa490b0d0219e2b0d7c710121ba82ab8c721315d68e029d5f1", "annex": "IIIA", "before": {"end": 144, "start": 0, "text": "HIV infection such as abacavir, atazanavir, cobicistat, darunavir, dolutegravir, efavirenz, elvitegravir, emtricitabine, rilpivirine, ritonavir.", "truncated": false}, "before_length": 144, "before_sha256": "bb4bb67d4cd899ef57aa188b6be15f242d19379c3bf58c76c11d08799253863d", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 22, "before_start": 0, "kind": "delete"}, {"after_end": 146, "after_start": 121, "before_end": 143, "before_start": 143, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 22, "chars_inserted": 25}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5937d5e487b20f32369c3a20", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3204}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "Tel: +39 02 3182881", "truncated": false}, "before_length": 19, "before_sha256": "6f9e6ac8eafb4bbd7cd7d97ab4e13855ff3f41c067de37fccc45629f603eab76", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 19, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 19, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5955e51e140aac0132daaac1", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1132}
{"after": {"end": 20, "start": 0, "text": "msd.slovenia@msd.com", "truncated": false}, "after_length": 20, "after_sha256": "32f245e2e4036e3b467769cde309d09f05bcdd6f4f0f06a8cc91d81e4a082213", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "msd.slovenia@merck.com", "truncated": false}, "before_length": 22, "before_sha256": "fde9163edb7de43fa3b79d2f1f0c2a3195d3f29d316528e4141d99f1f940d448", "change_kind": "content", "change_operations": [{"after_end": 16, "after_start": 14, "before_end": 18, "before_start": 14, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-59c566b008cb1783029ef521", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3575}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 14, "start": 0, "text": "Pfizer Limited", "truncated": false}, "before_length": 14, "before_sha256": "faadd350d247ecbb0e8edac0805fa3d4cdbf449fbb9a1a9614eee6624274a2f6", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-59e321da1257704cadffc233", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 10165}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "Tél: +33 1 40 65 29 29", "truncated": false}, "before_length": 22, "before_sha256": "80f8b635bfd20be9b4f761a79c7cf6d1a5a2894b709f54f7104b9cc6382753ad", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 22, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 22, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-59f40d119ab57816f30ed8f4", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1092}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 18, "start": 0, "text": "medis.lt@medis.com", "truncated": false}, "before_length": 18, "before_sha256": "728d3d606791c6b09f567fff9013bcbe51b504b37bbdcf449ccd76825c396355", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 18, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 18, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-59f9373bfd8a98ca792c5173", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1078}
{"after": {"end": 19, "start": 0, "text": "Oedema peripheralee", "truncated": false}, "after_length": 19, "after_sha256": "76dd6c9236b74b3d34d2519ffe997cc061323e58ab95c55f88fcbd3a03e23bec", "annex": "I", "before": {"end": 19, "start": 0, "text": "Oedema peripheraldd", "truncated": false}, "before_length": 19, "before_sha256": "8cd23d73dde54af29ebd603ab50cdad8a1f9060e03af45e9ead323ed29c99a28", "change_kind": "content", "change_operations": [{"after_end": 19, "after_start": 17, "before_end": 19, "before_start": 17, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-59fae8ccd43d622791501a47", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "IMJUDO 20 mg/ml concentrate for solution for infusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 889}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IV", "before": {"end": 353, "start": 0, "text": "In view of available data on rhabdomyolysis from the literature and spontaneous reports, the PRAC considers a causal relationship between tremelimumab in combination with durvalumab and rhabdomyolysis is at least a reasonable possibility. The PRAC concluded that the product information of products containing tremelimumab should be amended accordingly.", "truncated": false}, "before_length": 353, "before_sha256": "98c92ec06f2004cce7e1af3f8149d9e0042f0f34074e73d1f7d55b5e84a76e27", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 353, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 353, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5aa226e8c23ac7741b89f107", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2531}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 11, "start": 0, "text": "Takeda GmbH", "truncated": false}, "before_length": 11, "before_sha256": "94e4e4fc81542d4a8a0deb904c666e74cf300a1075af4d0d2e564a29e287bafb", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 11, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 11, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5ac2f9c4cb08a0aac0e9428a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1207}
{"after": {"end": 95, "start": 0, "text": "• your Terrosa Pen and a new Terrosa cartridge/your Terrosa Pen with inserted Terrosa cartridge", "truncated": false}, "after_length": 95, "after_sha256": "ba7a6c7c51b21d54c20eacdeffc5eb5b4091f35cfec7a621b778f82576edd26e", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 95, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 95}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5ac31c73fb849c8ae80443aa", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1970}
{"after": {"end": 7, "start": 0, "text": "Anxiety", "truncated": false}, "after_length": 7, "after_sha256": "7806c4ea4cdc269ec9bef57b3d8967ae6a4dcf4ba20017db416fbaab45412b66", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 7, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 7}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5b159bea4676ea5e8a976794", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:30Z", "pipeline_version": "2.0.0", "presentation_label": "Otezla 10 mg film-coated tablets Otezla 20 mg film-coated tablets Otezla 30 mg film-coated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "35ab6716aa09492c14ac6849111486ec47235c0bc65ef055350de950f316c5e6", "source_snapshot_id": "source-f20a60110d1f8fef5225317d", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 337}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 102, "start": 0, "text": "êtes âgés de plus de 65 ans car une pression artérielle basse est plus fréquente dans ce groupe d’âge.", "truncated": false}, "before_length": 102, "before_sha256": "3e4f42713390d918b17484f55bce64af32822894bc0ea5158f409742c9296b6a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 102, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 102, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5b2c01cb3277ab997a5a1989", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3273}
{"after": {"end": 19, "start": 0, "text": "Tel: +46 77 5700488", "truncated": false}, "after_length": 19, "after_sha256": "a968f6c96e435fb9594d06eee9f260814621b5e791fe61e1569bed42d6c801a6", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Tel: + 46 77 5700488", "truncated": false}, "before_length": 20, "before_sha256": "cb17614fcd82c944ba52cdd6413741cfa9e5ecd4d08eb5b092e244324255c763", "change_kind": "content", "change_operations": [{"after_end": 6, "after_start": 6, "before_end": 7, "before_start": 6, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5be3fbff57346f4838fa1972", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3106}
{"after": {"end": 115, "start": 0, "text": "Caution: The Terrosa Pen has a service life of two years. Do not use the Terrosa Pen after the end of service life.", "truncated": false}, "after_length": 115, "after_sha256": "caf0cc9972634390ed3f3c3fab63432d24e4c4b46f82802b47f26781cfe6b95e", "annex": "IIIA", "before": {"end": 48, "start": 0, "text": "The Terrosa Pen has a service life of two years.", "truncated": false}, "before_length": 48, "before_sha256": "edcdc670eb0a7ff96e0b93c173a9650997d7e4d455c80d684750f49287af81aa", "change_kind": "content", "change_operations": [{"after_end": 9, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}, {"after_end": 114, "after_start": 56, "before_end": 47, "before_start": 47, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 67}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5bf5fba947dffd36e82571e9", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2112}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 18, "start": 0, "text": "medis.lt@medis.com", "truncated": false}, "before_length": 18, "before_sha256": "728d3d606791c6b09f567fff9013bcbe51b504b37bbdcf449ccd76825c396355", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 18, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 18, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5c3458407e66d45fde43e16a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1063}
{"after": {"end": 89, "start": 0, "text": "No data are available yet regarding the use of SARSCoV2 LP.8.1 mRNA during breastfeeding.", "truncated": false}, "after_length": 89, "after_sha256": "bdf2e9b28a3ee016bca8c65010452c57c676a97cfb3a9376eccce2ee9a4833be", "annex": "I", "before": {"end": 87, "start": 0, "text": "No data are available yet regarding the use of SARSCoV2 JN.1 mRNA during breastfeeding.", "truncated": false}, "before_length": 87, "before_sha256": "85cbf89f310f81bec94da75bc59ba74a88f4a5d9c2e1277bbcf8f6ce715fad5d", "change_kind": "content", "change_operations": [{"after_end": 60, "after_start": 56, "before_end": 58, "before_start": 56, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5c36f772e517beb990bda555", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.6", "section_type": "pregnancy", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5623}
{"after": {"end": 61, "start": 0, "text": "2. What you need to know before you are given Spikevax LP.8.1", "truncated": false}, "after_length": 61, "after_sha256": "cd457f13453b5d3a87adf48826cfe59280e506fbdda396edfdf16fc9a13c28f2", "annex": "I", "before": {"end": 59, "start": 0, "text": "2. What you need to know before you are given Spikevax JN.1", "truncated": false}, "before_length": 59, "before_sha256": "8419e6ddb3ee3676df5263149aef68a2957beab12729bfea3051045fc943165f", "change_kind": "administrative", "change_operations": [{"after_end": 59, "after_start": 55, "before_end": 57, "before_start": 55, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5c3b6a16f9db91735b045801", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12633}
{"after": {"end": 22, "start": 0, "text": "Scientific conclusions", "truncated": false}, "after_length": 22, "after_sha256": "48a176450b72da083aae0c461d4b9485bc052767229342ad7b9f3b91fb4b3641", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 22, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 22}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5c3fb562a9c685829e2c28d0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2536}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 26, "start": 0, "text": "mundipharma@mundipharma.sk", "truncated": false}, "before_length": 26, "before_sha256": "4424124df62454025b9a7894fddc50e29858aaba98931eb68c3e6ef2c2e49693", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 26, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 26, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5c4d2d973421699f10fcda48", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1129}
{"after": {"end": 29, "start": 0, "text": "What Spikevax LP.8.1 contains", "truncated": false}, "after_length": 29, "after_sha256": "8dee2f7d4ca042d16b9624b5403fc19955a037ac498e2f62bfedf1d87bb73a41", "annex": "I", "before": {"end": 27, "start": 0, "text": "What Spikevax JN.1 contains", "truncated": false}, "before_length": 27, "before_sha256": "015cfb77b4ead47cb73662ad62910b3faf4f7e30e54914623465b96355d9b065", "change_kind": "administrative", "change_operations": [{"after_end": 18, "after_start": 14, "before_end": 16, "before_start": 14, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5c854752d326f3753fe9013e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12835}
{"after": {"end": 87, "start": 0, "text": "N’utilisez pas votre Terrosa Pen pour injecter un autre médicament (par ex., insuline).", "truncated": false}, "after_length": 87, "after_sha256": "efb868ea4a4a84c10d88d9d502a646b34ca35e07fe174e7e839a436760840810", "annex": "IIIA", "before": {"end": 89, "start": 0, "text": "N’utilisez pas votre stylo Terrosa pour injecter un autre médicament (par ex., insuline).", "truncated": false}, "before_length": 89, "before_sha256": "a8b728c579e08a33dcb5a6fcdb15cbf855810b0ac640ff141dabe545170fe4db", "change_kind": "content", "change_operations": [{"after_end": 21, "after_start": 21, "before_end": 27, "before_start": 21, "kind": "delete"}, {"after_end": 32, "after_start": 28, "before_end": 34, "before_start": 34, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5cb42be8338f5a0d4ac94ef3", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1793}
{"after": {"end": 161, "start": 0, "text": "Spikevax LP.8.1 is indicated for active immunisation to prevent COVID19 caused by SARS-CoV-2 in individuals 6 months of age and older (see sections 4.2 and 5.1).", "truncated": false}, "after_length": 161, "after_sha256": "4169436f8f4aa7ae46370e82f1b88e6ed455ea721bf03bdde535ddd5d37540d3", "annex": "I", "before": {"end": 159, "start": 0, "text": "Spikevax JN.1 is indicated for active immunisation to prevent COVID19 caused by SARS-CoV-2 in individuals 6 months of age and older (see sections 4.2 and 5.1).", "truncated": false}, "before_length": 159, "before_sha256": "521d7ab14c64c94e4e8167a0a25eb2bc1ff4d5ee025ba20d57527b91ca60f2f8", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5cca62fdf7ab90d13109c70a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.1", "section_type": "indication", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5460}
{"after": {"end": 256, "start": 0, "text": "Before disposing of the Terrosa Pen always remove the pen needle and the cartridge. Needles and used cartridges must be disposed separately and safely. The Terrosa Pen can be disposed according to local waste regulations or along with your household waste.", "truncated": false}, "after_length": 256, "after_sha256": "7c885313d7cd80edc81450e06fa9e9bc23ef0ee100c63798e2781d6488fef3a2", "annex": "IIIA", "before": {"end": 245, "start": 0, "text": "Before disposing of the Terrosa Pen always remove the pen needle and the cartridge. Needles and used cartridges must be disposed of separately and safely. The Terrosa Pen can be disposed of according to the instructions of the local authorities.", "truncated": false}, "before_length": 245, "before_sha256": "d97d9834b884ebe69c5c284b7e19680eb85c65006231522f6812eed6a861bafb", "change_kind": "content", "change_operations": [{"after_end": 129, "after_start": 129, "before_end": 132, "before_start": 129, "kind": "delete"}, {"after_end": 184, "after_start": 184, "before_end": 190, "before_start": 187, "kind": "delete"}, {"after_end": 206, "after_start": 197, "before_end": 203, "before_start": 203, "kind": "insert"}, {"after_end": 207, "after_start": 207, "before_end": 205, "before_start": 204, "kind": "delete"}, {"after_end": 209, "after_start": 209, "before_end": 211, "before_start": 207, "kind": "delete"}, {"after_end": 212, "after_start": 210, "before_end": 212, "before_start": 212, "kind": "insert"}, {"after_end": 215, "after_start": 213, "before_end": 214, "before_start": 213, "kind": "replace"}, {"after_end": 223, "after_start": 222, "before_end": 222, "before_start": 221, "kind": "replace"}, {"after_end": 232, "after_start": 224, "before_end": 223, "before_start": 223, "kind": "insert"}, {"after_end": 234, "after_start": 234, "before_end": 226, "before_start": 225, "kind": "delete"}, {"after_end": 236, "after_start": 235, "before_end": 228, "before_start": 227, "kind": "replace"}, {"after_end": 239, "after_start": 237, "before_end": 232, "before_start": 229, "kind": "replace"}, {"after_end": 240, "after_start": 240, "before_end": 236, "before_start": 233, "kind": "delete"}, {"after_end": 253, "after_start": 242, "before_end": 240, "before_start": 238, "kind": "replace"}, {"after_end": 254, "after_start": 254, "before_end": 242, "before_start": 241, "kind": "delete"}, {"after_end": 255, "after_start": 255, "before_end": 244, "before_start": 243, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 25, "chars_inserted": 36}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5cca9b11f1af79626b2c340a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2114}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 28, "start": 0, "text": "Mundipharma Farmacêutica Lda", "truncated": false}, "before_length": 28, "before_sha256": "92b5c1da95eda2f54f4735853a1250cd9cb07176a9c2d50fe2ecbe0500e6711a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 28, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 28, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5d39ead6e0f5771e62e7a5ff", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1109}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IV", "before": {"end": 319, "start": 0, "text": "In view of available data on myelitis transverse, the PRAC considers a causal relationship between tremelimumab in combination with durvalumab and myelitis transverse is at least a reasonable possibility. The PRAC concluded that the product information of products containing tremelimumab should be amended accordingly.", "truncated": false}, "before_length": 319, "before_sha256": "528f24627eb015a1ef8bedc13dfe2c7b6e55434c3fe588f40c6199154b401816", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 319, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 319, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5d723883b052487b6adc6066", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2530}
{"after": {"end": 70, "start": 0, "text": "Conserver le flacon dans l'emballage extérieur, à l'abri de la lumière", "truncated": false}, "after_length": 70, "after_sha256": "dbcad915dff15478d74b99def52aa5d8b19e1d1216ad9d07530c5a8c5cc59c7e", "annex": "IIIA", "before": {"end": 80, "start": 0, "text": "Conserver le flacon dans l’emballage extérieur afin de le protéger de la lumière", "truncated": false}, "before_length": 80, "before_sha256": "614ec3b3fb3662cdd1f6566029d740a09943b455b8fd05ab3d30c0dc1f154c94", "change_kind": "content", "change_operations": [{"after_end": 27, "after_start": 26, "before_end": 27, "before_start": 26, "kind": "replace"}, {"after_end": 47, "after_start": 46, "before_end": 46, "before_start": 46, "kind": "insert"}, {"after_end": 49, "after_start": 48, "before_end": 54, "before_start": 47, "kind": "replace"}, {"after_end": 54, "after_start": 51, "before_end": 59, "before_start": 56, "kind": "replace"}, {"after_end": 56, "after_start": 55, "before_end": 66, "before_start": 60, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 17, "chars_inserted": 7}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5db5410ab31c7ab855fe828d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2691}
{"after": {"end": 18, "start": 0, "text": "msdromania@msd.com", "truncated": false}, "after_length": 18, "after_sha256": "5820201082e5902b1d6a84673e62d34f129a4dc7106dc8e5e365973da4db652f", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "msdromania@merck.com", "truncated": false}, "before_length": 20, "before_sha256": "ed43025368036055834b7ab01c906dfab567b905345a39d35f9d1f659762c1b4", "change_kind": "content", "change_operations": [{"after_end": 14, "after_start": 12, "before_end": 16, "before_start": 12, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5dc81868efa4c6370cfdff95", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3565}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 14, "start": 0, "text": "Mundipharma AS", "truncated": false}, "before_length": 14, "before_sha256": "d225185bff45a7cac37b15c1c4f727bba36274dd9de05d7963fb65498b07991d", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5dd19420de5fa7137de27950", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1066}
{"after": {"end": 305, "start": 0, "text": "Microangiopathie thrombotique rénale avec ou sans utilisation concomitante du sunitinib, et microangiopathie glomérulaire occlusive hyaline qui pourraient se manifester cliniquement par une protéinurie (non connue). Pour plus d’informations sur la protéinurie voir rubrique 4.4 et Protéinurie rubrique 4.8", "truncated": false}, "after_length": 305, "after_sha256": "0b6d368d9ad9168bdd00ec76fda9e377b235976e781bcbb5da7b10e141348aa9", "annex": "I", "before": {"end": 254, "start": 0, "text": "Microangiopathie thrombotique rénale, qui pourrait se manifester cliniquement par une protéinurie (non connue) avec ou sans l’utilisation concomitante du sunitinib. Pour plus d’informations sur la protéinurie voir rubrique 4.4 et Protéinurie rubrique 4.8", "truncated": false}, "before_length": 254, "before_sha256": "e2dc127cf7b70f62c254ffc032711b6e1ecf4d7aefa7c1cfde27152d9f074876", "change_kind": "content", "change_operations": [{"after_end": 87, "after_start": 36, "before_end": 36, "before_start": 36, "kind": "insert"}, {"after_end": 139, "after_start": 88, "before_end": 37, "before_start": 37, "kind": "insert"}, {"after_end": 153, "after_start": 151, "before_end": 49, "before_start": 49, "kind": "insert"}, {"after_end": 214, "after_start": 214, "before_end": 163, "before_start": 110, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 53, "chars_inserted": 104}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5e0dd11aaa00d21b228644e9", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 871}
{"after": {"end": 133, "start": 0, "text": "have low blood pressure before you start treatment with Adempas. To start with Adempas your systolic blood pressure value needs to be", "truncated": false}, "after_length": 133, "after_sha256": "1e2faa49905eaa8ece660ef5707fb1c24097c8284e0d7105b574f52eb7654d63", "annex": "IIIA", "before": {"end": 121, "start": 0, "text": "have low blood pressure before you take Adempas the first time. To start with Adempas your systolic blood value should be", "truncated": false}, "before_length": 121, "before_sha256": "f8823cc1e744d13feee0af39fbfd713e52e99df71ef0c29f2539af31fc87b83a", "change_kind": "content", "change_operations": [{"after_end": 36, "after_start": 35, "before_end": 35, "before_start": 35, "kind": "insert"}, {"after_end": 43, "after_start": 38, "before_end": 38, "before_start": 37, "kind": "replace"}, {"after_end": 55, "after_start": 44, "before_end": 39, "before_start": 39, "kind": "insert"}, {"after_end": 63, "after_start": 63, "before_end": 62, "before_start": 47, "kind": "delete"}, {"after_end": 116, "after_start": 107, "before_end": 106, "before_start": 106, "kind": "insert"}, {"after_end": 126, "after_start": 122, "before_end": 112, "before_start": 112, "kind": "insert"}, {"after_end": 129, "after_start": 127, "before_end": 114, "before_start": 113, "kind": "replace"}, {"after_end": 130, "after_start": 130, "before_end": 118, "before_start": 115, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 20, "chars_inserted": 32}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5e5cea4c7fce1848f7f974e9", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3164}
{"after": {"end": 162, "start": 0, "text": "Spikevax LP.8.1 is a white to off white dispersion supplied in a pre-filled syringe (cyclic olefin copolymer) with plunger stopper and a tip cap (without needle).", "truncated": false}, "after_length": 162, "after_sha256": "9bb4217751d7be8859ea8dd5a1ed2960dae3f81aba9956f1bc5f47fd340da8e9", "annex": "I", "before": {"end": 160, "start": 0, "text": "Spikevax JN.1 is a white to off white dispersion supplied in a pre-filled syringe (cyclic olefin copolymer) with plunger stopper and a tip cap (without needle).", "truncated": false}, "before_length": 160, "before_sha256": "e166b84dc7169c51c4394ddefeeb6e446fab6608e54cae1d37b1acdca11f221a", "change_kind": "administrative", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5e85c15764fa9d0f226e21e9", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12894}
{"after": {"end": 69, "start": 0, "text": "le granisétron, utilisé pour traiter les nausées ou les vomissements.", "truncated": false}, "after_length": 69, "after_sha256": "1598cba28776c9c26fb1a0f1177724e96bf761c7aeea405f69479d468c353e51", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 69, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 69}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5e986535184730627046319f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3310}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 7, "start": 0, "text": "Germany", "truncated": false}, "before_length": 7, "before_sha256": "80db4ccdca106d37b920206331fcfe3e9e50a9e763d89b54ce3ad5ac8cf30f03", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 7, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5eb093d447b0ddb3571647ef", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1209}
{"after": {"end": 55, "start": 0, "text": "Etanercept treatment may increase the risk of infection", "truncated": false}, "after_length": 55, "after_sha256": "85355e94745364e432b5d8e0fc0a8ea88b6605b7fc5b9ab6d35c5b2316a5e510", "annex": "I", "before": {"end": 38, "start": 0, "text": "and congestive heart failure in adults", "truncated": false}, "before_length": 38, "before_sha256": "f6da8dd5bac0f2284c01d18dfc5aec06984fa32c35124b3e608a4b2625fe31a2", "change_kind": "unassigned", "change_operations": [{"after_end": 2, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}, {"after_end": 10, "after_start": 4, "before_end": 3, "before_start": 2, "kind": "replace"}, {"after_end": 11, "after_start": 11, "before_end": 10, "before_start": 4, "kind": "delete"}, {"after_end": 13, "after_start": 12, "before_end": 16, "before_start": 11, "kind": "replace"}, {"after_end": 19, "after_start": 15, "before_end": 19, "before_start": 18, "kind": "replace"}, {"after_end": 22, "after_start": 21, "before_end": 22, "before_start": 21, "kind": "replace"}, {"after_end": 24, "after_start": 23, "before_end": 28, "before_start": 23, "kind": "replace"}, {"after_end": 33, "after_start": 27, "before_end": 31, "before_start": 31, "kind": "insert"}, {"after_end": 34, "after_start": 34, "before_end": 36, "before_start": 32, "kind": "delete"}, {"after_end": 40, "after_start": 35, "before_end": 37, "before_start": 37, "kind": "insert"}, {"after_end": 55, "after_start": 41, "before_end": 38, "before_start": 38, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 23, "chars_inserted": 40}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5eccd4cab8103fc2bf67e955", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6575}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IV", "before": {"end": 105, "start": 0, "text": "CONCLUSIONS SCIENTIFIQUES ET MOTIFS DE LA MODIFICATION DES TERMES DES AUTORISATIONS DE MISE SUR LE MARCHE", "truncated": false}, "before_length": 105, "before_sha256": "1479acc7c4b6af3a607988ec6848ca436997955a02ca6073138d9d9007079fe1", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 105, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 105, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5ed512f006223ec759e453a4", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:32:00Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "3ff8cd4d67d22ba799aa348aeda944d6d896a16dcf54b030db101cbc095fc8ad", "source_snapshot_id": "source-a79a7cba8bf5dbc72fd40574", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3510}
{"after": {"end": 7, "start": 0, "text": "Irlande", "truncated": false}, "after_length": 7, "after_sha256": "a8cdfff5dbbda1b070a2acb339b6f0aa20b6230d9b5500c9ce066eaa89bc9a64", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 7, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 7}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5f0a9e4ce2c2b4829644021e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1216}
{"after": {"end": 72, "start": 0, "text": "Fycompa (pérampanel) est indiqué en association dans le traitement des :", "truncated": false}, "after_length": 72, "after_sha256": "cf29cd34688db3e294862c482ea2c9a0d8fab0e4e1433428a7f730c92100abce", "annex": "I", "before": {"end": 70, "start": 0, "text": "Fycompa (pérampanel) est indiqué en association dans le traitement des", "truncated": false}, "before_length": 70, "before_sha256": "341ca3f06fd8ca33e5b0838e03fd369b6c08d7701c7a43a9dd3856e3fc5db987", "change_kind": "content", "change_operations": [{"after_end": 72, "after_start": 70, "before_end": 70, "before_start": 70, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5f4dd4b4d4b2c049220adfe5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:32:00Z", "pipeline_version": "2.0.0", "presentation_label": "Fycompa 2 mg comprimés pelliculés Fycompa 4 mg comprimés pelliculés Fycompa 6 mg comprimés pelliculés Fycompa 8 mg comprimés pelliculés Fycompa 10 mg comprimés pelliculés Fycompa 12 mg comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.1", "section_type": "indication", "source_provider": "European Medicines Agency", "source_sha256": "3ff8cd4d67d22ba799aa348aeda944d6d896a16dcf54b030db101cbc095fc8ad", "source_snapshot_id": "source-a79a7cba8bf5dbc72fd40574", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 112}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 52, "start": 0, "text": "Spikevax JN.1 50 micrograms dispersion for injection", "truncated": false}, "before_length": 52, "before_sha256": "597e6a2a3b4949004d4fc05201b82efef68b5595489c6b3279e0567739db5110", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 52, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 52, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5f6473db9f5ec2a709f6bd42", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12601}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 29, "start": 0, "text": "Mundipharma Polska Sp. z o.o.", "truncated": false}, "before_length": 29, "before_sha256": "5e6140688b90710113e04659df6f0ddaf7cd759aa25f2b444fd5a94495e5a1d4", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 29, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 29, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5f6fd591e55c9b5861302591", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1099}
{"after": {"end": 19, "start": 0, "text": "dpoc.greece@msd.com", "truncated": false}, "after_length": 19, "after_sha256": "d96a401106c51f4f8693adaf45abc406ae4e520f06826181cac8e7fb34e045be", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "dpoc_greece@merck.com", "truncated": false}, "before_length": 21, "before_sha256": "9b56f5b84cf1285f2f89288b0c6eaf5971bf26de57aec36149b36f892216f048", "change_kind": "content", "change_operations": [{"after_end": 5, "after_start": 4, "before_end": 5, "before_start": 4, "kind": "replace"}, {"after_end": 15, "after_start": 13, "before_end": 17, "before_start": 13, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 5, "chars_inserted": 3}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5f8b9c89ef7e2d83fb9c6a41", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3121}
{"after": {"end": 307, "start": 0, "text": "Dans une analyse pharmacocinétique de population chez des patients atteints de spondylarthrite ankylosante, les ASC de l’etanercept à l’état d’équilibre ont été de 466 gh/mL et de 474 gh/mL respectivement pour Enbrel 50 mg une fois par semaine (n = 154) et pour Enbrel 25 mg deux fois par semaine (n = 148).", "truncated": false}, "after_length": 307, "after_sha256": "1c43c823b021ca355a70ce91caf9457501b150b77ff3824f2ada9508e781e74b", "annex": "I", "before": {"end": 307, "start": 0, "text": "Dans une analyse pharmacocinétique de population chez des patients atteints de spondylarthrite ankylosante, les ASC de l’etanercept à l’état d’équilibre ont été de 466 gh/ml et de 474 gh/ml respectivement pour Enbrel 50 mg une fois par semaine (n = 154) et pour Enbrel 25 mg deux fois par semaine (n = 148).", "truncated": false}, "before_length": 307, "before_sha256": "5d8df1dfa3590f8cd7f05f183c4a37b7abc74223db55f470f360af9b806b6cab", "change_kind": "content", "change_operations": [{"after_end": 173, "after_start": 172, "before_end": 173, "before_start": 172, "kind": "replace"}, {"after_end": 189, "after_start": 188, "before_end": 189, "before_start": 188, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5fa0fe7520569a14a520589b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg poudre et solvant pour solution injectable", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2149}
{"after": {"end": 50, "start": 0, "text": "90 mmHg ou plus si vous êtes âgé(e) de 6 à 11 ans,", "truncated": false}, "after_length": 50, "after_sha256": "a9f3b6467af9e2aab30a1084cc98d94f5ebeea71850ede435cc01512f254d0de", "annex": "IIIA", "before": {"end": 50, "start": 0, "text": "90 mmHg ou plus si vous êtes âgé(e) de 6 à 12 ans,", "truncated": false}, "before_length": 50, "before_sha256": "d95e47a2baf14015972b611c4461be7215d6834f07af7cba1327fdfd50cd5fdf", "change_kind": "content", "change_operations": [{"after_end": 45, "after_start": 44, "before_end": 45, "before_start": 44, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5fbe1040781a566e3dd8e155", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2814}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 176, "start": 0, "text": "push button; display window; threaded rod; flange; Terrosa cartridge; peel foil; pen needle; inner needle cap; outer needle cap; pen cap; cartridge holder, dosage knob, housing", "truncated": false}, "before_length": 176, "before_sha256": "b01a9e89e018b37e41fbd7c3aa52b26864646a0e441aaa21989d018424025afb", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 176, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 176, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5fc22d9640bce83b52b487c0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1963}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 100, "start": 0, "text": "Signs or symptoms of these safety concerns and when to seek attention from a healthcare professional", "truncated": false}, "before_length": 100, "before_sha256": "bc972f9c14b54b6429e63d660793b6a6f13f16ea14f85050c963adf733a905d4", "change_kind": "unassigned", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 100, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 100, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5fcbc5fe7ac354d5a21feed9", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6583}
{"after": {"end": 127, "start": 0, "text": "Flacon en verre transparent (2 mL, verre de type I) avec bouchon en caoutchouc, opercule en aluminium et capuchon en plastique.", "truncated": false}, "after_length": 127, "after_sha256": "3a22432466c30f586fabcb833407d8cc0cae215bdb5696cb80223c9f3ce8cf19", "annex": "I", "before": {"end": 127, "start": 0, "text": "Flacon en verre transparent (2 ml, verre de type I) avec bouchon en caoutchouc, opercule en aluminium et capuchon en plastique.", "truncated": false}, "before_length": 127, "before_sha256": "ff0cb8edaf005b819af78795f95a87f3503b25503870f51d4bbeeea38b61bc8d", "change_kind": "content", "change_operations": [{"after_end": 33, "after_start": 32, "before_end": 33, "before_start": 32, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5ff1b3341a2124d752fdf06d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 10 mg poudre et solvant pour solution injectable pour usage pédiatrique", "presentation_occurrence": 5, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.5", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5403}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "Tel: +44 (0)1304 616161", "truncated": false}, "before_length": 23, "before_sha256": "eba81e6ccdbae471c024a5ba77d9ec9e0617a3c443fd22205a626861e87fbd8c", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 23, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 23, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5ff30e0c9ac7cceb83270eaf", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 10683}
{"after": {"end": 69, "start": 0, "text": "ketoconazole, posaconazole, itraconazole, to treat fungal infections.", "truncated": false}, "after_length": 69, "after_sha256": "42d7d0bd4b0caa8c0b4650a4f0bd7296721223e220be20c6c140f10f6c8575e2", "annex": "IIIA", "before": {"end": 67, "start": 0, "text": "fungal infections such as ketoconazole, posaconazole, itraconazole.", "truncated": false}, "before_length": 67, "before_sha256": "e37e7e1b0744d11e9f6ffc90f1618e885bbe55720c10347853278995ef1ee095", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 26, "before_start": 0, "kind": "delete"}, {"after_end": 68, "after_start": 40, "before_end": 66, "before_start": 66, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 26, "chars_inserted": 28}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6073d376d76eb087bfc68c3c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2776}
{"after": {"end": 43, "start": 0, "text": "Pfizer Healthcare Ireland Unlimited Company", "truncated": false}, "after_length": 43, "after_sha256": "1f203777a0ec6fed9c840d52631b6a74c7e25b5d318485d8147e2404f52dc981", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "Pfizer Healthcare Ireland", "truncated": false}, "before_length": 25, "before_sha256": "4beeea9b6d0c491f03a9511d9f9576b9c75cbcdcfd736e4934f768fdded936f5", "change_kind": "content", "change_operations": [{"after_end": 43, "after_start": 25, "before_end": 25, "before_start": 25, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 18}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-607c34c0c3b49858f9eed1a4", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9990}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 26, "start": 0, "text": "Medis Pharma Lithuania UAB", "truncated": false}, "before_length": 26, "before_sha256": "1016178a7e6ddebf9ca5f1ab2b491b24607475ceededd18bdcff956f1d201890", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 26, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 26, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-60931b599b51a488df5257f7", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1149}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 14, "start": 0, "text": "Pfizer Limited", "truncated": false}, "before_length": 14, "before_sha256": "faadd350d247ecbb0e8edac0805fa3d4cdbf449fbb9a1a9614eee6624274a2f6", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-609cfbfa0daad8f66a9dc05e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9014}
{"after": {"end": 16, "start": 0, "text": "EU/1/20/1507/034", "truncated": false}, "after_length": 16, "after_sha256": "ea7c03cfd37208fc376a9b207b390a5af5782d0b9c41a1d40dac8f1a7efda06c", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "administrative", "change_operations": [{"after_end": 16, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 16}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-60a489439a625331b1e52a75", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "8", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6487}
{"after": {"end": 19, "start": 0, "text": "hungary_msd@msd.com", "truncated": false}, "after_length": 19, "after_sha256": "4ffcdd5eaf215819b6063b291e957577af48205584cf794ece9fd17a4802c6e1", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "hungary_msd@merck.com", "truncated": false}, "before_length": 21, "before_sha256": "da92e6e80d6625405a462b85c1135580d63c6c4a9e76a7c5be0eef07e90aee85", "change_kind": "content", "change_operations": [{"after_end": 15, "after_start": 13, "before_end": 17, "before_start": 13, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-60a685fdd1c46ec67c9a792f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2999}
{"after": {"end": 35, "start": 0, "text": "Tel: 0800 9999 000 (+31 23 5153153)", "truncated": false}, "after_length": 35, "after_sha256": "52e92ac1d067259b9fece48e0e06ad1c09748623062f243703b5d4f40455bd17", "annex": "IIIA", "before": {"end": 36, "start": 0, "text": "Tel: 0800 9999 000 (+ 31 23 5153153)", "truncated": false}, "before_length": 36, "before_sha256": "08802d516c69cefe10e1332d399e866d902441cca33557fa68396eaecaf1d321", "change_kind": "content", "change_operations": [{"after_end": 21, "after_start": 21, "before_end": 22, "before_start": 21, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-60a8a78391697f84edfb9311", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3105}
{"after": {"end": 11, "start": 0, "text": "Voie orale.", "truncated": false}, "after_length": 11, "after_sha256": "dd303ff5eaeb3946adedda2cb1cc0525b4d6b7561b2450d515addd890456afe9", "annex": "IIIA", "before": {"end": 10, "start": 0, "text": "Voie orale", "truncated": false}, "before_length": 10, "before_sha256": "b21e8d51c5cf6ffc46ec58c52f7fd9782e18be932f51e39153050c410cb9b1b2", "change_kind": "content", "change_operations": [{"after_end": 11, "after_start": 10, "before_end": 10, "before_start": 10, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-60d5dbb11d33a7349e915cf4", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:32:00Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3ff8cd4d67d22ba799aa348aeda944d6d896a16dcf54b030db101cbc095fc8ad", "source_snapshot_id": "source-a79a7cba8bf5dbc72fd40574", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1888}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 14, "start": 0, "text": "Mundipharma Oy", "truncated": false}, "before_length": 14, "before_sha256": "28b7df80a5f9916e0ed8cfdc9a679cf8d1a386e6b8194ccb23b30136da9e9cd5", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-60e1634b5c1e516dccb20855", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1135}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 6, "start": 0, "text": "Italia", "truncated": false}, "before_length": 6, "before_sha256": "a7ca3e3d756601d5a22a4c0d8629da0c0ce425e5be526078d3e4583737150f52", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 6, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-614ffbb73c62429dee6effe2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1130}
{"after": {"end": 2, "start": 0, "text": "SC", "truncated": false}, "after_length": 2, "after_sha256": "32da6721804f1dd3226c0551970304ebf1059ec19a27451426541027861c9388", "annex": "IIIA", "before": {"end": 16, "start": 0, "text": "Subcutaneous use", "truncated": false}, "before_length": 16, "before_sha256": "363fd22613abec178143cdac0b1a34f04ee8ccdaa7d6988b3722fa7540374cde", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 1, "before_end": 16, "before_start": 1, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 15, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-617a81885baa37ab4ca74b74", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 7830}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "Tel: + 420 296 188 338", "truncated": false}, "before_length": 22, "before_sha256": "cade761d1991183690c5d39848f424472df61dbad0bc430b6f01fef8e76b3e31", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 22, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 22, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-61cb232f9d21de77b9e17834", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1051}
{"after": {"end": 149, "start": 0, "text": "g Inclut thrombopénie immunitaire, pancréatite, cystite non infectieuse, arthrite à médiation immunitaire, uvéite et pseudopolyarthrite rhizomélique.", "truncated": false}, "after_length": 149, "after_sha256": "bf115799711cafbd0737b9be4ee92dafac2dc1bc6a5c64acd03ef1a9782e5a6d", "annex": "I", "before": {"end": 116, "start": 0, "text": "g Inclut thrombopénie immunitaire, pancréatite, cystite non infectieuse, arthrite à médiation immunitaire et uvéite.", "truncated": false}, "before_length": 116, "before_sha256": "085d91d670bc0466396fdd6f06cf03bc269208841f2e3eabba177cb67157c191", "change_kind": "content", "change_operations": [{"after_end": 106, "after_start": 105, "before_end": 108, "before_start": 105, "kind": "replace"}, {"after_end": 147, "after_start": 112, "before_end": 114, "before_start": 114, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 3, "chars_inserted": 36}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-61d86e1bc77f1da7d7d86536", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:18Z", "pipeline_version": "2.0.0", "presentation_label": "IMJUDO 20 mg/ml, solution à diluer pour perfusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "2437ab76633f46c9eee5e002e5c7a7caba6367f59567d750be0eb67c74d1db4e", "source_snapshot_id": "source-7f4d129b0a0fd2d3684d27c5", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 217}
{"after": {"end": 35, "start": 0, "text": "The HCP Guidance Document includes:", "truncated": false}, "after_length": 35, "after_sha256": "63525d065e12eaa1e66291fae24ecd629121aab9f97b2f89e982c78bfc020d3c", "annex": "II", "before": {"end": 41, "start": 0, "text": "The HCP Guidance Document should include:", "truncated": false}, "before_length": 41, "before_sha256": "624bdb70514233f69d67e4b1ba15ca025e47a2a9b7a4dd3256a4b54fb6038b65", "change_kind": "content", "change_operations": [{"after_end": 26, "after_start": 26, "before_end": 33, "before_start": 26, "kind": "delete"}, {"after_end": 34, "after_start": 33, "before_end": 40, "before_start": 40, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-62137d007642ffc32679a885", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:33Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "21d66bf1e9a74479f577de09da3cf8517d65c1ce1b1d8bbdfe4bc38f79410def", "source_snapshot_id": "source-2c39c998fdaf05159687c016", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 421}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 26, "start": 0, "text": "Medis Pharma Lithuania UAB", "truncated": false}, "before_length": 26, "before_sha256": "1016178a7e6ddebf9ca5f1ab2b491b24607475ceededd18bdcff956f1d201890", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 26, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 26, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-621aef0afde8afc427764340", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1159}
{"after": {"end": 18, "start": 0, "text": "msdromania@msd.com", "truncated": false}, "after_length": 18, "after_sha256": "5820201082e5902b1d6a84673e62d34f129a4dc7106dc8e5e365973da4db652f", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "msdromania@merck.com", "truncated": false}, "before_length": 20, "before_sha256": "ed43025368036055834b7ab01c906dfab567b905345a39d35f9d1f659762c1b4", "change_kind": "content", "change_operations": [{"after_end": 14, "after_start": 12, "before_end": 16, "before_start": 12, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6232e4b59fc2c29554e47d7d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3155}
{"after": {"end": 77, "start": 0, "text": "Le document de recommandations destiné aux professionnels de santé comprend :", "truncated": false}, "after_length": 77, "after_sha256": "d240494dfa7fbfdcf623de4a1c5ee976033fc65e0773846c7d8f674813c0bbab", "annex": "II", "before": {"end": 84, "start": 0, "text": "Le document de recommandations destiné aux professionnels de santé doit comprendre :", "truncated": false}, "before_length": 84, "before_sha256": "8c50829f21ea77158b8912738068cde6c2215e7b1b2604de216a1f0b4d21dbf8", "change_kind": "content", "change_operations": [{"after_end": 67, "after_start": 67, "before_end": 72, "before_start": 67, "kind": "delete"}, {"after_end": 75, "after_start": 75, "before_end": 82, "before_start": 80, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-628672aa8dbbd16e872c904e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 424}
{"after": {"end": 22, "start": 0, "text": "Scientific conclusions", "truncated": false}, "after_length": 22, "after_sha256": "48a176450b72da083aae0c461d4b9485bc052767229342ad7b9f3b91fb4b3641", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 22, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 22}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6297ccc7e4feca05b2072fcb", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:18Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "89a938df5e41f86548301270084e3d1ecf171802e24b5429f62e3bede7ee32dd", "source_snapshot_id": "source-b71aeee5a07abebc34c02e28", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3424}
{"after": {"end": 470, "start": 0, "text": "Des cas de surdosage volontaire ou accidentel ont été observés après la commercialisation du produit. Les doses de pérampanel rapportées étaient d’environ 50 mg chez les patients pédiatriques et de 300 mg maximum chez les patients adultes. Les effets indésirables observés comprenaient l’altération de l’état mental, l’agitation, un comportement agressif, les vomissements, le coma et une diminution du niveau de conscience. Les patients se sont rétablis sans séquelles.", "truncated": false}, "after_length": 470, "after_sha256": "85227fb77d8eb4f0aef6dc9c7b2fbdd024cc5aeaa30ed9845fcbea281e46bd35", "annex": "I", "before": {"end": 461, "start": 0, "text": "Des cas de surdosage volontaire ou accidentel ont été observés après la commercialisation du produit chez des patients pédiatriques avec des doses de pérampanel allant jusqu’à 36 mg et chez des patients adultes avec des doses allant jusqu’à 300 mg. Les effets indésirables observés comprenaient l’altération de l’état mental, l’agitation, un comportement agressif, le coma et une diminution du niveau de conscience. Les patients se sont rétablis sans séquelles.", "truncated": false}, "before_length": 461, "before_sha256": "fb6ee73f00a7cfe043f95065d0beb7330f394aa890bd2a8568a89d309aa8d885", "change_kind": "content", "change_operations": [{"after_end": 160, "after_start": 100, "before_end": 100, "before_start": 100, "kind": "insert"}, {"after_end": 167, "after_start": 166, "before_end": 107, "before_start": 106, "kind": "replace"}, {"after_end": 192, "after_start": 192, "before_end": 134, "before_start": 132, "kind": "delete"}, {"after_end": 194, "after_start": 193, "before_end": 146, "before_start": 135, "kind": "replace"}, {"after_end": 198, "after_start": 198, "before_end": 176, "before_start": 150, "kind": "delete"}, {"after_end": 201, "after_start": 199, "before_end": 178, "before_start": 177, "kind": "replace"}, {"after_end": 212, "after_start": 205, "before_end": 184, "before_start": 182, "kind": "replace"}, {"after_end": 219, "after_start": 218, "before_end": 191, "before_start": 190, "kind": "replace"}, {"after_end": 238, "after_start": 238, "before_end": 247, "before_start": 210, "kind": "delete"}, {"after_end": 372, "after_start": 354, "before_end": 363, "before_start": 363, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 81, "chars_inserted": 90}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-62b3025855297fdc90726a48", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:32:00Z", "pipeline_version": "2.0.0", "presentation_label": "Fycompa 0,5 mg/mL suspension buvable", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.9", "section_type": "overdose", "source_provider": "European Medicines Agency", "source_sha256": "3ff8cd4d67d22ba799aa348aeda944d6d896a16dcf54b030db101cbc095fc8ad", "source_snapshot_id": "source-a79a7cba8bf5dbc72fd40574", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1379}
{"after": {"end": 385, "start": 0, "text": "There have been postmarketing cases of intentional and accidental overdose. Reported doses of perampanel were up to approximately 50 mg in paediatric patients and up to 300 mg in adult patients. The adverse reactions observed included altered mental status, agitation, aggressive behaviour, vomiting, coma, and depressed level of consciousness. The patients recovered without sequelae.", "truncated": false}, "after_length": 385, "after_sha256": "6e07c6334ef8479da1ec43ef216e237f6491e05f5402850708586a25a6092b55", "annex": "I", "before": {"end": 361, "start": 0, "text": "There have been postmarketing cases of intentional and accidental overdose in paediatric patients with doses of perampanel up to 36 mg and in adult patients with doses up to 300 mg. The adverse reactions observed included altered mental status, agitation, aggressive behaviour, coma and depressed level of consciousness. The patients recovered without sequelae.", "truncated": false}, "before_length": 361, "before_sha256": "3da8de3889f1fb62e5898a784d4e4b9ebed5ad283faefe7f1d79f6cd4dea9730", "change_kind": "content", "change_operations": [{"after_end": 135, "after_start": 74, "before_end": 74, "before_start": 74, "kind": "insert"}, {"after_end": 159, "after_start": 159, "before_end": 118, "before_start": 98, "kind": "delete"}, {"after_end": 162, "after_start": 161, "before_end": 122, "before_start": 120, "kind": "replace"}, {"after_end": 172, "after_start": 170, "before_end": 131, "before_start": 130, "kind": "replace"}, {"after_end": 175, "after_start": 175, "before_end": 138, "before_start": 134, "kind": "delete"}, {"after_end": 193, "after_start": 193, "before_end": 180, "before_start": 156, "kind": "delete"}, {"after_end": 301, "after_start": 291, "before_end": 278, "before_start": 278, "kind": "insert"}, {"after_end": 306, "after_start": 305, "before_end": 282, "before_start": 282, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 51, "chars_inserted": 75}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-62bd25c6d95a3bd3b5288695", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "Fycompa 2 mg filmcoated tablets Fycompa 4 mg filmcoated tablets Fycompa 6 mg filmcoated tablets Fycompa 8 mg filmcoated tablets Fycompa 10 mg filmcoated tablets Fycompa 12 mg filmcoated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.9", "section_type": "overdose", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 544}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "Tel: +34 91 3821870", "truncated": false}, "before_length": 19, "before_sha256": "117ebc6bfe06f8e0b5ae2e854e665f02a5c68de0b64f7ffb83bee1e039844483", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 19, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 19, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-62fedd2a6d938e0f75104808", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1096}
{"after": {"end": 25, "start": 0, "text": "Tél: +33 (0)1 80 46 40 40", "truncated": false}, "after_length": 25, "after_sha256": "8039903c80fe171d38545fabfbccd20dc939429edfd9799a4e988d97cb003cb2", "annex": "IIIA", "before": {"end": 28, "start": 0, "text": "Tél : + 33 (0) 1 80 46 40 40", "truncated": false}, "before_length": 28, "before_sha256": "f613785efd391db758f618a86bd171bd9e80b85a925313be3d64c23235cd5289", "change_kind": "content", "change_operations": [{"after_end": 3, "after_start": 3, "before_end": 4, "before_start": 3, "kind": "delete"}, {"after_end": 6, "after_start": 6, "before_end": 8, "before_start": 7, "kind": "delete"}, {"after_end": 12, "after_start": 12, "before_end": 15, "before_start": 14, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 3, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6323666a1e3c9cead0e136e9", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3053}
{"after": {"end": 8, "start": 0, "text": "Uncommon", "truncated": false}, "after_length": 8, "after_sha256": "ce9b9e6a2b753fcc9983ec052783411178629695a448d9b8cb4e0f5e5afef843", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 8, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-632d63de8a31a1bb0dd39b9c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "IMJUDO 20 mg/ml concentrate for solution for infusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 842}
{"after": {"end": 196, "start": 0, "text": "l’abacavir, l’atazanavir, le cobicistat, le darunavir, le dolutégravir, l’éfavirenz, l’elvitégravir, l’emtricitabine, la rilpivirine, le ritonavir, utilisés pour traiter les infections par le VIH.", "truncated": false}, "after_length": 196, "after_sha256": "bdc7a3372558da5d604284f4481702f7e55287d6546bbf60710e1180ef43c1ed", "annex": "IIIA", "before": {"end": 179, "start": 0, "text": "de l’infection par le VIH comme l’abacavir, l’atazanavir, le cobicistat, le darunavir, le dolutégravir, l’éfavirenz, l’elvitégravir, l’emtricitabine, la rilpivirine, le ritonavir.", "truncated": false}, "before_length": 179, "before_sha256": "f1448576a1c856772836bafb89d35875a01686034dcb0b89d85c4dc5cdf5e0a4", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 32, "before_start": 0, "kind": "delete"}, {"after_end": 195, "after_start": 146, "before_end": 178, "before_start": 178, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 32, "chars_inserted": 49}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-63429ef8c480f06a7ffc06ce", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2858}
{"after": {"end": 21, "start": 0, "text": "Psychiatric disorders", "truncated": false}, "after_length": 21, "after_sha256": "1bcbeb481288d19789a0efc2670a598eb28cee086fd7a75d35c39119f95d695a", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 21, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 21}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-635db9bc9f52de9a7799f560", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:30Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "35ab6716aa09492c14ac6849111486ec47235c0bc65ef055350de950f316c5e6", "source_snapshot_id": "source-f20a60110d1f8fef5225317d", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2355}
{"after": {"end": 54, "start": 0, "text": "Takeda Pharmaceuticals International AG Ireland Branch", "truncated": false}, "after_length": 54, "after_sha256": "81709515d3af1f0e4041ce3c760d8fc81fefa358805810b0b53a84e121d5efa6", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 54, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 54}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6393135ce03e64ac907913a8", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2176}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 31, "start": 0, "text": "Mundipharma Gesellschaft m.b.H.", "truncated": false}, "before_length": 31, "before_sha256": "e6851d5a437200a1e4e127bb5a9b932fc5c74eb39e861c56ae687ec74d8fc5ad", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 31, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 31, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-63a745c98093e7c7540db655", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1090}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "II", "before": {"end": 113, "start": 0, "text": "Une Clé USB à utiliser par les professionnels de santé pour se former, si un accès Internet n’est pas disponible.", "truncated": false}, "before_length": 113, "before_sha256": "50338b449d346a59e34c68c2c9c99430069b2de10b614d3b0adfc773a510ffdf", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 113, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 113, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-63ca0ada1396d43b175c8193", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 465}
{"after": {"end": 89, "start": 0, "text": "Microangiopathie thrombotique rénalea,b, microangiopathie glomérulaire occlusive hyalinea", "truncated": false}, "after_length": 89, "after_sha256": "5b08becd572f861ee096127b1872bb1f1704c18bdb7a2ba6b59ceeaad81a21d0", "annex": "I", "before": {"end": 40, "start": 0, "text": "Microangiopathie thrombotique rénalea,b,", "truncated": false}, "before_length": 40, "before_sha256": "536a025d61a5fc3b9bbcdf4d8977d17079c0fa987916c1c60e49f57cabfb9230", "change_kind": "content", "change_operations": [{"after_end": 89, "after_start": 40, "before_end": 40, "before_start": 40, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 49}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-643059721737f2640b09a8a6", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 428}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 33, "start": 0, "text": "United Kingdom (Northern Ireland)", "truncated": false}, "before_length": 33, "before_sha256": "9379d82927cdb505cfb186e912177065e56a1314de3a2b914ebbb8b5fe21525a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 33, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 33, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6432cc8d248fd98a09660c32", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12162}
{"after": {"end": 119, "start": 0, "text": "Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu", "truncated": false}, "after_length": 119, "after_sha256": "0f2b81ab8009e1a279ca008eb6e21bdb2e532de63aef52b62bdac980c49555d4", "annex": "IIIA", "before": {"end": 118, "start": 0, "text": "Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu", "truncated": false}, "before_length": 118, "before_sha256": "d114210a3c6f4b6710e22609ee80410ff17f5efd93b30ab72728a60b65635068", "change_kind": "technical", "change_operations": [{"after_end": 99, "after_start": 98, "before_end": 98, "before_start": 98, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-643eed4dd7f2c207356cb16f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11625}
{"after": {"end": 16, "start": 0, "text": "Belgique/Belgien", "truncated": false}, "after_length": 16, "after_sha256": "285fbbb0fb545626c1ab2137e927e36673874e494048cabaa6015adaed72c06a", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 16, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 16}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-645c27452ebfc6aa262f1e5f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000112", "medicine_name": "Twinrix Adult", "medicine_slug": "twinrix-adult", "observed_at": "2026-10-12T13:29:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "bc8ba3adecfe04d3079e5b502251cec982d6197257fe3b7ec3a22dc5f2ace654", "source_snapshot_id": "source-8439a1a319b62d1bd67256a4", "source_updated_at": "2026-08-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/twinrix-adult-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 892}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 9, "start": 0, "text": "Allemagne", "truncated": false}, "before_length": 9, "before_sha256": "6b58dbd6a994339b48d8446597da22402857b3409613459c7e3a293788fbe66a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 9, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 9, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-64a8c047a6f494479138665d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1340}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 66, "start": 0, "text": "• a puncture-resistant sharps disposal container for used needles.", "truncated": false}, "before_length": 66, "before_sha256": "ac5234d86e8aa012e833d5a171607f0b1d90cee2971de8c303b934fb04d299df", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 66, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 66, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-64b43549629cbd864c5d37fd", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2033}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 18, "start": 0, "text": "medis.hr@medis.com", "truncated": false}, "before_length": 18, "before_sha256": "8544591a2cde06226d45116ff621fd59cca137bb8ddd85c10baaa55da94c1172", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 18, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 18, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-64f3d7074bfe0337493a9c09", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1115}
{"after": {"end": 85, "start": 0, "text": "la phénytoïne, la carbamazépine, le phénobarbital, utilisés pour traiter l’épilepsie.", "truncated": false}, "after_length": 85, "after_sha256": "bc40a46091d73609ca7eb99dc7275094d3cbf1b44ba79437600d2802b30579f2", "annex": "IIIA", "before": {"end": 74, "start": 0, "text": "de l’épilepsie tels que la phénytoïne, la carbamazépine, le phénobarbital.", "truncated": false}, "before_length": 74, "before_sha256": "721fb70147ef6b074d1bdb1088d531b99ad9070b2ee24ab0962f033df222cc6b", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 24, "before_start": 0, "kind": "delete"}, {"after_end": 84, "after_start": 49, "before_end": 73, "before_start": 73, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 24, "chars_inserted": 35}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6516eb2878bdfee69dc9e2b9", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3300}
{"after": {"end": 44, "start": 0, "text": "La carte d’information du patient comprend :", "truncated": false}, "after_length": 44, "after_sha256": "0d7c684a347531290e7f6afd5e05ee60dca50bd8ad8a62ad45cfc04cbd96609e", "annex": "II", "before": {"end": 51, "start": 0, "text": "La carte d’information du patient doit comprendre :", "truncated": false}, "before_length": 51, "before_sha256": "d84d5db2c99be0eafa2c82a47514d1e25402c56beb2b02f27c6af998f6e07b65", "change_kind": "content", "change_operations": [{"after_end": 34, "after_start": 34, "before_end": 39, "before_start": 34, "kind": "delete"}, {"after_end": 42, "after_start": 42, "before_end": 49, "before_start": 47, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-651c802a0694b4be268cd40e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 438}
{"after": {"end": 221, "start": 0, "text": "Please contact the doctor if you used more Adempas than you should and if you notice any side effects (see section 4). If the blood pressure drops (which can make you feel dizzy) immediate medical attention may be needed.", "truncated": false}, "after_length": 221, "after_sha256": "5b2fbd831ac808d61fcbd42fbb7947979b4af80eb466f54158311dbc3b94b4f8", "annex": "IIIA", "before": {"end": 222, "start": 0, "text": "Please contact the doctor if you used more Adempas than you should and if you notice any side effects (see section 4). If the blood pressure drops (which can cause dizziness) then immediate medical attention may be needed.", "truncated": false}, "before_length": 222, "before_sha256": "d4d184be0bd117c9be3463170a1148b8f1e08237fa0ddf03efa5d4626236c252", "change_kind": "content", "change_operations": [{"after_end": 159, "after_start": 158, "before_end": 159, "before_start": 158, "kind": "replace"}, {"after_end": 165, "after_start": 160, "before_end": 160, "before_start": 160, "kind": "insert"}, {"after_end": 168, "after_start": 166, "before_end": 162, "before_start": 161, "kind": "replace"}, {"after_end": 171, "after_start": 169, "before_end": 163, "before_start": 163, "kind": "insert"}, {"after_end": 177, "after_start": 176, "before_end": 173, "before_start": 168, "kind": "replace"}, {"after_end": 178, "after_start": 178, "before_end": 179, "before_start": 174, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 12, "chars_inserted": 11}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6524f39c399545915f667467", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3271}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "II", "before": {"end": 48, "start": 0, "text": "6, Boulevard de l’Europe F-21800 Quétigny France", "truncated": false}, "before_length": 48, "before_sha256": "ce3eed78b1540f95e467a513061584e06c4bac360e44a6efc60ccc70531ed451", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 48, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 48, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6599f5979f7109bb78726a6b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000174", "medicine_name": "Plavix", "medicine_slug": "plavix", "observed_at": "2026-10-12T19:26:25Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "8d1630f20e7a86728cac32eaccf248b0a0e88d4d9a2a9cfa6e6429b883e20247", "source_snapshot_id": "source-77d6cc5bd19bd71f20e22a8e", "source_updated_at": "2025-07-14", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/plavix-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 883}
{"after": {"end": 48, "start": 0, "text": "Do not take the following medicines with Adempas", "truncated": false}, "after_length": 48, "after_sha256": "bddcdac4dfa438c949a610ee79758d3e1231ab93d08bf3c7d25e9c60377d3e27", "annex": "IIIA", "before": {"end": 30, "start": 0, "text": "Do not take medicines used for", "truncated": false}, "before_length": 30, "before_sha256": "d596261e10c1143a295defa398637159897eb0f74ecbd056b340d8c950c356c2", "change_kind": "content", "change_operations": [{"after_end": 26, "after_start": 12, "before_end": 12, "before_start": 12, "kind": "insert"}, {"after_end": 47, "after_start": 36, "before_end": 23, "before_start": 22, "kind": "replace"}, {"after_end": 48, "after_start": 48, "before_end": 30, "before_start": 24, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 25}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-65b70ee9e34175b9fd2a6829", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3196}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IV", "before": {"end": 122, "start": 0, "text": "Having reviewed the PRAC recommendation, the CHMP agrees with the PRAC overall conclusions and grounds for recommendation.", "truncated": false}, "before_length": 122, "before_sha256": "095a3b724a58255112d0ae23e9c65e77959b40571fcaaf1946c9da9f699beeda", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 122, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 122, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-65efb02522b7dc66ff43a356", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2532}
{"after": {"end": 40, "start": 0, "text": "Utiliser uniquement avec le Terrosa Pen.", "truncated": false}, "after_length": 40, "after_sha256": "aed7f82f872636f40f26b9514ed636a41831a228d3009772b51d8875af7480dd", "annex": "IIIA", "before": {"end": 43, "start": 0, "text": "Utiliser uniquement avec le stylo Terrosa .", "truncated": false}, "before_length": 43, "before_sha256": "292d9e7fa33440a86b7133a6eca76f5500d6bf985bdd87b3af354b396c087f0e", "change_kind": "content", "change_operations": [{"after_end": 28, "after_start": 28, "before_end": 34, "before_start": 28, "kind": "delete"}, {"after_end": 39, "after_start": 36, "before_end": 42, "before_start": 42, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 3}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6619709e616bdd364e2ab987", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1282}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Sími: + 354 540 8000", "truncated": false}, "before_length": 20, "before_sha256": "a7506b4a5595314995c42e298571584be2588dc0ed55a3beeea4c2d5fe939c85", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 20, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 20, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-66257f5315c9a348d691549e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1132}
{"after": {"end": 90, "start": 0, "text": "If you are taking these medicines, ask your doctor whether their doses need to be changed.", "truncated": false}, "after_length": 90, "after_sha256": "3898554d9d5a1e13fe88506cfde9addb53ce036936a77cf7b57b26ebc11d194a", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 90, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 90}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-66429b2b7f0b1967e101c783", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2789}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 14, "start": 0, "text": "78467 Konstanz", "truncated": false}, "before_length": 14, "before_sha256": "ee960a86a16086f43d4c7f3f51bd93d39025d5227fb1a6f1c825d1015754ff53", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-66553022be102ced148a8fed", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "Qdenga powder and solvent for solution for injection Qdenga powder and solvent for solution for injection in pre-filled syringe Dengue tetravalent vaccine (live, attenuated)", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 971}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 16, "start": 0, "text": "Single-dose vial", "truncated": false}, "before_length": 16, "before_sha256": "e524099369c6feef1de2df0ae572b99a4dff2799165a4afd5f6a7a6e4beaef70", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 16, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 16, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-665d67ef764b02a912fc26a8", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13093}
{"after": {"end": 23, "start": 0, "text": "Tel: +43 (0)1 523 25 05", "truncated": false}, "after_length": 23, "after_sha256": "1c871405cc2b2c04561b63ec0520ec0b01c5f9571be60e896ddbf90186d9c8da", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "Tel: +43 (0)1 523 25 05-0", "truncated": false}, "before_length": 25, "before_sha256": "5df3b28c904ca135a41fa3881c6d241cdc62f65913ad6cbd06cbb3d76c98d230", "change_kind": "content", "change_operations": [{"after_end": 23, "after_start": 23, "before_end": 25, "before_start": 23, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-668b9194bcd514449a6caa2c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:33Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "21d66bf1e9a74479f577de09da3cf8517d65c1ce1b1d8bbdfe4bc38f79410def", "source_snapshot_id": "source-2c39c998fdaf05159687c016", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1012}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 6, "start": 0, "text": "Italia", "truncated": false}, "before_length": 6, "before_sha256": "a7ca3e3d756601d5a22a4c0d8629da0c0ce425e5be526078d3e4583737150f52", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 6, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-66ac8176c93dc59d89a15881", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1139}
{"after": {"end": 97, "start": 0, "text": "le kétoconazole, le posaconazole, l’itraconazole, utilisés pour traiter des infections fongiques.", "truncated": false}, "after_length": 97, "after_sha256": "a94167610bc3b5f572ca235063f6e3ad8f8ba3b8cd0991e89bdc2a6bcb999ec9", "annex": "IIIA", "before": {"end": 80, "start": 0, "text": "des infections fongiques comme le kétoconazole, le posaconazole, l’itraconazole.", "truncated": false}, "before_length": 80, "before_sha256": "1e6739885a5088453c57a13b4d76d86926fd193c092dd939ff746f6bdc279fde", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 31, "before_start": 0, "kind": "delete"}, {"after_end": 96, "after_start": 48, "before_end": 79, "before_start": 79, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 31, "chars_inserted": 48}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-679d4894b42726ed4b8712f8", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3298}
{"after": {"end": 76, "start": 0, "text": "Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe", "truncated": false}, "after_length": 76, "after_sha256": "6c7ff1bbd2f6d8c84f1254cce87065dac51505e1edd888622047a746e34551e6", "annex": "I", "before": {"end": 74, "start": 0, "text": "Spikevax JN.1 50 micrograms dispersion for injection in pre-filled syringe", "truncated": false}, "before_length": 74, "before_sha256": "ebe036d056b86be90e582dc3803425dce3820674579f962bd2fc8976b65c292a", "change_kind": "administrative", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-67a0c2f68c82cad2ba5e1bf7", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12892}
{"after": {"end": 25, "start": 0, "text": "50-58 Baggot Street Lower", "truncated": false}, "after_length": 25, "after_sha256": "2b6052bef6a7051ce20b776d1525055c417fc02e59b9e559cd21b7aa4c7859f0", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 25, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 25}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-67b08b4543d6d3212ceddd5c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2178}
{"after": {"end": 19, "start": 0, "text": "dpoc.greece@msd.com", "truncated": false}, "after_length": 19, "after_sha256": "d96a401106c51f4f8693adaf45abc406ae4e520f06826181cac8e7fb34e045be", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Dpoc_greece@merck.com", "truncated": false}, "before_length": 21, "before_sha256": "0e58b408798c0d2dce72f7f9b6fbca9c33c77ce71bb2d3fbab6c0b153e44fc5e", "change_kind": "content", "change_operations": [{"after_end": 1, "after_start": 0, "before_end": 1, "before_start": 0, "kind": "replace"}, {"after_end": 5, "after_start": 4, "before_end": 5, "before_start": 4, "kind": "replace"}, {"after_end": 15, "after_start": 13, "before_end": 17, "before_start": 13, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-67ca4e98bc0f2edc2aa4f8e2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3034}
{"after": {"end": 27, "start": 0, "text": "Pulvérisez dans une narine.", "truncated": false}, "after_length": 27, "after_sha256": "7e9f6fd511d4035388ac95cb13c1bf680c426e4b9e234322e6ff4503c2545266", "annex": "IIIA", "before": {"end": 27, "start": 0, "text": "Pulvériser dans une narine.", "truncated": false}, "before_length": 27, "before_sha256": "edf78c4e8b492aab8529cf00b250c61acfc3937c76182367a1b9f2e215b6f681", "change_kind": "content", "change_operations": [{"after_end": 10, "after_start": 9, "before_end": 10, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-67e4a2265c1b43e72464a7f5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 670}
{"after": {"end": 4, "start": 0, "text": "1 mL", "truncated": false}, "after_length": 4, "after_sha256": "af7727a32f7da2545262756526dd30894df734889f01f15bae043a9c9443b45c", "annex": "IIIA", "before": {"end": 40, "start": 0, "text": "1 ml d’eau pour préparations injectables", "truncated": false}, "before_length": 40, "before_sha256": "7320ef009a039bfb5b64c92a3e9af87ed7993238585713618b8f611093a39f08", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 40, "before_start": 3, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 37, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-683c47fc71c15b673e22c752", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 7733}
{"after": {"end": 12, "start": 0, "text": "MSD Α.Φ.Ε.Ε.", "truncated": false}, "after_length": 12, "after_sha256": "2920f5081525207a4790665fb26df902fdae978fe29baab6a51bbb705bb0115e", "annex": "IIIA", "before": {"end": 11, "start": 0, "text": "MSD Α.Φ.Ε.Ε", "truncated": false}, "before_length": 11, "before_sha256": "59152f94c242dd20eb3ac511729a3bc6beb5b7295232b77ad5bd9aa45afa4c63", "change_kind": "content", "change_operations": [{"after_end": 12, "after_start": 11, "before_end": 11, "before_start": 11, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-68500f7c347c504fc785f37e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3529}
{"after": {"end": 268, "start": 0, "text": "In view of spontaneous and literature cases of overdose, a causal relationship between perampanel and vomiting in overdose context is considered at least a reasonable possibility. The product information of products containing perampanel should be amended accordingly.", "truncated": false}, "after_length": 268, "after_sha256": "d184ca25ba001e8cdedcdcec5070368918a88559faba21c4f425fde05582e471", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 268, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 268}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-68aa74ea6bd5f0cc41e0d656", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3444}
{"after": {"end": 11, "start": 0, "text": "Not knowncc", "truncated": false}, "after_length": 11, "after_sha256": "4fd68b72297823f0bf0e9918370e79790c5557e1e351bd59ff6997578f945ce3", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 11, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 11}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-68c8ef604fe39dbc5aad48aa", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "IMJUDO 20 mg/ml concentrate for solution for infusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 839}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 65, "start": 0, "text": "Transportation of single-dose vials in liquid state at 2°C to 8°C", "truncated": false}, "before_length": 65, "before_sha256": "b4ab3a05b547e41feea104dd9731b5d9cc8a397eb6178990d9b3639eb81de016", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 65, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 65, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-68ccdad1d3690e7823735e56", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.4", "section_type": "storage", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6297}
{"after": {"end": 100, "start": 0, "text": "Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (s)", "truncated": false}, "after_length": 100, "after_sha256": "98ba2efcadc49812a35cee3ffbb8fdfdf62ec64dfe287f30acece74971c3bdd6", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 100, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 100}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6910d220ffdd6045914a63d5", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:18Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "89a938df5e41f86548301270084e3d1ecf171802e24b5429f62e3bede7ee32dd", "source_snapshot_id": "source-b71aeee5a07abebc34c02e28", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3422}
{"after": {"end": 435, "start": 0, "text": "L’objectif principal d’amélioration de la SSP a été atteint. Les patientes ayant reçu du bevacizumab à la dose de 15 mg/kg toutes les 3 semaines en association à la chimiothérapie et ayant continué à recevoir du bevacizumab seul (CPB15+), ont eu une amélioration cliniquement pertinente et statistiquement significative de la SSP, comparée aux patientes traitées par chimiothérapie seule (carboplatine et paclitaxel) en première ligne.", "truncated": false}, "after_length": 435, "after_sha256": "ac3d99ed3992bed6e0db702b6e988923bccaded12e8c479324e318a419053c59", "annex": "I", "before": {"end": 435, "start": 0, "text": "L’objectif principal d’amélioration de la PFS a été atteint. Les patientes ayant reçu du bevacizumab à la dose de 15 mg/kg toutes les 3 semaines en association à la chimiothérapie et ayant continué à recevoir du bevacizumab seul (CPB15+), ont eu une amélioration cliniquement pertinente et statistiquement significative de la PFS, comparée aux patientes traitées par chimiothérapie seule (carboplatine et paclitaxel) en première ligne.", "truncated": false}, "before_length": 435, "before_sha256": "7c82ecfbd87fd5cb879dd8f40f6dfb7dc90d55fc1e21ee8989ec22ea189ab442", "change_kind": "content", "change_operations": [{"after_end": 44, "after_start": 42, "before_end": 42, "before_start": 42, "kind": "insert"}, {"after_end": 45, "after_start": 45, "before_end": 45, "before_start": 43, "kind": "delete"}, {"after_end": 328, "after_start": 326, "before_end": 326, "before_start": 326, "kind": "insert"}, {"after_end": 329, "after_start": 329, "before_end": 329, "before_start": 327, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-691968aae9e07fe75954d9a9", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1715}
{"after": {"end": 36, "start": 0, "text": "EU/1/20/1507/033 (blister pack of 1)", "truncated": false}, "after_length": 36, "after_sha256": "3fa2f1de8dd45aa5894d8b177bd32395d7356407d1467ded4b76b28594441784", "annex": "IIIA", "before": {"end": 35, "start": 0, "text": "EU/1/20/1507/023(blister pack of 1)", "truncated": false}, "before_length": 35, "before_sha256": "8ceb4319270e34928426967f06a7c3e5a1000b429cb6186e29e2bc343a76f8af", "change_kind": "content", "change_operations": [{"after_end": 14, "after_start": 14, "before_end": 15, "before_start": 14, "kind": "delete"}, {"after_end": 17, "after_start": 15, "before_end": 16, "before_start": 16, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-691fd46f2dc45e3837a3d7aa", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9264}
{"after": {"end": 52, "start": 0, "text": "Administration du médicament à l’aide du Terrosa Pen", "truncated": false}, "after_length": 52, "after_sha256": "7f7755a6e5d0f5fbc0796859800c35e226459885f428a6e2ab8f5fbc82783e22", "annex": "IIIA", "before": {"end": 54, "start": 0, "text": "Administration du médicament à l’aide du stylo Terrosa", "truncated": false}, "before_length": 54, "before_sha256": "806d39b5e15c86c7b63b9f24c3bb89622286a3fe0474afedd148faf55b789f3c", "change_kind": "content", "change_operations": [{"after_end": 41, "after_start": 41, "before_end": 47, "before_start": 41, "kind": "delete"}, {"after_end": 52, "after_start": 48, "before_end": 54, "before_start": 54, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6927eb15ab154eabb15c9e31", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2013}
{"after": {"end": 370, "start": 0, "text": "Verify that the vial has a blue flip-off cap and the product name is Spikevax LP.8.1. If the vial has a blue flip-off cap and the product name is Spikevax 0.1 mg/mL, Spikevax bivalent Original/Omicron BA.1, Spikevax bivalent Original/Omicron BA.4-5, Spikevax XBB.1.5 or Spikevax JN.1, please make reference to the Summary of Product Characteristics for that formulation.", "truncated": false}, "after_length": 370, "after_sha256": "ab80b495b4a43380292e85994f2b5576d387e6659f69c2311a3d40d1abdff2f5", "annex": "I", "before": {"end": 353, "start": 0, "text": "Verify that the vial has a blue flip-off cap and the product name is Spikevax JN.1. If the vial has a blue flip-off cap and the product name is Spikevax 0.1 mg/mL, Spikevax bivalent Original/Omicron BA.1, Spikevax bivalent Original/Omicron BA.4-5 or Spikevax XBB.1.5, please make reference to the Summary of Product Characteristics for that formulation.", "truncated": false}, "before_length": 353, "before_sha256": "a85ffca853de6089ac216d9c5ad89cdcd7e9924a83268f1a1579d3321e9c55bb", "change_kind": "administrative", "change_operations": [{"after_end": 82, "after_start": 78, "before_end": 80, "before_start": 78, "kind": "replace"}, {"after_end": 249, "after_start": 248, "before_end": 249, "before_start": 246, "kind": "replace"}, {"after_end": 283, "after_start": 266, "before_end": 266, "before_start": 266, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 5, "chars_inserted": 22}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-698d9304b0e01d7fd63e53f1", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13046}
{"after": {"end": 108, "start": 0, "text": "Adempas doit être pris par voie orale. Prenez votre dose d’Adempas 3 fois par jour, toutes les 6 à 8 heures.", "truncated": false}, "after_length": 108, "after_sha256": "1c7a8274ae8a6be025f0f7433b4c783dfa55fa848364ef2dba2926cdd19b4950", "annex": "IIIA", "before": {"end": 200, "start": 0, "text": "Adempas doit être pris par voie orale. Chaque dose d’Adempas doit être avalée. Le patient doit avaler la dose complète de médicament. Utilisez Adempas 3 fois par jour, toutes les 6 à 8 heures environ.", "truncated": false}, "before_length": 200, "before_sha256": "00181c536ec909a8142d5ae06e8b9b15ec9c774faa0d4a02b765e999bd00957b", "change_kind": "content", "change_operations": [{"after_end": 50, "after_start": 39, "before_end": 44, "before_start": 39, "kind": "replace"}, {"after_end": 59, "after_start": 59, "before_end": 143, "before_start": 53, "kind": "delete"}, {"after_end": 107, "after_start": 107, "before_end": 199, "before_start": 191, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 103, "chars_inserted": 11}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-699a0510396c250f10d496d0", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3356}
{"after": {"end": 870, "start": 0, "text": "Apremilast is associated with an increased risk of psychiatric disorders such as insomnia, anxiety, altered mood, and depression. Instances of suicidal ideation and behaviour, including suicide, have been observed in patients with or without history of depression (see section 4.8). The risks and benefits of starting or continuing treatment with apremilast should be carefully assessed if patients report previous or existing psychiatric symptoms or if concomitant treatment with other medicinal products likely to cause psychiatric events is intended. Patients and caregivers should be instructed to notify the prescriber of any changes in behaviour or mood and of any suicidal ideation. If patients suffered from new or worsening psychiatric symptoms, or suicidal ideation or suicidal attempt is identified, it is recommended to discontinue treatment with apremilast.", "truncated": false}, "after_length": 870, "after_sha256": "0f45d2d9dd89dc3a16613a0772163a974024e276778627fd38e7718827e6ba42", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 870, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 870}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-69b6d9f58ef2a387f650887c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:30Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "35ab6716aa09492c14ac6849111486ec47235c0bc65ef055350de950f316c5e6", "source_snapshot_id": "source-f20a60110d1f8fef5225317d", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2357}
{"after": {"end": 38, "start": 0, "text": "A warning should be amended as follow:", "truncated": false}, "after_length": 38, "after_sha256": "61cb0a14ba45866330834f4a47a805c5821b969cb7e6e9f803eb62b58ab26cd4", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 38, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 38}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-69cd3a399f4a6f5a6865710a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:30Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "35ab6716aa09492c14ac6849111486ec47235c0bc65ef055350de950f316c5e6", "source_snapshot_id": "source-f20a60110d1f8fef5225317d", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2353}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 8, "start": 0, "text": "България", "truncated": false}, "before_length": 8, "before_sha256": "a7215e5aa55f878990c076bb8195d75ca42044d4d5c7d2ba90af610508b643d3", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 8, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 8, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-69e640fe7d8c5a4a6ea046ca", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1023}
{"after": {"end": 8, "start": 0, "text": "D02 HW68", "truncated": false}, "after_length": 8, "after_sha256": "1ed87437489fcb80b59bfa5d17082f438d78a8aff5deaac6125946420fbf0992", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 8, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6a6ce993dfa5b3523cd9fb8a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1719}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 192, "start": 0, "text": "Votre médecin vous remettra également une Carte Patient qui comportera des informations importantes de sécurité d’emploi que vous devez connaître, avant et pendant votre traitement par Enbrel.", "truncated": false}, "before_length": 192, "before_sha256": "a9b61621aee7f348e503c6ef13da6f1d4dc6f2a4d953f840016b3daaebeecd6a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 192, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 192, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6ac24bbcac7ebaef7bd8966c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11926}
{"after": {"end": 52, "start": 0, "text": "Élimination du Terrosa Pen et des accessoires usagés", "truncated": false}, "after_length": 52, "after_sha256": "399d42a91bb3f1a565fd23543a0e8f842c48782ce4a7e07bfc46988346c3032b", "annex": "IIIA", "before": {"end": 54, "start": 0, "text": "Élimination du stylo Terrosa et des accessoires usagés", "truncated": false}, "before_length": 54, "before_sha256": "ce5be490711de1882fc3cdf75bee28ed1da71bf8bed323bfae6ec52359317c6e", "change_kind": "content", "change_operations": [{"after_end": 15, "after_start": 15, "before_end": 21, "before_start": 15, "kind": "delete"}, {"after_end": 26, "after_start": 22, "before_end": 28, "before_start": 28, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6ad0401beafb95daab29e83e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2096}
{"after": {"end": 8, "start": 0, "text": "D02 HW68", "truncated": false}, "after_length": 8, "after_sha256": "1ed87437489fcb80b59bfa5d17082f438d78a8aff5deaac6125946420fbf0992", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 8, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6b5e4c52a39b8c1ad3dc0e6c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1720}
{"after": {"end": 679, "start": 0, "text": "PDMS-2 total score was measured as a secondary endpoint throughout the clinical studies. PDMS-2 maximal scores are 450-482, depending on age (<12 months or >12 months). All subjects treated with eladocagene exuparvovec showed increases from baseline in mean PDMS-2 total scores over time, with some benefit observed as early as 3 months (Figure 3). The least squares (LS) mean of change from baseline in PDMS-2 total score was 77.9, 111.6, 138.2, and 144.3 points at Month 12, Month 24, Month 60, and Month 96 timepoints, respectively. Patients who receive eladocagene exuparvovec at a younger age demonstrate a faster treatment response and appear to reach a higher final level.", "truncated": false}, "after_length": 679, "after_sha256": "dec644255d7cf5e6a240e2944e74469b07068277630fee5eba8abefe768bacb3", "annex": "I", "before": {"end": 785, "start": 0, "text": "PDMS-2 total score was measured as a secondary endpoint throughout the clinical studies. PDMS-2 maximal scores are 450-482, depending on age (<12 months or >12 months). All subjects treated with eladocagene exuparvovec showed increases from baseline in mean PDMS-2 total scores over time, with some benefit observed as early as 3 months (Figure 3). At the 24-month timepoint, the least squares (LS) mean of change from baseline in PDMS-2 total score was 111.2 points. Improvement from baseline in PDMS-2 total score was as early as 12 months after treatment (77.6 points) and was maintained to 60 months (139.0 points) and 96 months (141.6). Patients who receive eladocagene exuparvovec at a younger age demonstrate a faster treatment response and appear to reach a higher final level.", "truncated": false}, "before_length": 785, "before_sha256": "71d8286f17911ee74a67c13016d82dc08e1db49c8c1bffe4615de5dd4f62bd9f", "change_kind": "content", "change_operations": [{"after_end": 350, "after_start": 349, "before_end": 377, "before_start": 349, "kind": "replace"}, {"after_end": 433, "after_start": 427, "before_end": 454, "before_start": 454, "kind": "insert"}, {"after_end": 444, "after_start": 437, "before_end": 458, "before_start": 458, "kind": "insert"}, {"after_end": 456, "after_start": 445, "before_end": 459, "before_start": 459, "kind": "insert"}, {"after_end": 463, "after_start": 463, "before_end": 467, "before_start": 466, "kind": "delete"}, {"after_end": 465, "after_start": 464, "before_end": 478, "before_start": 468, "kind": "replace"}, {"after_end": 467, "after_start": 467, "before_end": 499, "before_start": 480, "kind": "delete"}, {"after_end": 468, "after_start": 468, "before_end": 536, "before_start": 500, "kind": "delete"}, {"after_end": 496, "after_start": 472, "before_end": 541, "before_start": 540, "kind": "replace"}, {"after_end": 504, "after_start": 498, "before_end": 544, "before_start": 543, "kind": "replace"}, {"after_end": 509, "after_start": 505, "before_end": 547, "before_start": 545, "kind": "replace"}, {"after_end": 512, "after_start": 511, "before_end": 553, "before_start": 549, "kind": "replace"}, {"after_end": 514, "after_start": 514, "before_end": 564, "before_start": 555, "kind": "delete"}, {"after_end": 521, "after_start": 520, "before_end": 571, "before_start": 570, "kind": "replace"}, {"after_end": 524, "after_start": 522, "before_end": 578, "before_start": 572, "kind": "replace"}, {"after_end": 529, "after_start": 525, "before_end": 582, "before_start": 579, "kind": "replace"}, {"after_end": 531, "after_start": 530, "before_end": 588, "before_start": 583, "kind": "replace"}, {"after_end": 534, "after_start": 532, "before_end": 640, "before_start": 589, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 177, "chars_inserted": 71}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6b62ba5f815b8ca6b7b7de40", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005352", "medicine_name": "Upstaza", "medicine_slug": "upstaza", "observed_at": "2026-10-12T13:36:07Z", "pipeline_version": "2.0.0", "presentation_label": "Upstaza 2.8 × 1011 vector genomes (vg)/0.5 mL solution for infusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8561a0c5aed752dd415d30acef76bf620ad205d702080a0bca765e086873fe20", "source_snapshot_id": "source-4b712d5f9e4e2e8cd620aa93", "source_updated_at": "2026-06-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/upstaza-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 359}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "Tel: +44 (0)1304 616161", "truncated": false}, "before_length": 23, "before_sha256": "eba81e6ccdbae471c024a5ba77d9ec9e0617a3c443fd22205a626861e87fbd8c", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 23, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 23, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6b666ab64f665a47a005e0c1", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 10552}
{"after": {"end": 68, "start": 0, "text": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection (multidose vials)", "truncated": false}, "after_length": 68, "after_sha256": "f5f1beca1e5749b2903a5e2cb2014d788c8731962a72b68f5748383bb0fce157", "annex": "I", "before": {"end": 66, "start": 0, "text": "Spikevax JN.1 0.1 mg/mL dispersion for injection (multidose vials)", "truncated": false}, "before_length": 66, "before_sha256": "6f4af5e44b1ec25d468896b61a90c845b84f703de2c49e23017c4c87baa76838", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6b8bf6625ddb47b434b4684f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.5", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6312}
{"after": {"end": 624, "start": 0, "text": "Chez les patients qui développent un SEPR, outre l’arrêt du bevacizumab, une reconnaissance précoce des symptômes avec un traitement rapide des symptômes spécifiques, incluant le contrôle de l’hypertension (si associé à une hypertension artérielle sévère non contrôlée), est recommandée. Les symptômes, habituellement, se dissipent ou s’améliorent dans les jours suivant l’arrêt du traitement, bien que certains patients ont développé quelques séquelles neurologiques. Les conséquences en terme de tolérance d’une reprise du traitement par Avastin chez les patients ayant préalablement développé un SEPR ne sont pas connues.", "truncated": false}, "after_length": 624, "after_sha256": "319ce07617aa30c0122996ba4fe85c27b18a78698a7f1b32b0f5c79dcb9ab491", "annex": "I", "before": {"end": 619, "start": 0, "text": "Chez les patients qui développent un SEPR, outre l’arrêt d’Avastin, une reconnaissance précoce des symptômes avec un traitement rapide des symptômes spécifiques, incluant le contrôle de l’hypertension (si associé à une hypertension artérielle sévère non contrôlée), est recommandée. Les symptômes, habituellement, se dissipent ou s’améliorent dans les jours suivant l’arrêt du traitement, bien que certains patients ont développé quelques séquelles neurologiques. Les conséquences en terme de tolérance d’une reprise du traitement par Avastin chez les patients ayant préalablement développé un SEPR ne sont pas connues.", "truncated": false}, "before_length": 619, "before_sha256": "8b84b7d8616324b57f627aa8ec8ea76a13f843d37fcbc7c332f569ed541a9c32", "change_kind": "content", "change_operations": [{"after_end": 62, "after_start": 58, "before_end": 60, "before_start": 58, "kind": "replace"}, {"after_end": 65, "after_start": 64, "before_end": 64, "before_start": 62, "kind": "replace"}, {"after_end": 71, "after_start": 66, "before_end": 66, "before_start": 65, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 5, "chars_inserted": 10}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6b972e7b9f48a26e7ae12652", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 765}
{"after": {"end": 18, "start": 0, "text": "dpoccyprus@msd.com", "truncated": false}, "after_length": 18, "after_sha256": "492fae7e6db021703bcb80e4b139bc2be78a7e6cf4c6056a9314c70cfe643716", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "malta_info@merck.com", "truncated": false}, "before_length": 20, "before_sha256": "d0529053ac5f753b95c76e02b64d46efbc0d61183bea7de30faa0abc218a9e1c", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 0, "before_end": 9, "before_start": 0, "kind": "replace"}, {"after_end": 10, "after_start": 3, "before_end": 10, "before_start": 10, "kind": "insert"}, {"after_end": 14, "after_start": 12, "before_end": 16, "before_start": 12, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 13, "chars_inserted": 11}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6ba613132a85157e774a3a95", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3009}
{"after": {"end": 9, "start": 0, "text": "Oral use.", "truncated": false}, "after_length": 9, "after_sha256": "3cb600334d66cfc50b70bcea280eaeb9fc125e589d372d56f3fae261332b8ee9", "annex": "IIIA", "before": {"end": 8, "start": 0, "text": "Oral use", "truncated": false}, "before_length": 8, "before_sha256": "1a1f6c65b762e8cde9480afdbb709dcfb59c2d46c38f5d3112c9f605bcbdf25f", "change_kind": "content", "change_operations": [{"after_end": 9, "after_start": 8, "before_end": 8, "before_start": 8, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6bd1fc0cef28460d7f140aa0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1948}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 33, "start": 0, "text": "United Kingdom (Northern Ireland)", "truncated": false}, "before_length": 33, "before_sha256": "9379d82927cdb505cfb186e912177065e56a1314de3a2b914ebbb8b5fe21525a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 33, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 33, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6c2587dec11c53a050b6c43c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9689}
{"after": {"end": 186, "start": 0, "text": "Nyxoid est indiqué dans le traitement d’urgence du surdosage aux opioïdes, connus ou suspectés, chez les adultes et adolescents âgés de plus de 14 ans. Les signes du surdosage incluent :", "truncated": false}, "after_length": 186, "after_sha256": "6ca15a6d6007bb04d18c75f1e83ff32411124b8bc5b0c771bc13d7804cdb6b7a", "annex": "IIIA", "before": {"end": 189, "start": 0, "text": "Le Nyxoid est indiqué dans le traitement d’urgence du surdosage aux opioïdes, connus ou suspectés, chez les adultes et adolescents âgés de plus de 14 ans. Les signes du surdosage incluent :", "truncated": false}, "before_length": 189, "before_sha256": "eb1fb9c5fe9e68506fca542d40d7ae0178c489b2cccc7fd26b248cb2de896dfc", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 3, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 3, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6c2e698d3013e99529b40c3e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 756}
{"after": {"end": 254, "start": 0, "text": "utilisez des inhibiteurs de la PDE-5 tels que le sildénafil, le tadalafil, le vardénafil. Ces médicaments sont utilisés pour traiter la pression sanguine élevée dans les artères des poumons ou pour traiter les problèmes d’érection (dysfonction érectile).", "truncated": false}, "after_length": 254, "after_sha256": "5e4d5b816aa21b9cefc6d9a343cad01884daec3e72b36afe2e8283f9c59f0440", "annex": "IIIA", "before": {"end": 241, "start": 0, "text": "utilisez des inhibiteurs de la PDE-5 tels que le sildénafil, le tadalafil, le vardénafil. Ces médicaments sont utilisés pour traiter la pression sanguine élevée dans les artères des poumons ou les problèmes d’érection (dysfonction érectile).", "truncated": false}, "before_length": 241, "before_sha256": "3c4cb31538420d89619a7d7a56058b75936a7a0cc317520770facdf785bbb725", "change_kind": "content", "change_operations": [{"after_end": 206, "after_start": 193, "before_end": 193, "before_start": 193, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 13}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6c357dc973e8d469671d2b3e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3250}
{"after": {"end": 13, "start": 0, "text": "Hermeslaan 11", "truncated": false}, "after_length": 13, "after_sha256": "6426889eacea87c88f1e0405aad54515d8a889ca0f1b2ab39e2039040651e7d3", "annex": "II", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 13}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6c39fc7a97855f0ebf5f7b66", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004310", "medicine_name": "Daptomycin Hospira", "medicine_slug": "daptomycin-hospira", "observed_at": "2026-10-12T19:09:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "e544a64f1681af82ba143ddd0cfa7cca4ef0de691ed43076b92bb75f66ec7f7b", "source_snapshot_id": "source-a214fce23bf43c3222026b3d", "source_updated_at": "2025-09-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/daptomycin-hospira-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1021}
{"after": {"end": 236, "start": 0, "text": "On the basis of the scientific conclusions for perampanel the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing perampanel is unchanged subject to the proposed changes to the product information", "truncated": false}, "after_length": 236, "after_sha256": "a1f4dbe73d901782db389b8f100ba994091e97e73f177a04bba849e8743f1072", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 236, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 236}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6cd9be11f07f7e4b4c83583a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3450}
{"after": {"end": 105, "start": 0, "text": "Tableau 19 Résultats de la SSP1 par stade de la maladie et statut de l’exérèse de l’étude BO17707 (ICON7)", "truncated": false}, "after_length": 105, "after_sha256": "82352344bf94c44dae900c60c5548339f14f09eaa795bf6490d6887bda8b96ca", "annex": "I", "before": {"end": 105, "start": 0, "text": "Tableau 19 Résultats de la PFS1 par stade de la maladie et statut de l’exérèse de l’étude BO17707 (ICON7)", "truncated": false}, "before_length": 105, "before_sha256": "858a1c3bd08a1f2c76e1f351685e4a7afc326527849e4942337a60ea7c676941", "change_kind": "content", "change_operations": [{"after_end": 29, "after_start": 27, "before_end": 27, "before_start": 27, "kind": "insert"}, {"after_end": 30, "after_start": 30, "before_end": 30, "before_start": 28, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6cf9a314bca71da7959cdc15", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1910}
{"after": {"end": 125, "start": 0, "text": "• Remove the outer needle cap and keep it for later. You will need it for the safe removal of the needle after the injection.", "truncated": false}, "after_length": 125, "after_sha256": "3b659c5919102afeaa83b7ed828359660a8059a426a8555afa49d0f0b7b7b191", "annex": "IIIA", "before": {"end": 42, "start": 0, "text": "• Remove the outer needle cap and save it.", "truncated": false}, "before_length": 42, "before_sha256": "7103acc1f054e1f2223f37e53e4d11aea56f1c79b5292292603a9598dbcebfb8", "change_kind": "content", "change_operations": [{"after_end": 78, "after_start": 34, "before_end": 34, "before_start": 34, "kind": "insert"}, {"after_end": 87, "after_start": 80, "before_end": 36, "before_start": 36, "kind": "insert"}, {"after_end": 113, "after_start": 88, "before_end": 37, "before_start": 37, "kind": "insert"}, {"after_end": 120, "after_start": 116, "before_end": 40, "before_start": 40, "kind": "insert"}, {"after_end": 124, "after_start": 121, "before_end": 41, "before_start": 41, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 83}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6dbc0453f427482e70dda7f8", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2044}
{"after": {"end": 336, "start": 0, "text": "les dérivés nitrés ou des produits dits « donneurs de monoxyde d’azote » tels que le nitrite d’amyle. Ces médicaments sont souvent utilisés pour traiter la pression sanguine élevée, les douleurs thoraciques d’origine cardiaque ou autres maladies du cœur. Cela comprend également les drogues à usage récréatif telles que les « poppers ».", "truncated": false}, "after_length": 336, "after_sha256": "48318973b9b906d4e5ba4140ee90fb0ceb16b3b7cb490f87da107b39afb435ba", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 336, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 336}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6dc2dcd3553fcc75b2df2aeb", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3292}
{"after": {"end": 94, "start": 0, "text": "As with all vaccines, vaccination with Spikevax LP.8.1 may not protect all vaccine recipients.", "truncated": false}, "after_length": 94, "after_sha256": "c66af8cc41127fa191d6dbdb597a527eea0490aac08be755e651f69ef1d56acf", "annex": "I", "before": {"end": 92, "start": 0, "text": "As with all vaccines, vaccination with Spikevax JN.1 may not protect all vaccine recipients.", "truncated": false}, "before_length": 92, "before_sha256": "36c2aa6c3292e83b6df6ca8f805361033c802aa4930c1dd914ccf533bf438713", "change_kind": "content", "change_operations": [{"after_end": 52, "after_start": 48, "before_end": 50, "before_start": 48, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6def3bc9d6f1c5dbd067f2ca", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5600}
{"after": {"end": 33, "start": 0, "text": "Critères secondaires d’évaluation", "truncated": false}, "after_length": 33, "after_sha256": "452fb1d774cab4a12cadb5315c2822450ff1451048a7d55e9cad4ea39dc1fdb7", "annex": "I", "before": {"end": 20, "start": 0, "text": "Critères secondaires", "truncated": false}, "before_length": 20, "before_sha256": "b2f8ba592c452ae9089186b53799f8faaf2b7a1e68039dd9016f50fa1d1ec67c", "change_kind": "content", "change_operations": [{"after_end": 33, "after_start": 20, "before_end": 20, "before_start": 20, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 13}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6e0e71446ef51c45c8f4dc54", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2158}
{"after": {"end": 3, "start": 0, "text": "0.2", "truncated": false}, "after_length": 3, "after_sha256": "44896b09365746b5f7167ee4d64988a38f7f4628803cbf86224e74eeb7c69e9d", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 3, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 3}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6e1c8622c7f7988f45767fb4", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "IMJUDO 20 mg/ml concentrate for solution for infusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 844}
{"after": {"end": 8, "start": 0, "text": "Dublin 2", "truncated": false}, "after_length": 8, "after_sha256": "b9d41e7d3be3ec3e12457949fb5c2f7be98290b5d2919e8b974df9c98fab02b9", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 8, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6e58efd1843c172fb0743e7a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2179}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Tel: +353 1 206 3800", "truncated": false}, "before_length": 20, "before_sha256": "b76fef5190d612d91d8ee1c3f52c40e30fcc7f25541faffe2a0c00e33c8cb7c1", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 20, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 20, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6eb07d6d30d999582d3b3940", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:33Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "21d66bf1e9a74479f577de09da3cf8517d65c1ce1b1d8bbdfe4bc38f79410def", "source_snapshot_id": "source-2c39c998fdaf05159687c016", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1088}
{"after": {"end": 249, "start": 0, "text": "Le critère primaire était la survie sans progression (SSP) basée sur une évaluation indépendante. Les critères secondaires comprenaient la survie globale, le taux de réponse, le taux de contrôle de la maladie, la durée de la réponse et la tolérance.", "truncated": false}, "after_length": 249, "after_sha256": "57c9efa9e8fde5f178f1ab31e492092ba4cb8905fcab042c9f0bc456ace6be27", "annex": "I", "before": {"end": 249, "start": 0, "text": "Le critère primaire était la survie sans progression (PFS) basée sur une évaluation indépendante. Les critères secondaires comprenaient la survie globale, le taux de réponse, le taux de contrôle de la maladie, la durée de la réponse et la tolérance.", "truncated": false}, "before_length": 249, "before_sha256": "256c14e045dbb6f48c54c0c1d6227416a8e7935ab57e7d25b29b48f5cbd585f7", "change_kind": "content", "change_operations": [{"after_end": 56, "after_start": 54, "before_end": 54, "before_start": 54, "kind": "insert"}, {"after_end": 57, "after_start": 57, "before_end": 57, "before_start": 55, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6eeec1688c130bdc8ba68a06", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1578}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 10, "start": 0, "text": "Österreich", "truncated": false}, "before_length": 10, "before_sha256": "b1b763860d4f30c2e1feafdcd57b714a1422b4fbc1a93d94969118a0faa65288", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 10, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 10, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6ef87ecf2a4b83eba24dba58", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1089}
{"after": {"end": 24, "start": 0, "text": "dpoc_czechslovak@msd.com", "truncated": false}, "after_length": 24, "after_sha256": "337ee03ecaecb8e917a1c5d342c556aebf19918c2dc3ac63cf08adeafa748373", "annex": "IIIA", "before": {"end": 26, "start": 0, "text": "dpoc_czechslovak@merck.com", "truncated": false}, "before_length": 26, "before_sha256": "a4642d78bee1d644f5eed542e84f756d52a7869d19900b6efa351b35ef1062c2", "change_kind": "content", "change_operations": [{"after_end": 20, "after_start": 18, "before_end": 22, "before_start": 18, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6f18b194aaf152329bd11c1e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2994}
{"after": {"end": 15, "start": 0, "text": "3832 RC Leusden", "truncated": false}, "after_length": 15, "after_sha256": "ba405ef0bf36eca0b0c6d25a5c566d076892169d711c353d3632e2a334a18c52", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 15, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 15}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6f5450201b30ae4a94a3b28b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1009}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 6, "start": 0, "text": "France", "truncated": false}, "before_length": 6, "before_sha256": "7a1ca4ef7515f7276bae7230545829c27810c9d9e98ab2c06066bee6270d5153", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 6, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6f718064d191fcf0ed4903d2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1090}
{"after": {"end": 220, "start": 0, "text": "Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Spikevax LP.8.1 may affect the way other medicines work, and other medicines may affect how Spikevax LP.8.1 works.", "truncated": false}, "after_length": 220, "after_sha256": "cff9a8e35b5a5cdb842ff15dcc8ad4a04ff1848261eeced2aafeee78b3cb625f", "annex": "I", "before": {"end": 216, "start": 0, "text": "Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Spikevax JN.1 may affect the way other medicines work, and other medicines may affect how Spikevax JN.1 works.", "truncated": false}, "before_length": 216, "before_sha256": "7440068ac71c5715f38a1d31d56c24943b0c3622b44d3b1b6e1ca68b946ec471", "change_kind": "administrative", "change_operations": [{"after_end": 119, "after_start": 115, "before_end": 117, "before_start": 115, "kind": "replace"}, {"after_end": 211, "after_start": 207, "before_end": 207, "before_start": 205, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6fb5b763129c3c07fe271b84", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12670}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 27, "start": 0, "text": "Tel: + 49 (0) 69 506029-000", "truncated": false}, "before_length": 27, "before_sha256": "df366bebba18e0852d6df09e630f0a6ddc47e99580e0b1cf5b6bbc551d6b38f1", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 27, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 27, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-6fe2376ac1ab71a21681201f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1068}
{"after": {"end": 22, "start": 0, "text": "Tel.: +40 21 529 29 00", "truncated": false}, "after_length": 22, "after_sha256": "c0def45751c8a6f47b191f68953f4156d333424fdfacc770cf07669eae1210a5", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "Tel: + 40 21 529 29 00", "truncated": false}, "before_length": 22, "before_sha256": "ab360a5cc3194a1966bd86bcee0a1a2cf6cc97342e9c07c5a45039ca6bac64ef", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}, {"after_end": 7, "after_start": 7, "before_end": 7, "before_start": 6, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-70575a347ea39f3085aee751", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3154}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 48, "start": 0, "text": "Once thawed, the vaccine should not be refrozen.", "truncated": false}, "before_length": 48, "before_sha256": "c2c8fda562591268edfc4a7dce038a758e3ca9d8529c08d6241c8f939d56fb69", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 48, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 48, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-70cb920adc120680610ae622", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.3", "section_type": "storage", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6255}
{"after": {"end": 153, "start": 0, "text": "• Replacez le Terrosa Pen avec la cartouche insérée au réfrigérateur, à une température comprise entre 2 et 8 °C, immédiatement après chaque utilisation.", "truncated": false}, "after_length": 153, "after_sha256": "286dafde015c33fd5dc38c4445a4ae092f10bd8df16f90688b96ab02ffd00f7e", "annex": "IIIA", "before": {"end": 155, "start": 0, "text": "• Replacez le stylo Terrosa avec la cartouche insérée au réfrigérateur, à une température comprise entre 2 et 8 °C, immédiatement après chaque utilisation.", "truncated": false}, "before_length": 155, "before_sha256": "90fcb85b3076596067f3421f9550913bdc61f5d81250af0a99aedf1637a6ba05", "change_kind": "content", "change_operations": [{"after_end": 14, "after_start": 14, "before_end": 20, "before_start": 14, "kind": "delete"}, {"after_end": 25, "after_start": 21, "before_end": 27, "before_start": 27, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-717cbc5f82f26b86edf8cd89", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2073}
{"after": {"end": 20, "start": 0, "text": "Tlf.: +45 44 201 100", "truncated": false}, "after_length": 20, "after_sha256": "a342c892cb893e888e9b98929ab7ba413528a3b19847cefc774fcc7b2c91291e", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "Tlf: +45 44 201 100", "truncated": false}, "before_length": 19, "before_sha256": "c639c1fe70f9701d8cecb70d89ff79995abd4e41911073143438fc69a41a0363", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-71f77e629e9db922f81ef22d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 10968}
{"after": {"end": 370, "start": 0, "text": "Verify that the vial has a blue flip-off cap and the product name is Spikevax LP.8.1. If the vial has a blue flip-off cap and the product name is Spikevax 0.1 mg/mL, Spikevax bivalent Original/Omicron BA.1, Spikevax bivalent Original/Omicron BA.4-5, Spikevax XBB.1.5 or Spikevax JN.1, please make reference to the Summary of Product Characteristics for that formulation.", "truncated": false}, "after_length": 370, "after_sha256": "ab80b495b4a43380292e85994f2b5576d387e6659f69c2311a3d40d1abdff2f5", "annex": "I", "before": {"end": 353, "start": 0, "text": "Verify that the vial has a blue flip-off cap and the product name is Spikevax JN.1. If the vial has a blue flip-off cap and the product name is Spikevax 0.1 mg/mL, Spikevax bivalent Original/Omicron BA.1, Spikevax bivalent Original/Omicron BA.4-5 or Spikevax XBB.1.5, please make reference to the Summary of Product Characteristics for that formulation.", "truncated": false}, "before_length": 353, "before_sha256": "a85ffca853de6089ac216d9c5ad89cdcd7e9924a83268f1a1579d3321e9c55bb", "change_kind": "content", "change_operations": [{"after_end": 82, "after_start": 78, "before_end": 80, "before_start": 78, "kind": "replace"}, {"after_end": 249, "after_start": 248, "before_end": 249, "before_start": 246, "kind": "replace"}, {"after_end": 283, "after_start": 266, "before_end": 266, "before_start": 266, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 5, "chars_inserted": 22}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-720583265a19d57c8c1c05ae", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6352}
{"after": {"end": 50, "start": 0, "text": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection", "truncated": false}, "after_length": 50, "after_sha256": "8c0d5490a68da1e449c0490ed0defe0da9d9d8c2d6ae11271b883fa7dfd5a64a", "annex": "I", "before": {"end": 48, "start": 0, "text": "Spikevax JN.1 0.1 mg/mL dispersion for injection", "truncated": false}, "before_length": 48, "before_sha256": "f251c20d6a11d153458ca69aaf22627ccbe0cce3064c14f8eb27faf9c2c0f105", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-720bcf47b21d7ea22cab5bba", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "2", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5414}
{"after": {"end": 74, "start": 0, "text": "* Do not use the prefilled syringe to deliver a partial volume of 0.25 mL.", "truncated": false}, "after_length": 74, "after_sha256": "75e296bff3c238176d513ed450c19057750a20263b5a3152d3b7a7c0a0d4190e", "annex": "I", "before": {"end": 94, "start": 0, "text": "* Do not use the single-dose vial or prefilled syringe to deliver a partial volume of 0.25 mL.", "truncated": false}, "before_length": 94, "before_sha256": "34a3dd6a9a278560b1c455186ca0846462be29c70b70a4dd2f194f53b65e7df3", "change_kind": "administrative", "change_operations": [{"after_end": 17, "after_start": 17, "before_end": 37, "before_start": 17, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 20, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7217b7735bac3d8b3848a0ea", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13203}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 10, "start": 0, "text": "15 minutes", "truncated": false}, "before_length": 10, "before_sha256": "2f18bc2a00e782d933b393e8b28adb86b81162d593dc4d307e70b38e8d6428cb", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 10, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 10, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-722d880dd002a1ee8c4c3ad9", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13097}
{"after": {"end": 68, "start": 0, "text": "* The cartridge and the pen needles are not supplied in the package.", "truncated": false}, "after_length": 68, "after_sha256": "4c008488ed09af0da1bdaeaa74963325cfd00c71b7fb9ba137f56d3701b6879e", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 68, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 68}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-72365a9ff334b2c35855cc5f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1964}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 72, "start": 0, "text": "Spikevax JN.1 50 micrograms dispersion for injection (single-dose vials)", "truncated": false}, "before_length": 72, "before_sha256": "41ccaa4784373a30743e6194685d229de5b4a64699df21c150e5a91151740b4d", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 72, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 72, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-725fa0ed20f2a66ac88a342b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.4", "section_type": "storage", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6290}
{"after": {"end": 19, "start": 0, "text": "Tel: +46 77 5700488", "truncated": false}, "after_length": 19, "after_sha256": "a968f6c96e435fb9594d06eee9f260814621b5e791fe61e1569bed42d6c801a6", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Tel: + 46 77 5700488", "truncated": false}, "before_length": 20, "before_sha256": "cb17614fcd82c944ba52cdd6413741cfa9e5ecd4d08eb5b092e244324255c763", "change_kind": "content", "change_operations": [{"after_end": 6, "after_start": 6, "before_end": 7, "before_start": 6, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-72f1210cba553364776a1891", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3603}
{"after": {"end": 307, "start": 0, "text": "Dans une analyse pharmacocinétique de population chez des patients atteints de spondylarthrite ankylosante, les ASC de l’etanercept à l’état d’équilibre ont été de 466 gh/mL et de 474 gh/mL respectivement pour Enbrel 50 mg une fois par semaine (N = 154) et pour Enbrel 25 mg deux fois par semaine (N = 148).", "truncated": false}, "after_length": 307, "after_sha256": "445870142470edbee85068c085acaa8d962222bc450c83799c30cbe7b49fb204", "annex": "I", "before": {"end": 307, "start": 0, "text": "Dans une analyse pharmacocinétique de population chez des patients atteints de spondylarthrite ankylosante, les ASC de l’etanercept à l’état d’équilibre ont été de 466 gh/ml et de 474 gh/ml respectivement pour Enbrel 50 mg une fois par semaine (N = 154) et pour Enbrel 25 mg deux fois par semaine (N = 148).", "truncated": false}, "before_length": 307, "before_sha256": "09aa65a9d586f557689bbea185133e8ec9cffea9570ee70355d94315e6ffcc64", "change_kind": "content", "change_operations": [{"after_end": 173, "after_start": 172, "before_end": 173, "before_start": 172, "kind": "replace"}, {"after_end": 189, "after_start": 188, "before_end": 189, "before_start": 188, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-730476572b1735ee7ef52e9b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg, solution injectable en cartouche distributrice de dose Enbrel 50 mg, solution injectable en cartouche distributrice de dose", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6452}
{"after": {"end": 20, "start": 0, "text": "Tlf.: +45 44 201 100", "truncated": false}, "after_length": 20, "after_sha256": "a342c892cb893e888e9b98929ab7ba413528a3b19847cefc774fcc7b2c91291e", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "Tlf: +45 44 201 100", "truncated": false}, "before_length": 19, "before_sha256": "c639c1fe70f9701d8cecb70d89ff79995abd4e41911073143438fc69a41a0363", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7364fac9b6c5c9c6acec1665", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9007}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 33, "start": 0, "text": "United Kingdom (Northern Ireland)", "truncated": false}, "before_length": 33, "before_sha256": "9379d82927cdb505cfb186e912177065e56a1314de3a2b914ebbb8b5fe21525a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 33, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 33, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-73845a15cb6ffb96d858e936", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 10681}
{"after": {"end": 18, "start": 0, "text": "info-msdbg@msd.com", "truncated": false}, "after_length": 18, "after_sha256": "a9564ace7f83680b30d249e1267cfecfc6de3252d14464719ba30061fb8124b8", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "info-msdbg@merck.com", "truncated": false}, "before_length": 20, "before_sha256": "0b46e48b14b2f549da86787bd2d27cc0b14ced470375af44415dc160418b8ba4", "change_kind": "content", "change_operations": [{"after_end": 14, "after_start": 12, "before_end": 16, "before_start": 12, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-738e56abaded022a31954a4b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2984}
{"after": {"end": 117, "start": 0, "text": "présentez des symptômes de pression sanguine basse tels que des vertiges, des étourdissements ou des évanouissements,", "truncated": false}, "after_length": 117, "after_sha256": "b55139a238b4e3eae3e513e86718422152bcf661eb5d8275a56b3da9dff1dbb2", "annex": "IIIA", "before": {"end": 120, "start": 0, "text": "présentez des symptômes de pression sanguine basse tels que des vertiges, des étourdissements ou des évanouissements, ou", "truncated": false}, "before_length": 120, "before_sha256": "bf6938bda7397cbc3b9160a0e9d19ee4d146b14b85451fbb7179c529a91c424a", "change_kind": "content", "change_operations": [{"after_end": 117, "after_start": 117, "before_end": 120, "before_start": 117, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 3, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-739bdf221f2ee5566467cb8d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2827}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 18, "start": 0, "text": "medis.ro@medis.com", "truncated": false}, "before_length": 18, "before_sha256": "10bcfb4a98edb8b9489af20261809c7c33f79ad3fed38294101e21ae5cfff776", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 18, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 18, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-73b19e7198d3949768d0e8fc", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1123}
{"after": {"end": 148, "start": 0, "text": "Des informations détaillées sur ce médicament sont disponibles sur le site internet de l’Agence européenne des médicaments https://www.ema.europa.eu", "truncated": false}, "after_length": 148, "after_sha256": "0144d9770eb4c4153d7e7b1c9dec56544610f245adee115432038125fa622184", "annex": "IIIA", "before": {"end": 147, "start": 0, "text": "Des informations détaillées sur ce médicament sont disponibles sur le site internet de l’Agence européenne des médicaments http://www.ema.europa.eu", "truncated": false}, "before_length": 147, "before_sha256": "d0dd4118d52714b2cfcf09f73f7031efc575f51b70183bf3d601893b6bf4e936", "change_kind": "technical", "change_operations": [{"after_end": 128, "after_start": 127, "before_end": 127, "before_start": 127, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-73ed98ab87b8d6c2a1f189be", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9107}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 33, "start": 0, "text": "Mundipharma Pharmaceuticals, S.L.", "truncated": false}, "before_length": 33, "before_sha256": "446fa3011719739274b4086253796403ba3069098384e7226a20327278e75f63", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 33, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 33, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-742db2304957ab073f5f6d81", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1081}
{"after": {"end": 480, "start": 0, "text": "Des cas de surdosage volontaire ou accidentel ont été observés après la commercialisation du produit. Des doses de pérampanel allant jusqu’à environ 50 mg chez les patients pédiatriques et jusqu’à 300 mg chez les patients adultes ont été rapportées. Les effets indésirables observés comprenaient l’altération de l’état mental, l’agitation, un comportement agressif, les vomissements, le coma et une diminution du niveau de conscience. Les patients se sont rétablis sans séquelles.", "truncated": false}, "after_length": 480, "after_sha256": "9c404b5fc53d83b2cb8f98266cde8494d7b99485a039984ce0a2af786d21eb7c", "annex": "I", "before": {"end": 461, "start": 0, "text": "Des cas de surdosage volontaire ou accidentel ont été observés après la commercialisation du produit chez des patients pédiatriques avec des doses de pérampanel allant jusqu’à 36 mg et chez des patients adultes avec des doses allant jusqu’à 300 mg. Les effets indésirables observés comprenaient l’altération de l’état mental, l’agitation, un comportement agressif, le coma et une diminution du niveau de conscience. Les patients se sont rétablis sans séquelles.", "truncated": false}, "before_length": 461, "before_sha256": "fb6ee73f00a7cfe043f95065d0beb7330f394aa890bd2a8568a89d309aa8d885", "change_kind": "content", "change_operations": [{"after_end": 101, "after_start": 100, "before_end": 100, "before_start": 100, "kind": "insert"}, {"after_end": 103, "after_start": 102, "before_end": 138, "before_start": 101, "kind": "replace"}, {"after_end": 151, "after_start": 141, "before_end": 178, "before_start": 176, "kind": "replace"}, {"after_end": 154, "after_start": 154, "before_end": 184, "before_start": 181, "kind": "delete"}, {"after_end": 175, "after_start": 160, "before_end": 190, "before_start": 190, "kind": "insert"}, {"after_end": 210, "after_start": 176, "before_end": 191, "before_start": 191, "kind": "insert"}, {"after_end": 230, "after_start": 230, "before_end": 221, "before_start": 211, "kind": "delete"}, {"after_end": 231, "after_start": 231, "before_end": 230, "before_start": 222, "kind": "delete"}, {"after_end": 247, "after_start": 234, "before_end": 235, "before_start": 233, "kind": "replace"}, {"after_end": 248, "after_start": 248, "before_end": 247, "before_start": 236, "kind": "delete"}, {"after_end": 382, "after_start": 364, "before_end": 363, "before_start": 363, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 73, "chars_inserted": 92}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-744c3db7be365751ef2ddb49", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:32:00Z", "pipeline_version": "2.0.0", "presentation_label": "Fycompa 2 mg comprimés pelliculés Fycompa 4 mg comprimés pelliculés Fycompa 6 mg comprimés pelliculés Fycompa 8 mg comprimés pelliculés Fycompa 10 mg comprimés pelliculés Fycompa 12 mg comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.9", "section_type": "overdose", "source_provider": "European Medicines Agency", "source_sha256": "3ff8cd4d67d22ba799aa348aeda944d6d896a16dcf54b030db101cbc095fc8ad", "source_snapshot_id": "source-a79a7cba8bf5dbc72fd40574", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 553}
{"after": {"end": 85, "start": 0, "text": "Green, round, biconvex tablet, engraved with E296 on one side and ‘10’ on other side.", "truncated": false}, "after_length": 85, "after_sha256": "a4faebe99e62231fd5b22a9474648e2de171d02b52b986e9b757a51f20cd628a", "annex": "I", "before": {"end": 84, "start": 0, "text": "Green, round, biconvex tablet, engraved with E296 on one side and ‘10’ on other side", "truncated": false}, "before_length": 84, "before_sha256": "e4cf44f3b0bc4615d0ef414c38c1af9390c7ab25b5e4448186ed7c14aa728f7a", "change_kind": "content", "change_operations": [{"after_end": 85, "after_start": 84, "before_end": 84, "before_start": 84, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-744fde2576f8678d16448716", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "Fycompa 2 mg filmcoated tablets Fycompa 4 mg filmcoated tablets Fycompa 6 mg filmcoated tablets Fycompa 8 mg filmcoated tablets Fycompa 10 mg filmcoated tablets Fycompa 12 mg filmcoated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "3", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 107}
{"after": {"end": 433, "start": 0, "text": "Le prescripteur doit décrire les symptômes qui permettent un diagnostic présumé de dépression du système nerveux central (SNC)/dépression respiratoire, l’indication et les instructions d’utilisation au patient et/ou à la personne qui pourrait être amenée à administrer ce produit à un patient qui présente un surdosage connu ou suspecté aux opioïdes. Cela doit être réalisé conformément aux recommandations éducationnelles de Nyxoid.", "truncated": false}, "after_length": 433, "after_sha256": "ada8d06a1a5178e3b002000278a28e6e95136ce31f03b06d7236d1a6262a6232", "annex": "I", "before": {"end": 433, "start": 0, "text": "Le prescripteur doit décrire les symptômes qui permettent un diagnostic présumé de dépression du système nerveux central (SNC)/dépression respiratoire, l’indication et les instructions d’utilisation au patient et/ou à la personne qui pourrait être amenée à administrer ce produit à un patient qui présente un surdosage connu ou suspecté aux opioïdes. Cela doit être réalisé conformément aux recommandations educationnelles de Nyxoid.", "truncated": false}, "before_length": 433, "before_sha256": "3dc1a742d50aa7d120ee10c59dfcfc6485822003b14ce79b54465688fdabb073", "change_kind": "content", "change_operations": [{"after_end": 408, "after_start": 407, "before_end": 408, "before_start": 407, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7458d5a711074644daa015b5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "Nyxoid 1,8 mg, solution pour pulvérisation nasale en récipient unidose", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 90}
{"after": {"end": 89, "start": 0, "text": "Microangiopathie thrombotique rénaleb,c, microangiopathie glomérulaire occlusive hyalinec", "truncated": false}, "after_length": 89, "after_sha256": "25401784eaaa5ce9fdf606e83d5265602e9cb1db4dd383317799bec34fedff91", "annex": "I", "before": {"end": 40, "start": 0, "text": "Microangiopathie thrombotique rénaleb,c,", "truncated": false}, "before_length": 40, "before_sha256": "7a67746b4ef6ab243ed962c7c6191abcc7574f24bd998c7210a551fd501b297f", "change_kind": "content", "change_operations": [{"after_end": 89, "after_start": 40, "before_end": 40, "before_start": 40, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 49}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-747b68ba1ffa9b774c90d80f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 617}
{"after": {"end": 52, "start": 0, "text": "Placez la personne en position latérale de sécurité.", "truncated": false}, "after_length": 52, "after_sha256": "f2de9fe99c9ba93fec1f2875142a0145f74f518d1446df45b1d74231a347ef68", "annex": "IIIA", "before": {"end": 52, "start": 0, "text": "Placer la personne en position latérale de sécurité.", "truncated": false}, "before_length": 52, "before_sha256": "ef20976157b1adf2dbb70703c52ef8e70ac0220e44cd0fff44a3d38355d11b12", "change_kind": "content", "change_operations": [{"after_end": 6, "after_start": 5, "before_end": 6, "before_start": 5, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-74822aa3fe61c80eb82c14f8", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 673}
{"after": {"end": 183, "start": 0, "text": "Spikevax LP.8.1 is supplied in a single-dose, pre-filled syringe (without needle) containing 0.5 mL (50 micrograms of SARSCoV2 LP.8.1 mRNA) and must be thawed prior to administration.", "truncated": false}, "after_length": 183, "after_sha256": "3c6aff2db038cf0f7c697693529afc9ff01398453a28b572bb34c4c013445638", "annex": "I", "before": {"end": 179, "start": 0, "text": "Spikevax JN.1 is supplied in a single-dose, pre-filled syringe (without needle) containing 0.5 mL (50 micrograms of SARSCoV2 JN.1 mRNA) and must be thawed prior to administration.", "truncated": false}, "before_length": 179, "before_sha256": "0d215f448cf75c972b5d334d33be50113bbb15d9cf70b8afd185fe0d7bb48fc9", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}, {"after_end": 131, "after_start": 127, "before_end": 127, "before_start": 125, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7498db3388039810422fd41a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6423}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "Teл.: + 359 2 962 13 56", "truncated": false}, "before_length": 23, "before_sha256": "bfb4a42942146d3ccf5bea091cf10ea2e677a3059cc805c633c7ec4fe1347908", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 23, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 23, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-74e236403c1f41c93d8865cf", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1025}
{"after": {"end": 158, "start": 0, "text": "Spikevax LP.8.1 is a white to off white dispersion supplied in a glass multidose vial with a rubber stopper and blue flip-off plastic cap with aluminium seal.", "truncated": false}, "after_length": 158, "after_sha256": "fed504252cb6878387fcc284fd3678bdc4352ec8e2260025b2124fef7b412a63", "annex": "I", "before": {"end": 156, "start": 0, "text": "Spikevax JN.1 is a white to off white dispersion supplied in a glass multidose vial with a rubber stopper and blue flip-off plastic cap with aluminium seal.", "truncated": false}, "before_length": 156, "before_sha256": "6786da5270578c2a0b771fa81595395ccbe3ec50af8fa071f2a2564e050e975b", "change_kind": "administrative", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-74e739af577286f473890e3a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12877}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 16, "start": 0, "text": "Mundipharma GmbH", "truncated": false}, "before_length": 16, "before_sha256": "2de27f129414a5929fea0d2e4e89e1533c2f6c526e876dc36d57a357db32188a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 16, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 16, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-752a1b3e61dac68cea424a2c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1051}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 9, "start": 0, "text": "Allemagne", "truncated": false}, "before_length": 9, "before_sha256": "6b58dbd6a994339b48d8446597da22402857b3409613459c7e3a293788fbe66a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 9, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 9, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-75528a6b13894bcc03b4713c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1210}
{"after": {"end": 21, "start": 0, "text": "Tel.: +421 2 58282010", "truncated": false}, "after_length": 21, "after_sha256": "32c933770f90d44663e373be0c519eb7428907366f1868c6a270ab7f76ac5d6c", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tel: + 421 2 58282010", "truncated": false}, "before_length": 21, "before_sha256": "90cacf7d3ec61fa882ae694eb785acb84b5a4d5dc4e01a35b7899e1f2403cc28", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}, {"after_end": 7, "after_start": 7, "before_end": 7, "before_start": 6, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-758cf093b0fdb5a423aa67f3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3086}
{"after": {"end": 311, "start": 0, "text": "The efficacy of Spikevax LP.8.1 may be lower in people who are immunocompromised. In these cases, you should continue to maintain physical precautions to help prevent COVID-19. In addition, your close contacts should be vaccinated as appropriate. Discuss appropriate individual recommendations with your doctor.", "truncated": false}, "after_length": 311, "after_sha256": "3e2729829d566a138a3f77d448d8327b8ed767cc1009517df2dd81e71ade060f", "annex": "I", "before": {"end": 309, "start": 0, "text": "The efficacy of Spikevax JN.1 may be lower in people who are immunocompromised. In these cases, you should continue to maintain physical precautions to help prevent COVID-19. In addition, your close contacts should be vaccinated as appropriate. Discuss appropriate individual recommendations with your doctor.", "truncated": false}, "before_length": 309, "before_sha256": "69dfa371024e7d832945499818a8a04f955ce4ba1688e9dff8221c41bac0c17a", "change_kind": "administrative", "change_operations": [{"after_end": 29, "after_start": 25, "before_end": 27, "before_start": 25, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-75a3cf05f5ac3a9af1fec323", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12673}
{"after": {"end": 402, "start": 0, "text": "L’analyse prévue au protocole de la SSP évaluée par les investigateurs (données de progression CA 125 et traitements hors protocole non censurés) a montré un risque relatif stratifié de 0,71 (IC 95 % : 0,61-0,83, valeur de p du test du log-rank unilatéral < 0,0001) quand le bras CPB15+ est comparé au bras CPP, avec une médiane de SSP de 10,4 mois dans le bras CPP et de 14,1 mois dans le bras CPB15+.", "truncated": false}, "after_length": 402, "after_sha256": "21d5c29dda26872c103dba9fd326b5926ba44f26485cd5130ff40cdb29b6bd76", "annex": "I", "before": {"end": 402, "start": 0, "text": "L’analyse prévue au protocole de la PFS évaluée par les investigateurs (données de progression CA 125 et traitements hors protocole non censurés) a montré un risque relatif stratifié de 0,71 (IC 95 % : 0,61-0,83, valeur de p du test du log-rank unilatéral < 0,0001) quand le bras CPB15+ est comparé au bras CPP, avec une médiane de PFS de 10,4 mois dans le bras CPP et de 14,1 mois dans le bras CPB15+.", "truncated": false}, "before_length": 402, "before_sha256": "b3ea8a1e192b1e54c8af75205e72144d42a3dc8dc269e885a0f9a9df9f6e149f", "change_kind": "content", "change_operations": [{"after_end": 38, "after_start": 36, "before_end": 36, "before_start": 36, "kind": "insert"}, {"after_end": 39, "after_start": 39, "before_end": 39, "before_start": 37, "kind": "delete"}, {"after_end": 334, "after_start": 332, "before_end": 332, "before_start": 332, "kind": "insert"}, {"after_end": 335, "after_start": 335, "before_end": 335, "before_start": 333, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-75b025c2dcb2c2fbdc2eda84", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1786}
{"after": {"end": 65, "start": 0, "text": "Le traitement par etanercept peut augmenter le risque d’infection", "truncated": false}, "after_length": 65, "after_sha256": "603ff3c167487469c94a557b5da8fedc8c0ae34ef1dffdbd816bf283f7bf7b0a", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 65, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 65}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-75bdb182ead1b8631a9e8f74", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6661}
{"after": {"end": 307, "start": 0, "text": "Dans une analyse pharmacocinétique de population chez des patients atteints de spondylarthrite ankylosante, les ASC de l’etanercept à l’état d’équilibre ont été de 466 gh/mL et de 474 gh/mL respectivement pour Enbrel 50 mg une fois par semaine (n = 154) et pour Enbrel 25 mg deux fois par semaine (n = 148).", "truncated": false}, "after_length": 307, "after_sha256": "1c43c823b021ca355a70ce91caf9457501b150b77ff3824f2ada9508e781e74b", "annex": "I", "before": {"end": 307, "start": 0, "text": "Dans une analyse pharmacocinétique de population chez des patients atteints de spondylarthrite ankylosante, les ASC de l’etanercept à l’état d’équilibre ont été de 466 gh/ml et de 474 gh/ml respectivement pour Enbrel 50 mg une fois par semaine (n = 154) et pour Enbrel 25 mg deux fois par semaine (n = 148).", "truncated": false}, "before_length": 307, "before_sha256": "5d8df1dfa3590f8cd7f05f183c4a37b7abc74223db55f470f360af9b806b6cab", "change_kind": "content", "change_operations": [{"after_end": 173, "after_start": 172, "before_end": 173, "before_start": 172, "kind": "replace"}, {"after_end": 189, "after_start": 188, "before_end": 189, "before_start": 188, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-766418cdc367684a7cc65633", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 10 mg poudre et solvant pour solution injectable pour usage pédiatrique", "presentation_occurrence": 5, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5349}
{"after": {"end": 20, "start": 0, "text": "Tel.: +351 214465700", "truncated": false}, "after_length": 20, "after_sha256": "6171ae007b6c82d5a612a6a3443de26f3c5ee9320b52f7c4fbca51dda821fe28", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Tel: + 351 214465700", "truncated": false}, "before_length": 20, "before_sha256": "4a3d7a7c5925473eef92c2cd7a2e616c5dd3e20a042ab127910a184d9dfd503d", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}, {"after_end": 7, "after_start": 7, "before_end": 7, "before_start": 6, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-76a42cec58b2ea867f24abcb", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3144}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 32, "start": 0, "text": "Mundipharma Pharmaceuticals B.V.", "truncated": false}, "before_length": 32, "before_sha256": "5e3117c414bcce433a82de23b7ca56a59a8584ed386564084c3eb341a17c8520", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 32, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 32, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-77316fab33d86ef199c33802", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1072}
{"after": {"end": 76, "start": 0, "text": "Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe", "truncated": false}, "after_length": 76, "after_sha256": "6c7ff1bbd2f6d8c84f1254cce87065dac51505e1edd888622047a746e34551e6", "annex": "I", "before": {"end": 74, "start": 0, "text": "Spikevax JN.1 50 micrograms dispersion for injection in pre-filled syringe", "truncated": false}, "before_length": 74, "before_sha256": "ebe036d056b86be90e582dc3803425dce3820674579f962bd2fc8976b65c292a", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-773a07cdc0d65127abffeaba", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "1", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5401}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 31, "start": 0, "text": "Mundipharma Pharmaceuticals Srl", "truncated": false}, "before_length": 31, "before_sha256": "4419218cfed83a9f85981140bd12e9057539600b69b7dc2d3af8d9b505c21441", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 31, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 31, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7750231da8d90180088f6037", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1131}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "II", "before": {"end": 45, "start": 0, "text": "Étude d’efficacité post-autorisation (PAES) :", "truncated": false}, "before_length": 45, "before_sha256": "249049f510d207b3d15c6b99f3d17d29017b276a9c898ba202cc0f4b2e6a71ad", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 45, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 45, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-775d4837fda5cf1566b2a2de", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 473}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "info@mundipharma.nl", "truncated": false}, "before_length": 19, "before_sha256": "f601339a5851491b7ab1e06c9ac38eabff98b5665d314730b6204165ee158589", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 19, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 19, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-775ef0e21b58e54828f1a943", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1074}
{"after": {"end": 78, "start": 0, "text": "Effets indésirables peu fréquents (peuvent affecter jusqu’à 1 patient sur 100)", "truncated": false}, "after_length": 78, "after_sha256": "a2c905c924dcfec2ea9ad518c4e0a3838e73c2da69eafcbc7d2dd6eb431dc8cf", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 78, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 78}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-77688a6ee60fdc50e8d3b092", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "9ac80b0d56ebad4970f7a8335a177613af59ef25517bcd0bdd3397c207cc1bac", "source_snapshot_id": "source-c11aa9e32420f125a88005bc", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2739}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 14, "start": 0, "text": "Pfizer Limited", "truncated": false}, "before_length": 14, "before_sha256": "faadd350d247ecbb0e8edac0805fa3d4cdbf449fbb9a1a9614eee6624274a2f6", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-77748d4125315ca3ee312026", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12163}
{"after": {"end": 9, "start": 0, "text": "ANNEXE IV", "truncated": false}, "after_length": 9, "after_sha256": "5623d2bfc35b28c1d982ab389e6c5fa37f50e40d0b9b737593e164d081c1191d", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 9, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 9}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-77874a85188a00f8a65fe39a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "9ac80b0d56ebad4970f7a8335a177613af59ef25517bcd0bdd3397c207cc1bac", "source_snapshot_id": "source-c11aa9e32420f125a88005bc", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2705}
{"after": {"end": 60, "start": 0, "text": "phenytoin, carbamazepine, phenobarbitone, to treat epilepsy.", "truncated": false}, "after_length": 60, "after_sha256": "3cd2e95fc326fc31b76edb4215ac264caed159c0394757224b923fb0cc160636", "annex": "IIIA", "before": {"end": 58, "start": 0, "text": "epilepsy such as phenytoin, carbamazepine, phenobarbitone.", "truncated": false}, "before_length": 58, "before_sha256": "631dd593dace958ad6a6e13df7ccb81562e52426ce144155729128fe758aa4ba", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 17, "before_start": 0, "kind": "delete"}, {"after_end": 59, "after_start": 40, "before_end": 57, "before_start": 57, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 17, "chars_inserted": 19}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-77c0844a3af47601dec209c0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2778}
{"after": {"end": 12, "start": 0, "text": "Rubrique 4.8", "truncated": false}, "after_length": 12, "after_sha256": "f3fee7b722580006f8db31856054102555361528a1106b4ed3ff4d7db7798d14", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 12, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 12}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-77f62573dc98648910752dc1", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "9ac80b0d56ebad4970f7a8335a177613af59ef25517bcd0bdd3397c207cc1bac", "source_snapshot_id": "source-c11aa9e32420f125a88005bc", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2731}
{"after": {"end": 24, "start": 0, "text": "dpoc_czechslovak@msd.com", "truncated": false}, "after_length": 24, "after_sha256": "337ee03ecaecb8e917a1c5d342c556aebf19918c2dc3ac63cf08adeafa748373", "annex": "IIIA", "before": {"end": 26, "start": 0, "text": "dpoc_czechslovak@merck.com", "truncated": false}, "before_length": 26, "before_sha256": "a4642d78bee1d644f5eed542e84f756d52a7869d19900b6efa351b35ef1062c2", "change_kind": "content", "change_operations": [{"after_end": 20, "after_start": 18, "before_end": 22, "before_start": 18, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-782fe41e42c39bd6dab643d7", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3488}
{"after": {"end": 83, "start": 0, "text": "low blood pressure (hypotension) (very common: may affect more than 1 in 10 people)", "truncated": false}, "after_length": 83, "after_sha256": "58bc23b2724245054e76a3fc64901249e3b7f464dbe1b089f39df03820eb0823", "annex": "IIIA", "before": {"end": 83, "start": 0, "text": "low blood pressure (hypotension) (Very common: may affect more than 1 in 10 people)", "truncated": false}, "before_length": 83, "before_sha256": "4e224e02c76da6fe7d20a6e48e539dfada1394932785f6a63260208aa3c375b8", "change_kind": "content", "change_operations": [{"after_end": 35, "after_start": 34, "before_end": 35, "before_start": 34, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7848cbbc34e26a5f9dcd96c2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2900}
{"after": {"end": 22, "start": 0, "text": "Tel.: +420 277 050 000", "truncated": false}, "after_length": 22, "after_sha256": "5a73afc7c7a9b40fee1c264ddd73318b7831c01ad752d8e98c531d058ff77e22", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tel: +420 233 010 111", "truncated": false}, "before_length": 21, "before_sha256": "86999b702f11fb434a8ae044a79bf67743758f2695ac34bae0355d2effa55dff", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}, {"after_end": 14, "after_start": 12, "before_end": 13, "before_start": 11, "kind": "replace"}, {"after_end": 17, "after_start": 16, "before_end": 16, "before_start": 15, "kind": "replace"}, {"after_end": 22, "after_start": 19, "before_end": 21, "before_start": 18, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 7}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-78978a8e2504363d350e57aa", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2993}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 14, "start": 0, "text": "78467 Konstanz", "truncated": false}, "before_length": 14, "before_sha256": "ee960a86a16086f43d4c7f3f51bd93d39025d5227fb1a6f1c825d1015754ff53", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-789c3b296dd420579749041f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2181}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "icepharma@icepharma.is", "truncated": false}, "before_length": 22, "before_sha256": "1d615bc2c915498be3f3e7960f34d5af0bec545d614ea24eba34ab7ead4041e7", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 22, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 22, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-78c87c6b9ebc091db1c91fa7", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1133}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 52, "start": 0, "text": "Spikevax JN.1 50 micrograms dispersion for injection", "truncated": false}, "before_length": 52, "before_sha256": "597e6a2a3b4949004d4fc05201b82efef68b5595489c6b3279e0567739db5110", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 52, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 52, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-78ded04e03b7017c48657a36", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12881}
{"after": {"end": 194, "start": 0, "text": "- Check for signs of overdose, such as: no response to touch or sounds, slow uneven breathing or no breathing, snoring, gasping or gulping, blue or purple fingernails or lips, very small pupils.", "truncated": false}, "after_length": 194, "after_sha256": "95cec7b35b4a1cf7f9f2883b37c2f6ec14559f096c6d568a8deeac309ad9bd7d", "annex": "IIIA", "before": {"end": 175, "start": 0, "text": "- Check for signs of overdose, such as: no response to touch or sounds, slow uneven breathing or no breathing, snoring, gasping or gulping, blue or purple fingernails or lips.", "truncated": false}, "before_length": 175, "before_sha256": "28f6f4cab6b0239b5b708581c6554ea8823cb9fc628cae6b6bde486b9405f946", "change_kind": "content", "change_operations": [{"after_end": 193, "after_start": 174, "before_end": 174, "before_start": 174, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 19}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-78fec6dd22c882b6aeb3380e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:33Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "21d66bf1e9a74479f577de09da3cf8517d65c1ce1b1d8bbdfe4bc38f79410def", "source_snapshot_id": "source-2c39c998fdaf05159687c016", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 828}
{"after": {"end": 85, "start": 0, "text": "la phénytoïne, la carbamazépine, le phénobarbital, utilisés pour traiter l’épilepsie.", "truncated": false}, "after_length": 85, "after_sha256": "bc40a46091d73609ca7eb99dc7275094d3cbf1b44ba79437600d2802b30579f2", "annex": "IIIA", "before": {"end": 65, "start": 0, "text": "de l’épilepsie tels que phénytoïne, carbamazépine, phénobarbital.", "truncated": false}, "before_length": 65, "before_sha256": "2faf3402acd178f9e7b471a070716348471e64223ad8c7dafbb8e44fd3641c43", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 3, "before_start": 0, "kind": "delete"}, {"after_end": 2, "after_start": 1, "before_end": 23, "before_start": 4, "kind": "replace"}, {"after_end": 17, "after_start": 14, "before_end": 35, "before_start": 35, "kind": "insert"}, {"after_end": 36, "after_start": 33, "before_end": 51, "before_start": 51, "kind": "insert"}, {"after_end": 84, "after_start": 49, "before_end": 64, "before_start": 64, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 22, "chars_inserted": 42}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-793e26bb10a4303ce3cb50f2", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2859}
{"after": {"end": 44, "start": 0, "text": "24 seringues pré-remplies de 1 mL de solvant", "truncated": false}, "after_length": 44, "after_sha256": "c13f1c797f5b1abf1cbab99d4734aa32de506db8908b4d483f51f9226f8bf99f", "annex": "IIIA", "before": {"end": 44, "start": 0, "text": "24 seringues pré-remplies de 1 ml de solvant", "truncated": false}, "before_length": 44, "before_sha256": "7f4e621808aca7e117ab4886af883c882dab335ec56f45d82418e9364908f7f4", "change_kind": "content", "change_operations": [{"after_end": 33, "after_start": 32, "before_end": 33, "before_start": 32, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7941fb984e9f4ffd13e0aae5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6932}
{"after": {"end": 101, "start": 0, "text": "Si vous prenez ces médicaments, demandez à votre médecin s’il est nécessaire de modifier leurs doses.", "truncated": false}, "after_length": 101, "after_sha256": "e000fe02fa43ba1cbdf38919b8b55a81dd96a8aacbb80810eb04586c675d2725", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 101, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 101}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-79426f9ef0d05d2d0fb88304", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3312}
{"after": {"end": 134, "start": 0, "text": "Detailed information on this medicinal product is available on the website of the European Medicines Agency https://www.ema.europa.eu.", "truncated": false}, "after_length": 134, "after_sha256": "9f2a855337f11701b0cd4191c51820fa5a70b201b2e0721ba6acd34544486f89", "annex": "I", "before": {"end": 133, "start": 0, "text": "Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.", "truncated": false}, "before_length": 133, "before_sha256": "eabdb61a543e11ee016c5c43ada549964199ddf9e287a2eb3256e15d4a87fe4a", "change_kind": "technical", "change_operations": [{"after_end": 113, "after_start": 112, "before_end": 112, "before_start": 112, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7998d433ddf303a0c4337d73", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 10 mg powder and solvent for solution for injection for paediatric use", "presentation_occurrence": 5, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "10", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5350}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 16, "start": 0, "text": "EU/1/20/1507/020", "truncated": false}, "before_length": 16, "before_sha256": "24e41f53013b46d585ebe8856fcbf0da6b83f359b8ac25b77c32888ae8d565f1", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 16, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 16, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-799bc1a6c6be524f80242cda", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "8", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6477}
{"after": {"end": 531, "start": 0, "text": "Flacon en verre transparent (2 mL, verre de type I) avec bouchon en caoutchouc, opercule en aluminium et capuchon en plastique. Enbrel est fourni avec des seringues remplies d’eau pour préparations injectables. Les seringues sont en verre de type I. Le capuchon de la seringue contient du caoutchouc naturel sec (latex) (voir rubrique 4.4). Chaque coffret contient 4, 8 ou 24 flacons d’Enbrel, 4, 8 ou 24 seringues pré-remplies de solvant, 4, 8 ou 24 aiguilles, 4, 8 ou 24 adaptateurs pour flacon et 8, 16 ou 48 tampons alcoolisés.", "truncated": false}, "after_length": 531, "after_sha256": "a1d72836b8a2c3f4b36907d2e56ffbafc82f28a6f0170b48e0342cee01ef4bb8", "annex": "I", "before": {"end": 531, "start": 0, "text": "Flacon en verre transparent (2 ml, verre de type I) avec bouchon en caoutchouc, opercule en aluminium et capuchon en plastique. Enbrel est fourni avec des seringues remplies d’eau pour préparations injectables. Les seringues sont en verre de type I. Le capuchon de la seringue contient du caoutchouc naturel sec (latex) (voir rubrique 4.4). Chaque coffret contient 4, 8 ou 24 flacons d’Enbrel, 4, 8 ou 24 seringues pré-remplies de solvant, 4, 8 ou 24 aiguilles, 4, 8 ou 24 adaptateurs pour flacon et 8, 16 ou 48 tampons alcoolisés.", "truncated": false}, "before_length": 531, "before_sha256": "beddfb6f7e0a8aee2cf322c1721ba09b7b47b6b58edb2efc413abdf051cc7df5", "change_kind": "content", "change_operations": [{"after_end": 33, "after_start": 32, "before_end": 33, "before_start": 32, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-799f0aa579736df1b357011b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg poudre et solvant pour solution injectable", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.5", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2226}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 11, "start": 0, "text": "Takeda GmbH", "truncated": false}, "before_length": 11, "before_sha256": "94e4e4fc81542d4a8a0deb904c666e74cf300a1075af4d0d2e564a29e287bafb", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 11, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 11, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-79a23b5057ef1af57be82fe4", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2179}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IV", "before": {"end": 8, "start": 0, "text": "ANNEX IV", "truncated": false}, "before_length": 8, "before_sha256": "29972ab77d4b1358a0bdb16d438bcde59007e95356d1f5f9ee2f7045597f9574", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 8, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 8, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-79d0b69e1a99f1fddfad07a4", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3418}
{"after": {"end": 15, "start": 0, "text": "Package Leaflet", "truncated": false}, "after_length": 15, "after_sha256": "796e28cb034d12fd5f4d3e0c27e49b2371918130eccbf158a91b27e6d6955491", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 15, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 15}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-79dba1fb84543882f930bfc3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:30Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "35ab6716aa09492c14ac6849111486ec47235c0bc65ef055350de950f316c5e6", "source_snapshot_id": "source-f20a60110d1f8fef5225317d", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2363}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 18, "start": 0, "text": "medis.lt@medis.com", "truncated": false}, "before_length": 18, "before_sha256": "728d3d606791c6b09f567fff9013bcbe51b504b37bbdcf449ccd76825c396355", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 18, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 18, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-79ddeaffc0dd8de8485caae6", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1161}
{"after": {"end": 33, "start": 0, "text": "Table 1. Spikevax LP.8.1 posology", "truncated": false}, "after_length": 33, "after_sha256": "0466000be06a9312bec70569d8637fc469f24a980a33b065a44a9eb106dd01e1", "annex": "I", "before": {"end": 31, "start": 0, "text": "Table 1. Spikevax JN.1 posology", "truncated": false}, "before_length": 31, "before_sha256": "0f665f9e0711686368e9e7ae20cdabdcb1afe3ad797a6dd8b0d0bc8c543ae3cd", "change_kind": "administrative", "change_operations": [{"after_end": 22, "after_start": 18, "before_end": 20, "before_start": 18, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-79e3cc9af742754c97186b6e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12691}
{"after": {"end": 47, "start": 0, "text": "Spikevax LP.8.1 50 mcg dispersion for injection", "truncated": false}, "after_length": 47, "after_sha256": "23cc0e8e2074df0ca7dbef2f4bdf752856993c6717cee4dc7b6447156576ba72", "annex": "IIIA", "before": {"end": 45, "start": 0, "text": "Spikevax JN.1 50 mcg dispersion for injection", "truncated": false}, "before_length": 45, "before_sha256": "1e678948233d2a25b779218928966af3f5643f17a6c1ee085306e6bf41c3568e", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7a21a1104792c0d64f666f5a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9305}
{"after": {"end": 345, "start": 0, "text": "Compte tenu des rapports spontanés et issus de la littérature sur le surdosage, une relation de cause à effet entre le pérampanel et les vomissements dans le cadre d’un surdosage constitue au minimum une possibilité raisonnable. Les informations sur le produit relatives aux produits contenant du pérampanel doivent être modifies en conséquence.", "truncated": false}, "after_length": 345, "after_sha256": "e649e1d1fa00bc4eef46b370e5f5ad4320248a2760c112bb722d7065990920e8", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 345, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 345}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7a2ab42cdf848621d328fe3b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:32:00Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "3ff8cd4d67d22ba799aa348aeda944d6d896a16dcf54b030db101cbc095fc8ad", "source_snapshot_id": "source-a79a7cba8bf5dbc72fd40574", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3533}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "office@mundipharma.cz", "truncated": false}, "before_length": 21, "before_sha256": "502b326847805f2dbe39170c7111e402160b27e2622e4dc4d2c62c9ba45db561", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 21, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 21, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7a4740fcba69a6a3c5e76b7f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1037}
{"after": {"end": 328, "start": 0, "text": "Instructions that the HCP has to provide the patient/carer with the PIC and to make sure that the patients/carers know they can also view a training video on nyxoid.com, and are encouraged to read the package leaflet included in the medicinal product outer carton, and the quick start guide (QSG) on the inner packaging blister.", "truncated": false}, "after_length": 328, "after_sha256": "05ee9a906ef3ea7e1d9b6527f26fe422faa15142442409388d8dca31bd347cc3", "annex": "II", "before": {"end": 310, "start": 0, "text": "Instructions that the HCP has to provide the patient/carer with the PIC and to make sure that the patients/carers will have access to the video (either through the PIC or memory stick) and are encouraged to read the quick starting guide (QSG) and package leaflet included in the medicinal product outer carton.", "truncated": false}, "before_length": 310, "before_sha256": "10b9c4b395b4d7c3db6e31c48c016f84bc8196e9d65b67fc1abe34fc01353d8c", "change_kind": "content", "change_operations": [{"after_end": 117, "after_start": 114, "before_end": 114, "before_start": 114, "kind": "insert"}, {"after_end": 118, "after_start": 118, "before_end": 133, "before_start": 115, "kind": "delete"}, {"after_end": 148, "after_start": 122, "before_end": 137, "before_start": 137, "kind": "insert"}, {"after_end": 162, "after_start": 155, "before_end": 146, "before_start": 144, "kind": "replace"}, {"after_end": 166, "after_start": 163, "before_end": 155, "before_start": 147, "kind": "replace"}, {"after_end": 167, "after_start": 167, "before_end": 171, "before_start": 156, "kind": "delete"}, {"after_end": 169, "after_start": 168, "before_end": 184, "before_start": 172, "kind": "replace"}, {"after_end": 200, "after_start": 200, "before_end": 246, "before_start": 215, "kind": "delete"}, {"after_end": 327, "after_start": 263, "before_end": 309, "before_start": 309, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 86, "chars_inserted": 104}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7ae74950879fead09c916336", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:33Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "21d66bf1e9a74479f577de09da3cf8517d65c1ce1b1d8bbdfe4bc38f79410def", "source_snapshot_id": "source-2c39c998fdaf05159687c016", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 433}
{"after": {"end": 22, "start": 0, "text": "Tel.: +420 277 050 000", "truncated": false}, "after_length": 22, "after_sha256": "5a73afc7c7a9b40fee1c264ddd73318b7831c01ad752d8e98c531d058ff77e22", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tel: +420 233 010 111", "truncated": false}, "before_length": 21, "before_sha256": "86999b702f11fb434a8ae044a79bf67743758f2695ac34bae0355d2effa55dff", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}, {"after_end": 14, "after_start": 12, "before_end": 13, "before_start": 11, "kind": "replace"}, {"after_end": 17, "after_start": 16, "before_end": 16, "before_start": 15, "kind": "replace"}, {"after_end": 22, "after_start": 19, "before_end": 21, "before_start": 18, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 7}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7b395414054e13599c453ae0", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3080}
{"after": {"end": 22, "start": 0, "text": "Teл.: +359 2 819 37 37", "truncated": false}, "after_length": 22, "after_sha256": "f99d9da7522776c9e193c3d902a0bfac1449878008698e67a70066d46f048b40", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "Teл.: + 359 2 819 37 37", "truncated": false}, "before_length": 23, "before_sha256": "c607221a5f8b9a53eea2b30c436402b48449ce353ad88bc41c01cdb4f8bb48e8", "change_kind": "content", "change_operations": [{"after_end": 7, "after_start": 7, "before_end": 8, "before_start": 7, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7b3e830db9d89ad4302787ed", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2983}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 7, "start": 0, "text": "Sverige", "truncated": false}, "before_length": 7, "before_sha256": "3a7d70b4edb982a403e97d77681309e5fb1032b12d727aa1e92b145b069b9aa4", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 7, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7b560da66746dc7fb1694962", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1143}
{"after": {"end": 13, "start": 0, "text": "Getting Ready", "truncated": false}, "after_length": 13, "after_sha256": "4b1c18aa0d141bf5dab1162686376baa5d9294b3534cd444b11958da7eb1a13d", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 13}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7b6551a63f57df631c58ef0a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1966}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "medinfo@mundipharma.pt", "truncated": false}, "before_length": 22, "before_sha256": "5459a27479d0597a7c1b1ca3825cab8fd8337cfb671df321accb79b7a7f908a8", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 22, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 22, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7bab92e4c2b813b03da9089d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1099}
{"after": {"end": 192, "start": 0, "text": "Votre médecin vous remettra également une Carte Patient qui comportera des informations importantes de sécurité d’emploi que vous devez connaître, avant et pendant votre traitement par Enbrel.", "truncated": false}, "after_length": 192, "after_sha256": "a9b61621aee7f348e503c6ef13da6f1d4dc6f2a4d953f840016b3daaebeecd6a", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 192, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 192}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7bda69e6d2ad4c3cdb2c38dd", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11375}
{"after": {"end": 43, "start": 0, "text": "Pfizer Healthcare Ireland Unlimited Company", "truncated": false}, "after_length": 43, "after_sha256": "1f203777a0ec6fed9c840d52631b6a74c7e25b5d318485d8147e2404f52dc981", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "Pfizer Healthcare Ireland", "truncated": false}, "before_length": 25, "before_sha256": "4beeea9b6d0c491f03a9511d9f9576b9c75cbcdcfd736e4934f768fdded936f5", "change_kind": "content", "change_operations": [{"after_end": 43, "after_start": 25, "before_end": 25, "before_start": 25, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 18}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7c0e88636a3c535bba1ae281", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 8556}
{"after": {"end": 164, "start": 0, "text": "douleurs musculaires ou raideurs ou faiblesse ou fatigue rapide des muscles (pouvant être les signes d’une inflammation ou d’autres problèmes au niveau des muscles)", "truncated": false}, "after_length": 164, "after_sha256": "1a013ae9070a8a01827126b4e11f87dd9be7781b15a00557ad168f855c805379", "annex": "IIIA", "before": {"end": 153, "start": 0, "text": "douleurs musculaires, ou faiblesse ou fatigue rapide des muscles (pouvant être les signes d’une inflammation ou d’autres problèmes au niveau des muscles)", "truncated": false}, "before_length": 153, "before_sha256": "d50d66ee631cf6254935dfd98da0c3d9bd53ea7e19a2d48b6bac0b587ceca911", "change_kind": "content", "change_operations": [{"after_end": 32, "after_start": 20, "before_end": 21, "before_start": 20, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 12}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7c495b48362c164bc932e35e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:18Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "2437ab76633f46c9eee5e002e5c7a7caba6367f59567d750be0eb67c74d1db4e", "source_snapshot_id": "source-7f4d129b0a0fd2d3684d27c5", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2072}
{"after": {"end": 43, "start": 0, "text": "Pfizer Healthcare Ireland Unlimited Company", "truncated": false}, "after_length": 43, "after_sha256": "1f203777a0ec6fed9c840d52631b6a74c7e25b5d318485d8147e2404f52dc981", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "Pfizer Healthcare Ireland", "truncated": false}, "before_length": 25, "before_sha256": "4beeea9b6d0c491f03a9511d9f9576b9c75cbcdcfd736e4934f768fdded936f5", "change_kind": "content", "change_operations": [{"after_end": 43, "after_start": 25, "before_end": 25, "before_start": 25, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 18}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7c58f43930cbd2338076f844", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9661}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 20, "start": 0, "text": "For single-use only.", "truncated": false}, "before_length": 20, "before_sha256": "f7b36887a4d8d6c0230c11c845772064907c62d5d036ebc2ec7a8d66cdc325df", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 20, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 20, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7c6e18498a8371ab5bb39900", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12857}
{"after": {"end": 21, "start": 0, "text": "Block 2 Miesian Plaza", "truncated": false}, "after_length": 21, "after_sha256": "99b504ac4fff9020da29e00aeb786f0975177380626e2b3347bd3fbd75afeeba", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "administrative", "change_operations": [{"after_end": 21, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 21}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7c9b89b2666afeb59989cc6c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "Qdenga powder and solvent for solution for injection Qdenga powder and solvent for solution for injection in pre-filled syringe Dengue tetravalent vaccine (live, attenuated)", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 974}
{"after": {"end": 44, "start": 0, "text": "Contact details of the etanercept prescriber", "truncated": false}, "after_length": 44, "after_sha256": "5f704ce7d984777b146dfe967410fa58e0ac8f8cb334ef0dd4e0c05ab4879167", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 44, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 44}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7cd4a0f3a5888fd0637ae6e9", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6578}
{"after": {"end": 43, "start": 0, "text": "Pfizer Healthcare Ireland Unlimited Company", "truncated": false}, "after_length": 43, "after_sha256": "1f203777a0ec6fed9c840d52631b6a74c7e25b5d318485d8147e2404f52dc981", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "Pfizer Healthcare Ireland", "truncated": false}, "before_length": 25, "before_sha256": "4beeea9b6d0c491f03a9511d9f9576b9c75cbcdcfd736e4934f768fdded936f5", "change_kind": "content", "change_operations": [{"after_end": 43, "after_start": 25, "before_end": 25, "before_start": 25, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 18}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7cd53c05654c9187ef7f7d59", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9547}
{"after": {"end": 22, "start": 0, "text": "Tel: + 420 296 188 338", "truncated": false}, "after_length": 22, "after_sha256": "cade761d1991183690c5d39848f424472df61dbad0bc430b6f01fef8e76b3e31", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "Tel: + 420 222 318 221", "truncated": false}, "before_length": 22, "before_sha256": "bb97657d5fa1378aa53d1991199309e2efe0a292f06fc3bf2e0ab4b83ac0c8eb", "change_kind": "content", "change_operations": [{"after_end": 18, "after_start": 12, "before_end": 14, "before_start": 12, "kind": "replace"}, {"after_end": 21, "after_start": 20, "before_end": 17, "before_start": 16, "kind": "replace"}, {"after_end": 22, "after_start": 22, "before_end": 22, "before_start": 18, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 7}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7d4e5e84e3c37b684aeccba5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1018}
{"after": {"end": 60, "start": 0, "text": "Vidéo/plus d’information : <code QR inclus> + www.nyxoid.com", "truncated": false}, "after_length": 60, "after_sha256": "7ce67ab6bdd7e9000ebcec4a826d9004d8d489139f02173e9d98d256b92d7ea7", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 60, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 60}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7d9884b347db21895ad2ee73", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 613}
{"after": {"end": 494, "start": 0, "text": "a Les termes représentent des groupes d’évènements indésirables décrivant un concept médical plutôt qu’une condition particulière ou terme privilégié MedDRA (Medical Dictionary for Regulatory Activities). Ce groupe de termes médicaux peut impliquer la même physiopathologie sous-jacente (ex : les effets thromboemboliques artériels incluent les accidents vasculaires cérébraux, les infarctus du myocarde, les accidents ischémiques transitoires et les autres effets thromboemboliques artériels).", "truncated": false}, "after_length": 494, "after_sha256": "e1f57e4840933819187adda135c911bfaac3b436d9307fd3081669360b4f99b8", "annex": "I", "before": {"end": 494, "start": 0, "text": "a Les termes représentent des groupes d’évènements indésirables décrivant un concept médical plutôt qu’une condition particulière ou terme privilégié MedDRA (Medical Dictionnay for Regulatory Activities). Ce groupe de termes médicaux peut impliquer la même physiopathologie sous-jacente (ex : les effets thromboemboliques artériels incluent les accidents vasculaires cérébraux, les infarctus du myocarde, les accidents ischémiques transitoires et les autres effets thromboemboliques artériels).", "truncated": false}, "before_length": 494, "before_sha256": "b45a70960afb14e09437426b518b17df535e9550c29a65564a6d291eea32d838", "change_kind": "content", "change_operations": [{"after_end": 173, "after_start": 173, "before_end": 174, "before_start": 173, "kind": "delete"}, {"after_end": 175, "after_start": 174, "before_end": 175, "before_start": 175, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7dd617cf4061ea4fafa1e6a6", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 710}
{"after": {"end": 12, "start": 0, "text": "Mood altered", "truncated": false}, "after_length": 12, "after_sha256": "4cb039f460aa36d38a27b9aab449a350bdeb3095feae82411590221c08c2e3d0", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 12, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 12}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7e1059c5468b8bee38253934", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:30Z", "pipeline_version": "2.0.0", "presentation_label": "Otezla 10 mg film-coated tablets Otezla 20 mg film-coated tablets Otezla 30 mg film-coated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "35ab6716aa09492c14ac6849111486ec47235c0bc65ef055350de950f316c5e6", "source_snapshot_id": "source-f20a60110d1f8fef5225317d", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 340}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 32, "start": 0, "text": "Mundipharma Pharmaceuticals B.V.", "truncated": false}, "before_length": 32, "before_sha256": "5e3117c414bcce433a82de23b7ca56a59a8584ed386564084c3eb341a17c8520", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 32, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 32, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7e1bb815308abdb0548aaef5", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1056}
{"after": {"end": 20, "start": 0, "text": "Tel. +370 5 2780 247", "truncated": false}, "after_length": 20, "after_sha256": "be9916884a39997d225e35a54dcbad608c2f1450d383ed91a2b2c37447acf059", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Tel + 370 5 2780 247", "truncated": false}, "before_length": 20, "before_sha256": "efbdd6098836fb2d599921d1b729194cb12c4277b6ed9ce6d128aeedf65638c9", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}, {"after_end": 6, "after_start": 6, "before_end": 6, "before_start": 5, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7e616e8f097bb667415af15c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3379}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 41, "start": 0, "text": "Mundipharma Corporation (Ireland) Limited", "truncated": false}, "before_length": 41, "before_sha256": "1508b8eae555a7f920ad3f9f7dc0b3f86d6bca3f7a3f44b91a1699e58db6295c", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 41, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 41, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7e97a695a7af9f5f44baa97a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1071}
{"after": {"end": 247, "start": 0, "text": "Les utilisateurs sont les personnes disposant de capacités visuelles, manuelles et tactiles suffisantes pour utiliser le Terrosa Pen, conformément aux Instructions d’utilisation. En cas de handicap, une consultation avec le médecin est nécessaire.", "truncated": false}, "after_length": 247, "after_sha256": "4f5181909f4b007f3143d5c171fd389e8efc72340c93b911e354e4650af0da85", "annex": "IIIA", "before": {"end": 249, "start": 0, "text": "Les utilisateurs sont les personnes disposant de capacités visuelles, manuelles et tactiles suffisantes pour utiliser le stylo Terrosa, conformément aux Instructions d’utilisation. En cas de handicap, une consultation avec le médecin est nécessaire.", "truncated": false}, "before_length": 249, "before_sha256": "1d68956d7c6a3424b680ae719468281db9034083177ba60157f3183263ab5065", "change_kind": "content", "change_operations": [{"after_end": 121, "after_start": 121, "before_end": 127, "before_start": 121, "kind": "delete"}, {"after_end": 132, "after_start": 128, "before_end": 134, "before_start": 134, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7ea593df59b2228090ddd884", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1943}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "II", "before": {"end": 143, "start": 0, "text": "L’efficacité de l’administration de Nyxoid (naloxone intranasale) par des non professionnels de santé sur à inverser un surdosage aux opioïdes.", "truncated": false}, "before_length": 143, "before_sha256": "0950f68f871f3be13e73a1ecef1059f9145e3701d031c112e4b561763b3a07b4", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 143, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 143, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7ec53d3ca24311f0610a2821", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 474}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 14, "start": 0, "text": "Pfizer Limited", "truncated": false}, "before_length": 14, "before_sha256": "faadd350d247ecbb0e8edac0805fa3d4cdbf449fbb9a1a9614eee6624274a2f6", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7ed20941552dcdaeed3e6393", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 8520}
{"after": {"end": 8, "start": 0, "text": "ANNEX IV", "truncated": false}, "after_length": 8, "after_sha256": "29972ab77d4b1358a0bdb16d438bcde59007e95356d1f5f9ee2f7045597f9574", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 8, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7ede2bf74de17c76473fba6c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2525}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "Tel: +44 (0)1304 616161", "truncated": false}, "before_length": 23, "before_sha256": "eba81e6ccdbae471c024a5ba77d9ec9e0617a3c443fd22205a626861e87fbd8c", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 23, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 23, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7f4647e93a9120feed90b545", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11175}
{"after": {"end": 6, "start": 0, "text": "9 (41)", "truncated": false}, "after_length": 6, "after_sha256": "661a4337da5a45b9124e2c8a883aa948806860c37388fe296424d58060cbe9f4", "annex": "I", "before": {"end": 6, "start": 0, "text": "7 (32)", "truncated": false}, "before_length": 6, "before_sha256": "5381cf2caeeb0c444d378826e402319e8afb7abc2f842250a25d2f9e776cc61e", "change_kind": "content", "change_operations": [{"after_end": 1, "after_start": 0, "before_end": 1, "before_start": 0, "kind": "replace"}, {"after_end": 5, "after_start": 3, "before_end": 5, "before_start": 3, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 3, "chars_inserted": 3}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7f5a51857e918d62dcec3447", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005352", "medicine_name": "Upstaza", "medicine_slug": "upstaza", "observed_at": "2026-10-12T13:36:07Z", "pipeline_version": "2.0.0", "presentation_label": "Upstaza 2.8 × 1011 vector genomes (vg)/0.5 mL solution for infusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8561a0c5aed752dd415d30acef76bf620ad205d702080a0bca765e086873fe20", "source_snapshot_id": "source-4b712d5f9e4e2e8cd620aa93", "source_updated_at": "2026-06-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/upstaza-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 316}
{"after": {"end": 35, "start": 0, "text": "Grossesse, allaitement et fertilité", "truncated": false}, "after_length": 35, "after_sha256": "a3f31be351c315977f1ed7fdb7ec82bdf1c6f2166951e68356fb7dac43cc0a41", "annex": "IIIA", "before": {"end": 35, "start": 0, "text": "Grossesse, allaitement et fécondité", "truncated": false}, "before_length": 35, "before_sha256": "978e9c247774861ffb3738b81331bbe27115c9c310f7135d60310259a0cd6fa1", "change_kind": "content", "change_operations": [{"after_end": 32, "after_start": 27, "before_end": 32, "before_start": 27, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 5, "chars_inserted": 5}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7f63d46a88327785bf3bb5c0", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3041}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 14, "start": 0, "text": "Mundipharma BV", "truncated": false}, "before_length": 14, "before_sha256": "aa43c52e5bcfdc7b36232711c5dd25de9255fafdc355d6d9a2d1955654fe4598", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7f70c61fa4560dc7b7b54e0a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1030}
{"after": {"end": 588, "start": 0, "text": "La naloxone n’a eu aucun effet sur la fertilité et la reproduction chez le rat ou sur le développement embryonnaire précoce du rat et du lapin. Dans les études péri-postnatalités chez le rat, la naloxone à des doses élevées a entraîné une augmentation de la mortalité des nouveau-nés dans la période post-partum immédiate et une toxicité maternelle significative (par ex. perte de masse corporelle, convulsions). La naloxone n’a pas affecté le développement ou le comportement des animaux survivants issus de ces portées. La naloxone n’est donc pas tératogène chez les rats ou les lapins.", "truncated": false}, "after_length": 588, "after_sha256": "266cc4c23815aae9045b6454979856397aebb1a05f4b308a4c93c664394eac02", "annex": "I", "before": {"end": 587, "start": 0, "text": "La naloxone n’a eu aucun effet sur la fertilité et la reproduction chez le rat ou sur le développement embryonnaire précoce du rat et du lapin. Dans les études péri-postnatalités chez le rat, la naloxone à des doses élevées a entraîné une augmentation de la mortalité des nouveau-nés dans la période postpartum immédiate et une toxicité maternelle significative (par ex. perte de masse corporelle, convulsions). La naloxone n’a pas affecté le développement ou le comportement des animaux survivants issus de ces portées. La naloxone n’est donc pas tératogène chez les rats ou les lapins.", "truncated": false}, "before_length": 587, "before_sha256": "4270ef86262fa8cae6d8fd3ab080fcb98a5e227611c9cd8f297f4f8a8a0cee1f", "change_kind": "content", "change_operations": [{"after_end": 305, "after_start": 304, "before_end": 304, "before_start": 304, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7fb02a29c9db69da5ffef3eb", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "Nyxoid 1,8 mg, solution pour pulvérisation nasale en récipient unidose", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.3", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 281}
{"after": {"end": 8, "start": 0, "text": "D02 HW68", "truncated": false}, "after_length": 8, "after_sha256": "1ed87437489fcb80b59bfa5d17082f438d78a8aff5deaac6125946420fbf0992", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 8, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7fb09d4d9f9cd1d4fe464cb0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2187}
{"after": {"end": 25, "start": 0, "text": "• a compatible pen needle", "truncated": false}, "after_length": 25, "after_sha256": "18085f47cf798ee6c653801d669468dcd807cc02d0661d672ac7e33ef4bdcb60", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 25, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 25}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-7fbf2af34484762ac04579b1", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1971}
{"after": {"end": 19, "start": 0, "text": "Mundipharma DC B.V.", "truncated": false}, "after_length": 19, "after_sha256": "e3293d50ef13895d680c96110997100aa9ea415c79a538edde8c542ffb4f7ce6", "annex": "II", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 19, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 19}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8031289b7be178ddec431198", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 533}
{"after": {"end": 358, "start": 0, "text": "Adempas a une influence modérée sur l’aptitude à faire du vélo, à conduire des véhicules et à utiliser des machines. Adempas peut provoquer des effets indésirables tels que des étourdissements. Vous devez connaître les effets indésirables de ce médicament sur vous avant de faire du vélo, de conduire un véhicule ou d’utiliser des machines (voir rubrique 4).", "truncated": false}, "after_length": 358, "after_sha256": "6ac6f21fd29b27ab0f8b0ccafa69b2f9fdbcb0db0ea81d37fd4c0621d8b8d965", "annex": "IIIA", "before": {"end": 372, "start": 0, "text": "Adempas a une influence modérée sur l’aptitude à faire du vélo, à conduire des véhicules et à utiliser des machines. Adempas peut provoquer des effets indésirables tels que des étourdissements. Vous devez connaître les effets indésirables de ce médicament sur vous avant de faire du vélo, de conduire un véhicule ou d’utiliser des outils ou des machines (voir rubrique 4).", "truncated": false}, "before_length": 372, "before_sha256": "df4dfcc54b3457523c3f8dc3b0393d499e05a328d7e7cfca9df6967aa74085bd", "change_kind": "content", "change_operations": [{"after_end": 331, "after_start": 331, "before_end": 345, "before_start": 331, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-803277569dd71808f42f01d8", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3324}
{"after": {"end": 37, "start": 0, "text": "St. John’s Wort, to treat depression.", "truncated": false}, "after_length": 37, "after_sha256": "c65491c42b0e77c12917a8d6e7ce7701b4d3f76af5da04ad99883ca4ca919fb7", "annex": "IIIA", "before": {"end": 35, "start": 0, "text": "depression such as St. John’s Wort.", "truncated": false}, "before_length": 35, "before_sha256": "c6ca9212f5b5a19d813161b53399a45d1a7b73ae24cc5df4ef1e68707378853e", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 19, "before_start": 0, "kind": "delete"}, {"after_end": 36, "after_start": 15, "before_end": 34, "before_start": 34, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 19, "chars_inserted": 21}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-80442109fd7d90ebba101820", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3206}
{"after": {"end": 25, "start": 0, "text": "50-58 Baggot Street Lower", "truncated": false}, "after_length": 25, "after_sha256": "2b6052bef6a7051ce20b776d1525055c417fc02e59b9e559cd21b7aa4c7859f0", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "administrative", "change_operations": [{"after_end": 25, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 25}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-80514d8852aee87382f21da0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "Qdenga powder and solvent for solution for injection Qdenga powder and solvent for solution for injection in pre-filled syringe Dengue tetravalent vaccine (live, attenuated)", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 975}
{"after": {"end": 74, "start": 0, "text": "* Do not use the prefilled syringe to deliver a partial volume of 0.25 mL.", "truncated": false}, "after_length": 74, "after_sha256": "75e296bff3c238176d513ed450c19057750a20263b5a3152d3b7a7c0a0d4190e", "annex": "I", "before": {"end": 94, "start": 0, "text": "* Do not use the single-dose vial or prefilled syringe to deliver a partial volume of 0.25 mL.", "truncated": false}, "before_length": 94, "before_sha256": "34a3dd6a9a278560b1c455186ca0846462be29c70b70a4dd2f194f53b65e7df3", "change_kind": "administrative", "change_operations": [{"after_end": 17, "after_start": 17, "before_end": 37, "before_start": 17, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 20, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-808840ee7e944b10fc418a2e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12722}
{"after": {"end": 22, "start": 0, "text": "Tlf.: + 45 36 35 91 00", "truncated": false}, "after_length": 22, "after_sha256": "ee5cfc7acaf9dfe8868ac7e8cd8079d0cb8f85922089533a08d33e515be7aea6", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tlf: + 45 36 35 91 00", "truncated": false}, "before_length": 21, "before_sha256": "18d8cf6a57f2048255a4474230a78ae1192c8bd63af3a4aa0c409cccfeafcba9", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-80c89d8b53fafbe641b34c1d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000112", "medicine_name": "Twinrix Adult", "medicine_slug": "twinrix-adult", "observed_at": "2026-10-12T13:29:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "bc8ba3adecfe04d3079e5b502251cec982d6197257fe3b7ec3a22dc5f2ace654", "source_snapshot_id": "source-8439a1a319b62d1bd67256a4", "source_updated_at": "2026-08-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/twinrix-adult-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 905}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 26, "start": 0, "text": "Tel: + 385 (0) 1 230 34 46", "truncated": false}, "before_length": 26, "before_sha256": "6619ab5d144eee4d434c704be01e6c2c45b7995dba9dc48588a036bbe5033fa8", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 26, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 26, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8169fb6a6cc10b7182ad3a92", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1102}
{"after": {"end": 191, "start": 0, "text": "Le Terrosa Pen peut être utilisé par des patients de plus de 18 ans qui effectuent eux-mêmes les injections, des professionnels de santé, des soignants ou des tiers comme des parents adultes.", "truncated": false}, "after_length": 191, "after_sha256": "efd722cd42787556d8ccde1ab3d3a7f7228e7b2a178bf3e29f04dccdf7a1fdbc", "annex": "IIIA", "before": {"end": 193, "start": 0, "text": "Le stylo Terrosa peut être utilisé par des patients de plus de 18 ans qui effectuent eux-mêmes les injections, des professionnels de santé, des soignants ou des tiers comme des parents adultes.", "truncated": false}, "before_length": 193, "before_sha256": "e78814379bff9ffaa4fbac68dfc9c1a27bd3cc6ef1478005ad1e54dd89686e92", "change_kind": "content", "change_operations": [{"after_end": 3, "after_start": 3, "before_end": 9, "before_start": 3, "kind": "delete"}, {"after_end": 14, "after_start": 10, "before_end": 16, "before_start": 16, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-81d9bf95235e3b1d7807756c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2083}
{"after": {"end": 54, "start": 0, "text": "Takeda Pharmaceuticals International AG Ireland Branch", "truncated": false}, "after_length": 54, "after_sha256": "81709515d3af1f0e4041ce3c760d8fc81fefa358805810b0b53a84e121d5efa6", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 54, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 54}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-81dd854fba79a228022a4110", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1211}
{"after": {"end": 41, "start": 0, "text": "granisetron, to treat nausea or vomiting.", "truncated": false}, "after_length": 41, "after_sha256": "02313269663817b1422e036a2a8bbb2c823289fc07314b73564db7ea9513ad81", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 41, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 41}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-821dac3b75d7d369e046d3a9", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3216}
{"after": {"end": 78, "start": 0, "text": "d’autres stimulateurs de la guanylate cyclase soluble, tels que le vériciguat.", "truncated": false}, "after_length": 78, "after_sha256": "059958cf15d8017283a6ca168e2980976c8fc984ded0844928869b4986562cb6", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 78, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 78}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-823c6af487794aa3415e229f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3293}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 14, "start": 0, "text": "Thawed vaccine", "truncated": false}, "before_length": 14, "before_sha256": "7864c2e98568bc0a8ed25705c428702f002a7985738cc04fffeeaa761c6c0d30", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-823d2db2aae06075e7ccc27d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13081}
{"after": {"end": 78, "start": 0, "text": "Inflammation of the muscles causing pain or stiffness (polymyalgia rheumatica)", "truncated": false}, "after_length": 78, "after_sha256": "229dc70dfa970159cf016d3e6065174409e558a2b7a84702f2b27a06e9040a9e", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 78, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 78}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8250e944100aea11b1fb1323", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2281}
{"after": {"end": 247, "start": 0, "text": "Ce document constitue les informations sur le produit approuvées pour NovoRapid, les modifications apportées depuis la procédure précédente qui ont une incidence sur les informations sur le produit (EMEA/H/C/000258/N/0146) étant mises en évidence.", "truncated": false}, "after_length": 247, "after_sha256": "e6532c1e3b6104ac5b91cdd2cb13c858f438a505ceae1f596270942c870e148d", "annex": "", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 247, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 247}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-825ac8e4b4d7f0b2bcbb474d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000258", "medicine_name": "NovoRapid", "medicine_slug": "novorapid", "observed_at": "2026-10-12T19:05:20Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "7a2e275dc85e326e218371029d27a1433946e84b3ea473376b27254ac744b108", "source_snapshot_id": "source-a7dd2dd81f4bb5f7de078b9c", "source_updated_at": "2025-10-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/novorapid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 4}
{"after": {"end": 13, "start": 0, "text": "Hermeslaan 11", "truncated": false}, "after_length": 13, "after_sha256": "6426889eacea87c88f1e0405aad54515d8a889ca0f1b2ab39e2039040651e7d3", "annex": "I", "before": {"end": 11, "start": 0, "text": "Hoge Wei 10", "truncated": false}, "before_length": 11, "before_sha256": "ba5c0cab58e83e9dc6ec41e55e6acc00077e1be63c8a1ed970723221f2f12ba4", "change_kind": "administrative", "change_operations": [{"after_end": 1, "after_start": 1, "before_end": 3, "before_start": 1, "kind": "delete"}, {"after_end": 4, "after_start": 2, "before_end": 6, "before_start": 4, "kind": "replace"}, {"after_end": 10, "after_start": 5, "before_end": 8, "before_start": 7, "kind": "replace"}, {"after_end": 13, "after_start": 12, "before_end": 11, "before_start": 10, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-82ee2b8a1c4fbea87603a62e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004310", "medicine_name": "Daptomycin Hospira", "medicine_slug": "daptomycin-hospira", "observed_at": "2026-10-12T19:09:33Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "3242bb93d94dc3b7e86b89af5160c6986e8caa2e4f8d73bf8a634a557420452a", "source_snapshot_id": "source-dd7a18b7c210239223fa10ad", "source_updated_at": "2025-09-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/daptomycin-hospira-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1990}
{"after": {"end": 187, "start": 0, "text": "Les effets indésirables suivants doivent être ajoutés dans la classe de systèmes d’organes « Affections psychiatriques », avec une fréquence « peu fréquent » : anxiété et humeur modifiée.", "truncated": false}, "after_length": 187, "after_sha256": "1a801af2bca0d03462304f46ae73bf3c01d83b0e80c6adc4fd7c22199b54e056", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 187, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 187}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-82f53341ed9ce5944c8905b2", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "9ac80b0d56ebad4970f7a8335a177613af59ef25517bcd0bdd3397c207cc1bac", "source_snapshot_id": "source-c11aa9e32420f125a88005bc", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2733}
{"after": {"end": 604, "start": 0, "text": "L’etanercept est absorbé lentement depuis le site d’injection sous-cutanée, atteignant une concentration maximale environ 48 heures après administration unique. La biodisponibilité absolue est de 76 %. Avec deux doses par semaine, on peut s’attendre à ce que les concentrations à l’état d’équilibre représentent environ deux fois celles que l’on mesure après administration unique. Après l’administration unique, par voie sous-cutanée, de 25 mg d’Enbrel, la concentration sérique maximale moyenne observée chez les volontaires sains était de 1,65 0,66 g/mL, l’aire sous la courbe étant de 235 96,6 gh/mL.", "truncated": false}, "after_length": 604, "after_sha256": "6f40ddbb33800058afb763e3202115e0356ab1fbfa07ceaf21c15a552d5c4836", "annex": "I", "before": {"end": 604, "start": 0, "text": "L’etanercept est absorbé lentement depuis le site d’injection sous-cutanée, atteignant une concentration maximale environ 48 heures après administration unique. La biodisponibilité absolue est de 76 %. Avec deux doses par semaine, on peut s’attendre à ce que les concentrations à l’état d’équilibre représentent environ deux fois celles que l’on mesure après administration unique. Après l’administration unique, par voie sous-cutanée, de 25 mg d’Enbrel, la concentration sérique maximale moyenne observée chez les volontaires sains était de 1,65 0,66 g/ml, l’aire sous la courbe étant de 235 96,6 gh/ml.", "truncated": false}, "before_length": 604, "before_sha256": "5d4f40654f407d6f697d5385a203da2afc4d7a966ce1dde15c489f8a85003f89", "change_kind": "content", "change_operations": [{"after_end": 556, "after_start": 555, "before_end": 556, "before_start": 555, "kind": "replace"}, {"after_end": 603, "after_start": 602, "before_end": 603, "before_start": 602, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8317595f9a5fda9277078c47", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg solution injectable en seringue pré-remplie Enbrel 50 mg solution injectable en seringue pré-remplie", "presentation_occurrence": 3, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3281}
{"after": {"end": 150, "start": 0, "text": "avez une pression sanguine basse avant de commencer le traitement par Adempas. Pour débuter Adempas, votre pression artérielle systolique doit être de", "truncated": false}, "after_length": 150, "after_sha256": "2503e139c5d118c26ecf8aa3ecf85940b381cbe486544cc0884d35cd1a2e0343", "annex": "IIIA", "before": {"end": 152, "start": 0, "text": "avez une pression sanguine basse avant de prendre Adempas pour la première fois. Pour débuter Adempas, votre pression artérielle systolique doit être de", "truncated": false}, "before_length": 152, "before_sha256": "de644e15a17b5698dff5bdedbef63385c8071ff48a77da4918e39bedf5f29e17", "change_kind": "content", "change_operations": [{"after_end": 46, "after_start": 42, "before_end": 44, "before_start": 42, "kind": "replace"}, {"after_end": 50, "after_start": 48, "before_end": 47, "before_start": 46, "kind": "replace"}, {"after_end": 53, "after_start": 51, "before_end": 48, "before_start": 48, "kind": "insert"}, {"after_end": 69, "after_start": 54, "before_end": 49, "before_start": 49, "kind": "insert"}, {"after_end": 76, "after_start": 76, "before_end": 78, "before_start": 56, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 25, "chars_inserted": 23}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8363613aa03cf386e948e427", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3256}
{"after": {"end": 283, "start": 0, "text": "les inhibiteurs de la PDE-5 tels que le sildénafil, le tadalafil ou le vardénafil. Ces médicaments sont utilisés pour traiter l’hypertension artérielle pulmonaire (pression sanguine élevée dans les artères des poumons) ou pour traiter les problèmes d’érection (dysfonction érectile).", "truncated": false}, "after_length": 283, "after_sha256": "279d99a9cef605f0dbd56cc664a400ea4471714a54e094b6f3df8b90f95cde2c", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 283, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 283}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8369ef9869e4556c266f1f6d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3291}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tel: +44(0)800 221441", "truncated": false}, "before_length": 21, "before_sha256": "b60520b7c3f5143a4052286ffe553fbf86751da23ca567680dc9998e034a172d", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 21, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 21, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-838af276803db2aa816b5705", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000112", "medicine_name": "Twinrix Adult", "medicine_slug": "twinrix-adult", "observed_at": "2026-10-12T13:29:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "bc8ba3adecfe04d3079e5b502251cec982d6197257fe3b7ec3a22dc5f2ace654", "source_snapshot_id": "source-8439a1a319b62d1bd67256a4", "source_updated_at": "2026-08-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/twinrix-adult-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1006}
{"after": {"end": 3, "start": 0, "text": "0.6", "truncated": false}, "after_length": 3, "after_sha256": "b4af4e0d40391d3a00179d935c63b7e15ba8cd3dfa29f218dedc270bd3eb3e79", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 3, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 3}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-83982c3a9e86625e94f7c1c1", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "IMJUDO 20 mg/ml concentrate for solution for infusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 843}
{"after": {"end": 146, "start": 0, "text": "La substance active d’Enbrel est l’etanercept. Chaque cartouche distributrice de dose contient 0,5 mL de solution, fournissant 25 mg d’etanercept.", "truncated": false}, "after_length": 146, "after_sha256": "6ec698bd03512ab94e51509df9690a3deb6a4aae4999e9076a462aca43947708", "annex": "IIIA", "before": {"end": 146, "start": 0, "text": "La substance active d’Enbrel est l’etanercept. Chaque cartouche distributrice de dose contient 0,5 ml de solution, fournissant 25 mg d’etanercept.", "truncated": false}, "before_length": 146, "before_sha256": "fc14c39edf596be10c9a0afd14d5a257db07edc5c900a5cd07ee4f0eb951b3a8", "change_kind": "content", "change_operations": [{"after_end": 101, "after_start": 100, "before_end": 101, "before_start": 100, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-83ba1c39bec2e20d10fad6cc", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11612}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 310, "start": 0, "text": "Le titulaire de l’autorisation de mise sur le marché veille à ce que, dans chaque État membre où l’etanercept est commercialisé, tous les professionnels de santé qui sont censés prescrire l’etanercept et tous les patients qui sont censés l’utiliser aient accès aumatériel éducationnel suivant ou le reçoivent :", "truncated": false}, "before_length": 310, "before_sha256": "a92b5ac8844164a537bdc7e75097e0015c1e6bb568918105f975d054dd01e5ab", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 310, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 310, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-83cdb9c2cb364d8c19ee99b7", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6658}
{"after": {"end": 8, "start": 0, "text": "D02 HW68", "truncated": false}, "after_length": 8, "after_sha256": "1ed87437489fcb80b59bfa5d17082f438d78a8aff5deaac6125946420fbf0992", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "administrative", "change_operations": [{"after_end": 8, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-83e205a0d77c745314ec20ba", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "Qdenga powder and solvent for solution for injection Qdenga powder and solvent for solution for injection in pre-filled syringe Dengue tetravalent vaccine (live, attenuated)", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 977}
{"after": {"end": 249, "start": 0, "text": "Sur la base des conclusions scientifiques relatives au pérampanel, le CHMP estime que le rapport bénéfice-risque du/des médicament(s) contenant du pérampanel demeure inchangé, sous réserve des modifications proposées des informations sur le produit.", "truncated": false}, "after_length": 249, "after_sha256": "2a24231e66a600d3309cb99ce0ffef71280e752ced74591e76c807f8457520db", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 249, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 249}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-84543a605e48d5bacca17c1f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:32:00Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "3ff8cd4d67d22ba799aa348aeda944d6d896a16dcf54b030db101cbc095fc8ad", "source_snapshot_id": "source-a79a7cba8bf5dbc72fd40574", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3539}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 42, "start": 0, "text": "• your Terrosa Pen with inserted cartridge", "truncated": false}, "before_length": 42, "before_sha256": "8404f4bc2782edf47834af472217e5d60abc45cde3c4e8971bf73f228d73a5d7", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 42, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 42, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-847f87ffbafa5d8349fabf31", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2031}
{"after": {"end": 149, "start": 0, "text": "Des informations détaillées sur ce médicament sont disponibles sur le site internet de l’Agence européenne des médicaments https://www.ema.europa.eu.", "truncated": false}, "after_length": 149, "after_sha256": "0e6b9f35caaf0258b468a6e9a53665f0ec5536787f68eefee5f242bf64add02e", "annex": "I", "before": {"end": 148, "start": 0, "text": "Des informations détaillées sur ce médicament sont disponibles sur le site internet de l’Agence européenne des médicaments http://www.ema.europa.eu.", "truncated": false}, "before_length": 148, "before_sha256": "8781a4dba25cf8cb978f0efd517b11bd29ec42e3e0fffadb61d4b9c2e7362806", "change_kind": "technical", "change_operations": [{"after_end": 128, "after_start": 127, "before_end": 127, "before_start": 127, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-84816fc64ce62665d8561aa8", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg poudre pour solution injectable", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "10", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1140}
{"after": {"end": 280, "start": 0, "text": "Thaw each pre-filled syringe before use following the instructions below. Syringes may be thawed in the blister packs (each blister containing 1 or 2 pre-filled syringes, depending on pack size) or in the carton itself, either in the refrigerator or at room temperature (Table 9).", "truncated": false}, "after_length": 280, "after_sha256": "a58f560b0f9c18f498487dbd19ffbc245842b97a54305e21f6c942201983b758", "annex": "I", "before": {"end": 281, "start": 0, "text": "Thaw each pre-filled syringe before use following the instructions below. Syringes may be thawed in the blister packs (each blister containing 1 or 2 pre-filled syringes, depending on pack size) or in the carton itself, either in the refrigerator or at room temperature (Table 10).", "truncated": false}, "before_length": 281, "before_sha256": "2c64c92e20872452f1e10bfe2e7124f5e2103c398a58963cbbe1f0464b1b1e17", "change_kind": "content", "change_operations": [{"after_end": 278, "after_start": 277, "before_end": 279, "before_start": 277, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-848f8f6ee4493be673b38ab0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6425}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 32, "start": 0, "text": "Mundipharma Gesellschaft m.b.H.,", "truncated": false}, "before_length": 32, "before_sha256": "bbfa033123b5282f87503ec9344a52a3ae5eee16c0337a64e37aa2fd94bc739f", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 32, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 32, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-849a54887f282a8c6dd70037", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1049}
{"after": {"end": 105, "start": 0, "text": "Avant de commencer l'administration de Terrosa, assurez-vous que le Terrosa Pen ne présente aucun défaut.", "truncated": false}, "after_length": 105, "after_sha256": "964542a1cc4696c587a20e9b9d42b3a8731b6e24bc4a0d2e1792c5d28cef263c", "annex": "IIIA", "before": {"end": 107, "start": 0, "text": "Avant de commencer l'administration de Terrosa, assurez-vous que le stylo Terrosa ne présente aucun défaut.", "truncated": false}, "before_length": 107, "before_sha256": "9de31dc945bdc163783f7fab86a1d8b985847b170e4fe22e91d53823b4eb0d98", "change_kind": "content", "change_operations": [{"after_end": 68, "after_start": 68, "before_end": 74, "before_start": 68, "kind": "delete"}, {"after_end": 79, "after_start": 75, "before_end": 81, "before_start": 81, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-84cf42fc6988a0d19d01ecc8", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1952}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 5, "start": 0, "text": "Norge", "truncated": false}, "before_length": 5, "before_sha256": "882f535a7da00cd72aec9957f14113085717f72c791945420043b48876276628", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 5, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 5, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-84d9eb7f349915d8ddf3f64d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1080}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 8, "start": 0, "text": "България", "truncated": false}, "before_length": 8, "before_sha256": "a7215e5aa55f878990c076bb8195d75ca42044d4d5c7d2ba90af610508b643d3", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 8, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 8, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-84da7f4e31b0ebceaf7a9caf", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1039}
{"after": {"end": 52, "start": 0, "text": "ff Includes infusion-related reaction and urticaria.", "truncated": false}, "after_length": 52, "after_sha256": "e833892540df92cebf9b28a41f1487382016a4b5704755db87441139ebf8595a", "annex": "I", "before": {"end": 52, "start": 0, "text": "ee Includes infusion-related reaction and urticaria.", "truncated": false}, "before_length": 52, "before_sha256": "d4c6b87f5922cf9a9e1cef9428b6a4efda57e7e8342f6825c9a938cfa4d72bb1", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 0, "before_end": 2, "before_start": 0, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8517b8744be55ddd86b446a1", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "IMJUDO 20 mg/ml concentrate for solution for infusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 935}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 2, "start": 0, "text": "or", "truncated": false}, "before_length": 2, "before_sha256": "7175517a370b5cd2e664e3fd29c4ea9db5ce17058eb9772fe090a5485e49dad6", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 2, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-85197d70efae14fd8d1bd7f2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000174", "medicine_name": "Plavix", "medicine_slug": "plavix", "observed_at": "2026-10-12T19:27:50Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3818c2e3c9979bf5f8be3f164dfce187fccfccf62bbd1e3227c64ca7c00ad02f", "source_snapshot_id": "source-4aff1b64c7cf58337d33ecfa", "source_updated_at": "2025-07-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/plavix-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1441}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "info@mundipharma.be", "truncated": false}, "before_length": 19, "before_sha256": "fc5e5b98df902cc2264e183a9bf7b097d1330cde86581ebd0467522133fb8584", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 19, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 19, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8621ab2b7e354ec735c1fa79", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1032}
{"after": {"end": 133, "start": 0, "text": "have low blood pressure before you start treatment with Adempas. To start with Adempas your systolic blood pressure value needs to be", "truncated": false}, "after_length": 133, "after_sha256": "1e2faa49905eaa8ece660ef5707fb1c24097c8284e0d7105b574f52eb7654d63", "annex": "IIIA", "before": {"end": 121, "start": 0, "text": "have low blood pressure before you take Adempas the first time. To start with Adempas your systolic blood value should be", "truncated": false}, "before_length": 121, "before_sha256": "f8823cc1e744d13feee0af39fbfd713e52e99df71ef0c29f2539af31fc87b83a", "change_kind": "content", "change_operations": [{"after_end": 36, "after_start": 35, "before_end": 35, "before_start": 35, "kind": "insert"}, {"after_end": 43, "after_start": 38, "before_end": 38, "before_start": 37, "kind": "replace"}, {"after_end": 55, "after_start": 44, "before_end": 39, "before_start": 39, "kind": "insert"}, {"after_end": 63, "after_start": 63, "before_end": 62, "before_start": 47, "kind": "delete"}, {"after_end": 116, "after_start": 107, "before_end": 106, "before_start": 106, "kind": "insert"}, {"after_end": 126, "after_start": 122, "before_end": 112, "before_start": 112, "kind": "insert"}, {"after_end": 129, "after_start": 127, "before_end": 114, "before_start": 113, "kind": "replace"}, {"after_end": 130, "after_start": 130, "before_end": 118, "before_start": 115, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 20, "chars_inserted": 32}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8635d0f88a868602f1f54e4d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2732}
{"after": {"end": 215, "start": 0, "text": "Des Cartes Patient sont fournies aux médecins prescripteurs d’etanercept pour être remises aux patients recevant de l’etanercept. Cette carte fournit aux patients les informations de sécurité importantes suivantes :", "truncated": false}, "after_length": 215, "after_sha256": "da7c6d0404ffd6f1a0e8e68ca16409b0c1dc904967294cc4ba77583468a92b37", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 215, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 215}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-86543c8589162ae29c6df047", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6660}
{"after": {"end": 19, "start": 0, "text": "dpoc.greece@msd.com", "truncated": false}, "after_length": 19, "after_sha256": "d96a401106c51f4f8693adaf45abc406ae4e520f06826181cac8e7fb34e045be", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "dpoc_greece@merck.com", "truncated": false}, "before_length": 21, "before_sha256": "9b56f5b84cf1285f2f89288b0c6eaf5971bf26de57aec36149b36f892216f048", "change_kind": "content", "change_operations": [{"after_end": 5, "after_start": 4, "before_end": 5, "before_start": 4, "kind": "replace"}, {"after_end": 15, "after_start": 13, "before_end": 17, "before_start": 13, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 5, "chars_inserted": 3}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-86f18e4d965c2be3de01070a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3531}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 90, "start": 0, "text": "Number of Subjects Achieved Motor MilestonesNumber of Subjects Achieved Motor Milestones24", "truncated": false}, "before_length": 90, "before_sha256": "198e77b51bfaa757973e0d9d83079c73411f01e23f30ddb30ff2c6443b421284", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 90, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 90, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-87088121126cfb65caf3e3ef", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005352", "medicine_name": "Upstaza", "medicine_slug": "upstaza", "observed_at": "2026-10-12T13:36:07Z", "pipeline_version": "2.0.0", "presentation_label": "Upstaza 2.8 × 1011 vector genomes (vg)/0.5 mL solution for infusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8561a0c5aed752dd415d30acef76bf620ad205d702080a0bca765e086873fe20", "source_snapshot_id": "source-4b712d5f9e4e2e8cd620aa93", "source_updated_at": "2026-06-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/upstaza-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 321}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 41, "start": 0, "text": "Mundipharma Corporation (Ireland) Limited", "truncated": false}, "before_length": 41, "before_sha256": "1508b8eae555a7f920ad3f9f7dc0b3f86d6bca3f7a3f44b91a1699e58db6295c", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 41, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 41, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-871faf20159db4230a6615d5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1086}
{"after": {"end": 93, "start": 0, "text": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection (multidose vials with a blue flip-off cap)", "truncated": false}, "after_length": 93, "after_sha256": "18c9054388219911253a1d5cc7412c1d6fddca107589ea06b4289e111d55aa57", "annex": "I", "before": {"end": 91, "start": 0, "text": "Spikevax JN.1 0.1 mg/mL dispersion for injection (multidose vials with a blue flip-off cap)", "truncated": false}, "before_length": 91, "before_sha256": "a39501c86c9fc7e4b41ef4dbf447751a11062db9e34e0610b960b0130e7b77ff", "change_kind": "administrative", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8721cc61bf1f66257ddd25ad", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13040}
{"after": {"end": 28, "start": 0, "text": "Tél/Tel: + 32 (0)10 85 52 00", "truncated": false}, "after_length": 28, "after_sha256": "21991020d31ee1ff18b7e886e60c72625978ff6aaf6b37b3b94d159c09e80017", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "Tél/Tel: + 32 10 85 52 00", "truncated": false}, "before_length": 25, "before_sha256": "0a43db96a0eb6a17e821e1b2c7fb04323930ea184ab3ecb536a9297f8de45db1", "change_kind": "content", "change_operations": [{"after_end": 17, "after_start": 14, "before_end": 14, "before_start": 14, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 3}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8727893d043e32b62b7cf2ee", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000112", "medicine_name": "Twinrix Adult", "medicine_slug": "twinrix-adult", "observed_at": "2026-10-12T13:29:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "bc8ba3adecfe04d3079e5b502251cec982d6197257fe3b7ec3a22dc5f2ace654", "source_snapshot_id": "source-8439a1a319b62d1bd67256a4", "source_updated_at": "2026-08-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/twinrix-adult-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 893}
{"after": {"end": 192, "start": 0, "text": "Votre médecin vous remettra également une Carte Patient qui comportera des informations importantes de sécurité d’emploi que vous devez connaître, avant et pendant votre traitement par Enbrel.", "truncated": false}, "after_length": 192, "after_sha256": "a9b61621aee7f348e503c6ef13da6f1d4dc6f2a4d953f840016b3daaebeecd6a", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 192, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 192}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-87346f5b43e9d7d33a6a5aaf", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9301}
{"after": {"end": 12, "start": 0, "text": "25 mg/0,5 mL", "truncated": false}, "after_length": 12, "after_sha256": "46e5380e927990cf15221f8049ebcf74c4b711d4516f6c2e7e82c8518c127d25", "annex": "IIIA", "before": {"end": 12, "start": 0, "text": "25 mg/0,5 ml", "truncated": false}, "before_length": 12, "before_sha256": "80b887636c832cc7740bd32b98c07488f5022cb3920ced1a54bd52030d2ad71d", "change_kind": "content", "change_operations": [{"after_end": 12, "after_start": 11, "before_end": 12, "before_start": 11, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-875364582a8d42adb565a9d9", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 7911}
{"after": {"end": 10, "start": 0, "text": "Néphritedd", "truncated": false}, "after_length": 10, "after_sha256": "b863d8cf4312870e1605d50922dfc652acc9400cbc2383a52106c9c289b0ac55", "annex": "I", "before": {"end": 10, "start": 0, "text": "Néphritecc", "truncated": false}, "before_length": 10, "before_sha256": "bb7f7bd5a338ffaa862cf6172a868fc7523a90d877c2ba7815fc7f54b7355f31", "change_kind": "content", "change_operations": [{"after_end": 10, "after_start": 8, "before_end": 10, "before_start": 8, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-87ad71b60c01d679f2ce4e50", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:18Z", "pipeline_version": "2.0.0", "presentation_label": "IMJUDO 20 mg/ml, solution à diluer pour perfusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "2437ab76633f46c9eee5e002e5c7a7caba6367f59567d750be0eb67c74d1db4e", "source_snapshot_id": "source-7f4d129b0a0fd2d3684d27c5", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 852}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 5, "start": 0, "text": "Eesti", "truncated": false}, "before_length": 5, "before_sha256": "ed7477d6100948d0d4e6b914d9769159823c21b23bf4846b1676338b9b439b72", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 5, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 5, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-87b26bf5f06c94f48886af7f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1075}
{"after": {"end": 554, "start": 0, "text": "Le critère principal d’efficacité de l’étude était la survie globale. L’association Avastin + IFL a conduit à une augmentation statistiquement significative de la survie globale, de la survie sans progression et du taux de réponse globale (voir tableau 4). Le bénéfice clinique, évalué par la survie globale, a été constaté dans toutes les sous-populations de patients prédéfinies en fonction de l’âge, du sexe, de l’indice de performance, de la localisation de la tumeur primitive, du nombre d’organes atteints et de la durée de la maladie métastatique.", "truncated": false}, "after_length": 554, "after_sha256": "10ae24f1627a587f3ac59f29eb101d8ee8bd6ca5ebabe2c249f16b056176d21d", "annex": "I", "before": {"end": 554, "start": 0, "text": "Le critère principal d’efficacité de l’étude était la survie globale. L’association Avastin + IFL a conduit à une augmentation statistiquement significative de la survie globale, de la survie sans progression et du taux de réponse globale (voir tableau 4). Le bénéfice clinique, évalué par la survie globale, a été constaté dans toutes les sous populations de patients prédéfinies en fonction de l’âge, du sexe, de l’indice de performance, de la localisation de la tumeur primitive, du nombre d’organes atteints et de la durée de la maladie métastatique.", "truncated": false}, "before_length": 554, "before_sha256": "98a82b6d247862f1764b69f88badcfdba0e457f8da9040169aa70e9f9af4375d", "change_kind": "content", "change_operations": [{"after_end": 345, "after_start": 344, "before_end": 345, "before_start": 344, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-87c340da31e1a01b1f4747e3", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 930}
{"after": {"end": 19, "start": 0, "text": "Sími: +354 535 7000", "truncated": false}, "after_length": 19, "after_sha256": "4147b258aaf4f6d0d9b2ae441e0fa1eb5f0dadfd4e4fea070a7673c7133bf389", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Sími: + 354 535 7000", "truncated": false}, "before_length": 20, "before_sha256": "66fcdd056ccfbc5ba6d0c26580292977898106c90655c78208bc87c3d941892c", "change_kind": "content", "change_operations": [{"after_end": 7, "after_start": 7, "before_end": 8, "before_start": 7, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-87da50bf5ac671777ef80c58", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3579}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 399, "start": 0, "text": "de la pression sanguine élevée dans les artères des poumons, puisque vous ne devez pas prendre certains médicaments comme le sildénafil et le tadalafil en même temps qu’Adempas. D’autres médicaments utilisés pour le traitement de la pression sanguine élevée dans les artères des poumons, comme le bosentan et l’iloprost, peuvent être utilisés avec Adempas, mais vous devez en informer votre médecin.", "truncated": false}, "before_length": 399, "before_sha256": "2bd739a7be6101aa67e0225aaf6a8c3f0a37217165927305e4af9a7e35a21d20", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 399, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 399, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8817a322bd63b1e54f2f31ec", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3295}
{"after": {"end": 190, "start": 0, "text": "Patient Cards are provided to etanercept prescribing physicians for distribution to patients receiving etanercept. This card provides the following important safety information for patients:", "truncated": false}, "after_length": 190, "after_sha256": "75d71b12bfee4fbfee6b211d4c12b3fa45c5628d4fd5a5506eeedb2a96e282a0", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 190, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 190}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-889aeead78c4b4a89548214f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6574}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "info@mundipharma.at", "truncated": false}, "before_length": 19, "before_sha256": "7b20dc8f57783374adb30e55d582211b3496a4f85781e5658eaffb383009893c", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 19, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 19, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-88aefdc49c86fca0e3daee82", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1078}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "nordics@mundipharma.dk", "truncated": false}, "before_length": 22, "before_sha256": "f439d81e92f339fb15af44387dc1531c6265af6c724b25a05f18a5ab6acd0f1e", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 22, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 22, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-88bd47f8be280dc76ec3351b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1045}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 74, "start": 0, "text": "Table 5. Thawing instructions for single-dose vials and cartons before use", "truncated": false}, "before_length": 74, "before_sha256": "235a2524c1d0b74961b3d3547bd28b7fb20c412c5919a5f3c17393ac8d08e4e5", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 74, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 74, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8910cc1b7d83d74cc22d53b6", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13084}
{"after": {"end": 133, "start": 0, "text": "Write down the first injection date of each new cartridge. This helps you to remember when the 28 daily doses per cartridge are used.", "truncated": false}, "after_length": 133, "after_sha256": "dd017de1dcf0139714b51f6ad402a976a64b2b12a031588804e969628f7920d3", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 133, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 133}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-894715aa531ed84d8085cf5c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1993}
{"after": {"end": 149, "start": 0, "text": "Des informations détaillées sur ce médicament sont disponibles sur le site internet de l’Agence européenne des médicaments https://www.ema.europa.eu.", "truncated": false}, "after_length": 149, "after_sha256": "0e6b9f35caaf0258b468a6e9a53665f0ec5536787f68eefee5f242bf64add02e", "annex": "I", "before": {"end": 148, "start": 0, "text": "Des informations détaillées sur ce médicament sont disponibles sur le site internet de l’Agence européenne des médicaments http://www.ema.europa.eu.", "truncated": false}, "before_length": 148, "before_sha256": "8781a4dba25cf8cb978f0efd517b11bd29ec42e3e0fffadb61d4b9c2e7362806", "change_kind": "technical", "change_operations": [{"after_end": 128, "after_start": 127, "before_end": 127, "before_start": 127, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8994987ff9b3cec5aca5888c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg solution injectable en stylo pré-rempli Enbrel 50 mg solution injectable en stylo pré-rempli", "presentation_occurrence": 4, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "10", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 4556}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 14, "start": 0, "text": "Mundipharma BV", "truncated": false}, "before_length": 14, "before_sha256": "aa43c52e5bcfdc7b36232711c5dd25de9255fafdc355d6d9a2d1955654fe4598", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-899a40754f163d34198f4e96", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1015}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IV", "before": {"end": 86, "start": 0, "text": "The CHMP recommends that the terms of the marketing authorisation(s) should be varied.", "truncated": false}, "before_length": 86, "before_sha256": "58ed8da449860435afd7d26d286a000f65c5901b49253a30ae46cbbcbca82784", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 86, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 86, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-89d6e92ed482bced7c4c0331", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3435}
{"after": {"end": 20, "start": 0, "text": "Tel.: +36 1 888 5300", "truncated": false}, "after_length": 20, "after_sha256": "b83b25ec254a4166b3f210dedbd33d8e207b4ceaadec1095ccd49882767eb509", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tel.: + 36 1 888 5300", "truncated": false}, "before_length": 21, "before_sha256": "e840a2e7dcac912eac697222649c523cf85354b94f2ef4174a7e446b7bf36b6f", "change_kind": "content", "change_operations": [{"after_end": 7, "after_start": 7, "before_end": 8, "before_start": 7, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8a2d7920e83ea1eaf606015e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3085}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "nordics@mundipharma.dk", "truncated": false}, "before_length": 22, "before_sha256": "f439d81e92f339fb15af44387dc1531c6265af6c724b25a05f18a5ab6acd0f1e", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 22, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 22, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8a2e5c6fcffca6f0bfcf94f7", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1146}
{"after": {"end": 11, "start": 0, "text": "Vistor ehf.", "truncated": false}, "after_length": 11, "after_sha256": "7b79f0f888fc32453606a29b908677d0b6c13a510070ab26fe31e12b995d77fe", "annex": "IIIA", "before": {"end": 10, "start": 0, "text": "Vistor hf.", "truncated": false}, "before_length": 10, "before_sha256": "4b40dfc2a19551f982dad779994a624f3432207c4666bbd66f0ec59c2f229b32", "change_kind": "content", "change_operations": [{"after_end": 8, "after_start": 7, "before_end": 7, "before_start": 7, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8a850ce7fa83d10edec78a16", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000112", "medicine_name": "Twinrix Adult", "medicine_slug": "twinrix-adult", "observed_at": "2026-10-12T13:29:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "bc8ba3adecfe04d3079e5b502251cec982d6197257fe3b7ec3a22dc5f2ace654", "source_snapshot_id": "source-8439a1a319b62d1bd67256a4", "source_updated_at": "2026-08-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/twinrix-adult-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 975}
{"after": {"end": 800, "start": 0, "text": "Les patients atteints de psoriasis en plaques pédiatrique (âgés de 4 à 17 ans) ont reçu 0,8 mg/kg (jusqu’à une dose maximale de 50 mg par semaine) d’etanercept une fois par semaine jusqu’à 48 semaines. Les concentrations sériques moyennes à l’état d’équilibre ont varié de 1,6 à 2,1 g/mL aux semaines 12, 24 et 48. Ces concentrations moyennes chez les patients atteints de psoriasis en plaques pédiatrique ont été similaires aux concentrations observées chez les patients atteints d’arthrite juvénile idiopathique (traités par 0,4 mg/kg d’etanercept deux fois par semaine, jusqu’à une dose maximale de 50 mg par semaine). Ces concentrations moyennes étaient similaires à celles observées chez les patients adultes atteints de psoriasis en plaques traités par 25 mg d’etanercept deux fois par semaine.", "truncated": false}, "after_length": 800, "after_sha256": "45cec5f493545419a45e5abbb1dd4ac0a9e852e76d7b20b526414eed5d33951b", "annex": "I", "before": {"end": 800, "start": 0, "text": "Les patients atteints de psoriasis en plaques pédiatrique (âgés de 4 à 17 ans) ont reçu 0,8 mg/kg (jusqu’à une dose maximale de 50 mg par semaine) d’etanercept une fois par semaine jusqu’à 48 semaines. Les concentrations sériques moyennes à l’état d’équilibre ont varié de 1,6 à 2,1 g/ml aux semaines 12, 24 et 48. Ces concentrations moyennes chez les patients atteints de psoriasis en plaques pédiatrique ont été similaires aux concentrations observées chez les patients atteints d’arthrite juvénile idiopathique (traités par 0,4 mg/kg d’etanercept deux fois par semaine, jusqu’à une dose maximale de 50 mg par semaine). Ces concentrations moyennes étaient similaires à celles observées chez les patients adultes atteints de psoriasis en plaques traités par 25 mg d’etanercept deux fois par semaine.", "truncated": false}, "before_length": 800, "before_sha256": "fe7d3d907bc892858ed04c3fdbb1d64ae7c6b7ed8a81004a623298b1197fad7e", "change_kind": "content", "change_operations": [{"after_end": 287, "after_start": 286, "before_end": 287, "before_start": 286, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8a94fb85e045a2981ddab5a9", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg, solution injectable en cartouche distributrice de dose Enbrel 50 mg, solution injectable en cartouche distributrice de dose", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6485}
{"after": {"end": 9, "start": 0, "text": "ANNEXE IV", "truncated": false}, "after_length": 9, "after_sha256": "5623d2bfc35b28c1d982ab389e6c5fa37f50e40d0b9b737593e164d081c1191d", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 9, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 9}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8a9829f744d4fbbe6e3c87ff", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3394}
{"after": {"end": 91, "start": 0, "text": "2 Analyse de la SSP évaluée par les investigateurs à la date du 30 novembre 2010 (cut-off).", "truncated": false}, "after_length": 91, "after_sha256": "698101866aa677cba4f5caadc345ff4e0cb0d4405f863c5c42decaedda78fffc", "annex": "I", "before": {"end": 91, "start": 0, "text": "2 Analyse de la PFS évaluée par les investigateurs à la date du 30 novembre 2010 (cut-off).", "truncated": false}, "before_length": 91, "before_sha256": "77fe95cd794fb5793ad9c2a63bc90256d34531ca2aeb6964e92a03568d3d0d3f", "change_kind": "content", "change_operations": [{"after_end": 18, "after_start": 16, "before_end": 16, "before_start": 16, "kind": "insert"}, {"after_end": 19, "after_start": 19, "before_end": 19, "before_start": 17, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8aae88df4e8fbf1b15598a12", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1903}
{"after": {"end": 175, "start": 0, "text": "ne commencez pas Adempas avant au moins 24 heures après votre dernière dose de sildénafil et au moins 48 heures après votre dernière dose de tadalafil, si vous êtes un adulte.", "truncated": false}, "after_length": 175, "after_sha256": "b451ae874e49624c3499a5bfc2f3c5e78d22c1684a1ee8ccc7adf9b999126fe9", "annex": "IIIA", "before": {"end": 153, "start": 0, "text": "ne commencez pas Adempas pendant au moins 24 heures après votre dernière dose de sildénafil et au moins 48 heures après votre dernière dose de tadalafil.", "truncated": false}, "before_length": 153, "before_sha256": "0497253b8f002d5ef3165ba1f441a9c82be4ba370477a6eb52e4cb2c3d7d191d", "change_kind": "content", "change_operations": [{"after_end": 27, "after_start": 25, "before_end": 29, "before_start": 25, "kind": "replace"}, {"after_end": 174, "after_start": 150, "before_end": 152, "before_start": 152, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 26}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8ac89aa796a4b30d7f4d4272", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2938}
{"after": {"end": 218, "start": 0, "text": "• Warning: Store your Terrosa Pen, cartridges and pen needles out of reach of others. Prevent access to pen, cartridges and pen needles especially for children. Terrosa Pen contains small parts that might be swallowed.", "truncated": false}, "after_length": 218, "after_sha256": "fbe52ac2abb1eb8a855cff64dbbd5da84fb10753d097f96bb81ff05a0f994c9b", "annex": "IIIA", "before": {"end": 78, "start": 0, "text": "• Store your Terrosa Pen, cartridges and pen needles out of reach of children.", "truncated": false}, "before_length": 78, "before_sha256": "1be7e07ec0c2b7426708f1c2d5294b1eca5e66f7c5db78247716c2e789763ea1", "change_kind": "content", "change_operations": [{"after_end": 11, "after_start": 2, "before_end": 2, "before_start": 2, "kind": "insert"}, {"after_end": 151, "after_start": 78, "before_end": 69, "before_start": 69, "kind": "insert"}, {"after_end": 217, "after_start": 159, "before_end": 77, "before_start": 77, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 140}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8ae28ffd62e706904726f55a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2108}
{"after": {"end": 7, "start": 0, "text": "anxiety", "truncated": false}, "after_length": 7, "after_sha256": "ab0231f72dd9f07809f05d962bfc823a935461a2f194cc1b3be51dae6670836e", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 7, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 7}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8b0353655b05ce8950208e23", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:30Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "35ab6716aa09492c14ac6849111486ec47235c0bc65ef055350de950f316c5e6", "source_snapshot_id": "source-f20a60110d1f8fef5225317d", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2102}
{"after": {"end": 256, "start": 0, "text": "Avant d’insérer une cartouche dans le Terrosa Pen, écrivez le numéro de lot de la cartouche et la date de sa première injection sur l’emballage en carton extérieur de la cartouche et mentionnez ces informations au moment de signaler les effets secondaires.", "truncated": false}, "after_length": 256, "after_sha256": "c619bfb48434405537fbfe9986d84a3f2a6529d3153d6ffbb0e90d7a50360ade", "annex": "IIIA", "before": {"end": 258, "start": 0, "text": "Avant d’insérer une cartouche dans le stylo Terrosa, écrivez le numéro de lot de la cartouche et la date de sa première injection sur l’emballage en carton extérieur de la cartouche et mentionnez ces informations au moment de signaler les effets secondaires.", "truncated": false}, "before_length": 258, "before_sha256": "b6cab843a92bebec7d3a529e2f6a75179108000a166be602ca37c2967b0fc9da", "change_kind": "content", "change_operations": [{"after_end": 38, "after_start": 38, "before_end": 44, "before_start": 38, "kind": "delete"}, {"after_end": 49, "after_start": 45, "before_end": 51, "before_start": 51, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8b5bfb319188d63a8798c962", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1751}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 35, "start": 0, "text": "Mundipharma Pharmaceuticals Limited", "truncated": false}, "before_length": 35, "before_sha256": "c9f3bc818698700e6aea923854537c9e902c0d2d4a55bc83c3346f2abbcfd880", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 35, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 35, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8bbd2d35050dd74b67d2d09c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1106}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 192, "start": 0, "text": "Votre médecin vous remettra également une Carte Patient qui comportera des informations importantes de sécurité d’emploi que vous devez connaître, avant et pendant votre traitement par Enbrel.", "truncated": false}, "before_length": 192, "before_sha256": "a9b61621aee7f348e503c6ef13da6f1d4dc6f2a4d953f840016b3daaebeecd6a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 192, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 192, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8c0b05e047bbd3229b003d5f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 8217}
{"after": {"end": 19, "start": 0, "text": "Тел.: +359 80018205", "truncated": false}, "after_length": 19, "after_sha256": "f5f367eaaff7cc8ec0eae02bede54e52e0981b7e2173b089e0995b3c4e5fcfcc", "annex": "IIIA", "before": {"end": 18, "start": 0, "text": "Тел. +359 80018205", "truncated": false}, "before_length": 18, "before_sha256": "dc975259f263b4707615ae3eac8e6f86171b01925b3dfba71254945c8f613dd1", "change_kind": "content", "change_operations": [{"after_end": 5, "after_start": 4, "before_end": 4, "before_start": 4, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8c1f31a1ea29b29969e14d7d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000112", "medicine_name": "Twinrix Adult", "medicine_slug": "twinrix-adult", "observed_at": "2026-10-12T13:29:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "bc8ba3adecfe04d3079e5b502251cec982d6197257fe3b7ec3a22dc5f2ace654", "source_snapshot_id": "source-8439a1a319b62d1bd67256a4", "source_updated_at": "2026-08-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/twinrix-adult-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 888}
{"after": {"end": 83, "start": 0, "text": "Comment Nyxoid 1,8 mg, solution pour pulvérisation nasale doit-il être administré ?", "truncated": false}, "after_length": 83, "after_sha256": "e16fd5202fc07f2fe3efb54ba8ccecad5f70d62cdcba574cb26c14406893a1b0", "annex": "IIIA", "before": {"end": 81, "start": 0, "text": "Comment Nyxoid 1,8 mg, solution pour pulvérisation nasale doit-il être administré", "truncated": false}, "before_length": 81, "before_sha256": "4c17a9b1870c5eca133e60fd0485bb6a7333a14f07b53d00ce35b0689a8ed19c", "change_kind": "content", "change_operations": [{"after_end": 83, "after_start": 81, "before_end": 81, "before_start": 81, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8c67e561a7c7354e9d431b0e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 746}
{"after": {"end": 20, "start": 0, "text": "Tlf.: +45 44 201 100", "truncated": false}, "after_length": 20, "after_sha256": "a342c892cb893e888e9b98929ab7ba413528a3b19847cefc774fcc7b2c91291e", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "Tlf: +45 44 201 100", "truncated": false}, "before_length": 19, "before_sha256": "c639c1fe70f9701d8cecb70d89ff79995abd4e41911073143438fc69a41a0363", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8c769c9addfef7e850673074", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11082}
{"after": {"end": 192, "start": 0, "text": "Votre médecin vous remettra également une Carte Patient qui comportera des informations importantes de sécurité d’emploi que vous devez connaître, avant et pendant votre traitement par Enbrel.", "truncated": false}, "after_length": 192, "after_sha256": "a9b61621aee7f348e503c6ef13da6f1d4dc6f2a4d953f840016b3daaebeecd6a", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 192, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 192}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8c8ec4212a9c7c93766d5a58", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9785}
{"after": {"end": 71, "start": 0, "text": "le bosentan, utilisé pour traiter l’hypertension artérielle pulmonaire.", "truncated": false}, "after_length": 71, "after_sha256": "2d214745467c14c815d7d04973792b27eca1894b9440fd8f23acc519a3d2b545", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 71, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 71}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8c9318d0e42d442cdbae70af", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2863}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 5, "start": 0, "text": "Norge", "truncated": false}, "before_length": 5, "before_sha256": "882f535a7da00cd72aec9957f14113085717f72c791945420043b48876276628", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 5, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 5, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8d0914acc12cc8c112a6c4aa", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1065}
{"after": {"end": 695, "start": 0, "text": "Chez les patients atteints de CBNPC, à l’exclusion de ceux ayant une histologie épidermoïde prédominante, les effets indésirables de tous grades ont été observés avec une fréquence allant jusqu’à 9,3 % chez les patients traités par Avastin plus chimiothérapie, comparé à jusqu’à 5 % chez les patients traités par chimiothérapie seule. Les effets de Grade 3-5 ont été observés chez jusqu’à 2,3 % des patients traités par Avastin plus chimiothérapie comparés à < 1 % chez ceux traités par chimiothérapie seule (NCI-CTCAE v.3). Des hémorragies pulmonaires/hémoptysies majeures ou massives peuvent survenir de manière soudaine : jusqu’à deux tiers des hémorragies pulmonaires graves ont été fatales.", "truncated": false}, "after_length": 695, "after_sha256": "e4938f02ef2ecd7afb6f9cae6795bc1ba3087e567121f7bc05f94170189969ad", "annex": "I", "before": {"end": 690, "start": 0, "text": "Chez les patients atteints de CBNPC, à l’exclusion de ceux ayant une histologie épidermoïde prédominante, les effets indésirables de tous grades ont été observés avec une fréquence allant jusqu’à 9,3 % chez les patients traités par Avastin plus chimiothérapie, comparé à jusqu’à 5 % chez les patients traités par chimiothérapie seule. Les effets de Grade 3-5 ont été observés jusqu’à 2,3 % des patients traités par Avastin plus chimiothérapie comparés à < 1 % chez ceux traités par chimiothérapie seule (NCI-CTCAE v.3). Des hémorragies pulmonaires/hémoptysies majeures ou massives peuvent survenir de manière soudaine : jusqu’à deux tiers des hémorragies pulmonaires graves ont été fatales.", "truncated": false}, "before_length": 690, "before_sha256": "d43f5945470480a252b8a01df4df08a67b3886542de9f68cecea94dcfde19fe8", "change_kind": "content", "change_operations": [{"after_end": 381, "after_start": 376, "before_end": 376, "before_start": 376, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 5}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8d1da7e6ba758aedf052cbcf", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 784}
{"after": {"end": 83, "start": 0, "text": "low blood pressure (hypotension) (very common: may affect more than 1 in 10 people)", "truncated": false}, "after_length": 83, "after_sha256": "58bc23b2724245054e76a3fc64901249e3b7f464dbe1b089f39df03820eb0823", "annex": "IIIA", "before": {"end": 83, "start": 0, "text": "low blood pressure (hypotension) (Very common: may affect more than 1 in 10 people)", "truncated": false}, "before_length": 83, "before_sha256": "4e224e02c76da6fe7d20a6e48e539dfada1394932785f6a63260208aa3c375b8", "change_kind": "content", "change_operations": [{"after_end": 35, "after_start": 34, "before_end": 35, "before_start": 34, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8d72403f3cef3159c4b5d0ca", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3296}
{"after": {"end": 101, "start": 0, "text": "Qu’est-ce que Nyxoid 1,8 mg, solution pour pulvérisation nasale et contenu de l’emballage extérieur ?", "truncated": false}, "after_length": 101, "after_sha256": "f80e79160d3bea794b1cb3de310e4cac9becb47cbaae0653165bdc28054a6283", "annex": "IIIA", "before": {"end": 99, "start": 0, "text": "Qu’est-ce que Nyxoid 1,8 mg, solution pour pulvérisation nasale et contenu de l’emballage extérieur", "truncated": false}, "before_length": 99, "before_sha256": "c260492f040151a92b697cf3474b8719b1a2e0fcf38bb1654a7312a87f23e80f", "change_kind": "content", "change_operations": [{"after_end": 101, "after_start": 99, "before_end": 99, "before_start": 99, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8d9a672259179961662dbe33", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 969}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 133, "start": 0, "text": "Les signes ou symptômes relatifs à ces problèmes de sécurité et le moment auquel l’avis d’un professionnel de santé doit être demandé", "truncated": false}, "before_length": 133, "before_sha256": "13600dea11d2c01addfc2ae19a787d344f1aaec090abbc43ef56b4b17319d2d9", "change_kind": "unassigned", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 133, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 133, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8df42f5d3e9c3563bac9deca", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6668}
{"after": {"end": 18, "start": 0, "text": "msdromania@msd.com", "truncated": false}, "after_length": 18, "after_sha256": "5820201082e5902b1d6a84673e62d34f129a4dc7106dc8e5e365973da4db652f", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "msdromania@merck.com", "truncated": false}, "before_length": 20, "before_sha256": "ed43025368036055834b7ab01c906dfab567b905345a39d35f9d1f659762c1b4", "change_kind": "content", "change_operations": [{"after_end": 14, "after_start": 12, "before_end": 16, "before_start": 12, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8e0d136c3a3c4d5709de75a3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3469}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 17, "start": 0, "text": "Byk-Gulden-Str. 2", "truncated": false}, "before_length": 17, "before_sha256": "5dc95d013d793b6958719e5db82aa51cd0c1864e2e8bc9bfcf2cfded1a05eba6", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 17, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 17, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8e443f02070121602410a9a3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "Qdenga powder and solvent for solution for injection Qdenga powder and solvent for solution for injection in pre-filled syringe Dengue tetravalent vaccine (live, attenuated)", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 970}
{"after": {"end": 50, "start": 0, "text": "headache (common: may affect up to 1 in 10 people)", "truncated": false}, "after_length": 50, "after_sha256": "64d18a1d2bf47f4db419d1ae049891a70bdb1dbb78571f933493535e7732527e", "annex": "IIIA", "before": {"end": 50, "start": 0, "text": "headache (Common: may affect up to 1 in 10 people)", "truncated": false}, "before_length": 50, "before_sha256": "473df29f950beda2ccef8c40e5bbef54d095a29cc6640578e4e77ec4c9373a02", "change_kind": "content", "change_operations": [{"after_end": 11, "after_start": 10, "before_end": 11, "before_start": 10, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8e5ccc148aeb014adf25ba5a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3297}
{"after": {"end": 22, "start": 0, "text": "medicalinfo.nl@msd.com", "truncated": false}, "after_length": 22, "after_sha256": "578550b051823e92654f0b1dd2f62a8da0f4aa2c1bad41b233b8e6951a41272c", "annex": "IIIA", "before": {"end": 24, "start": 0, "text": "medicalinfo.nl@merck.com", "truncated": false}, "before_length": 24, "before_sha256": "cc3a8af00f6f52af5b0956221d649740a16b082158e556d4b49a01bcba8e6a99", "change_kind": "content", "change_operations": [{"after_end": 18, "after_start": 16, "before_end": 20, "before_start": 16, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8e9375a8d8d1e3603fccc0ae", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3516}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "Tel: + 31 (0)33 450 82 70", "truncated": false}, "before_length": 25, "before_sha256": "c3bd4c4339096aa6c189d1dce364189e2604277f9761e06e2d64868ce9742c04", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 25, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 25, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8e955d0dc4a9c1ece06eccf8", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1057}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 10, "start": 0, "text": "15 minutes", "truncated": false}, "before_length": 10, "before_sha256": "2f18bc2a00e782d933b393e8b28adb86b81162d593dc4d307e70b38e8d6428cb", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 10, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 10, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8ec43a7daeb28a2684730760", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6401}
{"after": {"end": 22, "start": 0, "text": "Tel.: +420 277 050 000", "truncated": false}, "after_length": 22, "after_sha256": "5a73afc7c7a9b40fee1c264ddd73318b7831c01ad752d8e98c531d058ff77e22", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tel: +420 233 010 111", "truncated": false}, "before_length": 21, "before_sha256": "86999b702f11fb434a8ae044a79bf67743758f2695ac34bae0355d2effa55dff", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}, {"after_end": 14, "after_start": 12, "before_end": 13, "before_start": 11, "kind": "replace"}, {"after_end": 17, "after_start": 16, "before_end": 16, "before_start": 15, "kind": "replace"}, {"after_end": 22, "after_start": 19, "before_end": 21, "before_start": 18, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 7}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8f24fb499d32652e8d9d54ba", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3394}
{"after": {"end": 85, "start": 0, "text": "No data are available yet regarding the use of SARSCoV2 LP.8.1 mRNA during pregnancy.", "truncated": false}, "after_length": 85, "after_sha256": "397dee3953415b9c905f321b756e2df5bc0289b8c3ee20ffb09abfbcfdc82a79", "annex": "I", "before": {"end": 83, "start": 0, "text": "No data are available yet regarding the use of SARSCoV2 JN.1 mRNA during pregnancy.", "truncated": false}, "before_length": 83, "before_sha256": "60915c886c48f159e094427f2eeb49e5fbf20e3d1c8134ade728f34ac47c1d5f", "change_kind": "content", "change_operations": [{"after_end": 60, "after_start": 56, "before_end": 58, "before_start": 56, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8f55ae5104ed5d9b48972b39", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.6", "section_type": "pregnancy", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5617}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 7, "start": 0, "text": "Latvija", "truncated": false}, "before_length": 7, "before_sha256": "50b862d01712827e01a8c925a1ee290539baab7a60d18941f764c691cee16618", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 7, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8f7128cb91d8a0120a0fc5e1", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1148}
{"after": {"end": 101, "start": 0, "text": "1. Qu’est-ce que Nyxoid 1,8 mg, solution pour pulvérisation nasale et dans quels cas est-il utilisé ?", "truncated": false}, "after_length": 101, "after_sha256": "101f60f522a00550208acfe3a723eae59811a265ff5d0a9e71a3f004d46b15e6", "annex": "IIIA", "before": {"end": 99, "start": 0, "text": "1. Qu’est-ce que Nyxoid 1,8 mg, solution pour pulvérisation nasale et dans quels cas est-il utilisé", "truncated": false}, "before_length": 99, "before_sha256": "a11b021f276cf0173be5a1fdee82cd42d1cfa4d8e92195ca649343fe98c252b9", "change_kind": "content", "change_operations": [{"after_end": 101, "after_start": 99, "before_end": 99, "before_start": 99, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8f77a9715b8d4be032e8558e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 752}
{"after": {"end": 21, "start": 0, "text": "Block 2 Miesian Plaza", "truncated": false}, "after_length": 21, "after_sha256": "99b504ac4fff9020da29e00aeb786f0975177380626e2b3347bd3fbd75afeeba", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 21, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 21}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-8fb75a6b294124b3b5f5d7c3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1341}
{"after": {"end": 149, "start": 0, "text": "Des informations détaillées sur ce médicament sont disponibles sur le site Internet de l’Agence européenne des médicaments https://www.ema.europa.eu.", "truncated": false}, "after_length": 149, "after_sha256": "a1acb9aa232f00c2eb00b3365a65ce2956955c19113dd6804463f091d9a7c50e", "annex": "IIIA", "before": {"end": 148, "start": 0, "text": "Des informations détaillées sur ce médicament sont disponibles sur le site Internet de l’Agence européenne des médicaments http://www.ema.europa.eu.", "truncated": false}, "before_length": 148, "before_sha256": "b3ed3a5671f00ce0b2a633df1e24ea3eefb4c50cd082005c6212150c2a70d104", "change_kind": "technical", "change_operations": [{"after_end": 128, "after_start": 127, "before_end": 127, "before_start": 127, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-901b5d5affd1571b69cfc370", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12310}
{"after": {"end": 109, "start": 0, "text": "Utiliser uniquement avec Terrosa Pen. Ne pas retirer la cartouche du stylo durant les 28 jours d’utilisation.", "truncated": false}, "after_length": 109, "after_sha256": "bffe795dfbd5f0a3e0ea507ba893e249459de8b0f388415b0f6a64c3b757f907", "annex": "IIIA", "before": {"end": 114, "start": 0, "text": "Utiliser uniquement avec le stylo Terrosa. Ne pas retirer la cartouche du stylo durant les 28 jours d’utilisation.", "truncated": false}, "before_length": 114, "before_sha256": "e33f141757dbc7d867f1139044eda214fc12e83c5add746a8769392ccff93bb8", "change_kind": "content", "change_operations": [{"after_end": 25, "after_start": 25, "before_end": 34, "before_start": 25, "kind": "delete"}, {"after_end": 36, "after_start": 32, "before_end": 41, "before_start": 41, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 9, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-902a3e052516f0764719354c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1163}
{"after": {"end": 27, "start": 0, "text": "Filmcoated tablet (tablet).", "truncated": false}, "after_length": 27, "after_sha256": "e75c51b2c3132e20b55aab1d94bdd85aaa0730f2ea08811b1e008140605727b9", "annex": "I", "before": {"end": 26, "start": 0, "text": "Filmcoated tablet (tablet)", "truncated": false}, "before_length": 26, "before_sha256": "2ee8e831c1b7a350b06a2f1db91e89b8932b5f45a3d06bed47b8a110ea03ab4f", "change_kind": "content", "change_operations": [{"after_end": 27, "after_start": 26, "before_end": 26, "before_start": 26, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9054af62aa9e64865a196230", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "Fycompa 2 mg filmcoated tablets Fycompa 4 mg filmcoated tablets Fycompa 6 mg filmcoated tablets Fycompa 8 mg filmcoated tablets Fycompa 10 mg filmcoated tablets Fycompa 12 mg filmcoated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "3", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 87}
{"after": {"end": 147, "start": 0, "text": "abacavir, atazanavir, cobicistat, darunavir, dolutegravir, efavirenz, elvitegravir, emtricitabine, rilpivirine, ritonavir, to treat HIV infections.", "truncated": false}, "after_length": 147, "after_sha256": "f75263e469c2e9fa490b0d0219e2b0d7c710121ba82ab8c721315d68e029d5f1", "annex": "IIIA", "before": {"end": 144, "start": 0, "text": "HIV infection such as abacavir, atazanavir, cobicistat, darunavir, dolutegravir, efavirenz, elvitegravir, emtricitabine, rilpivirine, ritonavir.", "truncated": false}, "before_length": 144, "before_sha256": "bb4bb67d4cd899ef57aa188b6be15f242d19379c3bf58c76c11d08799253863d", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 22, "before_start": 0, "kind": "delete"}, {"after_end": 146, "after_start": 121, "before_end": 143, "before_start": 143, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 22, "chars_inserted": 25}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-906872f10d19ee5f57f7aca4", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2777}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 44, "start": 0, "text": "Contact details of the etanercept prescriber", "truncated": false}, "before_length": 44, "before_sha256": "5f704ce7d984777b146dfe967410fa58e0ac8f8cb334ef0dd4e0c05ab4879167", "change_kind": "unassigned", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 44, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 44, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-90713812b7fef103191d7cd6", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6585}
{"after": {"end": 98, "start": 0, "text": "inflammation des muscles provoquant des douleurs ou des raideurs (pseudopolyarthrite rhizomélique)", "truncated": false}, "after_length": 98, "after_sha256": "714713bcaa6533d567ca1b1e6120884b207d983355e458022f2ea9086d20d0d5", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 98, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 98}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9093fa31ddf131d3b404a830", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:18Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "2437ab76633f46c9eee5e002e5c7a7caba6367f59567d750be0eb67c74d1db4e", "source_snapshot_id": "source-7f4d129b0a0fd2d3684d27c5", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2189}
{"after": {"end": 57, "start": 0, "text": "• desinfection materials for treating the injection site.", "truncated": false}, "after_length": 57, "after_sha256": "9606304c69219665a7aeb476ce4fc7700020ca8faead9e7b0136851e5162cf37", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 57, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 57}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-90a2ebfde873eaacb6c070a8", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1973}
{"after": {"end": 298, "start": 0, "text": "Bras CPB : Carboplatine (ASC 5) et paclitaxel (175 mg/m2 intraveineux) en association avec Avastin, administrés toutes les 3 semaines pendant 6 cycles, et jusqu’à 8 cycles, suivis d’Avastin (15 mg/kg toutes les 3 semaines) en monothérapie jusqu’à progression de la maladie ou toxicité inacceptable.", "truncated": false}, "after_length": 298, "after_sha256": "2a8dc8065e527be297ba8f17b0c724b1a9a5e216eb6260ae8f5574564e36387f", "annex": "I", "before": {"end": 257, "start": 0, "text": "Bras CPB : Carboplatine (ASC 5) et paclitaxel (175 mg/m2 intraveineux) toutes les 3 semaines pendant 6 cycles, et jusqu’à 8 cycles, suivis d’Avastin (15 mg/kg toutes les 3 semaines) en monothérapie jusqu’à progression de la maladie ou toxicité inacceptable.", "truncated": false}, "before_length": 257, "before_sha256": "1b829b925cdf7a7d6324582bcab4767891841c8d0106c61bd7ad11c56eec3945", "change_kind": "content", "change_operations": [{"after_end": 112, "after_start": 71, "before_end": 71, "before_start": 71, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 41}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-90b7eadef865247c6e3ae5e9", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2082}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 30, "start": 0, "text": "Thaw instructions and duration", "truncated": false}, "before_length": 30, "before_sha256": "21e0f3dbd79a3786de0e170003075169ee12d311bd543dea304ec6546f9af6b9", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 30, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 30, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9124c9c872b75bb9a84a9d4d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13087}
{"after": {"end": 158, "start": 0, "text": "Afin d’assurer une administration correcte de Terrosa, lisez toujours les instructions d’utilisation de Terrosa Pen, qui sont incluses dans la boîte du stylo.", "truncated": false}, "after_length": 158, "after_sha256": "ecefb89174b04fb5bee6b992e7ece827408d128eb05149be34906f8fb1b0df55", "annex": "IIIA", "before": {"end": 160, "start": 0, "text": "Afin d’assurer une administration correcte de Terrosa, lisez toujours les instructions d’utilisation du stylo Terrosa, qui sont incluses dans la boîte du stylo.", "truncated": false}, "before_length": 160, "before_sha256": "2b69233a70ce89ee845824e92a024eb1ef1bb43bbeb1a9779108ddb3e13d39da", "change_kind": "content", "change_operations": [{"after_end": 103, "after_start": 102, "before_end": 109, "before_start": 102, "kind": "replace"}, {"after_end": 115, "after_start": 111, "before_end": 117, "before_start": 117, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 5}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-914c1cf0bfaca961bf87ff62", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1801}
{"after": {"end": 8, "start": 0, "text": "D02 HW68", "truncated": false}, "after_length": 8, "after_sha256": "1ed87437489fcb80b59bfa5d17082f438d78a8aff5deaac6125946420fbf0992", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 8, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-91686c6d36cfd79d0959ce8c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1344}
{"after": {"end": 21, "start": 0, "text": "Tel.: +421 2 58282010", "truncated": false}, "after_length": 21, "after_sha256": "32c933770f90d44663e373be0c519eb7428907366f1868c6a270ab7f76ac5d6c", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tel: + 421 2 58282010", "truncated": false}, "before_length": 21, "before_sha256": "90cacf7d3ec61fa882ae694eb785acb84b5a4d5dc4e01a35b7899e1f2403cc28", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}, {"after_end": 7, "after_start": 7, "before_end": 7, "before_start": 6, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9168bd0b3bd495fd62574930", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3173}
{"after": {"end": 21, "start": 0, "text": "Appelez une ambulance", "truncated": false}, "after_length": 21, "after_sha256": "2514b12560d03d42cdcfb5251d35b8dd11997dbebb130ecf2289dae23dd138c8", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Appeler une ambulance", "truncated": false}, "before_length": 21, "before_sha256": "6eef7b1005c5310f303b6d77c83081540eed6dd00926c7699eaee9dc90f9a7d4", "change_kind": "content", "change_operations": [{"after_end": 7, "after_start": 6, "before_end": 7, "before_start": 6, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9173b167382e8b6fb099c6e4", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 664}
{"after": {"end": 28, "start": 0, "text": "Tel.: +49 (0) 89 20 300 4500", "truncated": false}, "after_length": 28, "after_sha256": "2f47e24ea3b89eb99468dc43a719db1159dc130a0e2b969c67c6b5887bc5696f", "annex": "IIIA", "before": {"end": 27, "start": 0, "text": "Tel: +49 (0) 89 20 300 4500", "truncated": false}, "before_length": 27, "before_sha256": "3ec0c7ac949c3c79f60152bd053a52d41d0b7662db4cc5cb04f12ee2390fd91d", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-917ef7783525f373ef75c7e4", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3100}
{"after": {"end": 20, "start": 0, "text": "Tlf.: +45 44 201 100", "truncated": false}, "after_length": 20, "after_sha256": "a342c892cb893e888e9b98929ab7ba413528a3b19847cefc774fcc7b2c91291e", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "Tlf: +45 44 201 100", "truncated": false}, "before_length": 19, "before_sha256": "c639c1fe70f9701d8cecb70d89ff79995abd4e41911073143438fc69a41a0363", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-918098ed412f834132c4d237", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12209}
{"after": {"end": 470, "start": 0, "text": "La solution injectable Terrosa est fournie dans une cartouche. Les cartouches de Terrosa doivent être exclusivement utilisées dans un stylo multidose réutilisable Terrosa et ne doivent pas être utilisées avec un autre stylo. Le stylo et les aiguilles d’injection ne sont pas fournis avec ce médicament. Cependant, à l’instauration du traitement, un conditionnement de cartouche et stylo contenant un étui de cartouche Terrosa et un étui de Terrosa Pen doit être utilisé.", "truncated": false}, "after_length": 470, "after_sha256": "39cdb728acf5cdecf96d7e3e70a07aa10fb52548de24cd34b67320e04b84d8f6", "annex": "I", "before": {"end": 472, "start": 0, "text": "La solution injectable Terrosa est fournie dans une cartouche. Les cartouches de Terrosa doivent être exclusivement utilisées dans un stylo multidose réutilisable Terrosa et ne doivent pas être utilisées avec un autre stylo. Le stylo et les aiguilles d’injection ne sont pas fournis avec ce médicament. Cependant, à l’instauration du traitement, un conditionnement de cartouche et stylo contenant un étui de cartouche Terrosa et un étui de stylo Terrosa doit être utilisé.", "truncated": false}, "before_length": 472, "before_sha256": "9be85b2c261373ddbdbc120249aa5a88033ce19778181ac3548b41e3423556bf", "change_kind": "content", "change_operations": [{"after_end": 440, "after_start": 440, "before_end": 446, "before_start": 440, "kind": "delete"}, {"after_end": 451, "after_start": 447, "before_end": 453, "before_start": 453, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-918975f6234232cb6d8280cd", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "Terrosa 20 microgrammes/80 microlitres solution injectable", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 465}
{"after": {"end": 107, "start": 0, "text": "Problèmes de peau comme démangeaison, éruption cutanée, rougeur, gonflement, desquamation sévère de la peau", "truncated": false}, "after_length": 107, "after_sha256": "69bfc0ac8ed91164eb22a323b7615a320c1fd3da2de3c9c6b45c1ce26f9df8a6", "annex": "IIIA", "before": {"end": 108, "start": 0, "text": "Problèmes de peau comme démangeaison, éruption cutanée, rougeur, gonflement, desquamation sévère de la peau.", "truncated": false}, "before_length": 108, "before_sha256": "b342b09f200447d44fb4832b29d26bde883f1020857bbe25b7fda4227b45a281", "change_kind": "content", "change_operations": [{"after_end": 107, "after_start": 107, "before_end": 108, "before_start": 107, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-91ba194e7b7b8e2682afd867", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 943}
{"after": {"end": 67, "start": 0, "text": "Read the package leaflet for Terrosa cartridge provided separately.", "truncated": false}, "after_length": 67, "after_sha256": "d9c09080ba5797146a11e9e15564afd136521c237f3a1ab733162a65b818392d", "annex": "IIIA", "before": {"end": 79, "start": 0, "text": "Read the patient information leaflet for Terrosa cartridge provided separately.", "truncated": false}, "before_length": 79, "before_sha256": "af3ee86545bed4fe0de7a8eb09051bd46551383eedfc5108bc5ec07afb2e977b", "change_kind": "content", "change_operations": [{"after_end": 15, "after_start": 11, "before_end": 13, "before_start": 11, "kind": "replace"}, {"after_end": 16, "after_start": 16, "before_end": 28, "before_start": 14, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 16, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-91bef129f0a19131d86a6883", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1981}
{"after": {"end": 2, "start": 0, "text": "SC", "truncated": false}, "after_length": 2, "after_sha256": "32da6721804f1dd3226c0551970304ebf1059ec19a27451426541027861c9388", "annex": "IIIA", "before": {"end": 17, "start": 0, "text": "Voie sous-cutanée", "truncated": false}, "before_length": 17, "before_sha256": "2c39e73e194fa4f0fa51aa54d98a94765b3fcf21e9faf5848d5728b740ab316d", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 0, "before_end": 17, "before_start": 0, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 17, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-91d33693acfa94a7c3223cef", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 7534}
{"after": {"end": 84, "start": 0, "text": "Motifs de la modification des termes de la/des autorisation(s) de mise sur le marché", "truncated": false}, "after_length": 84, "after_sha256": "4ae2391ae7d822fcc157b2047bb5fc98dea0742b977efc28a87cde01dda2e02a", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 84, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 84}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-91fe104f9462bafb71b08f6f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:32:00Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "3ff8cd4d67d22ba799aa348aeda944d6d896a16dcf54b030db101cbc095fc8ad", "source_snapshot_id": "source-a79a7cba8bf5dbc72fd40574", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3537}
{"after": {"end": 50, "start": 0, "text": "1. What Spikevax LP.8.1 is and what it is used for", "truncated": false}, "after_length": 50, "after_sha256": "bb19f8c86fcc61d9b18f2acd20b1005ae82efc6b9981e8191bee1dd6c356a226", "annex": "I", "before": {"end": 48, "start": 0, "text": "1. What Spikevax JN.1 is and what it is used for", "truncated": false}, "before_length": 48, "before_sha256": "fda4b8f277afb7d6ebc82f9b889c70510b1a81c6e58f7cb1cdbec4998ea3579d", "change_kind": "administrative", "change_operations": [{"after_end": 21, "after_start": 17, "before_end": 19, "before_start": 17, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-92326c7f95494022abb97330", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12615}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tlf: + 47 67 51 89 00", "truncated": false}, "before_length": 21, "before_sha256": "7c43090a27c13dac0bc43320de0895010db2bed3594a32688343af9caeaf0ceb", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 21, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 21, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9250c8963ff2252cb4abc7f1", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1067}
{"after": {"end": 86, "start": 0, "text": "The CHMP recommends that the terms of the marketing authorisation(s) should be varied.", "truncated": false}, "after_length": 86, "after_sha256": "58ed8da449860435afd7d26d286a000f65c5901b49253a30ae46cbbcbca82784", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 86, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 86}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-925739fef70cd5dad5985c5c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:18Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "89a938df5e41f86548301270084e3d1ecf171802e24b5429f62e3bede7ee32dd", "source_snapshot_id": "source-b71aeee5a07abebc34c02e28", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3437}
{"after": {"end": 795, "start": 0, "text": "Le score PDMS-2 total a été mesuré comme critère d’évaluation secondaire dans les études cliniques de développement. Les scores PDMS-2 maximums sont compris entre 450 et 482, selon l’âge (< 12 mois ou > 12 mois). Chez tous les patients traités par éladocagène exuparvovec, une augmentation des scores PDMS-2 totaux moyens a été observée au cours du temps, avec un bénéfice observé dès le 3ème mois (Figure 3). La moyenne des moindres carrés (MC) du changement du score PDMS-2 total par rapport à l’initiation de l’étude était de 77,9 ; 111,6 ; 138,2 et 144,3 points aux mois 12, mois 24, mois 60 et mois 96, respectivement. Chez les patients les plus jeunes traités par éladocagène exuparvovec, une réponse plus rapide au traitement a été observée et semble atteindre un niveau final plus élevé.", "truncated": false}, "after_length": 795, "after_sha256": "14afb970aa099ad98fbdbdd604c4fabbdbcea15e02b30fc5c5204396d4517c92", "annex": "I", "before": {"end": 960, "start": 0, "text": "Le score PDMS-2 total a été mesuré comme critère d’évaluation secondaire dans les études cliniques de développement. Les scores PDMS-2 maximums sont compris entre 450 et 482, selon l’âge (< 12 mois ou > 12 mois). Chez tous les patients traités par éladocagène exuparvovec, une augmentation des scores PDMS-2 totaux moyens a été observée au cours du temps, avec un bénéfice observé dès le 3ème mois (Figure 3). Au point d’évaluation à 24 mois, la moyenne des moindres carrés (MC) du changement du score PDMS-2 total par rapport à l’initiation de l’étude était de 111,2 points. L’amélioration du score PDMS-2 total par rapport à l’initiation de l’étude a été observée dès le 12ème mois suivant le traitement (77,6 points) et a été maintenue jusqu’à 60mois (139,0 points) et 96 mois (141,6). Chez les patients les plus jeunes traités par éladocagène exuparvovec, une réponse plus rapide au traitement a été observée et semble atteindre un niveau final plus élevé.", "truncated": false}, "before_length": 960, "before_sha256": "26c61f97d3e332e30ca21ee197db15d250267cc7b7e7b67462b88ffcb088f8c9", "change_kind": "content", "change_operations": [{"after_end": 411, "after_start": 410, "before_end": 444, "before_start": 410, "kind": "replace"}, {"after_end": 536, "after_start": 529, "before_end": 562, "before_start": 562, "kind": "insert"}, {"after_end": 548, "after_start": 540, "before_end": 566, "before_start": 566, "kind": "insert"}, {"after_end": 558, "after_start": 549, "before_end": 567, "before_start": 567, "kind": "insert"}, {"after_end": 565, "after_start": 565, "before_end": 650, "before_start": 574, "kind": "delete"}, {"after_end": 569, "after_start": 567, "before_end": 678, "before_start": 652, "kind": "replace"}, {"after_end": 577, "after_start": 575, "before_end": 709, "before_start": 684, "kind": "replace"}, {"after_end": 578, "after_start": 578, "before_end": 774, "before_start": 710, "kind": "delete"}, {"after_end": 585, "after_start": 584, "before_end": 782, "before_start": 780, "kind": "replace"}, {"after_end": 586, "after_start": 586, "before_end": 784, "before_start": 783, "kind": "delete"}, {"after_end": 593, "after_start": 587, "before_end": 785, "before_start": 785, "kind": "insert"}, {"after_end": 622, "after_start": 594, "before_end": 787, "before_start": 786, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 229, "chars_inserted": 64}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-929d016c241853dd41061002", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005352", "medicine_name": "Upstaza", "medicine_slug": "upstaza", "observed_at": "2026-10-12T13:36:09Z", "pipeline_version": "2.0.0", "presentation_label": "Upstaza 2,8 × 1011 génomes de vecteur (vg)/0,5 mL, solution pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "42d7861913c7c415a9acf1067eeb3f9f1287a4e4718affc1402af95754bd6fed", "source_snapshot_id": "source-1e1e567efddae34509b5de34", "source_updated_at": "2026-06-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/upstaza-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 354}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 80, "start": 0, "text": "Unopened single-dose vial (Spikevax JN.1 50 micrograms dispersion for injection)", "truncated": false}, "before_length": 80, "before_sha256": "9aa89ee3e5fc00972d40760db90ffdd7a2746510360e2012e62c491dc04133c5", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 80, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 80, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-92b72ccb28a67801ced1a5ac", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.3", "section_type": "storage", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6241}
{"after": {"end": 28, "start": 0, "text": "Tel.: +49 (0) 89 20 300 4500", "truncated": false}, "after_length": 28, "after_sha256": "2f47e24ea3b89eb99468dc43a719db1159dc130a0e2b969c67c6b5887bc5696f", "annex": "IIIA", "before": {"end": 27, "start": 0, "text": "Tel: +49 (0) 89 20 300 4500", "truncated": false}, "before_length": 27, "before_sha256": "3ec0c7ac949c3c79f60152bd053a52d41d0b7662db4cc5cb04f12ee2390fd91d", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-92c986f65f7acbc39aa1c035", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3013}
{"after": {"end": 7, "start": 0, "text": "Irlande", "truncated": false}, "after_length": 7, "after_sha256": "a8cdfff5dbbda1b070a2acb339b6f0aa20b6230d9b5500c9ce066eaa89bc9a64", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 7, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 7}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-93247e60b859f5e1feadeaa1", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1721}
{"after": {"end": 22, "start": 0, "text": "Τηλ: +30 210 98 97 300", "truncated": false}, "after_length": 22, "after_sha256": "dd162db651d0bb933c67abbcfedf7247ba30b74281375422519823d66107bf57", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "Τηλ: + 30 210 98 97 300", "truncated": false}, "before_length": 23, "before_sha256": "1997a91a04dae627a7812e41999545eae97ed698432b9af730eba8006d8fde42", "change_kind": "content", "change_operations": [{"after_end": 6, "after_start": 6, "before_end": 7, "before_start": 6, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-933756ed19eb0c465c40f2c5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3120}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 79, "start": 0, "text": "Read the patient information leaflet for Terrosa cartridge provided separately.", "truncated": false}, "before_length": 79, "before_sha256": "af3ee86545bed4fe0de7a8eb09051bd46551383eedfc5108bc5ec07afb2e977b", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 79, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 79, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-93426e837614ad5ae059983d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2035}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 31, "start": 0, "text": "Mundipharma Pharmaceuticals Ltd", "truncated": false}, "before_length": 31, "before_sha256": "16a6c553b8ef125dae7ad452aab0e5f569dfcb615e35e199efe424dd624ea758", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 31, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 31, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-93549acd8e4e01ac9d5e4b6a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1149}
{"after": {"end": 409, "start": 0, "text": "Les patients doivent être formés pour appliquer les bonnes techniques d’injection. Pour les instructions relatives aux médicaments avant l’administration (voir rubrique 6.6) et les IDU (instructions d’utilisation)à la fin de la notice. Des instructions d’utilisation du Terrosa Pen, qui sont fournies avec le stylo, sont également disponibles pour que les patients apprennent à utiliser correctement ce stylo.", "truncated": false}, "after_length": 409, "after_sha256": "c827dfa01205ce16d532a9f94970d7739b95c65b4150ed98f9330da664d76952", "annex": "I", "before": {"end": 411, "start": 0, "text": "Les patients doivent être formés pour appliquer les bonnes techniques d’injection. Pour les instructions relatives aux médicaments avant l’administration (voir rubrique 6.6) et les IDU (instructions d’utilisation)à la fin de la notice. Des instructions d’utilisation du stylo Terrosa, qui sont fournies avec le stylo, sont également disponibles pour que les patients apprennent à utiliser correctement ce stylo.", "truncated": false}, "before_length": 411, "before_sha256": "62c1077dacd0d89cd21c6057da216252f56e5ad4c5cce24e75b3606591bfc7f3", "change_kind": "content", "change_operations": [{"after_end": 270, "after_start": 270, "before_end": 276, "before_start": 270, "kind": "delete"}, {"after_end": 281, "after_start": 277, "before_end": 283, "before_start": 283, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-938f67f4ecbf43cd3ede40e0", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "Terrosa 20 microgrammes/80 microlitres solution injectable", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 92}
{"after": {"end": 96, "start": 0, "text": "Spikevax LP.8.1 must not be mixed with other vaccines or medicinal products in the same syringe.", "truncated": false}, "after_length": 96, "after_sha256": "3f237ae019531c17c6d50aad0a4e56afea6ac4b2cb49207ecf40d255c2602d63", "annex": "I", "before": {"end": 94, "start": 0, "text": "Spikevax JN.1 must not be mixed with other vaccines or medicinal products in the same syringe.", "truncated": false}, "before_length": 94, "before_sha256": "4245016ad5e5fd1607f3582062bac2efa8f6b2b8504d7ba10de213d54a5fd50f", "change_kind": "administrative", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-93a2b7f064d4666781dde7d7", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13240}
{"after": {"end": 22, "start": 0, "text": "Tel: + 420 222 001 111", "truncated": false}, "after_length": 22, "after_sha256": "e9ffcc8c6f34f7eecd73051df872f6a828d1a6d7cd74e000b576ea4514e336b4", "annex": "IIIA", "before": {"end": 24, "start": 0, "text": "Tel: + 420 2 22 00 11 11", "truncated": false}, "before_length": 24, "before_sha256": "8826d8560384d6fbafb48544edc38636e5a2e9e992b8a864ab053908c5263c5d", "change_kind": "content", "change_operations": [{"after_end": 12, "after_start": 12, "before_end": 13, "before_start": 12, "kind": "delete"}, {"after_end": 18, "after_start": 17, "before_end": 18, "before_start": 18, "kind": "insert"}, {"after_end": 20, "after_start": 20, "before_end": 22, "before_start": 20, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 3, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-93b6d8abd5f625801399c85c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000112", "medicine_name": "Twinrix Adult", "medicine_slug": "twinrix-adult", "observed_at": "2026-10-12T13:29:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "bc8ba3adecfe04d3079e5b502251cec982d6197257fe3b7ec3a22dc5f2ace654", "source_snapshot_id": "source-8439a1a319b62d1bd67256a4", "source_updated_at": "2026-08-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/twinrix-adult-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 896}
{"after": {"end": 59, "start": 0, "text": "Video/more information: <QR code included> + www.nyxoid.com", "truncated": false}, "after_length": 59, "after_sha256": "e526fe64fad915324f6d928b6f97feb997a7629e0bd0e046099612d4d17ab4cd", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 59, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 59}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-93cc2e1addb6ba86d20db535", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:33Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "21d66bf1e9a74479f577de09da3cf8517d65c1ce1b1d8bbdfe4bc38f79410def", "source_snapshot_id": "source-2c39c998fdaf05159687c016", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 609}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 36, "start": 0, "text": "Thaw temperature (in a refrigerator)", "truncated": false}, "before_length": 36, "before_sha256": "6c7c18b3071e1d78468fad5c90eb7cd3964bdae6d3ec6da8bafd33c108710399", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 36, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 36, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-93e487a0722a297edd00e50f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13089}
{"after": {"end": 41, "start": 0, "text": "granisetron, to treat nausea or vomiting.", "truncated": false}, "after_length": 41, "after_sha256": "02313269663817b1422e036a2a8bbb2c823289fc07314b73564db7ea9513ad81", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 41, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 41}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-941c80e1907d9d2f01385306", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2787}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 333, "start": 0, "text": "Verify that the vial has a blue flip-off cap and the product name is Spikevax JN.1. If the vial has a blue flip-off cap and the product name is Spikevax bivalent Original/Omicron BA.1, Spikevax bivalent Original/Omicron BA.4-5 or Spikevax XBB.1.5, please make reference to the Summary of Product Characteristics for that formulation.", "truncated": false}, "before_length": 333, "before_sha256": "ff4fa1ac48ce1e8f1173e4441b0879c17039c7cc41b5ca20406a7c08630e7105", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 333, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 333, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-945a9418b5380bc525625cdd", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13079}
{"after": {"end": 276, "start": 0, "text": "• Avertissement : Conservez votre Terrosa Pen, vos cartouches et aiguilles pour stylo hors de portée d’autres personnes. Empêchez les enfants notamment, d'accéder au stylo, aux cartouches et aux aiguilles. Le Terrosa Pen contient de petites pièces qui pourraient être avalées.", "truncated": false}, "after_length": 276, "after_sha256": "2a071b534aac535c9844b0ae987c1deb425dacfe58da3d305937caf0a94660e7", "annex": "IIIA", "before": {"end": 280, "start": 0, "text": "• Avertissement : Conservez votre stylo Terrosa, vos cartouches et aiguilles pour stylo hors de portée d’autres personnes. Empêchez les enfants notamment, d'accéder au stylo, aux cartouches et aux aiguilles. Le stylo Terrosa contient de petites pièces qui pourraient être avalées.", "truncated": false}, "before_length": 280, "before_sha256": "b997fedb271f803da31083d918870ebf52403722f90ac69e6284bd2624881725", "change_kind": "content", "change_operations": [{"after_end": 34, "after_start": 34, "before_end": 40, "before_start": 34, "kind": "delete"}, {"after_end": 45, "after_start": 41, "before_end": 47, "before_start": 47, "kind": "insert"}, {"after_end": 209, "after_start": 209, "before_end": 217, "before_start": 211, "kind": "delete"}, {"after_end": 220, "after_start": 216, "before_end": 224, "before_start": 224, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 12, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9467c00da13dfefc0ada34a6", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2093}
{"after": {"end": 25, "start": 0, "text": "50-58 Baggot Street Lower", "truncated": false}, "after_length": 25, "after_sha256": "2b6052bef6a7051ce20b776d1525055c417fc02e59b9e559cd21b7aa4c7859f0", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 25, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 25}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-947bfa4eba66761296aee32b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1718}
{"after": {"end": 81, "start": 0, "text": "Talk to your doctor, pharmacist or nurse before you are given Spikevax LP.8.1 if:", "truncated": false}, "after_length": 81, "after_sha256": "34a2f9305574067674b4f027b9af9718fbbac7ca0205e7d3cd5928461934a41f", "annex": "I", "before": {"end": 79, "start": 0, "text": "Talk to your doctor, pharmacist or nurse before you are given Spikevax JN.1 if:", "truncated": false}, "before_length": 79, "before_sha256": "d453f2b3615a50c98804e60c5f73d74ed155674e28775aa7fe6a9f0e48c7d9fa", "change_kind": "administrative", "change_operations": [{"after_end": 75, "after_start": 71, "before_end": 73, "before_start": 71, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9486d5d04bbb1869fb19d83c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12638}
{"after": {"end": 22, "start": 0, "text": "Scientific conclusions", "truncated": false}, "after_length": 22, "after_sha256": "48a176450b72da083aae0c461d4b9485bc052767229342ad7b9f3b91fb4b3641", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 22, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 22}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-94f80eb4b84fd0cc9bd1784d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:30Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "35ab6716aa09492c14ac6849111486ec47235c0bc65ef055350de950f316c5e6", "source_snapshot_id": "source-f20a60110d1f8fef5225317d", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2337}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 129, "start": 0, "text": "Les instructions relatives à l’enregistrement du nom de marque et du numéro de lot du médicament afin d’en assurer la traçabilité", "truncated": false}, "before_length": 129, "before_sha256": "8cf8fd038e391835323b04d3328446de9913e56536257130c2dd3a92ab062615", "change_kind": "unassigned", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 129, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 129, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-94f9e184de3a4999aa2b5ba3", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6669}
{"after": {"end": 31, "start": 0, "text": "Spikevax LP.8.1 contains sodium", "truncated": false}, "after_length": 31, "after_sha256": "f192d4dbca660ae8b327192636b5125813949fbe6241de887ead1b94fe92d0af", "annex": "I", "before": {"end": 29, "start": 0, "text": "Spikevax JN.1 contains sodium", "truncated": false}, "before_length": 29, "before_sha256": "34803809d8627c8df5581a603b36eca79ad317c253a1864e1dab5b07486a62ea", "change_kind": "administrative", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-94fe40584da953e4a0014a57", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12685}
{"after": {"end": 230, "start": 0, "text": "Le Terrosa Pen ne doit pas être utilisé par des patients aveugles ou malvoyants sans l’aide d’une personne valide ayant reçu une formation adéquate. Consultez votre médecin si vous avez des problèmes d’audition ou de manipulation.", "truncated": false}, "after_length": 230, "after_sha256": "b72e3d64e892f6f6a1dc0dedf717c8d7527ac53a5a1037ba833da3a0ba97c4dd", "annex": "IIIA", "before": {"end": 232, "start": 0, "text": "Le stylo Terrosa ne doit pas être utilisé par des patients aveugles ou malvoyants sans l’aide d’une personne valide ayant reçu une formation adéquate. Consultez votre médecin si vous avez des problèmes d’audition ou de manipulation.", "truncated": false}, "before_length": 232, "before_sha256": "58790841c0fd33814819e08063faee8c0a2fe8da198e900da7c808e29c9dc597", "change_kind": "content", "change_operations": [{"after_end": 3, "after_start": 3, "before_end": 9, "before_start": 3, "kind": "delete"}, {"after_end": 14, "after_start": 10, "before_end": 16, "before_start": 16, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-95394a9939929af23c10530f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2084}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IV", "before": {"end": 8, "start": 0, "text": "ANNEX IV", "truncated": false}, "before_length": 8, "before_sha256": "29972ab77d4b1358a0bdb16d438bcde59007e95356d1f5f9ee2f7045597f9574", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 8, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 8, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-953bcf65377549063a1f20eb", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2500}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 81, "start": 0, "text": "Do not use the pen if the cartridge is cloudy, discoloured or contains particles.", "truncated": false}, "before_length": 81, "before_sha256": "046bb913395f51e6bf4c6343f07eab5e628ae8bc009d7a6e8238900962568ce1", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 81, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 81, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9548fcd1fd2c506be7542597", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2034}
{"after": {"end": 7, "start": 0, "text": "Ireland", "truncated": false}, "after_length": 7, "after_sha256": "02bf1dfa9a0365a86223f0e4ac9eaa0517b06b2e9273790f719feda656a247ae", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 7, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 7}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-957234f30b771566cf24d5a0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2188}
{"after": {"end": 3, "start": 0, "text": "0,2", "truncated": false}, "after_length": 3, "after_sha256": "a7841ea775e1dff3e5b22dd5f4b66487299bda2f6dc0b7932dc4d375e2ace554", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 3, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 3}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9590c46d29d9b9bf75a7bc26", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:18Z", "pipeline_version": "2.0.0", "presentation_label": "IMJUDO 20 mg/ml, solution à diluer pour perfusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "2437ab76633f46c9eee5e002e5c7a7caba6367f59567d750be0eb67c74d1db4e", "source_snapshot_id": "source-7f4d129b0a0fd2d3684d27c5", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 836}
{"after": {"end": 15, "start": 0, "text": "3832 RC Leusden", "truncated": false}, "after_length": 15, "after_sha256": "ba405ef0bf36eca0b0c6d25a5c566d076892169d711c353d3632e2a334a18c52", "annex": "II", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 15, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 15}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-95baf9dc5a098abc6921cf72", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 535}
{"after": {"end": 234, "start": 0, "text": "La substance active d’Enbrel est etanercept. Chaque flacon d’Enbrel 10 mg poudre et solvant pour solution injectable pour usage pédiatrique contient 10 mg d’etanercept. Après reconstitution, la solution contient 10 mg/mL d’etanercept.", "truncated": false}, "after_length": 234, "after_sha256": "8a24b82cc6ce05f62b5e72227182882cc0f1b75511ca395d06ddf137f0cb4f1f", "annex": "IIIA", "before": {"end": 234, "start": 0, "text": "La substance active d’Enbrel est etanercept. Chaque flacon d’Enbrel 10 mg poudre et solvant pour solution injectable pour usage pédiatrique contient 10 mg d’etanercept. Après reconstitution, la solution contient 10 mg/ml d’etanercept.", "truncated": false}, "before_length": 234, "before_sha256": "70cda14bc6c4457d223602a7ffe671a3d897590ccdff707ddf2ac764908c387a", "change_kind": "content", "change_operations": [{"after_end": 220, "after_start": 219, "before_end": 220, "before_start": 219, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-95cc12575fa5734bf0f27ce5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11030}
{"after": {"end": 258, "start": 0, "text": "Follow the instructions presented in this instructions for use. If the instructions are not followed, there are risks of incorrect medication, inaccurate dosage, disease transmission or infection. Seek immediate medical advice if you have any health concern.", "truncated": false}, "after_length": 258, "after_sha256": "47e7a8c43a7e7ad62f66514c024ba8b10dba19b1038d83093393a9f98fe2df72", "annex": "IIIA", "before": {"end": 258, "start": 0, "text": "Follow the instructions presented in this Instructions for use. If the instructions are not followed, there are risks of incorrect medication, inaccurate dosage, disease transmission or infection. Seek immediate medical advice if you have any health concern.", "truncated": false}, "before_length": 258, "before_sha256": "595131c30b41a11f54f56bea55898cc61d57debdba9168de0ac52461e4d0b8cd", "change_kind": "content", "change_operations": [{"after_end": 43, "after_start": 42, "before_end": 43, "before_start": 42, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-95cf21ac4bdd06d992ae5fe7", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2118}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 11, "start": 0, "text": "Deutschland", "truncated": false}, "before_length": 11, "before_sha256": "af6e56aacd8097c3fb7597b08ecb3d87a040f6ab58067a4b8ff9f5b747adb9be", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 11, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 11, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-95d87cc98eb7388d5aebc88f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1066}
{"after": {"end": 43, "start": 0, "text": "Pfizer Healthcare Ireland Unlimited Company", "truncated": false}, "after_length": 43, "after_sha256": "1f203777a0ec6fed9c840d52631b6a74c7e25b5d318485d8147e2404f52dc981", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "Pfizer Healthcare Ireland", "truncated": false}, "before_length": 25, "before_sha256": "4beeea9b6d0c491f03a9511d9f9576b9c75cbcdcfd736e4934f768fdded936f5", "change_kind": "content", "change_operations": [{"after_end": 43, "after_start": 25, "before_end": 25, "before_start": 25, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 18}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-95d9ac143e57627a2727da01", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 8985}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 248, "start": 0, "text": "de la pression sanguine élevée ou des maladies du cœur comme les dérivés nitrés et le nitrite d’amyle, ou un autre médicament stimulateur de la guanylate cyclase soluble tel que le vériciguat. Ne prenez pas ces médicaments en même temps qu’Adempas.", "truncated": false}, "before_length": 248, "before_sha256": "f47c994b5b974276c1a7e1cb3bae0def5ee190d893399351de30d9c311a88002", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 248, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 248, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-95eadb14d9ee32db2613f6a9", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3294}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 17, "start": 0, "text": "Byk-Gulden-Str. 2", "truncated": false}, "before_length": 17, "before_sha256": "5dc95d013d793b6958719e5db82aa51cd0c1864e2e8bc9bfcf2cfded1a05eba6", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 17, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 17, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9622f9e3008079fb9b82feb9", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "Qdenga poudre et solvant pour solution injectable. Qdenga poudre et solvant pour solution injectable en seringue pré-remplie Vaccin tétravalent contre la dengue (vivant, atténué)", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 971}
{"after": {"end": 176, "start": 0, "text": "Les patients sont les personnes auxquelles le médecin a prescrit un traitement par Terrosa, à l'aide du Terrosa Pen. Le médecin détermine si le Terrosa Pen convient au patient.", "truncated": false}, "after_length": 176, "after_sha256": "737797b90f998295cb41a1e8d0ae476508e785b72e81e55ed7b64e4bbe50f08d", "annex": "IIIA", "before": {"end": 180, "start": 0, "text": "Les patients sont les personnes auxquelles le médecin a prescrit un traitement par Terrosa, à l'aide du stylo Terrosa. Le médecin détermine si le stylo Terrosa convient au patient.", "truncated": false}, "before_length": 180, "before_sha256": "eb72bc3384b80838087983e805eb36a1c4efcf603ea88cbf4ff4ce8c9b6480d4", "change_kind": "content", "change_operations": [{"after_end": 104, "after_start": 104, "before_end": 110, "before_start": 104, "kind": "delete"}, {"after_end": 115, "after_start": 111, "before_end": 117, "before_start": 117, "kind": "insert"}, {"after_end": 144, "after_start": 144, "before_end": 152, "before_start": 146, "kind": "delete"}, {"after_end": 155, "after_start": 151, "before_end": 159, "before_start": 159, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 12, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-963baaed8b657edd606d4c92", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1940}
{"after": {"end": 1394, "start": 0, "text": "Dans une étude randomisée de phase II (BO20924) un total de 154 patients âgés de ≥ 6 mois à < 18 ans, nouvellement diagnostiqués atteints de rhabdomyosarcome et de sarcome des tissus mous non-rhabdomyosarcome métastatiques , a été traité par le traitement de référence (induction IVADO/IVA +/- thérapie locale suivi de Vinorelbine en maintenance et de cyclophosphamide) avec ou sans bevacizumab (2,5 mg/kg/semaine) pour une durée de traitement d’environ 18 mois. Au moment de l’analyse primaire finale, le critère principal d’évaluation de survie sans évènements basée sur une revue centrale indépendante n’a pas montré une différence statistiquement significative entre les deux bras de traitement, avec un HR de 0,93 (95 % IC : 0,61 – 1,41 ; p = 0,72). La différence de taux de réponse objective par revue centrale indépendante était de 18 % (IC : 0,6 % - 35,3 %) entre les deux bras de traitement chez les quelques patients ayant une tumeur évaluable à l’inclusion et une réponse confirmée avant de recevoir une thérapie locale : 27 patients sur 75 (36,0 %, IC à 95 % : 25,2 % - 47,9 %) dans le bras chimiothérapie et 34 patients sur 63 (54,0 %, IC à 95 % : 40,9 %, 66,6 %) dans le bras bevacizumab + chimiothérapie. Les analyses finales de survie globale (OS) n'ont montré aucun bénéfice clinique significatif de l'ajout du bevacizumab à la chimiothérapie dans cette population de patients.", "truncated": false}, "after_length": 1394, "after_sha256": "30e9dd1dbd44365b5072f22437a2dc166845961e010e0d30105c757b9f97a44e", "annex": "I", "before": {"end": 1381, "start": 0, "text": "Dans une étude randomisée de phase II (BO20924) un total de 154 patients âgés de ≥ 6 mois à < 18 ans, nouvellement diagnostiqués atteints de rhabdomyosarcome et de sarcome des tissus mous non-rhabdomyosarcome métastatiques , a été traité par le traitement de référence (induction IVADO/IVA +/- thérapie locale suivi de Vinorelbine en maintenance et de cyclophosphamide) avec ou sans bevacizumab (2,5 mg/kg/semaine) pour une durée de traitement d’environ 18 mois. Au moment de l’analyse primaire finale, le critère principal de survie sans évènements basée sur une revue centrale indépendante n’a pas montré une différence statistiquement significative entre les deux bras de traitement, avec un HR de 0,93 (95 % IC : 0,61 – 1,41 ; p = 0,72). La différence de taux de réponse objective par revue centrale indépendante était de 18 % (IC : 0,6 % - 35,3 %) entre les deux bras de traitement chez les quelques patients ayant une tumeur évaluable à l’inclusion et une réponse confirmée avant de recevoir une thérapie locale : 27 patients sur 75 (36,0 %, IC à 95 % : 25,2 % - 47,9 %) dans le bras chimiothérapie et 34 patients sur 63 (54,0 %, IC à 95 % : 40,9 %, 66,6 %) dans le bras bevacizumab + chimiothérapie. Les analyses finales de survie globale (OS) n'ont montré aucun bénéfice clinique significatif de l'ajout du bevacizumab à la chimiothérapie dans cette population de patients.", "truncated": false}, "before_length": 1381, "before_sha256": "d6def691724d851a5217bbcba933f8304fb245c184ef2250217bed754d884e63", "change_kind": "content", "change_operations": [{"after_end": 538, "after_start": 525, "before_end": 525, "before_start": 525, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 13}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9649129726f7a0425869219b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2370}
{"after": {"end": 23, "start": 0, "text": "Éléments du Terrosa Pen", "truncated": false}, "after_length": 23, "after_sha256": "d81f3edd30708c0c7fbd1da9400161646e2a1c560af94c89f217735c5cc805fc", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "Éléments du stylo Terrosa", "truncated": false}, "before_length": 25, "before_sha256": "90a9c9af371ee62b20167ac7c2e22fd2a3fd8fed3c08ecae7e1ff2386ec07e76", "change_kind": "content", "change_operations": [{"after_end": 12, "after_start": 12, "before_end": 18, "before_start": 12, "kind": "delete"}, {"after_end": 23, "after_start": 19, "before_end": 25, "before_start": 25, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-96c68390a4afe25857ee3721", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1947}
{"after": {"end": 99, "start": 0, "text": "pression sanguine basse (hypotension) (très fréquent : pouvant concerner plus de 1 personne sur 10)", "truncated": false}, "after_length": 99, "after_sha256": "a35f4b60746c801496166317d90c67d07370e7d6e16b1e1e6e4ad6f504895217", "annex": "IIIA", "before": {"end": 99, "start": 0, "text": "pression sanguine basse (hypotension) (Très fréquent : pouvant concerner plus de 1 personne sur 10)", "truncated": false}, "before_length": 99, "before_sha256": "21ca1c557433fe37d37567c8fe4eccf42cf81e974857013fc3602fd7dae423a6", "change_kind": "content", "change_operations": [{"after_end": 40, "after_start": 39, "before_end": 40, "before_start": 39, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-96eebd3cad1e697d0533e264", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3391}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 55, "start": 0, "text": "Do not remove the needle cap until instructed to do so.", "truncated": false}, "before_length": 55, "before_sha256": "31e19a488e6bcba148e42b0432b26c21723ca81297fb6ae98b737e5f2bbe22b0", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 55, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 55, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9764276f5444bf1f963890b3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12250}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Τηλ: + 353 1 206 3800", "truncated": false}, "before_length": 21, "before_sha256": "a050297c9d1beab810fdcd5ebcd16258aacb90bdf1ac91dea393687126595109", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 21, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 21, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-976759b22c69aa63c39e8789", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1072}
{"after": {"end": 125, "start": 0, "text": "• Put the Terrosa Pen, with the cartridge inserted, back into the refrigerator between 2 and 8 °C immediately after each use.", "truncated": false}, "after_length": 125, "after_sha256": "01c5e0cbfc828f72298e05a73c5d13d5b635052f2378ad975e20e78644c803f5", "annex": "IIIA", "before": {"end": 120, "start": 0, "text": "• Put the Terrosa Pen, with the cartridge inserted, back into the refrigerator between 2 and 8 °C immediately after use.", "truncated": false}, "before_length": 120, "before_sha256": "885e456c7cc3f0972b2c8c475704c66cd5f1fa4044f2dfa8719cf9daf6903842", "change_kind": "content", "change_operations": [{"after_end": 121, "after_start": 116, "before_end": 116, "before_start": 116, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 5}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9767f02d694998dd54843c85", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2087}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Luxembourg/Luxemburg", "truncated": false}, "before_length": 20, "before_sha256": "28ac4fa3aba2dfb4b228bd072edb8cc818b04e6f4b87f37114caa6154e0e706b", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 20, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 20, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9781b532139a1d338dce23a7", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1029}
{"after": {"end": 71, "start": 0, "text": "la ciclosporine, utilisée pour prévenir le rejet des greffes d’organes.", "truncated": false}, "after_length": 71, "after_sha256": "e3d3b57620f52899cdb330890a071521119758530576ca0cc2ff7105b82fd69f", "annex": "IIIA", "before": {"end": 73, "start": 0, "text": "de la prévention du rejet des greffes d’organes tels que la ciclosporine.", "truncated": false}, "before_length": 73, "before_sha256": "06cac6b07ec9d1485c3382e7a22a8128c9bab05c622042350ec741cdc5c14777", "change_kind": "content", "change_operations": [{"after_end": 24, "after_start": 0, "before_end": 1, "before_start": 0, "kind": "replace"}, {"after_end": 30, "after_start": 26, "before_end": 5, "before_start": 3, "kind": "replace"}, {"after_end": 37, "after_start": 37, "before_end": 13, "before_start": 12, "kind": "delete"}, {"after_end": 39, "after_start": 38, "before_end": 16, "before_start": 14, "kind": "replace"}, {"after_end": 42, "after_start": 40, "before_end": 19, "before_start": 17, "kind": "replace"}, {"after_end": 70, "after_start": 70, "before_end": 72, "before_start": 47, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 33, "chars_inserted": 31}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9789e0d3e3ba67dd4ab5049f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3302}
{"after": {"end": 151, "start": 0, "text": "ne commencez pas Adempas avant au moins 24 heures après votre dernière dose de sildénafil et au moins 72 heures après votre dernière dose de tadalafil.", "truncated": false}, "after_length": 151, "after_sha256": "229ccb9f5eea59da75ff2cf0848990621b51f68a8fe8b5fb909e8a93c861be64", "annex": "IIIA", "before": {"end": 153, "start": 0, "text": "ne commencez pas Adempas pendant au moins 24 heures après votre dernière dose de sildénafil et au moins 48 heures après votre dernière dose de tadalafil.", "truncated": false}, "before_length": 153, "before_sha256": "0497253b8f002d5ef3165ba1f441a9c82be4ba370477a6eb52e4cb2c3d7d191d", "change_kind": "content", "change_operations": [{"after_end": 27, "after_start": 25, "before_end": 29, "before_start": 25, "kind": "replace"}, {"after_end": 104, "after_start": 102, "before_end": 106, "before_start": 104, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-97a0565d48fc4fee8cf4514d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3377}
{"after": {"end": 20, "start": 0, "text": "msd.slovenia@msd.com", "truncated": false}, "after_length": 20, "after_sha256": "32f245e2e4036e3b467769cde309d09f05bcdd6f4f0f06a8cc91d81e4a082213", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "msd.slovenia@merck.com", "truncated": false}, "before_length": 22, "before_sha256": "fde9163edb7de43fa3b79d2f1f0c2a3195d3f29d316528e4141d99f1f940d448", "change_kind": "content", "change_operations": [{"after_end": 16, "after_start": 14, "before_end": 18, "before_start": 14, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-97a39e25e634f210ed1b8fb2", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3165}
{"after": {"end": 38, "start": 0, "text": "erlotinib, gefitinib, to treat cancer.", "truncated": false}, "after_length": 38, "after_sha256": "396bf8d8ba27e1b456460c2d12688afb4508d224774b66e37b52eccd0cf94a5d", "annex": "IIIA", "before": {"end": 36, "start": 0, "text": "cancer such as erlotinib, gefitinib.", "truncated": false}, "before_length": 36, "before_sha256": "d5fb14120c9c0fa7064768d76536801578a1b90b302236b272991e0fcaf781dc", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 15, "before_start": 0, "kind": "delete"}, {"after_end": 37, "after_start": 20, "before_end": 35, "before_start": 35, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 15, "chars_inserted": 17}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-97b2447694be0efa37c41611", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3209}
{"after": {"end": 19, "start": 0, "text": "Tel: +385 800787089", "truncated": false}, "after_length": 19, "after_sha256": "1d1dd19a6294ac43f4bc65ab1d531c8cf1be16a8a4a052fb96c010aeb11e0008", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Tel.: +385 800787089", "truncated": false}, "before_length": 20, "before_sha256": "22ceccd7ab6ab1e9a41429450e7ece1e5e7743422b9c87c431910642dadc3726", "change_kind": "content", "change_operations": [{"after_end": 3, "after_start": 3, "before_end": 4, "before_start": 3, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-97e1ceb981d38cbef5d391a2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000112", "medicine_name": "Twinrix Adult", "medicine_slug": "twinrix-adult", "observed_at": "2026-10-12T13:29:23Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "cfad5fb0086c9b5d6a36b454f3f546373def1f56cded73e0652b498d02d68e41", "source_snapshot_id": "source-17627897b0874bf1160c7372", "source_updated_at": "2026-08-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/twinrix-adult-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 985}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 10, "start": 0, "text": "2°C to 8°C", "truncated": false}, "before_length": 10, "before_sha256": "81d810716acbe950b41556ad0d6f83327c0c94aaaad43647bd6107d8f320a304", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 10, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 10, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-97f927ecc03fdb97599f0fa5", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13099}
{"after": {"end": 163, "start": 0, "text": "antacids such as aluminium hydroxide / magnesium hydroxide, to treat indigestion or heartburn. Take antacids at least 2 hours before or 1 hour after using Adempas.", "truncated": false}, "after_length": 163, "after_sha256": "232e7f1d9186d9d59d3c81d5e0bcc0af889d462df398316f3a0354a8630eff6b", "annex": "IIIA", "before": {"end": 164, "start": 0, "text": "stomach disease or heartburn called antacids such as aluminium hydroxide / magnesium hydroxide. Take antacids at least 2 hours before or 1 hour after using Adempas.", "truncated": false}, "before_length": 164, "before_sha256": "0d99d827e00383f47e768be623dddb5436df6371aa57373e3fd28f8c51055227", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 36, "before_start": 0, "kind": "delete"}, {"after_end": 93, "after_start": 58, "before_end": 94, "before_start": 94, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 36, "chars_inserted": 35}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-98294fff4c576c075ac355f8", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3213}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 18, "start": 0, "text": "1 single-dose vial", "truncated": false}, "before_length": 18, "before_sha256": "1affd6db765a6968ad5115033d17409302823e2ce547d08312d93d249661e887", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 18, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 18, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9833f2752e992b3b7afbe56a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12886}
{"after": {"end": 392, "start": 0, "text": "Les cartouches de Terrosa sont conçues pour être utilisées uniquement avec le stylo d’administration de médicament multidose réutilisable Terrosa Pen et les aiguilles pour stylo compatibles. Le stylo et les aiguilles à injection ne sont pas fournis avec Terrosa. Cependant, à l’instauration de traitement un conditionnement contenant une cartouche Terrosa et un Terrosa Pen doit être utilisé.", "truncated": false}, "after_length": 392, "after_sha256": "3326e2eefde46cbf168cf9dad43cc93a714f90686b05a0b580f2aad1900ed003", "annex": "IIIA", "before": {"end": 390, "start": 0, "text": "Les cartouches de Terrosa sont conçues pour être utilisées uniquement avec le stylo d’administration de médicament multidose réutilisable Terrosa et les aiguilles pour stylo compatibles. Le stylo et les aiguilles à injection ne sont pas fournis avec Terrosa. Cependant, à l’instauration de traitement un conditionnement contenant une cartouche Terrosa et un stylo Terrosa doit être utilisé.", "truncated": false}, "before_length": 390, "before_sha256": "1de48dc20f71c8b06d216f1eca0a91d60f10bbb039e8d370aeb95c3077fdd32a", "change_kind": "content", "change_operations": [{"after_end": 150, "after_start": 146, "before_end": 146, "before_start": 146, "kind": "insert"}, {"after_end": 362, "after_start": 362, "before_end": 364, "before_start": 358, "kind": "delete"}, {"after_end": 373, "after_start": 369, "before_end": 371, "before_start": 371, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-984a2fef8ae117d28e021297", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1785}
{"after": {"end": 8, "start": 0, "text": "D02 HW68", "truncated": false}, "after_length": 8, "after_sha256": "1ed87437489fcb80b59bfa5d17082f438d78a8aff5deaac6125946420fbf0992", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 8, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-98972ff84a393143cad62d66", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1345}
{"after": {"end": 160, "start": 0, "text": "Des analyses pré-définies de la SSP ont été conduites, toutes avec un cut-off au 29 septembre 2009. Les résultats de ces analyses pré-définies sont comme suit :", "truncated": false}, "after_length": 160, "after_sha256": "a972e2f86acdb3214262f177f28a56d62c34ffde432e4efc5deef4e5aa76a65f", "annex": "I", "before": {"end": 160, "start": 0, "text": "Des analyses pré-définies de la PFS ont été conduites, toutes avec un cut-off au 29 septembre 2009. Les résultats de ces analyses pré-définies sont comme suit :", "truncated": false}, "before_length": 160, "before_sha256": "cf4b16822e55209094de1d4da4b70f9b22bd724ecb01409a7f50886d42ed5e5b", "change_kind": "content", "change_operations": [{"after_end": 34, "after_start": 32, "before_end": 32, "before_start": 32, "kind": "insert"}, {"after_end": 35, "after_start": 35, "before_end": 35, "before_start": 33, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9904043c342a0e339e6c7e3b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1784}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 7, "start": 0, "text": "Sverige", "truncated": false}, "before_length": 7, "before_sha256": "3a7d70b4edb982a403e97d77681309e5fb1032b12d727aa1e92b145b069b9aa4", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 7, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-997d62700f2093c1dbb6d305", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1153}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Tel: +353 1 206 3800", "truncated": false}, "before_length": 20, "before_sha256": "b76fef5190d612d91d8ee1c3f52c40e30fcc7f25541faffe2a0c00e33c8cb7c1", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 20, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 20, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-99b3be6dde559a96a09e1b20", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1107}
{"after": {"end": 68, "start": 0, "text": "Spikevax LP.8.1 is not recommended for children aged under 6 months.", "truncated": false}, "after_length": 68, "after_sha256": "48b5a6f478301a58133df5f811898785f38e8ce2a7a14aabc0cd4cc44b404e3a", "annex": "I", "before": {"end": 66, "start": 0, "text": "Spikevax JN.1 is not recommended for children aged under 6 months.", "truncated": false}, "before_length": 66, "before_sha256": "19fc1c38af03163f7f7140e9dfb75b6932d606f26082c9ce065359c18a782443", "change_kind": "administrative", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-99ce82c8842e9e657b9d44ac", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12667}
{"after": {"end": 54, "start": 0, "text": "Takeda Pharmaceuticals International AG Ireland Branch", "truncated": false}, "after_length": 54, "after_sha256": "81709515d3af1f0e4041ce3c760d8fc81fefa358805810b0b53a84e121d5efa6", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 54, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 54}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-99ff7176db25efd599e33836", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1340}
{"after": {"end": 29, "start": 0, "text": "Survie sans progression (SSP)", "truncated": false}, "after_length": 29, "after_sha256": "617193974d6682c85a8af219a6f2b06ff66ff3e0e9b29cabebd5d5998461e7d8", "annex": "I", "before": {"end": 29, "start": 0, "text": "Survie sans progression (PFS)", "truncated": false}, "before_length": 29, "before_sha256": "8f5b37d99ddf529df1ca72d62d3cc355e8dee70624f1335d36a06a6f71013027", "change_kind": "content", "change_operations": [{"after_end": 27, "after_start": 25, "before_end": 25, "before_start": 25, "kind": "insert"}, {"after_end": 28, "after_start": 28, "before_end": 28, "before_start": 26, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9a5f0ce6c7155360e24b100e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1498}
{"after": {"end": 67, "start": 0, "text": "dd Inclut néphrite auto-immune et néphrite à médiation immunitaire.", "truncated": false}, "after_length": 67, "after_sha256": "cd9f1fccbdc28df72fb3dd9b48aeb5b5a4bd7bfbfe91e05c642ffbf5d2750792", "annex": "I", "before": {"end": 67, "start": 0, "text": "cc Inclut néphrite auto-immune et néphrite à médiation immunitaire.", "truncated": false}, "before_length": 67, "before_sha256": "819285fb739bcef2676fb275f56cd352247b9e896a89472a912ddcdc309bf19a", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 0, "before_end": 2, "before_start": 0, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9a7c055154eff3eec8b220fd", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:18Z", "pipeline_version": "2.0.0", "presentation_label": "IMJUDO 20 mg/ml, solution à diluer pour perfusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "2437ab76633f46c9eee5e002e5c7a7caba6367f59567d750be0eb67c74d1db4e", "source_snapshot_id": "source-7f4d129b0a0fd2d3684d27c5", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 925}
{"after": {"end": 28, "start": 0, "text": "Intended patient population:", "truncated": false}, "after_length": 28, "after_sha256": "1a8a30848865ea3c33fd44f33ba8f78f525bbc4a3ad66a4c332bcaf50ad9aa37", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 28, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 28}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9a7e0842d3043eb2ecdbdac9", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1950}
{"after": {"end": 54, "start": 0, "text": "CONCLUSIONS SCIENTIFIQUES ET MOTIFS DE LA MODIFICATION", "truncated": false}, "after_length": 54, "after_sha256": "923a6f5bb56e88c43a211adca028f81b56da56184220957daa36cc07841bc924", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 54, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 54}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9aa9d8bf6803697ec8f805ad", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3396}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "Tel: + 46 (0)31 773 75 30", "truncated": false}, "before_length": 25, "before_sha256": "7c0d1404bad5b8761b40f49f53ed365b3205af7da52ea8f044f6f6ed18aa6228", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 25, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 25, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9ab15e5cf28f00428f2ba0d3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1145}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "nordics@mundipharma.dk", "truncated": false}, "before_length": 22, "before_sha256": "f439d81e92f339fb15af44387dc1531c6265af6c724b25a05f18a5ab6acd0f1e", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 22, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 22, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9accbd251b8882104785dae6", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1060}
{"after": {"end": 51, "start": 0, "text": "bosentan, to treat pulmonary arterial hypertension.", "truncated": false}, "after_length": 51, "after_sha256": "4e9f73fbe1e293057fdbe2df3475f8930983032e714230de509bf7f990c258ac", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 51, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 51}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9ada96309184b818a0b7e517", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3211}
{"after": {"end": 242, "start": 0, "text": "Le Terrosa Pen réutilisable permet aux patients adultes atteints d'ostéoporose, aux professionnels de santé, aux soignants et aux tiers de réaliser des injections sous-cutanées quotidiennes de Terrosa, soit en milieu médical, soit à domicile.", "truncated": false}, "after_length": 242, "after_sha256": "c2c90b35d27125bc81ec64e2a9e8287624165823f52f778d254a224042e1dcb7", "annex": "IIIA", "before": {"end": 244, "start": 0, "text": "Le stylo Terrosa réutilisable permet aux patients adultes atteints d'ostéoporose, aux professionnels de santé, aux soignants et aux tiers de réaliser des injections sous-cutanées quotidiennes de Terrosa, soit en milieu médical, soit à domicile.", "truncated": false}, "before_length": 244, "before_sha256": "609a25cf0c8b4a7481e46f955efdc3730899bda4adb201a399973d6f8bc5dadc", "change_kind": "content", "change_operations": [{"after_end": 3, "after_start": 3, "before_end": 9, "before_start": 3, "kind": "delete"}, {"after_end": 14, "after_start": 10, "before_end": 16, "before_start": 16, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9aeb823a3d7748c8fcfc301b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1936}
{"after": {"end": 119, "start": 0, "text": "Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu", "truncated": false}, "after_length": 119, "after_sha256": "0f2b81ab8009e1a279ca008eb6e21bdb2e532de63aef52b62bdac980c49555d4", "annex": "IIIA", "before": {"end": 118, "start": 0, "text": "Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu", "truncated": false}, "before_length": 118, "before_sha256": "d114210a3c6f4b6710e22609ee80410ff17f5efd93b30ab72728a60b65635068", "change_kind": "technical", "change_operations": [{"after_end": 99, "after_start": 98, "before_end": 98, "before_start": 98, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9af0c58fa5142c979d4d2e25", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9024}
{"after": {"end": 21, "start": 0, "text": "changements d’humeur.", "truncated": false}, "after_length": 21, "after_sha256": "2274c9a08292c0726486f2ed667c8ee611945359268ebc0d7fa01abde0c8e992", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 21, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 21}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9b2ffdc76d7f69a2e76cac86", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "9ac80b0d56ebad4970f7a8335a177613af59ef25517bcd0bdd3397c207cc1bac", "source_snapshot_id": "source-c11aa9e32420f125a88005bc", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2476}
{"after": {"end": 191, "start": 0, "text": "If you have taken more Fycompa than you should, contact your doctor straight away. You may experience confusion, agitation, aggressive behaviour, vomiting, and reduced level of consciousness.", "truncated": false}, "after_length": 191, "after_sha256": "c5d2248c805383a83f7d35d055b32f8169c8826eecef95aa090a57c57e144016", "annex": "IIIA", "before": {"end": 181, "start": 0, "text": "If you have taken more Fycompa than you should contact your doctor straight away. You may experience confusion, agitation, aggressive behaviour and depressed level of consciousness.", "truncated": false}, "before_length": 181, "before_sha256": "8e457e87b421a62fd0f1d8b979440578bcb61c1989b6e79592533d336cb78dd6", "change_kind": "content", "change_operations": [{"after_end": 47, "after_start": 46, "before_end": 46, "before_start": 46, "kind": "insert"}, {"after_end": 155, "after_start": 144, "before_end": 143, "before_start": 143, "kind": "insert"}, {"after_end": 160, "after_start": 160, "before_end": 151, "before_start": 148, "kind": "delete"}, {"after_end": 165, "after_start": 162, "before_end": 155, "before_start": 153, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 5, "chars_inserted": 15}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9b498b293ad9b20e54c3bfd5", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3164}
{"after": {"end": 56, "start": 0, "text": "1. Qu’est-ce que Avastin et dans quel cas est-il utilisé", "truncated": false}, "after_length": 56, "after_sha256": "cfa0006b62fb521a7ff3be0ebaf941f5a802f8f5799b275fe31e37abce7bad8e", "annex": "IIIA", "before": {"end": 58, "start": 0, "text": "1. Qu’est-ce que Avastin et dans quel cas est-il utilisé ?", "truncated": false}, "before_length": 58, "before_sha256": "5ce0028d2bdc3e50e657e5d7affee0e8095d67b5819a6b66641f812e2a288a83", "change_kind": "content", "change_operations": [{"after_end": 56, "after_start": 56, "before_end": 58, "before_start": 56, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9b4a7e73e1c536897527bea1", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2954}
{"after": {"end": 602, "start": 0, "text": "L’etanercept est absorbé lentement depuis le site d’injection sous-cutanée, atteignant une concentration maximale environ 48 heures après administration unique. La biodisponibilité absolue est de 76 %. Avec deux doses par semaine, on peut s’attendre à ce que les concentrations à l’état d’équilibre représentent environ deux fois celles que l’on mesure après administration unique. Après l’administration unique par voie sous-cutanée de 25 mg d’Enbrel, la concentration sérique maximale moyenne observée chez les volontaires sains était de 1,65 0,66 g/mL, l’aire sous la courbe étant de 235 96,6 gh/mL.", "truncated": false}, "after_length": 602, "after_sha256": "6314a3bd2887cae2045cf42f95c84f67356ea2b9322450cf13aa4ed9554aeb12", "annex": "I", "before": {"end": 602, "start": 0, "text": "L’etanercept est absorbé lentement depuis le site d’injection sous-cutanée, atteignant une concentration maximale environ 48 heures après administration unique. La biodisponibilité absolue est de 76 %. Avec deux doses par semaine, on peut s’attendre à ce que les concentrations à l’état d’équilibre représentent environ deux fois celles que l’on mesure après administration unique. Après l’administration unique par voie sous-cutanée de 25 mg d’Enbrel, la concentration sérique maximale moyenne observée chez les volontaires sains était de 1,65 0,66 g/ml, l’aire sous la courbe étant de 235 96,6 gh/ml.", "truncated": false}, "before_length": 602, "before_sha256": "81e459b6de61f15e830aa6aeb2c4613af244d2ce10df117a49329704f0752546", "change_kind": "content", "change_operations": [{"after_end": 554, "after_start": 553, "before_end": 554, "before_start": 553, "kind": "replace"}, {"after_end": 601, "after_start": 600, "before_end": 601, "before_start": 600, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9b4de602a50e7a7318aea648", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 10 mg poudre et solvant pour solution injectable pour usage pédiatrique", "presentation_occurrence": 5, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5345}
{"after": {"end": 99, "start": 0, "text": "microangiopathya,b, Hyaline occlusive glomerular microangiopathya, Aneurysms and artery dissections", "truncated": false}, "after_length": 99, "after_sha256": "29deda29b3318f31961181414000447a6507609c11f7dae1daf7ba6c35cbcb93", "annex": "I", "before": {"end": 52, "start": 0, "text": "microangiopathya,b, Aneurysms and artery dissections", "truncated": false}, "before_length": 52, "before_sha256": "c41ca0c1cc460b761aa431e0098bc1ac516e8276074dbe0ad855e112ac1c3def", "change_kind": "content", "change_operations": [{"after_end": 67, "after_start": 20, "before_end": 20, "before_start": 20, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 47}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9b52429d279fc2e4a21f177d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:18Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml concentrate for solution for infusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "89a938df5e41f86548301270084e3d1ecf171802e24b5429f62e3bede7ee32dd", "source_snapshot_id": "source-b71aeee5a07abebc34c02e28", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 443}
{"after": {"end": 118, "start": 0, "text": "- have heart failure (can include symptoms like shortness of breath, feeling tired, fainting, swollen ankles and legs)", "truncated": false}, "after_length": 118, "after_sha256": "2811d4a9e2e249a6fce0ad7acf32431941a9f3721f4cf65dffa247a653336a1a", "annex": "IIIA", "before": {"end": 1, "start": 0, "text": "-", "truncated": false}, "before_length": 1, "before_sha256": "3973e022e93220f9212c18d0d0c543ae7c309e46640da93a4a0314de999f5112", "change_kind": "content", "change_operations": [{"after_end": 118, "after_start": 1, "before_end": 1, "before_start": 1, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 117}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9b68b36ec057daabebaa4ef2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002640", "medicine_name": "Cometriq", "medicine_slug": "cometriq", "observed_at": "2026-10-12T19:00:48Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "9a013f64c372a20a7dfcfd0a30d84c365e558413e28c71df200098486d1db15b", "source_snapshot_id": "source-a2dc64012a0e2142a7477fbb", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/cometriq-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1869}
{"after": {"end": 63, "start": 0, "text": "Warning: The pen needles must be used only once and the Terrosa", "truncated": false}, "after_length": 63, "after_sha256": "4f54466db7fbabdfa2525d0f3757fbf839d46120c2be24e92ead3182c57f157f", "annex": "IIIA", "before": {"end": 97, "start": 0, "text": "The pen needles must be used only once and the Terrosa cartridge must be used by one person only.", "truncated": false}, "before_length": 97, "before_sha256": "473606bf311a4427a0638b062f8b8a4999f34227231c7bd46189b3a6a753a769", "change_kind": "content", "change_operations": [{"after_end": 9, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}, {"after_end": 63, "after_start": 63, "before_end": 97, "before_start": 54, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 43, "chars_inserted": 9}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9ba68417a4a9b7b752bbb862", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2100}
{"after": {"end": 870, "start": 0, "text": "Apremilast is associated with an increased risk of psychiatric disorders such as insomnia, anxiety, altered mood, and depression. Instances of suicidal ideation and behaviour, including suicide, have been observed in patients with or without history of depression (see section 4.8). The risks and benefits of starting or continuing treatment with apremilast should be carefully assessed if patients report previous or existing psychiatric symptoms or if concomitant treatment with other medicinal products likely to cause psychiatric events is intended. Patients and caregivers should be instructed to notify the prescriber of any changes in behaviour or mood and of any suicidal ideation. If patients suffered from new or worsening psychiatric symptoms, or suicidal ideation or suicidal attempt is identified, it is recommended to discontinue treatment with apremilast.", "truncated": false}, "after_length": 870, "after_sha256": "0f45d2d9dd89dc3a16613a0772163a974024e276778627fd38e7718827e6ba42", "annex": "I", "before": {"end": 847, "start": 0, "text": "Apremilast is associated with an increased risk of psychiatric disorders such as insomnia, and depression. Instances of suicidal ideation and behaviour, including suicide, have been observed in patients with or without history of depression (see section 4.8). The risks and benefits of starting or continuing treatment with apremilast should be carefully assessed if patients report previous or existing psychiatric symptoms or if concomitant treatment with other medicinal products likely to cause psychiatric events is intended. Patients and caregivers should be instructed to notify the prescriber of any changes in behaviour or mood and of any suicidal ideation. If patients suffered from new or worsening psychiatric symptoms, or suicidal ideation or suicidal attempt is identified, it is recommended to discontinue treatment with apremilast.", "truncated": false}, "before_length": 847, "before_sha256": "21a946bb9c3f6efcbcac8f46600a4d529d9c39845fc55f9d9aaaf46ff98592d3", "change_kind": "content", "change_operations": [{"after_end": 116, "after_start": 93, "before_end": 93, "before_start": 93, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 23}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9ba772e7f6822dcfce675209", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:30Z", "pipeline_version": "2.0.0", "presentation_label": "Otezla 10 mg film-coated tablets Otezla 20 mg film-coated tablets Otezla 30 mg film-coated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "35ab6716aa09492c14ac6849111486ec47235c0bc65ef055350de950f316c5e6", "source_snapshot_id": "source-f20a60110d1f8fef5225317d", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 231}
{"after": {"end": 109, "start": 0, "text": "If you are taking these medicines, you may experience more side effects, or Adempas may not work as expected.", "truncated": false}, "after_length": 109, "after_sha256": "03696b91bbb3d0f21a713249836c659207436a01347f784537618316f06d5d05", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 109, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 109}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9bcee135d867c14a878ca7ee", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2785}
{"after": {"end": 20, "start": 0, "text": "Tel. +370 5 2780 247", "truncated": false}, "after_length": 20, "after_sha256": "be9916884a39997d225e35a54dcbad608c2f1450d383ed91a2b2c37447acf059", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tel: + 370 5 2780 247", "truncated": false}, "before_length": 21, "before_sha256": "faa31f75401420bbf0ff6f06d92fff41d82385ffc387084762acc731facfdedc", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 4, "before_start": 3, "kind": "replace"}, {"after_end": 6, "after_start": 6, "before_end": 7, "before_start": 6, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9bf8d570e4e27fa575d1484b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3475}
{"after": {"end": 148, "start": 0, "text": "Des informations détaillées sur ce médicament sont disponibles sur le site internet de l’Agence européenne des médicaments https://www.ema.europa.eu", "truncated": false}, "after_length": 148, "after_sha256": "0144d9770eb4c4153d7e7b1c9dec56544610f245adee115432038125fa622184", "annex": "IIIA", "before": {"end": 147, "start": 0, "text": "Des informations détaillées sur ce médicament sont disponibles sur le site internet de l’Agence européenne des médicaments http://www.ema.europa.eu", "truncated": false}, "before_length": 147, "before_sha256": "d0dd4118d52714b2cfcf09f73f7031efc575f51b70183bf3d601893b6bf4e936", "change_kind": "technical", "change_operations": [{"after_end": 128, "after_start": 127, "before_end": 127, "before_start": 127, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9c116da966bce49ea283626d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 10174}
{"after": {"end": 632, "start": 0, "text": "Les caractéristiques des concentrations sériques moyennes à l’état d’équilibre chez les patients atteints de PR étaient une Cmax de 2,4 mg/l vs 2,6 mg/l, une Cmin de 1,2 mg/l vs 1,4 mg/l, et une ASC partielle de 297 mgh/l vs 316 mgh/l pour la dose de 50 mg d’Enbrel une fois par semaine (n = 21) vs 25 mg d’Enbrel deux fois par semaine (n = 16) respectivement. Dans une étude en ouvert, croisée, avec administration unique de deux posologies différentes chez des volontaires sains, il a été démontré que l’administration d’une injection unique de 50 mg/mL d’etanercept était bioéquivalente à deux injections simultanées de 25 mg/mL.", "truncated": false}, "after_length": 632, "after_sha256": "a314719d36f9cbee570762008a9dbbdc562da2fa0fcbf7079b1f1d65515aa5c9", "annex": "I", "before": {"end": 632, "start": 0, "text": "Les caractéristiques des concentrations sériques moyennes à l’état d’équilibre chez les patients atteints de PR étaient une Cmax de 2,4 mg/l vs 2,6 mg/l, une Cmin de 1,2 mg/l vs 1,4 mg/l, et une ASC partielle de 297 mgh/l vs 316 mgh/l pour la dose de 50 mg d’Enbrel une fois par semaine (n = 21) vs 25 mg d’Enbrel deux fois par semaine (n = 16) respectivement. Dans une étude en ouvert, croisée, avec administration unique de deux posologies différentes chez des volontaires sains, il a été démontré que l’administration d’une injection unique de 50 mg/ml d’etanercept était bioéquivalente à deux injections simultanées de 25 mg/ml.", "truncated": false}, "before_length": 632, "before_sha256": "8c065fd129119e22879a2173b5d388342b9c02f7cde21405d481a9d61753f047", "change_kind": "content", "change_operations": [{"after_end": 555, "after_start": 554, "before_end": 555, "before_start": 554, "kind": "replace"}, {"after_end": 631, "after_start": 630, "before_end": 631, "before_start": 630, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9c2c76b72c672b7dfe11a391", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg poudre pour solution injectable", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1033}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 45, "start": 0, "text": "Spikevax JN.1 50 mcg dispersion for injection", "truncated": false}, "before_length": 45, "before_sha256": "1e678948233d2a25b779218928966af3f5643f17a6c1ee085306e6bf41c3568e", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 45, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 45, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9c360dbbf542e0bc3ee512db", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12852}
{"after": {"end": 95, "start": 0, "text": "Before you start the administration of Terrosa make sure you check the Terrosa Pen for defects.", "truncated": false}, "after_length": 95, "after_sha256": "6b712da6263b2414f24748a5798ab9496d72c2dc0aa1bf068252b3ee571f3c68", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 95, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 95}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9c4d5054a507d8f3483eba23", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1967}
{"after": {"end": 125, "start": 0, "text": "• Remove the outer needle cap and keep it for later. You will need it for the safe removal of the needle after the injection.", "truncated": false}, "after_length": 125, "after_sha256": "3b659c5919102afeaa83b7ed828359660a8059a426a8555afa49d0f0b7b7b191", "annex": "IIIA", "before": {"end": 42, "start": 0, "text": "• Remove the outer needle cap and save it.", "truncated": false}, "before_length": 42, "before_sha256": "7103acc1f054e1f2223f37e53e4d11aea56f1c79b5292292603a9598dbcebfb8", "change_kind": "content", "change_operations": [{"after_end": 78, "after_start": 34, "before_end": 34, "before_start": 34, "kind": "insert"}, {"after_end": 87, "after_start": 80, "before_end": 36, "before_start": 36, "kind": "insert"}, {"after_end": 113, "after_start": 88, "before_end": 37, "before_start": 37, "kind": "insert"}, {"after_end": 120, "after_start": 116, "before_end": 40, "before_start": 40, "kind": "insert"}, {"after_end": 124, "after_start": 121, "before_end": 41, "before_start": 41, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 83}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9ca450cfb0c24c6cb03cfb03", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2005}
{"after": {"end": 2, "start": 0, "text": "SC", "truncated": false}, "after_length": 2, "after_sha256": "32da6721804f1dd3226c0551970304ebf1059ec19a27451426541027861c9388", "annex": "IIIA", "before": {"end": 16, "start": 0, "text": "Subcutaneous use", "truncated": false}, "before_length": 16, "before_sha256": "363fd22613abec178143cdac0b1a34f04ee8ccdaa7d6988b3722fa7540374cde", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 1, "before_end": 16, "before_start": 1, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 15, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9cbeeb7cc365f8ddb556023b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6946}
{"after": {"end": 15, "start": 0, "text": "The Netherlands", "truncated": false}, "after_length": 15, "after_sha256": "91729ff7107ee698fe168dc62d5b2020678fcfcf55b4ea9065982ce1d071ba31", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 15, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 15}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9cc3c5f6f6ebbadcf588b770", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1010}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "info@mundipharma.com.cy", "truncated": false}, "before_length": 23, "before_sha256": "f29f1155cff09a2341c68da09f129bd1783cb3cd9c355966777e9e960f7f9753", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 23, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 23, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9cef787f65e825d9e76b620b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1151}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 10, "start": 0, "text": "2°C to 8°C", "truncated": false}, "before_length": 10, "before_sha256": "81d810716acbe950b41556ad0d6f83327c0c94aaaad43647bd6107d8f320a304", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 10, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 10, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9d185b41421b170266101f09", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6403}
{"after": {"end": 34, "start": 0, "text": "Summary of Product Characteristics", "truncated": false}, "after_length": 34, "after_sha256": "143de36cb8fe1ca677904a065b7a458a9a7e44594e8cfbbb16fff2130b442341", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 34, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 34}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9d3a58d5e9ba6ce1908252be", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:30Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "35ab6716aa09492c14ac6849111486ec47235c0bc65ef055350de950f316c5e6", "source_snapshot_id": "source-f20a60110d1f8fef5225317d", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2349}
{"after": {"end": 86, "start": 0, "text": "3. Comment Nyxoid 1,8 mg, solution pour pulvérisation nasale doit-il être administré ?", "truncated": false}, "after_length": 86, "after_sha256": "c32f1b39d6ccbc0963f473818145cd13580d39a3b83eed8d05f22175c46936d2", "annex": "IIIA", "before": {"end": 84, "start": 0, "text": "3. Comment Nyxoid 1,8 mg, solution pour pulvérisation nasale doit-il être administré", "truncated": false}, "before_length": 84, "before_sha256": "8700ec7b59e1b992d51c97c52d80ea5845480a300aa88789b7cca93e5f9b7697", "change_kind": "content", "change_operations": [{"after_end": 86, "after_start": 84, "before_end": 84, "before_start": 84, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9d494160fc39da2647bccfb5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 821}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "infomed@mundipharma.fr", "truncated": false}, "before_length": 22, "before_sha256": "83463da2089fc71aeedc706e29f711dec2b50ebe78b9338f2858bff9317f376b", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 22, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 22, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9d511aae2e0a420be97a60ba", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1106}
{"after": {"end": 72, "start": 0, "text": "5. Comment conserver Nyxoid 1,8 mg, solution pour pulvérisation nasale ?", "truncated": false}, "after_length": 72, "after_sha256": "2e97401cb394de0c01fcfb33bbf67718266922066bb50df244636d49b365d0d8", "annex": "IIIA", "before": {"end": 70, "start": 0, "text": "5. Comment conserver Nyxoid 1,8 mg, solution pour pulvérisation nasale", "truncated": false}, "before_length": 70, "before_sha256": "e187ca130dd10687eef6b60968f0cf9945c1b917cc708bfd52e32004ee30c5fc", "change_kind": "content", "change_operations": [{"after_end": 72, "after_start": 70, "before_end": 70, "before_start": 70, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9d73d5185b0ff1f6a496a5d9", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 951}
{"after": {"end": 24, "start": 0, "text": "EU/1/20/1507/031 (glass)", "truncated": false}, "after_length": 24, "after_sha256": "56790bf9bd5087858fcaadad3776a8c8b94d5621396bc5edf14a7200887856e1", "annex": "IIIA", "before": {"end": 24, "start": 0, "text": "EU/1/20/1507/019 (glass)", "truncated": false}, "before_length": 24, "before_sha256": "fe8230580853fea85c781b5faa94d535d167cca9b1588b55fbae910248d02f70", "change_kind": "content", "change_operations": [{"after_end": 15, "after_start": 14, "before_end": 14, "before_start": 14, "kind": "insert"}, {"after_end": 16, "after_start": 16, "before_end": 16, "before_start": 15, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9d8f3b096d9fa1f45d2e01e3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9120}
{"after": {"end": 105, "start": 0, "text": "CONCLUSIONS SCIENTIFIQUES ET MOTIFS DE LA MODIFICATION DES TERMES DES AUTORISATIONS DE MISE SUR LE MARCHÉ", "truncated": false}, "after_length": 105, "after_sha256": "986a5a8167262a2e1b34885d8bf0d8f1d06f2dd4da8ab0f4d7bedc4081ef8b90", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 105, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 105}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9d9531240038496145a686c7", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "9ac80b0d56ebad4970f7a8335a177613af59ef25517bcd0bdd3397c207cc1bac", "source_snapshot_id": "source-c11aa9e32420f125a88005bc", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2707}
{"after": {"end": 55, "start": 0, "text": "Do not remove the needle cap until instructed to do so.", "truncated": false}, "after_length": 55, "after_sha256": "31e19a488e6bcba148e42b0432b26c21723ca81297fb6ae98b737e5f2bbe22b0", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 55, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 55}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9dab7ef4945adcbdc487f9f2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12242}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 6, "start": 0, "text": "Polska", "truncated": false}, "before_length": 6, "before_sha256": "d1974e0e3e575b6dadb40f080dae05025f574cb23e5cababcac0f50cf2619549", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 6, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9e125ecf051233e1337331b1", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1098}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Tel.: +36 23 801 028", "truncated": false}, "before_length": 20, "before_sha256": "7f7869949c31dd79daffcb46cd116971dd2648bfe86226cbf32dac3588a8cfa1", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 20, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 20, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9e3402ae90d298cfbd98958c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1055}
{"after": {"end": 437, "start": 0, "text": "Les patients atteints d'un cancer colorectal métastatique chez lesquels un traitement par irinotécan n’était pas indiqué ont été inclus dans l’essai clinique AVF2192g, évaluant Avastin en association au 5-fluorouracile en bolus/acide folinique. Dans cette étude, des effets thromboemboliques artériels ont été observés chez 11 % (11/100) des patients du groupe Avastin comparé à 5,8 % (6/104) des patients du groupe chimiothérapie seule.", "truncated": false}, "after_length": 437, "after_sha256": "3b8205497604505b4fa4a19035fca56aafeb08094757cfa1b446a79885d08c5b", "annex": "I", "before": {"end": 424, "start": 0, "text": "Les patients atteints d'un cancer colorectal chez lesquels un traitement par irinotécan n’était pas indiqué ont été inclus dans l’essai clinique AVF2192g, évaluant Avastin en association au 5-fluorouracile en bolus/acide folinique. Dans cette étude, des effets thromboemboliques artériels ont été observés chez 11 % (11/100) des patients du groupe Avastin comparé à 5,8 % (6/104) des patients du groupe chimiothérapie seule.", "truncated": false}, "before_length": 424, "before_sha256": "345646b32b18e94ff98bf7ec90f8c53c6a0d091ff58558d728bc7bfd0c16bb1a", "change_kind": "content", "change_operations": [{"after_end": 58, "after_start": 45, "before_end": 45, "before_start": 45, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 13}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9e34a9761567b20d426b872d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 801}
{"after": {"end": 148, "start": 0, "text": "Des informations détaillées sur ce médicament sont disponibles sur le site internet de l’Agence européenne des médicaments https://www.ema.europa.eu", "truncated": false}, "after_length": 148, "after_sha256": "0144d9770eb4c4153d7e7b1c9dec56544610f245adee115432038125fa622184", "annex": "IIIA", "before": {"end": 147, "start": 0, "text": "Des informations détaillées sur ce médicament sont disponibles sur le site internet de l’Agence européenne des médicaments http://www.ema.europa.eu", "truncated": false}, "before_length": 147, "before_sha256": "d0dd4118d52714b2cfcf09f73f7031efc575f51b70183bf3d601893b6bf4e936", "change_kind": "technical", "change_operations": [{"after_end": 128, "after_start": 127, "before_end": 127, "before_start": 127, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9e48c8aad34e187624b107d6", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 8594}
{"after": {"end": 307, "start": 0, "text": "Dans une analyse pharmacocinétique de population chez des patients atteints de spondylarthrite ankylosante, les ASC de l’etanercept à l’état d’équilibre ont été de 466 gh/mL et de 474 gh/mL respectivement pour Enbrel 50 mg une fois par semaine (n = 154) et pour Enbrel 25 mg deux fois par semaine (n = 148).", "truncated": false}, "after_length": 307, "after_sha256": "1c43c823b021ca355a70ce91caf9457501b150b77ff3824f2ada9508e781e74b", "annex": "I", "before": {"end": 307, "start": 0, "text": "Dans une analyse pharmacocinétique de population chez des patients atteints de spondylarthrite ankylosante, les ASC de l’etanercept à l’état d’équilibre ont été de 466 gh/ml et de 474 gh/ml respectivement pour Enbrel 50 mg une fois par semaine (n = 154) et pour Enbrel 25 mg deux fois par semaine (n = 148).", "truncated": false}, "before_length": 307, "before_sha256": "5d8df1dfa3590f8cd7f05f183c4a37b7abc74223db55f470f360af9b806b6cab", "change_kind": "content", "change_operations": [{"after_end": 173, "after_start": 172, "before_end": 173, "before_start": 172, "kind": "replace"}, {"after_end": 189, "after_start": 188, "before_end": 189, "before_start": 188, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9e70b7b8245ec104f7b0d0c5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg poudre pour solution injectable", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1035}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Luxembourg/Luxemburg", "truncated": false}, "before_length": 20, "before_sha256": "28ac4fa3aba2dfb4b228bd072edb8cc818b04e6f4b87f37114caa6154e0e706b", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 20, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 20, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9ea3d24aaa0e387b0039823b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1044}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 34, "start": 0, "text": "EGIS Pharmaceuticals PLC atstovybė", "truncated": false}, "before_length": 34, "before_sha256": "10293ba397b571536dae2db03491721455ce79670e43c6a0834c8626388d7b9c", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 34, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 34, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9ef3e7cf0cea5eae81cfc2ef", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1035}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 11, "start": 0, "text": "Takeda GmbH", "truncated": false}, "before_length": 11, "before_sha256": "94e4e4fc81542d4a8a0deb904c666e74cf300a1075af4d0d2e564a29e287bafb", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 11, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 11, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9f2e023b945de2d68cb15509", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1712}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 192, "start": 0, "text": "Votre médecin vous remettra également une Carte Patient qui comportera des informations importantes de sécurité d’emploi que vous devez connaître, avant et pendant votre traitement par Enbrel.", "truncated": false}, "before_length": 192, "before_sha256": "a9b61621aee7f348e503c6ef13da6f1d4dc6f2a4d953f840016b3daaebeecd6a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 192, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 192, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9f3efa2a06138ca1efec3611", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9786}
{"after": {"end": 99, "start": 0, "text": "SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S)", "truncated": false}, "after_length": 99, "after_sha256": "4d43e1a4109e8a776bcf1a5f90e9a1bc3b91d0b8306edf4d773e154de56fdd42", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 99, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 99}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9f41b1e5d635be2ab94ce032", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2527}
{"after": {"end": 43, "start": 0, "text": "Pfizer Healthcare Ireland Unlimited Company", "truncated": false}, "after_length": 43, "after_sha256": "1f203777a0ec6fed9c840d52631b6a74c7e25b5d318485d8147e2404f52dc981", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "Pfizer Healthcare Ireland", "truncated": false}, "before_length": 25, "before_sha256": "4beeea9b6d0c491f03a9511d9f9576b9c75cbcdcfd736e4934f768fdded936f5", "change_kind": "content", "change_operations": [{"after_end": 43, "after_start": 25, "before_end": 25, "before_start": 25, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 18}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9f62c97dcf5a7bc0aafd99f4", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 8491}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 81, "start": 0, "text": "the outer carton should have been marked with the new discard date at 2°C to 8°C.", "truncated": false}, "before_length": 81, "before_sha256": "a156a465c6d980d8654f2b0b1b7462dcda11501b80593373c3d931c36d4014ef", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 81, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 81, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9f65e895f20bbe09d983cc25", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.3", "section_type": "storage", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6251}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 15, "start": 0, "text": "MUNDIPHARMA SAS", "truncated": false}, "before_length": 15, "before_sha256": "7c1f6441b59573c44ce170a41d1e84818840a5210ce6359a71d9f6aa263845fe", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 15, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 15, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9f7d234713db5eae71d8232a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1104}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 13, "start": 0, "text": "Configuration", "truncated": false}, "before_length": 13, "before_sha256": "b332c3492d5eb10a118eb6d8b0dcd689bc2477ce2ae16b303753b942b54377bc", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 13, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 13, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9fc7efd61bc6700a1462c8a2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6390}
{"after": {"end": 117, "start": 0, "text": "présentez des symptômes de pression sanguine basse tels que des vertiges, des étourdissements ou des évanouissements,", "truncated": false}, "after_length": 117, "after_sha256": "b55139a238b4e3eae3e513e86718422152bcf661eb5d8275a56b3da9dff1dbb2", "annex": "IIIA", "before": {"end": 120, "start": 0, "text": "présentez des symptômes de pression sanguine basse tels que des vertiges, des étourdissements ou des évanouissements, ou", "truncated": false}, "before_length": 120, "before_sha256": "bf6938bda7397cbc3b9160a0e9d19ee4d146b14b85451fbb7179c529a91c424a", "change_kind": "content", "change_operations": [{"after_end": 117, "after_start": 117, "before_end": 120, "before_start": 117, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 3, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-9fd468053d038407455d087a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3270}
{"after": {"end": 95, "start": 0, "text": "Instructions to record the brand name and batch number of the medication to ensure traceability", "truncated": false}, "after_length": 95, "after_sha256": "61670d4f4bc4995607c615b0cc2a31208cea23447738a86c87f2de0cd671bb02", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 95, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 95}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a01f3ccdde7277de3f8830d9", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6577}
{"after": {"end": 2, "start": 0, "text": "SC", "truncated": false}, "after_length": 2, "after_sha256": "32da6721804f1dd3226c0551970304ebf1059ec19a27451426541027861c9388", "annex": "IIIA", "before": {"end": 16, "start": 0, "text": "Subcutaneous use", "truncated": false}, "before_length": 16, "before_sha256": "363fd22613abec178143cdac0b1a34f04ee8ccdaa7d6988b3722fa7540374cde", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 1, "before_end": 16, "before_start": 1, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 15, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a0418649cd14f0baa1b0555c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 7467}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 6, "start": 0, "text": "Carton", "truncated": false}, "before_length": 6, "before_sha256": "debaef418bf153ff447599c58fc07da46f8c6bdacf576da1e2129b4de5a44dd3", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 6, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a0d8d54dad34cd6b01173a34", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6402}
{"after": {"end": 24, "start": 0, "text": "dpoc_czechslovak@msd.com", "truncated": false}, "after_length": 24, "after_sha256": "337ee03ecaecb8e917a1c5d342c556aebf19918c2dc3ac63cf08adeafa748373", "annex": "IIIA", "before": {"end": 26, "start": 0, "text": "dpoc_czechslovak@merck.com", "truncated": false}, "before_length": 26, "before_sha256": "a4642d78bee1d644f5eed542e84f756d52a7869d19900b6efa351b35ef1062c2", "change_kind": "content", "change_operations": [{"after_end": 20, "after_start": 18, "before_end": 22, "before_start": 18, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a0dc9ea6d60b04b838986f8b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3174}
{"after": {"end": 13, "start": 0, "text": "1932 Zaventem", "truncated": false}, "after_length": 13, "after_sha256": "cffe4475a5de91da7a3a6363a4d41ccfd1405766d95ae182d89bf39b29686221", "annex": "II", "before": {"end": 13, "start": 0, "text": "1930 Zaventem", "truncated": false}, "before_length": 13, "before_sha256": "ed9ea9385e3e50f6278214da5d7483a8543c36d1261df263d35022c5936c74db", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 4, "before_start": 3, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a0f00d525f32a37fcf4c35ce", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004310", "medicine_name": "Daptomycin Hospira", "medicine_slug": "daptomycin-hospira", "observed_at": "2026-10-12T19:09:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "e544a64f1681af82ba143ddd0cfa7cca4ef0de691ed43076b92bb75f66ec7f7b", "source_snapshot_id": "source-a214fce23bf43c3222026b3d", "source_updated_at": "2025-09-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/daptomycin-hospira-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1023}
{"after": {"end": 22, "start": 0, "text": "medicalinfo.nl@msd.com", "truncated": false}, "after_length": 22, "after_sha256": "578550b051823e92654f0b1dd2f62a8da0f4aa2c1bad41b233b8e6951a41272c", "annex": "IIIA", "before": {"end": 24, "start": 0, "text": "medicalinfo.nl@merck.com", "truncated": false}, "before_length": 24, "before_sha256": "cc3a8af00f6f52af5b0956221d649740a16b082158e556d4b49a01bcba8e6a99", "change_kind": "content", "change_operations": [{"after_end": 18, "after_start": 16, "before_end": 20, "before_start": 16, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a1017cbb278c63b62d0ae85b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3019}
{"after": {"end": 7, "start": 0, "text": "Irlande", "truncated": false}, "after_length": 7, "after_sha256": "a8cdfff5dbbda1b070a2acb339b6f0aa20b6230d9b5500c9ce066eaa89bc9a64", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 7, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 7}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a18b4107939744f095e6627d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1346}
{"after": {"end": 144, "start": 0, "text": "• Transportez et conservez votre Terrosa Pen avec sa cartouche insérée aux températures indiquées dans la notice de Terrosa, fournie séparément.", "truncated": false}, "after_length": 144, "after_sha256": "33bef3c75b1186c3851ddd543778859334c68b72cc7e4074d9247ec56365b73d", "annex": "IIIA", "before": {"end": 146, "start": 0, "text": "• Transportez et conservez votre stylo Terrosa avec sa cartouche insérée aux températures indiquées dans la notice de Terrosa, fournie séparément.", "truncated": false}, "before_length": 146, "before_sha256": "bf5f0995e05c85c13e74f20f95d47000d926da9d3db9d321cb33e2e390a28d25", "change_kind": "content", "change_operations": [{"after_end": 33, "after_start": 33, "before_end": 39, "before_start": 33, "kind": "delete"}, {"after_end": 44, "after_start": 40, "before_end": 46, "before_start": 46, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a18bd9ae0fbcd50e86d4ec5d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2092}
{"after": {"end": 119, "start": 0, "text": "Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu", "truncated": false}, "after_length": 119, "after_sha256": "0f2b81ab8009e1a279ca008eb6e21bdb2e532de63aef52b62bdac980c49555d4", "annex": "IIIA", "before": {"end": 118, "start": 0, "text": "Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu", "truncated": false}, "before_length": 118, "before_sha256": "d114210a3c6f4b6710e22609ee80410ff17f5efd93b30ab72728a60b65635068", "change_kind": "technical", "change_operations": [{"after_end": 99, "after_start": 98, "before_end": 98, "before_start": 98, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a1d0ac780d377235fc53f8c7", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9586}
{"after": {"end": 158, "start": 0, "text": "As with any vaccine, the additional dose of Spikevax LP.8.1 may not fully protect all those who receive it and it is not known how long you will be protected.", "truncated": false}, "after_length": 158, "after_sha256": "bea73130001bb6a989b563e77531391039ef21192f3f00aa73ee0c3495bb1231", "annex": "I", "before": {"end": 156, "start": 0, "text": "As with any vaccine, the additional dose of Spikevax JN.1 may not fully protect all those who receive it and it is not known how long you will be protected.", "truncated": false}, "before_length": 156, "before_sha256": "717d856de58a37942bbccbc8911d9e661976307e96affc63b4ea7c9ab6ad147f", "change_kind": "administrative", "change_operations": [{"after_end": 57, "after_start": 53, "before_end": 55, "before_start": 53, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a207667d9c3b79acdb955d6f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12664}
{"after": {"end": 13, "start": 0, "text": "1932 Zaventem", "truncated": false}, "after_length": 13, "after_sha256": "cffe4475a5de91da7a3a6363a4d41ccfd1405766d95ae182d89bf39b29686221", "annex": "I", "before": {"end": 13, "start": 0, "text": "1930 Zaventem", "truncated": false}, "before_length": 13, "before_sha256": "ed9ea9385e3e50f6278214da5d7483a8543c36d1261df263d35022c5936c74db", "change_kind": "administrative", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 4, "before_start": 3, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a23ca47ce5aa95a0e4679821", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004310", "medicine_name": "Daptomycin Hospira", "medicine_slug": "daptomycin-hospira", "observed_at": "2026-10-12T19:09:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "e544a64f1681af82ba143ddd0cfa7cca4ef0de691ed43076b92bb75f66ec7f7b", "source_snapshot_id": "source-a214fce23bf43c3222026b3d", "source_updated_at": "2025-09-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/daptomycin-hospira-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2002}
{"after": {"end": 148, "start": 0, "text": "Des informations détaillées sur ce médicament sont disponibles sur le site internet de l’Agence européenne des médicaments https://www.ema.europa.eu", "truncated": false}, "after_length": 148, "after_sha256": "0144d9770eb4c4153d7e7b1c9dec56544610f245adee115432038125fa622184", "annex": "IIIA", "before": {"end": 147, "start": 0, "text": "Des informations détaillées sur ce médicament sont disponibles sur le site internet de l’Agence européenne des médicaments http://www.ema.europa.eu", "truncated": false}, "before_length": 147, "before_sha256": "d0dd4118d52714b2cfcf09f73f7031efc575f51b70183bf3d601893b6bf4e936", "change_kind": "technical", "change_operations": [{"after_end": 128, "after_start": 127, "before_end": 127, "before_start": 127, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a2515fa36ec5cda3a9d7d00c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 10691}
{"after": {"end": 48, "start": 0, "text": "fibrillation auriculaire, insuffisance cardiaque", "truncated": false}, "after_length": 48, "after_sha256": "9367b616d81d1c34253a57bbf3bdd7692c617cce0ba0d1abdcada044d5ab308e", "annex": "I", "before": {"end": 24, "start": 0, "text": "fibrillation auriculaire", "truncated": false}, "before_length": 24, "before_sha256": "092327d18dd12662acfc36649d4c691bfd530c5add009f593e7d4d3520d35c29", "change_kind": "content", "change_operations": [{"after_end": 48, "after_start": 24, "before_end": 24, "before_start": 24, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 24}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a2529410c1aa03fd28927188", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002640", "medicine_name": "Cometriq", "medicine_slug": "cometriq", "observed_at": "2026-10-12T19:00:55Z", "pipeline_version": "2.0.0", "presentation_label": "COMETRIQ 20 mg, gélules COMETRIQ 80 mg, gélules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "c7f8aa8da9127064263770c4aed5506128bacd0c40693b863c48a757d735203e", "source_snapshot_id": "source-e4fa0b9c95a2e427d4c95a33", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/cometriq-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 266}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 30, "start": 0, "text": "GlaxoSmithKline Biologicals SA", "truncated": false}, "before_length": 30, "before_sha256": "9076f81d6649169dd6b3c0ca008f09f07b0f4fddd6f63a0eb13693ea63527328", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 30, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 30, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a26a141fdd5a423a7f213329", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000112", "medicine_name": "Twinrix Adult", "medicine_slug": "twinrix-adult", "observed_at": "2026-10-12T13:29:23Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "cfad5fb0086c9b5d6a36b454f3f546373def1f56cded73e0652b498d02d68e41", "source_snapshot_id": "source-17627897b0874bf1160c7372", "source_updated_at": "2026-08-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/twinrix-adult-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1032}
{"after": {"end": 208, "start": 0, "text": "Patients are persons for whom the prescribing physician has prescribed a therapy with Terrosa using Terrosa Pen. The responsible physician determines the suitability of the Terrosa Pen for a specific patient.", "truncated": false}, "after_length": 208, "after_sha256": "22d5f3af3bdcfc30f63238977e2aeb4397fe6024e3596014c0a2f4285b84e031", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 208, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 208}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a2765480a750b20b4b9db926", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1951}
{"after": {"end": 801, "start": 0, "text": "Les patients atteints de psoriasis en plaques pédiatrique (âgés de 4 à 17 ans) ont reçu 0,8 mg/kg (jusqu’à une dose maximale de 50 mg par semaine) d’etanercept une fois par semaine jusqu’à 48 semaines. Les concentrations sériques moyennes à l’état d’équilibre ont varié de 1,6 à 2,1 µg/mL aux semaines 12, 24 et 48. Ces concentrations moyennes chez les patients atteints de psoriasis en plaques pédiatrique ont été similaires aux concentrations observées chez les patients atteints d’arthrite juvénile idiopathique (traités par 0,4 mg/kg d’etanercept deux fois par semaine, jusqu’à une dose maximale de 50 mg par semaine). Ces concentrations moyennes étaient similaires à celles observées chez les patients adultes atteints de psoriasis en plaques traités par 25 mg d’etanercept deux fois par semaine.", "truncated": false}, "after_length": 801, "after_sha256": "5a9241299de0d00b1671784d63ea5f655e0be460780fb99d66c6810b9d4f53a0", "annex": "I", "before": {"end": 801, "start": 0, "text": "Les patients atteints de psoriasis en plaques pédiatrique (âgés de 4 à 17 ans) ont reçu 0,8 mg/kg (jusqu’à une dose maximale de 50 mg par semaine) d’etanercept une fois par semaine jusqu’à 48 semaines. Les concentrations sériques moyennes à l’état d’équilibre ont varié de 1,6 à 2,1 µg/ml aux semaines 12, 24 et 48. Ces concentrations moyennes chez les patients atteints de psoriasis en plaques pédiatrique ont été similaires aux concentrations observées chez les patients atteints d’arthrite juvénile idiopathique (traités par 0,4 mg/kg d’etanercept deux fois par semaine, jusqu’à une dose maximale de 50 mg par semaine). Ces concentrations moyennes étaient similaires à celles observées chez les patients adultes atteints de psoriasis en plaques traités par 25 mg d’etanercept deux fois par semaine.", "truncated": false}, "before_length": 801, "before_sha256": "e3a1c3d746033394d20349032e06f24add85b50a6b5f7606cd2db2e64c818637", "change_kind": "content", "change_operations": [{"after_end": 288, "after_start": 287, "before_end": 288, "before_start": 287, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a2d8d280deac91aece037cf9", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg solution injectable en seringue pré-remplie Enbrel 50 mg solution injectable en seringue pré-remplie", "presentation_occurrence": 3, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3318}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 13, "start": 0, "text": "Icepharma hf.", "truncated": false}, "before_length": 13, "before_sha256": "b10e8b5abc79456615b7bbf170d67bdcdfb8e87e7bd69bed75dffa3ce87100cb", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 13, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 13, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a2db953a9adb3576ccfd6751", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1122}
{"after": {"end": 198, "start": 0, "text": "Flacon en verre transparent (2 mL, verre de type I) avec bouchon en caoutchouc, opercule en aluminium et capuchon en plastique. Chaque coffret contient 4 flacons d’Enbrel, avec 8 tampons alcoolisés.", "truncated": false}, "after_length": 198, "after_sha256": "04a3b19f6cc43bc2e1795af3810efebf8ee5e538788fd28b70b443c070fb08bf", "annex": "I", "before": {"end": 198, "start": 0, "text": "Flacon en verre transparent (2 ml, verre de type I) avec bouchon en caoutchouc, opercule en aluminium et capuchon en plastique. Chaque coffret contient 4 flacons d’Enbrel, avec 8 tampons alcoolisés.", "truncated": false}, "before_length": 198, "before_sha256": "01c4042ab1000c0b82d6179ef0e7ddb1cfa9cf1c568530cab0f28f144991d599", "change_kind": "content", "change_operations": [{"after_end": 33, "after_start": 32, "before_end": 33, "before_start": 32, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a2dea33804350620113201f2", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg poudre pour solution injectable", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.5", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1107}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "Tel: +44 (0)1304 616161", "truncated": false}, "before_length": 23, "before_sha256": "eba81e6ccdbae471c024a5ba77d9ec9e0617a3c443fd22205a626861e87fbd8c", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 23, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 23, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a2e8947ac250cc9046bf2370", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11750}
{"after": {"end": 8, "start": 0, "text": "Dublin 2", "truncated": false}, "after_length": 8, "after_sha256": "b9d41e7d3be3ec3e12457949fb5c2f7be98290b5d2919e8b974df9c98fab02b9", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 8, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a31a5e480d6069decf129ac1", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1214}
{"after": {"end": 56, "start": 0, "text": "ee Inclut œdème périphérique et gonflement périphérique.", "truncated": false}, "after_length": 56, "after_sha256": "356816431cc3da58a657bf14d93bb4f0a93d475993e9f16f26193a982c33165d", "annex": "I", "before": {"end": 56, "start": 0, "text": "dd Inclut œdème périphérique et gonflement périphérique.", "truncated": false}, "before_length": 56, "before_sha256": "78019e3a97049df254bae335fc7cf74ec551e6788c670b7992c7729882a69054", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 0, "before_end": 2, "before_start": 0, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a376b4e1ffcc7e37b491d4bc", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:18Z", "pipeline_version": "2.0.0", "presentation_label": "IMJUDO 20 mg/ml, solution à diluer pour perfusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "2437ab76633f46c9eee5e002e5c7a7caba6367f59567d750be0eb67c74d1db4e", "source_snapshot_id": "source-7f4d129b0a0fd2d3684d27c5", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 926}
{"after": {"end": 54, "start": 0, "text": "Takeda Pharmaceuticals International AG Ireland Branch", "truncated": false}, "after_length": 54, "after_sha256": "81709515d3af1f0e4041ce3c760d8fc81fefa358805810b0b53a84e121d5efa6", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "administrative", "change_operations": [{"after_end": 54, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 54}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a3c6cb0e0705dd7fc2d920df", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "Qdenga powder and solvent for solution for injection Qdenga powder and solvent for solution for injection in pre-filled syringe Dengue tetravalent vaccine (live, attenuated)", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 973}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "Tel: +44 (0)1304 616161", "truncated": false}, "before_length": 23, "before_sha256": "eba81e6ccdbae471c024a5ba77d9ec9e0617a3c443fd22205a626861e87fbd8c", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 23, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 23, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a3cba98a4d1a51a8aa0b2b26", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9577}
{"after": {"end": 19, "start": 0, "text": "Mundipharma DC B.V.", "truncated": false}, "after_length": 19, "after_sha256": "e3293d50ef13895d680c96110997100aa9ea415c79a538edde8c542ffb4f7ce6", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 19, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 19}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a3e59090c77f4556deced633", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1007}
{"after": {"end": 65, "start": 0, "text": "Table 1. Spikevax LP.8.1 qualitative and quantitative composition", "truncated": false}, "after_length": 65, "after_sha256": "ad29412f8ab19d47567019ea209abcf1e4d9649c165462ad61e35180f45d837f", "annex": "I", "before": {"end": 63, "start": 0, "text": "Table 1. Spikevax JN.1 qualitative and quantitative composition", "truncated": false}, "before_length": 63, "before_sha256": "b29558674c90e7d3563bb11b331275c39f7dd11bb5176db06dce00efcb64260d", "change_kind": "content", "change_operations": [{"after_end": 22, "after_start": 18, "before_end": 20, "before_start": 18, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a409c0d7acccbed17be1288b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "2", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5407}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 27, "start": 0, "text": "9 months at -50ºC to -15ºC.", "truncated": false}, "before_length": 27, "before_sha256": "d000be8b3d49387a295c584a58792ebe1188039bb3cb9fef9f350f4456651152", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 27, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 27, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a43d7f96fe0f3d7f898abf42", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.3", "section_type": "storage", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6243}
{"after": {"end": 93, "start": 0, "text": "Scientific conclusions and grounds for variation to the terms of the marketing authorisations", "truncated": false}, "after_length": 93, "after_sha256": "34360f4c5ce999445c0d6d8e824a3579c60862208e9f7ea3f51908adb2b9003f", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 93, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 93}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a43e6feb47187adea72e7a79", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:30Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "35ab6716aa09492c14ac6849111486ec47235c0bc65ef055350de950f316c5e6", "source_snapshot_id": "source-f20a60110d1f8fef5225317d", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2341}
{"after": {"end": 198, "start": 0, "text": "Spikevax LP.8.1 is a white to off-white dispersion. It may contain white or translucent productrelated particulates. Do not administer if vaccine is discoloured or contains other particulate matter.", "truncated": false}, "after_length": 198, "after_sha256": "ccf5e59e0ae33f0518b496363820ac5f20393ec7dfb73ad5ae725a09dd80cfc9", "annex": "I", "before": {"end": 197, "start": 0, "text": "Spikevax JN.1 is a white to off-white dispersion. It may contain white or translucent product-related particulates. Do not administer if vaccine is discoloured or contains other particulate matter.", "truncated": false}, "before_length": 197, "before_sha256": "ef4d0d5157f11a38979142c01b394ea022b848da95f1c9cc7b8636bbb0ac0e52", "change_kind": "administrative", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}, {"after_end": 95, "after_start": 95, "before_end": 94, "before_start": 93, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 3, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a4a4d08129516d3c4b3e1908", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13154}
{"after": {"end": 25, "start": 0, "text": "50-58 Baggot Street Lower", "truncated": false}, "after_length": 25, "after_sha256": "2b6052bef6a7051ce20b776d1525055c417fc02e59b9e559cd21b7aa4c7859f0", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 25, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 25}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a4f87e18c5ceca36b7a5c2e0", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1343}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 14, "start": 0, "text": "Pfizer Limited", "truncated": false}, "before_length": 14, "before_sha256": "faadd350d247ecbb0e8edac0805fa3d4cdbf449fbb9a1a9614eee6624274a2f6", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a53ed862ebfd412a6401b9e5", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11615}
{"after": {"end": 166, "start": 0, "text": "Terrosa Pen is part of a pen system which consists of the pen itself, a cartridge and a pen needle. The cartridge and the pen needles are not supplied in the package.", "truncated": false}, "after_length": 166, "after_sha256": "fede8e0809c607183e7aa014562f84e6e6223917ce373011cfa9ccb4596f0a3c", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 166, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 166}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a5436b47c03d0b10530aa961", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1948}
{"after": {"end": 109, "start": 0, "text": "Utiliser uniquement avec Terrosa Pen. Ne pas retirer la cartouche du stylo durant les 28 jours d’utilisation.", "truncated": false}, "after_length": 109, "after_sha256": "bffe795dfbd5f0a3e0ea507ba893e249459de8b0f388415b0f6a64c3b757f907", "annex": "IIIA", "before": {"end": 114, "start": 0, "text": "Utiliser uniquement avec le stylo Terrosa .Ne pas retirer la cartouche du stylo durant les 28 jours d’utilisation.", "truncated": false}, "before_length": 114, "before_sha256": "5748d06a5331eb837d1d90be57b1aaf927dbbbd107fb8ccfc946860f492214f5", "change_kind": "content", "change_operations": [{"after_end": 25, "after_start": 25, "before_end": 34, "before_start": 25, "kind": "delete"}, {"after_end": 36, "after_start": 33, "before_end": 42, "before_start": 42, "kind": "insert"}, {"after_end": 38, "after_start": 37, "before_end": 43, "before_start": 43, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 9, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a595b84a683f0996a2c6c7a5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1392}
{"after": {"end": 135, "start": 0, "text": "If a child has received one prior dose of Spikevax, one dose of Spikevax LP.8.1 should be administered to complete the two-dose series.", "truncated": false}, "after_length": 135, "after_sha256": "59b607589a72efe9304a20eb773fdd61164ab03ebf47b32b383efe453cd4ec5f", "annex": "I", "before": {"end": 133, "start": 0, "text": "If a child has received one prior dose of Spikevax, one dose of Spikevax JN.1 should be administered to complete the two-dose series.", "truncated": false}, "before_length": 133, "before_sha256": "43acd2366b6fc8b352d78a1fd01db64cb064a927690f2b7cea8c5683a865f527", "change_kind": "administrative", "change_operations": [{"after_end": 77, "after_start": 73, "before_end": 75, "before_start": 73, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a59a4b8a3c15b24e70b6a624", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13180}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "II", "before": {"end": 24, "start": 0, "text": "6, Boulevard de l’Europe", "truncated": false}, "before_length": 24, "before_sha256": "1a420a398cfa742cd3389586aaa4449097e4f9c37404db0a4b3a07057bd335f5", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 24, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 24, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a5bc12ffdb51b67d0d47f07a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000174", "medicine_name": "Plavix", "medicine_slug": "plavix", "observed_at": "2026-10-12T19:27:50Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "3818c2e3c9979bf5f8be3f164dfce187fccfccf62bbd1e3227c64ca7c00ad02f", "source_snapshot_id": "source-4aff1b64c7cf58337d33ecfa", "source_updated_at": "2025-07-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/plavix-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 788}
{"after": {"end": 181, "start": 0, "text": "vous avez une insuffisance cardiaque (pouvant inclure des symptômes tels qu’un essoufflement, une sensation de fatigue, un évanouissement, un gonflement des chevilles et des jambes)", "truncated": false}, "after_length": 181, "after_sha256": "7e0ab57e86c2ce5a31eb70e449c5cce2cac86d5e09301d8b3a909d276095ff11", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 181, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 181}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a5bfc73f604862b69e263f9d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002640", "medicine_name": "Cometriq", "medicine_slug": "cometriq", "observed_at": "2026-10-12T19:00:55Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c7f8aa8da9127064263770c4aed5506128bacd0c40693b863c48a757d735203e", "source_snapshot_id": "source-e4fa0b9c95a2e427d4c95a33", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/cometriq-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1840}
{"after": {"end": 148, "start": 0, "text": "Des informations détaillées sur ce médicament sont disponibles sur le site internet de l’Agence européenne des médicaments https://www.ema.europa.eu", "truncated": false}, "after_length": 148, "after_sha256": "0144d9770eb4c4153d7e7b1c9dec56544610f245adee115432038125fa622184", "annex": "IIIA", "before": {"end": 147, "start": 0, "text": "Des informations détaillées sur ce médicament sont disponibles sur le site internet de l’Agence européenne des médicaments http://www.ema.europa.eu", "truncated": false}, "before_length": 147, "before_sha256": "d0dd4118d52714b2cfcf09f73f7031efc575f51b70183bf3d601893b6bf4e936", "change_kind": "technical", "change_operations": [{"after_end": 128, "after_start": 127, "before_end": 127, "before_start": 127, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a5e1424748f97a6b1b9b1054", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9699}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "Tel: + 420 296 188 338", "truncated": false}, "before_length": 22, "before_sha256": "cade761d1991183690c5d39848f424472df61dbad0bc430b6f01fef8e76b3e31", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 22, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 22, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a64f788c2a22aad6e0502771", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1036}
{"after": {"end": 65, "start": 0, "text": "• a puncture-resistant sharps disposal container for used needles", "truncated": false}, "after_length": 65, "after_sha256": "dfd314e3b9f252778c82758c55608ad0048dedfbdd18b9443f85c9288ea72ebf", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 65, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 65}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a65e31572dedc150f0b86880", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1972}
{"after": {"end": 8, "start": 0, "text": "Dublin 2", "truncated": false}, "after_length": 8, "after_sha256": "b9d41e7d3be3ec3e12457949fb5c2f7be98290b5d2919e8b974df9c98fab02b9", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 8, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a672328b0fe951430b585e1c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1719}
{"after": {"end": 81, "start": 0, "text": "B: Remove the cartridge sleeve by turning it 90 degrees, as shown in the picture.", "truncated": false}, "after_length": 81, "after_sha256": "d4e36c6bf666c693cd96511f78fa73a63442828dd8be3c62b5e9a61563a51979", "annex": "IIIA", "before": {"end": 64, "start": 0, "text": "B: Remove the cartridge holder by turning it (bayonet coupling).", "truncated": false}, "before_length": 64, "before_sha256": "0cf5479a6b1de717049ee16c129f686c65ba8aa062d8109eada31b7f5a2ef7db", "change_kind": "content", "change_operations": [{"after_end": 25, "after_start": 24, "before_end": 26, "before_start": 24, "kind": "replace"}, {"after_end": 26, "after_start": 26, "before_end": 28, "before_start": 27, "kind": "delete"}, {"after_end": 30, "after_start": 27, "before_end": 30, "before_start": 29, "kind": "replace"}, {"after_end": 57, "after_start": 45, "before_end": 47, "before_start": 45, "kind": "replace"}, {"after_end": 62, "after_start": 58, "before_end": 49, "before_start": 48, "kind": "replace"}, {"after_end": 64, "after_start": 63, "before_end": 50, "before_start": 50, "kind": "insert"}, {"after_end": 65, "after_start": 65, "before_end": 53, "before_start": 51, "kind": "delete"}, {"after_end": 66, "after_start": 66, "before_end": 59, "before_start": 54, "kind": "delete"}, {"after_end": 80, "after_start": 68, "before_end": 63, "before_start": 61, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 16, "chars_inserted": 33}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a673e692e35627b671c67460", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1986}
{"after": {"end": 63, "start": 0, "text": "Ne retirez pas le capuchon de l’aiguille avant d’y être invité.", "truncated": false}, "after_length": 63, "after_sha256": "4253650414791f649d08c88334e3aadafc33845e6bee35c68a21ef936df907a2", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 63, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 63}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a680937e20ed67c592e66f1b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11828}
{"after": {"end": 153, "start": 0, "text": "One dose (0.25 mL) contains 25 micrograms of SARSCoV2 LP.8.1 mRNA, a COVID-19 mRNA Vaccine (nucleoside modified) (embedded in SM102 lipid nanoparticles).", "truncated": false}, "after_length": 153, "after_sha256": "a2637ddef302562fe9a62168bb8b27c987cc9d52343563251dd5fecc8b1d8f0f", "annex": "I", "before": {"end": 151, "start": 0, "text": "One dose (0.25 mL) contains 25 micrograms of SARSCoV2 JN.1 mRNA, a COVID-19 mRNA Vaccine (nucleoside modified) (embedded in SM102 lipid nanoparticles).", "truncated": false}, "before_length": 151, "before_sha256": "c0c69051afa5195f6468e40f078a7db0529029d36b1dac728f1a78c5e344665c", "change_kind": "administrative", "change_operations": [{"after_end": 58, "after_start": 54, "before_end": 56, "before_start": 54, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a689c346b5163c1cd58c8dd9", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12850}
{"after": {"end": 35, "start": 0, "text": "Tel: 0800 9999 000 (+31 23 5153153)", "truncated": false}, "after_length": 35, "after_sha256": "52e92ac1d067259b9fece48e0e06ad1c09748623062f243703b5d4f40455bd17", "annex": "IIIA", "before": {"end": 36, "start": 0, "text": "Tel: 0800 9999 000 (+ 31 23 5153153)", "truncated": false}, "before_length": 36, "before_sha256": "08802d516c69cefe10e1332d399e866d902441cca33557fa68396eaecaf1d321", "change_kind": "content", "change_operations": [{"after_end": 21, "after_start": 21, "before_end": 22, "before_start": 21, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a6bcfcfa2cf8a81ef57db868", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3515}
{"after": {"end": 367, "start": 0, "text": "Le matériel approuvé par l’autorité locale sera publié sur le site internet non promotionnel nyxoid.com d’où il pourra être téléchargé gratuitement si nécessaire. Un code QR sur l’emballage et dans la notice destinée au patient renvoie à nyxoid.com pour garantir un accès rapide au site en cas de survenue d’un surdosage pour une nouvelle formation « juste à temps ».", "truncated": false}, "after_length": 367, "after_sha256": "de49cadfefe2a18d6c746c872480ba0fad2047178dde9257265a7033850c04b1", "annex": "II", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 367, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 367}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a6d46bd134a1ef9a0cfcfeb9", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 414}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 192, "start": 0, "text": "Votre médecin vous remettra également une Carte Patient qui comportera des informations importantes de sécurité d’emploi que vous devez connaître, avant et pendant votre traitement par Enbrel.", "truncated": false}, "before_length": 192, "before_sha256": "a9b61621aee7f348e503c6ef13da6f1d4dc6f2a4d953f840016b3daaebeecd6a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 192, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 192, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a6ff51ce8cb6ab2c6cfc8535", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9302}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "II", "before": {"end": 49, "start": 0, "text": "Obligation to conduct post-authorisation measures", "truncated": false}, "before_length": 49, "before_sha256": "ab1858aa478b8ecf132a5d5da99f1340f64b473f6547d140485c088da5d9f34f", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 49, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 49, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a70b4f5b3c0d51f8a12c42be", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:33Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "21d66bf1e9a74479f577de09da3cf8517d65c1ce1b1d8bbdfe4bc38f79410def", "source_snapshot_id": "source-2c39c998fdaf05159687c016", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 465}
{"after": {"end": 60, "start": 0, "text": "phenytoin, carbamazepine, phenobarbitone, to treat epilepsy.", "truncated": false}, "after_length": 60, "after_sha256": "3cd2e95fc326fc31b76edb4215ac264caed159c0394757224b923fb0cc160636", "annex": "IIIA", "before": {"end": 58, "start": 0, "text": "epilepsy such as phenytoin, carbamazepine, phenobarbitone.", "truncated": false}, "before_length": 58, "before_sha256": "631dd593dace958ad6a6e13df7ccb81562e52426ce144155729128fe758aa4ba", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 17, "before_start": 0, "kind": "delete"}, {"after_end": 59, "after_start": 40, "before_end": 57, "before_start": 57, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 17, "chars_inserted": 19}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a715ab3b2249a1a944068359", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3205}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 15, "start": 0, "text": "Mundipharma A/S", "truncated": false}, "before_length": 15, "before_sha256": "7e6d90255964287fd1353c1e83065108e556222b86a42d15fa103f15e7a960cf", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 15, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 15, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a79e0714df2b7d6b8173d049", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1058}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tel: + 4212 6381 1611", "truncated": false}, "before_length": 21, "before_sha256": "81bd347adb468135c4f9a20c3656db9d98eed722c50566c9f514fa504d3a8608", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 21, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 21, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a7a9595c39aeb336c2d38df5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1137}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 14, "start": 0, "text": "Pfizer Limited", "truncated": false}, "before_length": 14, "before_sha256": "faadd350d247ecbb0e8edac0805fa3d4cdbf449fbb9a1a9614eee6624274a2f6", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a7bb0ae91cc9c8fd12daa937", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 10551}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 36, "start": 0, "text": "Thaw temperature (in a refrigerator)", "truncated": false}, "before_length": 36, "before_sha256": "6c7c18b3071e1d78468fad5c90eb7cd3964bdae6d3ec6da8bafd33c108710399", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 36, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 36, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a7e3fe6276d4351c690c964b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6393}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 18, "start": 0, "text": "Tel: +370 68735006", "truncated": false}, "before_length": 18, "before_sha256": "df3697de4c912f22087263a7840d878fcfe378d8860ac1eb9020d1644ea4ab01", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 18, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 18, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a828d0fee47bd4bceeffe6e7", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1062}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 63, "start": 0, "text": "Ne retirez pas le capuchon de l’aiguille avant d’y être invité.", "truncated": false}, "before_length": 63, "before_sha256": "4253650414791f649d08c88334e3aadafc33845e6bee35c68a21ef936df907a2", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 63, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 63, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a8590620e1cce08573b9eb28", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12386}
{"after": {"end": 9, "start": 0, "text": "anxiété ;", "truncated": false}, "after_length": 9, "after_sha256": "4dc34c74ee86f8120b92afcdb99b65913e947dfebc3baa0456b4f889c0603493", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 9, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 9}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a85e69bd5b8fb543e53ae772", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "9ac80b0d56ebad4970f7a8335a177613af59ef25517bcd0bdd3397c207cc1bac", "source_snapshot_id": "source-c11aa9e32420f125a88005bc", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2475}
{"after": {"end": 299, "start": 0, "text": "E3200 : Avastin à la dose de 10 mg/kg de poids corporel toutes les deux semaines en association à la leucovorine et au 5-fluorouracile en bolus, suivi du 5-fluororouracile en perfusion, associé à l’oxaliplatine par voie intraveineuse (FOLFOX-4) chez des patients naïfs de traitement par bevacizumab.", "truncated": false}, "after_length": 299, "after_sha256": "ca8711b3075b21a053a16daea2060fa85c4bf19857f3e2640426a74e6bcb7dad", "annex": "I", "before": {"end": 298, "start": 0, "text": "E3200 : Avastin à la dose de 10 mg/kg de poids corporel toutes les deux semaines en association à la leucovorine et au 5-fluorouracile en bolus, suivi du 5-flurorouracile en perfusion, associé à l’oxaliplatine par voie intraveineuse (FOLFOX-4) chez des patients naïfs de traitement par bevacizumab.", "truncated": false}, "before_length": 298, "before_sha256": "53fe3a7d1bf13ffc9ea2c5af3499cd00cf1930a41f2a60d74f6078f12b133488", "change_kind": "content", "change_operations": [{"after_end": 160, "after_start": 159, "before_end": 159, "before_start": 159, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a870bf03654a0cbc1290d280", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 923}
{"after": {"end": 43, "start": 0, "text": "4 seringues pré-remplies de 1 mL de solvant", "truncated": false}, "after_length": 43, "after_sha256": "ebfac950c9aa338c1bc77c45d525865d556881a25922995ef6d475cc5a6772b6", "annex": "IIIA", "before": {"end": 43, "start": 0, "text": "4 seringues pré-remplies de 1 ml de solvant", "truncated": false}, "before_length": 43, "before_sha256": "339c013aec71992a822e6c84710fe78715830580515f79c89b045d4f714eacdf", "change_kind": "content", "change_operations": [{"after_end": 32, "after_start": 31, "before_end": 32, "before_start": 31, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a8807a281c0288322741e73c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6920}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 11, "start": 0, "text": "Takeda GmbH", "truncated": false}, "before_length": 11, "before_sha256": "94e4e4fc81542d4a8a0deb904c666e74cf300a1075af4d0d2e564a29e287bafb", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 11, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 11, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a8b6fec86e912120a785e466", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "Qdenga powder and solvent for solution for injection Qdenga powder and solvent for solution for injection in pre-filled syringe Dengue tetravalent vaccine (live, attenuated)", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 969}
{"after": {"end": 162, "start": 0, "text": "use PDE5 inhibitors such as sildenafil, tadalafil, vardenafil. These are medicines to treat high blood pressure in lung arteries or to treat erectile dysfunction.", "truncated": false}, "after_length": 162, "after_sha256": "4d00718855ce58072edac09fb65ef83b3852864908a531ecdc50b7f954504340", "annex": "IIIA", "before": {"end": 153, "start": 0, "text": "use PDE5 inhibitors such as sildenafil, tadalafil, vardenafil. These are medicines to treat high blood pressure in lung arteries or erectile dysfunction.", "truncated": false}, "before_length": 153, "before_sha256": "c46b2f5aa8c24a7331bbb83062a40361029d9f5a3721806756bf1a112c335d30", "change_kind": "content", "change_operations": [{"after_end": 141, "after_start": 132, "before_end": 132, "before_start": 132, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 9}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a8c3505096b845835d1a1b4c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3158}
{"after": {"end": 192, "start": 0, "text": "Votre médecin vous remettra également une Carte Patient qui comportera des informations importantes de sécurité d’emploi que vous devez connaître, avant et pendant votre traitement par Enbrel.", "truncated": false}, "after_length": 192, "after_sha256": "a9b61621aee7f348e503c6ef13da6f1d4dc6f2a4d953f840016b3daaebeecd6a", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 192, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 192}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a8c58a4dd9981ade7b18f9fd", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 8216}
{"after": {"end": 85, "start": 0, "text": "Orange, round, biconvex tablet, engraved with E275 on one side and ‘2’ on other side.", "truncated": false}, "after_length": 85, "after_sha256": "d09f00c728851c5052615e554fe5d72b7c7ff80df34804a722998742b563419b", "annex": "I", "before": {"end": 84, "start": 0, "text": "Orange, round, biconvex tablet, engraved with E275 on one side and ‘2’ on other side", "truncated": false}, "before_length": 84, "before_sha256": "6c1c893b0c50b181e57abd05be0cb6651f2c2852bbf6f97f8640541713f0ac94", "change_kind": "content", "change_operations": [{"after_end": 85, "after_start": 84, "before_end": 84, "before_start": 84, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a8ef907a52078e64c7272ecf", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "Fycompa 2 mg filmcoated tablets Fycompa 4 mg filmcoated tablets Fycompa 6 mg filmcoated tablets Fycompa 8 mg filmcoated tablets Fycompa 10 mg filmcoated tablets Fycompa 12 mg filmcoated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "3", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 91}
{"after": {"end": 98, "start": 0, "text": "Signs or symptoms of this safety concern and when to seek attention from a healthcare professional", "truncated": false}, "after_length": 98, "after_sha256": "ec73c7586cd1abc07779b36ca1c4719e5ba664487a2d4a833fc44fe769a41c40", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 98, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 98}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a93d79987c49a843380a1c0b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6576}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "Tel: + 46 (0)31 773 75 30", "truncated": false}, "before_length": 25, "before_sha256": "7c0d1404bad5b8761b40f49f53ed365b3205af7da52ea8f044f6f6ed18aa6228", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 25, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 25, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a954acbe57e24f8c5cb3a9f0", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1155}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 26, "start": 0, "text": "Tel: +49 (0) 69 506029-000", "truncated": false}, "before_length": 26, "before_sha256": "7cdbcbda6dbb962f997b6edec4af300bbe1c41e7ed84a9ddd146cbf2dd97aacc", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 26, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 26, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a956e8d33b37c71c2fe28237", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1052}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 14, "start": 0, "text": "78467 Konstanz", "truncated": false}, "before_length": 14, "before_sha256": "ee960a86a16086f43d4c7f3f51bd93d39025d5227fb1a6f1c825d1015754ff53", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a9708b087323dec25649a7ad", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1714}
{"after": {"end": 20, "start": 0, "text": "dpoc.croatia@msd.com", "truncated": false}, "after_length": 20, "after_sha256": "e6060fe9f944bc26788eae6c6fde884372f9d1fb19a754bedfaa7c027a1b33e8", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "croatia_info@merck.com", "truncated": false}, "before_length": 22, "before_sha256": "759280e179a26a0343b8a3e77f7b95e8375fadcd491da4367ac6580767a10fbf", "change_kind": "content", "change_operations": [{"after_end": 5, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}, {"after_end": 12, "after_start": 12, "before_end": 12, "before_start": 7, "kind": "delete"}, {"after_end": 16, "after_start": 14, "before_end": 18, "before_start": 14, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 9, "chars_inserted": 7}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a97a402784e520351e137536", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3464}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 13, "start": 0, "text": "Thaw duration", "truncated": false}, "before_length": 13, "before_sha256": "1192f885dc2df1a806d7eec521b69a527d874ceba16591d76aabb6dbb7166424", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 13, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 13, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a989c27ca1e19a14628ade4b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13092}
{"after": {"end": 16, "start": 0, "text": "EU/1/20/1507/036", "truncated": false}, "after_length": 16, "after_sha256": "e68f65e2cead5d34b18943332f1cc6cfc11ca5e0b4151a03f0a434eee9ce7f29", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "administrative", "change_operations": [{"after_end": 16, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 16}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a98d3cdf951dc6c3923aa3d4", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "8", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6489}
{"after": {"end": 37, "start": 0, "text": "EU/1/20/1507/034 (blister pack of 10)", "truncated": false}, "after_length": 37, "after_sha256": "c202e66e9f2ea7eb1b24fa47f96a1a02da39a5d716a5201d791bd6e2f05dfab2", "annex": "IIIA", "before": {"end": 37, "start": 0, "text": "EU/1/20/1507/024 (blister pack of 10)", "truncated": false}, "before_length": 37, "before_sha256": "735a7c158b60cb02ecdc4b49edf8f97211ab7b7e7f3a3d93d270f299dcf6409d", "change_kind": "content", "change_operations": [{"after_end": 15, "after_start": 14, "before_end": 15, "before_start": 14, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a9a60e1028e8bf65533b5e83", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9265}
{"after": {"end": 11, "start": 0, "text": "Voie orale.", "truncated": false}, "after_length": 11, "after_sha256": "dd303ff5eaeb3946adedda2cb1cc0525b4d6b7561b2450d515addd890456afe9", "annex": "IIIA", "before": {"end": 10, "start": 0, "text": "Voie orale", "truncated": false}, "before_length": 10, "before_sha256": "b21e8d51c5cf6ffc46ec58c52f7fd9782e18be932f51e39153050c410cb9b1b2", "change_kind": "content", "change_operations": [{"after_end": 11, "after_start": 10, "before_end": 10, "before_start": 10, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a9ac18334a5ce2a7ab5becd4", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:32:00Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3ff8cd4d67d22ba799aa348aeda944d6d896a16dcf54b030db101cbc095fc8ad", "source_snapshot_id": "source-a79a7cba8bf5dbc72fd40574", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1761}
{"after": {"end": 13, "start": 0, "text": "Hermeslaan 11", "truncated": false}, "after_length": 13, "after_sha256": "6426889eacea87c88f1e0405aad54515d8a889ca0f1b2ab39e2039040651e7d3", "annex": "IIIA", "before": {"end": 11, "start": 0, "text": "Hoge Wei 10", "truncated": false}, "before_length": 11, "before_sha256": "ba5c0cab58e83e9dc6ec41e55e6acc00077e1be63c8a1ed970723221f2f12ba4", "change_kind": "content", "change_operations": [{"after_end": 1, "after_start": 1, "before_end": 3, "before_start": 1, "kind": "delete"}, {"after_end": 4, "after_start": 2, "before_end": 6, "before_start": 4, "kind": "replace"}, {"after_end": 10, "after_start": 5, "before_end": 8, "before_start": 7, "kind": "replace"}, {"after_end": 13, "after_start": 12, "before_end": 11, "before_start": 10, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a9b8b48867b1e26a03dd5e65", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004310", "medicine_name": "Daptomycin Hospira", "medicine_slug": "daptomycin-hospira", "observed_at": "2026-10-12T19:09:33Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3242bb93d94dc3b7e86b89af5160c6986e8caa2e4f8d73bf8a634a557420452a", "source_snapshot_id": "source-dd7a18b7c210239223fa10ad", "source_updated_at": "2025-09-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/daptomycin-hospira-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1590}
{"after": {"end": 78, "start": 0, "text": "• Ne retirez pas la cartouche de votre Terrosa Pen avant qu’elle ne soit vide.", "truncated": false}, "after_length": 78, "after_sha256": "08dc254ca1f28e9a6e9f71446acc342593a9c488675d469303397ef613e7f880", "annex": "IIIA", "before": {"end": 80, "start": 0, "text": "• Ne retirez pas la cartouche de votre stylo Terrosa avant qu’elle ne soit vide.", "truncated": false}, "before_length": 80, "before_sha256": "724927f3d1beeb7deec21f54bfaff1b43566ae4dd8e21eccda5768c2b6a4c675", "change_kind": "content", "change_operations": [{"after_end": 39, "after_start": 39, "before_end": 45, "before_start": 39, "kind": "delete"}, {"after_end": 50, "after_start": 46, "before_end": 52, "before_start": 52, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-a9df4c4b7bccd591515333d7", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2068}
{"after": {"end": 22, "start": 0, "text": "Tel.: +40 21 529 29 00", "truncated": false}, "after_length": 22, "after_sha256": "c0def45751c8a6f47b191f68953f4156d333424fdfacc770cf07669eae1210a5", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "Tel: + 40 21 529 29 00", "truncated": false}, "before_length": 22, "before_sha256": "ab360a5cc3194a1966bd86bcee0a1a2cf6cc97342e9c07c5a45039ca6bac64ef", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}, {"after_end": 7, "after_start": 7, "before_end": 7, "before_start": 6, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-aa08ea76b06d8b5e5880bff1", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3468}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "Tel: +44 (0)1304 616161", "truncated": false}, "before_length": 23, "before_sha256": "eba81e6ccdbae471c024a5ba77d9ec9e0617a3c443fd22205a626861e87fbd8c", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 23, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 23, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-aa120eb0a89e539bbca92407", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12301}
{"after": {"end": 375, "start": 0, "text": "Le contenu total (0,5 mL pour la dose de 25 mg ou 1 mL pour la dose de 50 mg) de la cartouche distributrice de dose doit être administré à l’aide du dispositif d’injection SMARTCLIC pour une injection sous-cutanée uniquement. Les sites d’injection appropriés sont l’abdomen, la partie supérieure des cuisses ou, par le soignant uniquement, la partie arrière du haut des bras.", "truncated": false}, "after_length": 375, "after_sha256": "3954f8fa3d9b35e6d97620bd0d890eacd38bb98bea83549473aa2be5fe720e5e", "annex": "I", "before": {"end": 375, "start": 0, "text": "Le contenu total (0,5 ml pour la dose de 25 mg ou 1 ml pour la dose de 50 mg) de la cartouche distributrice de dose doit être administré à l’aide du dispositif d’injection SMARTCLIC pour une injection sous-cutanée uniquement. Les sites d’injection appropriés sont l’abdomen, la partie supérieure des cuisses ou, par le soignant uniquement, la partie arrière du haut des bras.", "truncated": false}, "before_length": 375, "before_sha256": "d92dc638e394fc268f840b75fa06aeab5da65f9a5c653c48f8b94a4abb49704a", "change_kind": "content", "change_operations": [{"after_end": 24, "after_start": 23, "before_end": 24, "before_start": 23, "kind": "replace"}, {"after_end": 54, "after_start": 53, "before_end": 54, "before_start": 53, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-aa1715f3778ead8f8759b38c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg, solution injectable en cartouche distributrice de dose Enbrel 50 mg, solution injectable en cartouche distributrice de dose", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5564}
{"after": {"end": 64, "start": 0, "text": "other soluble guanylate cyclase stimulators, such as vericiguat.", "truncated": false}, "after_length": 64, "after_sha256": "97aed5e38797a1c8c1bff120afcf015dfe8a74ff1508175b54788dc9956179b0", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 64, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 64}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-aa4b84b07483242bd21e391c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2771}
{"after": {"end": 119, "start": 0, "text": "Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu", "truncated": false}, "after_length": 119, "after_sha256": "0f2b81ab8009e1a279ca008eb6e21bdb2e532de63aef52b62bdac980c49555d4", "annex": "IIIA", "before": {"end": 118, "start": 0, "text": "Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu", "truncated": false}, "before_length": 118, "before_sha256": "d114210a3c6f4b6710e22609ee80410ff17f5efd93b30ab72728a60b65635068", "change_kind": "technical", "change_operations": [{"after_end": 99, "after_start": 98, "before_end": 98, "before_start": 98, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-aa7fc12219727c1200f817e7", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 8530}
{"after": {"end": 19, "start": 0, "text": "Tel: +421 800500589", "truncated": false}, "after_length": 19, "after_sha256": "884f1b01e514a00ba61283d8d84191fa0eef1f7eab38e87924a502f4d95d477a", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Tel.: +421 800500589", "truncated": false}, "before_length": 20, "before_sha256": "c8260c0f65d09012acb5e4ca97c11102dcee5f6f240c6f86d3d732e5f97c617b", "change_kind": "content", "change_operations": [{"after_end": 3, "after_start": 3, "before_end": 4, "before_start": 3, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-aa92434631f1309cef174bce", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000112", "medicine_name": "Twinrix Adult", "medicine_slug": "twinrix-adult", "observed_at": "2026-10-12T13:29:23Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "cfad5fb0086c9b5d6a36b454f3f546373def1f56cded73e0652b498d02d68e41", "source_snapshot_id": "source-17627897b0874bf1160c7372", "source_updated_at": "2026-08-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/twinrix-adult-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1010}
{"after": {"end": 18, "start": 0, "text": "Tel: +372 614 4200", "truncated": false}, "after_length": 18, "after_sha256": "7d3522618730b1de908f19c99d5ea234b90d83a5325dd2ec72bca1ef54fabcae", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "Tel: + 372 614 4200", "truncated": false}, "before_length": 19, "before_sha256": "6c17b65f6dae7b7eb8a66b70911f988e73da3c441a896be83003ab51482ef3fd", "change_kind": "content", "change_operations": [{"after_end": 6, "after_start": 6, "before_end": 7, "before_start": 6, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-aac099852e382be7b1f4f8ec", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3023}
{"after": {"end": 25, "start": 0, "text": "Conclusions scientifiques", "truncated": false}, "after_length": 25, "after_sha256": "b9dba41fa3c9d3b642cfe755c989781c6765c2e1667b80c2d6fb1f02a6cb6463", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 25, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 25}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-aaf6832e810b690631c5ed14", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3398}
{"after": {"end": 8, "start": 0, "text": "Dublin 2", "truncated": false}, "after_length": 8, "after_sha256": "b9d41e7d3be3ec3e12457949fb5c2f7be98290b5d2919e8b974df9c98fab02b9", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 8, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ab2be237125df7c77b70f4af", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1344}
{"after": {"end": 168, "start": 0, "text": "Warning: Ensure the use of the correct medicine. Check the label of the cartridge before its insertion into the cartridge sleeve. Do not use cartridge if it is damaged.", "truncated": false}, "after_length": 168, "after_sha256": "3d825469838527ea3dce64e5f67752e540b69faf41a4245c51a3ac771111ca7b", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 168, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 168}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ab32afe496daf05453558beb", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1990}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 7, "start": 0, "text": "Ireland", "truncated": false}, "before_length": 7, "before_sha256": "02bf1dfa9a0365a86223f0e4ac9eaa0517b06b2e9273790f719feda656a247ae", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 7, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ab45b23b044874e355118324", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1116}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 12, "start": 0, "text": "Magyarország", "truncated": false}, "before_length": 12, "before_sha256": "5206a7f7063a77a35861f95e022dafc37f3b3cf27ed423b1118e3fe580841b19", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 12, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 12, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ac29d3e0f3429ecee02d7ada", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1053}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 16, "start": 0, "text": "EU/1/20/1507/021", "truncated": false}, "before_length": 16, "before_sha256": "32228650a3ec5fa4f49752a0a38f94d19f19cfcdf693d2b5cc42f295fdc637e1", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 16, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 16, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ac69260c9f0cfac9cfd014ef", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "8", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6478}
{"after": {"end": 20, "start": 0, "text": "Tel.: +36 1 888 5300", "truncated": false}, "after_length": 20, "after_sha256": "b83b25ec254a4166b3f210dedbd33d8e207b4ceaadec1095ccd49882767eb509", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tel.: + 36 1 888 5300", "truncated": false}, "before_length": 21, "before_sha256": "e840a2e7dcac912eac697222649c523cf85354b94f2ef4174a7e446b7bf36b6f", "change_kind": "content", "change_operations": [{"after_end": 7, "after_start": 7, "before_end": 8, "before_start": 7, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ac728ae9151404a7d4ed85b6", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2998}
{"after": {"end": 11, "start": 0, "text": "Section 4.4", "truncated": false}, "after_length": 11, "after_sha256": "6a032bcb46c624ad04b7741eb0e93f3fcfbadae7b4bbf438c977bf139b6f0908", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 11, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 11}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ac809cc84922fd80fd59748f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:30Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "35ab6716aa09492c14ac6849111486ec47235c0bc65ef055350de950f316c5e6", "source_snapshot_id": "source-f20a60110d1f8fef5225317d", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2351}
{"after": {"end": 22, "start": 0, "text": "Tel: + 420 222 001 111", "truncated": false}, "after_length": 22, "after_sha256": "e9ffcc8c6f34f7eecd73051df872f6a828d1a6d7cd74e000b576ea4514e336b4", "annex": "IIIA", "before": {"end": 24, "start": 0, "text": "Tel: + 420 2 22 00 11 11", "truncated": false}, "before_length": 24, "before_sha256": "8826d8560384d6fbafb48544edc38636e5a2e9e992b8a864ab053908c5263c5d", "change_kind": "content", "change_operations": [{"after_end": 12, "after_start": 12, "before_end": 13, "before_start": 12, "kind": "delete"}, {"after_end": 18, "after_start": 17, "before_end": 18, "before_start": 18, "kind": "insert"}, {"after_end": 20, "after_start": 20, "before_end": 22, "before_start": 20, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 3, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ac8dd026b047d07761c72a07", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000112", "medicine_name": "Twinrix Adult", "medicine_slug": "twinrix-adult", "observed_at": "2026-10-12T13:29:23Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "cfad5fb0086c9b5d6a36b454f3f546373def1f56cded73e0652b498d02d68e41", "source_snapshot_id": "source-17627897b0874bf1160c7372", "source_updated_at": "2026-08-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/twinrix-adult-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 927}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 16, "start": 0, "text": "1 dose of 0.5 mL", "truncated": false}, "before_length": 16, "before_sha256": "1e83b15731626d86a57a8beccf3cef1907b37bc63878c6196c364300744551c5", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 16, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 16, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ac8e9cf49a1c108ebd443553", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "2", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5431}
{"after": {"end": 31, "start": 0, "text": "Table 6. Spikevax LP.8.1 dosing", "truncated": false}, "after_length": 31, "after_sha256": "865bc60cb29bdab154dcc9e17028db4ee1552d3aad8d31011437b68fc42786ab", "annex": "I", "before": {"end": 29, "start": 0, "text": "Table 7. Spikevax JN.1 dosing", "truncated": false}, "before_length": 29, "before_sha256": "bf2de247d8b3f4dc957b93594f35ad16713f6bcf4eaca380abbb35d49478bbf3", "change_kind": "administrative", "change_operations": [{"after_end": 7, "after_start": 6, "before_end": 7, "before_start": 6, "kind": "replace"}, {"after_end": 22, "after_start": 18, "before_end": 20, "before_start": 18, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 3, "chars_inserted": 5}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ac96fbfb173e9534e9385a1c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13169}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 14, "start": 0, "text": "78467 Konstanz", "truncated": false}, "before_length": 14, "before_sha256": "ee960a86a16086f43d4c7f3f51bd93d39025d5227fb1a6f1c825d1015754ff53", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-acc643abb7a54ec60808b007", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1339}
{"after": {"end": 28, "start": 0, "text": "Tel.: +49 (0) 89 20 300 4500", "truncated": false}, "after_length": 28, "after_sha256": "2f47e24ea3b89eb99468dc43a719db1159dc130a0e2b969c67c6b5887bc5696f", "annex": "IIIA", "before": {"end": 27, "start": 0, "text": "Tel: +49 (0) 89 20 300 4500", "truncated": false}, "before_length": 27, "before_sha256": "3ec0c7ac949c3c79f60152bd053a52d41d0b7662db4cc5cb04f12ee2390fd91d", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ace67274478f721b2ca3fd74", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3414}
{"after": {"end": 40, "start": 0, "text": "3. How you will be given Spikevax LP.8.1", "truncated": false}, "after_length": 40, "after_sha256": "fe22e2170264915aa71ec7fda8a055fbe6700cfddd2b00b3be23d4dae062ddc9", "annex": "I", "before": {"end": 38, "start": 0, "text": "3. How you will be given Spikevax JN.1", "truncated": false}, "before_length": 38, "before_sha256": "7af794b222bebf13bab916aa6614a024f0e69696772bcf251a3a58a21e6a1e18", "change_kind": "administrative", "change_operations": [{"after_end": 38, "after_start": 34, "before_end": 36, "before_start": 34, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ad2a932f34a6c2e71a7ff44b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12689}
{"after": {"end": 54, "start": 0, "text": "Takeda Pharmaceuticals International AG Ireland Branch", "truncated": false}, "after_length": 54, "after_sha256": "81709515d3af1f0e4041ce3c760d8fc81fefa358805810b0b53a84e121d5efa6", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 54, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 54}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ad2f452bba080afbe7a64484", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1341}
{"after": {"end": 201, "start": 0, "text": "As with all injectable vaccines, appropriate medical treatment and supervision must always be readily available in the event of an anaphylactic reaction following the administration of Spikevax LP.8.1.", "truncated": false}, "after_length": 201, "after_sha256": "27b416d9191514cfee52659664af16ef0da7ff62c26500d5a80375cbd7604b6d", "annex": "I", "before": {"end": 199, "start": 0, "text": "As with all injectable vaccines, appropriate medical treatment and supervision must always be readily available in the event of an anaphylactic reaction following the administration of Spikevax JN.1.", "truncated": false}, "before_length": 199, "before_sha256": "1920b3382159ded6bfbb173008e08b9a3a368ed683deb0b6f3c0276993bbae13", "change_kind": "administrative", "change_operations": [{"after_end": 198, "after_start": 194, "before_end": 196, "before_start": 194, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ad41c1b5e0c6912756ba4139", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13232}
{"after": {"end": 19, "start": 0, "text": "Tel: +385 800787089", "truncated": false}, "after_length": 19, "after_sha256": "1d1dd19a6294ac43f4bc65ab1d531c8cf1be16a8a4a052fb96c010aeb11e0008", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Tel.: +385 800787089", "truncated": false}, "before_length": 20, "before_sha256": "22ceccd7ab6ab1e9a41429450e7ece1e5e7743422b9c87c431910642dadc3726", "change_kind": "content", "change_operations": [{"after_end": 3, "after_start": 3, "before_end": 4, "before_start": 3, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ad51f9dd5955dc3747c57a2f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000112", "medicine_name": "Twinrix Adult", "medicine_slug": "twinrix-adult", "observed_at": "2026-10-12T13:29:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "bc8ba3adecfe04d3079e5b502251cec982d6197257fe3b7ec3a22dc5f2ace654", "source_snapshot_id": "source-8439a1a319b62d1bd67256a4", "source_updated_at": "2026-08-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/twinrix-adult-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 955}
{"after": {"end": 43, "start": 0, "text": "Pfizer Healthcare Ireland Unlimited Company", "truncated": false}, "after_length": 43, "after_sha256": "1f203777a0ec6fed9c840d52631b6a74c7e25b5d318485d8147e2404f52dc981", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "Pfizer Healthcare Ireland", "truncated": false}, "before_length": 25, "before_sha256": "4beeea9b6d0c491f03a9511d9f9576b9c75cbcdcfd736e4934f768fdded936f5", "change_kind": "content", "change_operations": [{"after_end": 43, "after_start": 25, "before_end": 25, "before_start": 25, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 18}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ad829259af30b2329c45a174", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11586}
{"after": {"end": 7, "start": 0, "text": "Ireland", "truncated": false}, "after_length": 7, "after_sha256": "02bf1dfa9a0365a86223f0e4ac9eaa0517b06b2e9273790f719feda656a247ae", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "administrative", "change_operations": [{"after_end": 7, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 7}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-adc5078a519d5f05ceb71e6f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "Qdenga powder and solvent for solution for injection Qdenga powder and solvent for solution for injection in pre-filled syringe Dengue tetravalent vaccine (live, attenuated)", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 978}
{"after": {"end": 22, "start": 0, "text": "Tel.: +48 22 549 51 00", "truncated": false}, "after_length": 22, "after_sha256": "b4f3ff473cb9a7a642bf71f33b5b5948d208175e4d85b587f2a38e81caf1a4cb", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tel: +48 22 549 51 00", "truncated": false}, "before_length": 21, "before_sha256": "222e9a202ca5b1cde4fca3b2b78aaf332f0c1aa8b98e03455889987c3316067a", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-adc68f710b18eba7fa336d1b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3449}
{"after": {"end": 286, "start": 0, "text": "Des fistules, touchant d’autres parties du corps que le tractus gastro-intestinal (ex. : fistule bronchopleurale ou biliaire) ont été peu fréquemment (≥ 0,1 % à < 1 %) rapportées, dans diverses indications. Des fistules ont été également rapportées après la commercialisation d’Avastin.", "truncated": false}, "after_length": 286, "after_sha256": "c5754860a87bdc9311688baa404d5073b5f4c8bfbdb459bd672acaf4e61f1343", "annex": "I", "before": {"end": 287, "start": 0, "text": "Des fistules, touchant d’autres parties du corps que le tractus gastro-intestinal (ex. : fistule broncho pleurale ou biliaire) ont été peu fréquemment (≥ 0,1 % à < 1 %) rapportées, dans diverses indications. Des fistules ont été également rapportées après la commercialisation d’Avastin.", "truncated": false}, "before_length": 287, "before_sha256": "1328788816e1518cac9ca4cacfa5b1a635288948a05cf9cb6bad111179378b9a", "change_kind": "content", "change_operations": [{"after_end": 104, "after_start": 104, "before_end": 105, "before_start": 104, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ae1e9d1c1e7358113c49eed5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 736}
{"after": {"end": 376, "start": 0, "text": "However, no effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breastfeeding woman to the vaccine is negligible. Observational data from women who were breastfeeding after vaccination with Spikevax (original) have not shown a risk for adverse effects in breastfed newborns/infants. SARSCoV2 LP.8.1 mRNA can be used during breastfeeding.", "truncated": false}, "after_length": 376, "after_sha256": "388f96bf8a8a9edae2ce271142d2677ddfed45d4330a0a167c225f3e5b062347", "annex": "I", "before": {"end": 374, "start": 0, "text": "However, no effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breastfeeding woman to the vaccine is negligible. Observational data from women who were breastfeeding after vaccination with Spikevax (original) have not shown a risk for adverse effects in breastfed newborns/infants. SARSCoV2 JN.1 mRNA can be used during breastfeeding.", "truncated": false}, "before_length": 374, "before_sha256": "0029e914fc91202fd642681ed888bcff7e657257b7dfa9b0f3c1d7bcf526d908", "change_kind": "content", "change_operations": [{"after_end": 335, "after_start": 331, "before_end": 333, "before_start": 331, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ae547df27b615a7352136091", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.6", "section_type": "pregnancy", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5625}
{"after": {"end": 4, "start": 0, "text": "1 ml", "truncated": false}, "after_length": 4, "after_sha256": "4103eeeca6e2548f11a7718ff403283afec588e4fb6e5622d0ed558b3d903b7b", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "1 ml water for injections", "truncated": false}, "before_length": 25, "before_sha256": "53bace9b82f7ee7e58335e0c77f95ec02d6803dc9840be083b8785c2b292d523", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 4, "before_end": 25, "before_start": 4, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 21, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ae68d4bd30a72570e99128be", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 7669}
{"after": {"end": 23, "start": 0, "text": "Tel: +43 (0)1 523 25 05", "truncated": false}, "after_length": 23, "after_sha256": "1c871405cc2b2c04561b63ec0520ec0b01c5f9571be60e896ddbf90186d9c8da", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "Tel: +43 (0)1 523 25 05-0", "truncated": false}, "before_length": 25, "before_sha256": "5df3b28c904ca135a41fa3881c6d241cdc62f65913ad6cbd06cbb3d76c98d230", "change_kind": "content", "change_operations": [{"after_end": 23, "after_start": 23, "before_end": 25, "before_start": 23, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-aeb14fe3e67a358cce38296f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1060}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 14, "start": 0, "text": "Pfizer Limited", "truncated": false}, "before_length": 14, "before_sha256": "faadd350d247ecbb0e8edac0805fa3d4cdbf449fbb9a1a9614eee6624274a2f6", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-aeb466d6da3434e0ef7d18aa", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11749}
{"after": {"end": 736, "start": 0, "text": "Dans l’étude NSABP C-08, un essai de phase III avec Avastin utilisé en traitement adjuvant chez des patients atteints d’un cancer du côlon, l’incidence des nouveaux cas d’insuffisance ovarienne, définie par une aménorrhée de 3 mois ou plus, un taux de FSH ≥ 30 mUI/mL et un test de grossesse β-HCG négatif, a été évalué chez 295 femmes non ménopausées. De nouveaux cas d’insuffisance ovarienne ont été rapportés chez 2,6 % des patients dans le groupe mFOLFOX-6 comparé à 39 % dans le groupe mFOLFOX-6 + bevacizumab. Après arrêt du traitement par le bevacizumab, la fonction ovarienne s’est rétablie chez 86,2 % des femmes évaluables. Les effets à long terme d’un traitement par bevacizumab sur la fertilité ne sont à ce jour pas connus.", "truncated": false}, "after_length": 736, "after_sha256": "44ef80ee1fa2c60bc2cb437548c37bc839b545adf14994dc34dd06b69d1d4679", "annex": "I", "before": {"end": 737, "start": 0, "text": "Dans l’étude NSABP C-08, un essai de phase III avec Avastin utilisé en traitement adjuvant chez des patients atteints d’un cancer du côlon, l’incidence des nouveaux cas d’insuffisance ovarienne, définie par une aménorrhée de 3 mois ou plus, un taux de FSH ≥ 30 mUI/mL et un test de grossesse β-HCG négatif, a été évalué chez 295 femmes non ménopausées. Des nouveaux cas d’insuffisance ovarienne ont été rapportés chez 2,6 % des patients dans le groupe mFOLFOX-6 comparé à 39 % dans le groupe mFOLFOX-6 + bevacizumab. Après arrêt du traitement par le bevacizumab, la fonction ovarienne s’est rétablie chez 86,2 % des femmes évaluables. Les effets à long terme d’un traitement par bevacizumab sur la fertilité ne sont à ce jour pas connus.", "truncated": false}, "before_length": 737, "before_sha256": "7c1161a3cc5fe2f5a678298373bd66d22629b57aadf4ecdf3c11af1a26f18f0f", "change_kind": "content", "change_operations": [{"after_end": 355, "after_start": 355, "before_end": 356, "before_start": 355, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-aed709b3999b8fa202a42c4b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 831}
{"after": {"end": 105, "start": 0, "text": "Le critère principal était la survie sans progression (SSP), évaluée par les investigateurs selon RECIST.", "truncated": false}, "after_length": 105, "after_sha256": "9ecaece2f99a4ae1e0f6196f0533b263f70b676ea1337b81c3664989d15a8f23", "annex": "I", "before": {"end": 105, "start": 0, "text": "Le critère principal était la survie sans progression (PFS), évaluée par les investigateurs selon RECIST.", "truncated": false}, "before_length": 105, "before_sha256": "6349c9285f816d7a3adb24051ac8f925f847318adf185582c9b481ea5e6b8e68", "change_kind": "content", "change_operations": [{"after_end": 57, "after_start": 55, "before_end": 55, "before_start": 55, "kind": "insert"}, {"after_end": 58, "after_start": 58, "before_end": 58, "before_start": 56, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-aed9cb9e67beeb8e3782e075", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1862}
{"after": {"end": 129, "start": 0, "text": "Après examen de la recommandation du PRAC, le CHMP approuve les conclusions générales du PRAC et les motifs de sa recommandation.", "truncated": false}, "after_length": 129, "after_sha256": "7f742dd4d84dfcd3eaee344b865d2447706c76828f7b7aeaa1db7fa5791f3aec", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 129, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 129}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-af0c9b31861a288cf76a33d9", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:32:00Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "3ff8cd4d67d22ba799aa348aeda944d6d896a16dcf54b030db101cbc095fc8ad", "source_snapshot_id": "source-a79a7cba8bf5dbc72fd40574", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3535}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tel: +44(0)800 221441", "truncated": false}, "before_length": 21, "before_sha256": "b60520b7c3f5143a4052286ffe553fbf86751da23ca567680dc9998e034a172d", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 21, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 21, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-af873485eb1889e645426b39", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000112", "medicine_name": "Twinrix Adult", "medicine_slug": "twinrix-adult", "observed_at": "2026-10-12T13:29:23Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "cfad5fb0086c9b5d6a36b454f3f546373def1f56cded73e0652b498d02d68e41", "source_snapshot_id": "source-17627897b0874bf1160c7372", "source_updated_at": "2026-08-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/twinrix-adult-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1033}
{"after": {"end": 20, "start": 0, "text": "dpoc_austria@msd.com", "truncated": false}, "after_length": 20, "after_sha256": "fffcced0c5785d318bead68b726572c8df5f6a7f283341dbbaa2c0e000b9f45e", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "dpoc_austria@merck.com", "truncated": false}, "before_length": 22, "before_sha256": "24a76a21b822b2b605efa994eaf3b0998f214621c2a7d0ab97cd100c212f6bc9", "change_kind": "content", "change_operations": [{"after_end": 16, "after_start": 14, "before_end": 18, "before_start": 14, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-afab70e3b272c75c88f91247", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3126}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 35, "start": 0, "text": "Not all pack sizes may be marketed.", "truncated": false}, "before_length": 35, "before_sha256": "be81359d16e6600d35fa2d803b9d851ff31cc7a1c48b622e9a0a7f0395154682", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 35, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 35, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-afe800ac7109f4ddd0970aa0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.5", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6327}
{"after": {"end": 99, "start": 0, "text": "microangiopathyb,c, Hyaline occlusive glomerular microangiopathyc, Aneurysms and artery dissections", "truncated": false}, "after_length": 99, "after_sha256": "d90959ebd90a79efe288f1b0ee530a35289f99d063fd6b758f02371a6fd2330b", "annex": "I", "before": {"end": 52, "start": 0, "text": "microangiopathyb,c, Aneurysms and artery dissections", "truncated": false}, "before_length": 52, "before_sha256": "b953137fa5756f2e476003837a6e260804e56c0aa057eacca97dea15d36ba685", "change_kind": "content", "change_operations": [{"after_end": 67, "after_start": 20, "before_end": 20, "before_start": 20, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 47}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b0058a75d1b153351f4ec1a7", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:18Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml concentrate for solution for infusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "89a938df5e41f86548301270084e3d1ecf171802e24b5429f62e3bede7ee32dd", "source_snapshot_id": "source-b71aeee5a07abebc34c02e28", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 666}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IV", "before": {"end": 9, "start": 0, "text": "ANNEXE IV", "truncated": false}, "before_length": 9, "before_sha256": "5623d2bfc35b28c1d982ab389e6c5fa37f50e40d0b9b737593e164d081c1191d", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 9, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 9, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b01a0974a1ce8937115a8479", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:32:00Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "3ff8cd4d67d22ba799aa348aeda944d6d896a16dcf54b030db101cbc095fc8ad", "source_snapshot_id": "source-a79a7cba8bf5dbc72fd40574", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3508}
{"after": {"end": 2, "start": 0, "text": "SC", "truncated": false}, "after_length": 2, "after_sha256": "32da6721804f1dd3226c0551970304ebf1059ec19a27451426541027861c9388", "annex": "IIIA", "before": {"end": 16, "start": 0, "text": "Subcutaneous use", "truncated": false}, "before_length": 16, "before_sha256": "363fd22613abec178143cdac0b1a34f04ee8ccdaa7d6988b3722fa7540374cde", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 1, "before_end": 16, "before_start": 1, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 15, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b034cecb3be5d0547ece9fa2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 7316}
{"after": {"end": 14, "start": 0, "text": "Indéterminéecc", "truncated": false}, "after_length": 14, "after_sha256": "251ce241a1874ddab60c44be96e8e897765069842afc4a1cdf62d2fcbe15ece8", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 14, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 14}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b0532c7f9b10ca5f0635c0a6", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:18Z", "pipeline_version": "2.0.0", "presentation_label": "IMJUDO 20 mg/ml, solution à diluer pour perfusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "2437ab76633f46c9eee5e002e5c7a7caba6367f59567d750be0eb67c74d1db4e", "source_snapshot_id": "source-7f4d129b0a0fd2d3684d27c5", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 831}
{"after": {"end": 76, "start": 0, "text": "Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe", "truncated": false}, "after_length": 76, "after_sha256": "6c7ff1bbd2f6d8c84f1254cce87065dac51505e1edd888622047a746e34551e6", "annex": "I", "before": {"end": 74, "start": 0, "text": "Spikevax JN.1 50 micrograms dispersion for injection in pre-filled syringe", "truncated": false}, "before_length": 74, "before_sha256": "ebe036d056b86be90e582dc3803425dce3820674579f962bd2fc8976b65c292a", "change_kind": "administrative", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b056950a3159a1370584b613", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13109}
{"after": {"end": 56, "start": 0, "text": "What Spikevax LP.8.1 looks like and contents of the pack", "truncated": false}, "after_length": 56, "after_sha256": "089418d51c8ca52524f8f02bab199d4d2921ad5d47d71d6dd2b0f83e554bc65e", "annex": "I", "before": {"end": 54, "start": 0, "text": "What Spikevax JN.1 looks like and contents of the pack", "truncated": false}, "before_length": 54, "before_sha256": "035323987f18f931115d1fe4b032f78dd45db8cafad632558ba003594847a589", "change_kind": "administrative", "change_operations": [{"after_end": 18, "after_start": 14, "before_end": 16, "before_start": 14, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b0598b36766bcebbd0f20b0e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12873}
{"after": {"end": 149, "start": 0, "text": "Des informations détaillées sur ce médicament sont disponibles sur le site internet de l’Agence européenne des médicaments https://www.ema.europa.eu.", "truncated": false}, "after_length": 149, "after_sha256": "0e6b9f35caaf0258b468a6e9a53665f0ec5536787f68eefee5f242bf64add02e", "annex": "I", "before": {"end": 148, "start": 0, "text": "Des informations détaillées sur ce médicament sont disponibles sur le site internet de l’Agence européenne des médicaments http://www.ema.europa.eu.", "truncated": false}, "before_length": 148, "before_sha256": "8781a4dba25cf8cb978f0efd517b11bd29ec42e3e0fffadb61d4b9c2e7362806", "change_kind": "technical", "change_operations": [{"after_end": 128, "after_start": 127, "before_end": 127, "before_start": 127, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b0631523ce364ec29d8545ba", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg solution injectable en seringue pré-remplie Enbrel 50 mg solution injectable en seringue pré-remplie", "presentation_occurrence": 3, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "10", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3412}
{"after": {"end": 146, "start": 0, "text": "La substance active d’Enbrel est l’etanercept. Chaque cartouche distributrice de dose contient 1,0 mL de solution, fournissant 50 mg d’etanercept.", "truncated": false}, "after_length": 146, "after_sha256": "fb8736d998253bd51ece6c729f9195ac4bfb4671bfe00b117f0bb6354443221c", "annex": "IIIA", "before": {"end": 146, "start": 0, "text": "La substance active d’Enbrel est l’etanercept. Chaque cartouche distributrice de dose contient 1,0 ml de solution, fournissant 50 mg d’etanercept.", "truncated": false}, "before_length": 146, "before_sha256": "fb4e601cb75f83bf8104d820dced78de3a8b4412d71f95dc0b6b558d4f3c5b88", "change_kind": "content", "change_operations": [{"after_end": 101, "after_start": 100, "before_end": 101, "before_start": 100, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b07ac5825665b12850bba32a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12163}
{"after": {"end": 307, "start": 0, "text": "Dans une analyse pharmacocinétique de population chez des patients atteints de spondylarthrite ankylosante, les ASC de l’etanercept à l’état d’équilibre ont été de 466 gh/mL et de 474 gh/mL respectivement pour Enbrel 50 mg une fois par semaine (n = 154) et pour Enbrel 25 mg deux fois par semaine (n = 148).", "truncated": false}, "after_length": 307, "after_sha256": "1c43c823b021ca355a70ce91caf9457501b150b77ff3824f2ada9508e781e74b", "annex": "I", "before": {"end": 307, "start": 0, "text": "Dans une analyse pharmacocinétique de population chez des patients atteints de spondylarthrite ankylosante, les ASC de l’etanercept à l’état d’équilibre ont été de 466 gh/ml et de 474 gh/ml respectivement pour Enbrel 50 mg une fois par semaine (n = 154) et pour Enbrel 25 mg deux fois par semaine (n = 148).", "truncated": false}, "before_length": 307, "before_sha256": "5d8df1dfa3590f8cd7f05f183c4a37b7abc74223db55f470f360af9b806b6cab", "change_kind": "content", "change_operations": [{"after_end": 173, "after_start": 172, "before_end": 173, "before_start": 172, "kind": "replace"}, {"after_end": 189, "after_start": 188, "before_end": 189, "before_start": 188, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b0abe32ee73e111c10406b85", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg solution injectable en stylo pré-rempli Enbrel 50 mg solution injectable en stylo pré-rempli", "presentation_occurrence": 4, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 4429}
{"after": {"end": 20, "start": 0, "text": "Tlf.: +45 44 201 100", "truncated": false}, "after_length": 20, "after_sha256": "a342c892cb893e888e9b98929ab7ba413528a3b19847cefc774fcc7b2c91291e", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "Tlf: +45 44 201 100", "truncated": false}, "before_length": 19, "before_sha256": "c639c1fe70f9701d8cecb70d89ff79995abd4e41911073143438fc69a41a0363", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b0c12394fa038f3f8a81bf02", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 10590}
{"after": {"end": 75, "start": 0, "text": "Spikevax LP.8.1 50 micrograms dispersion for injection in prefilled syringe", "truncated": false}, "after_length": 75, "after_sha256": "b642f3a1efc0a8ed8ce0e5dd97a5f30427a98c8bf512813984ee7e9626347d6e", "annex": "I", "before": {"end": 73, "start": 0, "text": "Spikevax JN.1 50 micrograms dispersion for injection in prefilled syringe", "truncated": false}, "before_length": 73, "before_sha256": "5150a8374dbe88d379a7e4130ac03fb7d42655ab8e494e1e9be5e8cd5d5f84c5", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b0ea09a1322b93f52538af3d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6415}
{"after": {"end": 18, "start": 0, "text": "Tel: +372 614 4200", "truncated": false}, "after_length": 18, "after_sha256": "7d3522618730b1de908f19c99d5ea234b90d83a5325dd2ec72bca1ef54fabcae", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "Tel: + 372 614 4200", "truncated": false}, "before_length": 19, "before_sha256": "6c17b65f6dae7b7eb8a66b70911f988e73da3c441a896be83003ab51482ef3fd", "change_kind": "content", "change_operations": [{"after_end": 6, "after_start": 6, "before_end": 7, "before_start": 6, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b135caab6e4db557369ea25d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3110}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "info@mundipharma.com.cy", "truncated": false}, "before_length": 23, "before_sha256": "f29f1155cff09a2341c68da09f129bd1783cb3cd9c355966777e9e960f7f9753", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 23, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 23, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b15c448f7ad9408efdd42296", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1142}
{"after": {"end": 29, "start": 0, "text": "Survie sans progression (SSP)", "truncated": false}, "after_length": 29, "after_sha256": "617193974d6682c85a8af219a6f2b06ff66ff3e0e9b29cabebd5d5998461e7d8", "annex": "I", "before": {"end": 29, "start": 0, "text": "Survie sans progression (PFS)", "truncated": false}, "before_length": 29, "before_sha256": "8f5b37d99ddf529df1ca72d62d3cc355e8dee70624f1335d36a06a6f71013027", "change_kind": "content", "change_operations": [{"after_end": 27, "after_start": 25, "before_end": 25, "before_start": 25, "kind": "insert"}, {"after_end": 28, "after_start": 28, "before_end": 28, "before_start": 26, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b17b2df7e9b0b66759781028", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2108}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 18, "start": 0, "text": "medis.si@medis.com", "truncated": false}, "before_length": 18, "before_sha256": "32ce83723f0e7c81efbc7b4c51505dc3014cc642bd846a12847ce5a003709876", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 18, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 18, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b1b6d9a23a760eeefb22aec1", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1119}
{"after": {"end": 21, "start": 0, "text": "Block 2 Miesian Plaza", "truncated": false}, "after_length": 21, "after_sha256": "99b504ac4fff9020da29e00aeb786f0975177380626e2b3347bd3fbd75afeeba", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 21, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 21}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b1c7eb77518a972c57f4b4eb", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1212}
{"after": {"end": 197, "start": 0, "text": "nitrates or nitric oxide donors such as amyl nitrite. These are medicines often used to treat high blood pressure, chest pain or heart disease. This also includes recreational drugs called poppers.", "truncated": false}, "after_length": 197, "after_sha256": "f2bdb81182b6b32853cffa30263faf6b158b7636a20027e7bae70d9670396d71", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 197, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 197}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b1e71c3e1a4def3803fc074d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3198}
{"after": {"end": 4, "start": 0, "text": "1 mL", "truncated": false}, "after_length": 4, "after_sha256": "af7727a32f7da2545262756526dd30894df734889f01f15bae043a9c9443b45c", "annex": "IIIA", "before": {"end": 40, "start": 0, "text": "1 ml d’eau pour préparations injectables", "truncated": false}, "before_length": 40, "before_sha256": "7320ef009a039bfb5b64c92a3e9af87ed7993238585713618b8f611093a39f08", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 40, "before_start": 3, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 37, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b215e2e9b3b8ebace8364345", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 7073}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 17, "start": 0, "text": "Medis Hungary Kft", "truncated": false}, "before_length": 17, "before_sha256": "1788967aa4a6065efb54b66c922a89e6f9d8cf865cf32093aaf092afd11fc6de", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 17, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 17, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b2489354c816d5f8b2399cb1", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1054}
{"after": {"end": 20, "start": 0, "text": "Tlf.: +45 44 201 100", "truncated": false}, "after_length": 20, "after_sha256": "a342c892cb893e888e9b98929ab7ba413528a3b19847cefc774fcc7b2c91291e", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "Tlf: +45 44 201 100", "truncated": false}, "before_length": 19, "before_sha256": "c639c1fe70f9701d8cecb70d89ff79995abd4e41911073143438fc69a41a0363", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b26962aee552536c1f60de76", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 8922}
{"after": {"end": 173, "start": 0, "text": "C: Remove the empty cartridge, in the case of changing cartridge. Insert a new Terrosa cartridge into the cartridge sleeve, with the silver metal cap of the cartridge first.", "truncated": false}, "after_length": 173, "after_sha256": "d82dcb68497f4b3c6e707a3959ac55c1af7d637c662c82e89ead4667c86e5fcc", "annex": "IIIA", "before": {"end": 174, "start": 0, "text": "C: Remove the empty cartridge, in the case of changing cartridge. Insert a new Terrosa cartridge into the cartridge holder, with the metal crimped cap of the cartridge first.", "truncated": false}, "before_length": 174, "before_sha256": "fc1064af56c2d74234437e2ac0041bba14b5982563e5bb7bd1952688d60e7b02", "change_kind": "content", "change_operations": [{"after_end": 117, "after_start": 116, "before_end": 118, "before_start": 116, "kind": "replace"}, {"after_end": 118, "after_start": 118, "before_end": 120, "before_start": 119, "kind": "delete"}, {"after_end": 122, "after_start": 119, "before_end": 122, "before_start": 121, "kind": "replace"}, {"after_end": 140, "after_start": 133, "before_end": 133, "before_start": 133, "kind": "insert"}, {"after_end": 145, "after_start": 145, "before_end": 146, "before_start": 138, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 12, "chars_inserted": 11}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b26fd036565abc5b8bf34c78", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1989}
{"after": {"end": 67, "start": 0, "text": "Read the package leaflet for Terrosa cartridge provided separately.", "truncated": false}, "after_length": 67, "after_sha256": "d9c09080ba5797146a11e9e15564afd136521c237f3a1ab733162a65b818392d", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 67, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 67}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b27f7cc99bb15d81642f1106", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1976}
{"after": {"end": 332, "start": 0, "text": "Dans le bras traité par FOLFOX, la SSP médiane était de 8,6 mois pour le bras placebo et de 9,4 mois pour le bras bevacizumab (risque relatif = 0,89, IC 97,5 % = [0,73 ; 1.08], p=0,1871), les résultats correspondant dans le bras traité par XELOX étant de 7,4 vs 9,3 mois (risque relatif = 0,77, IC 97,5 % = [0,63 ; 0,94], p=0,0026).", "truncated": false}, "after_length": 332, "after_sha256": "ca09d463fb73a96a6a202aa2fa40d2e32d6b9a8b70a042977bb7222d0db71ac2", "annex": "I", "before": {"end": 332, "start": 0, "text": "Dans le bras traité par FOLFOX, la PFS médiane était de 8,6 mois pour le bras placebo et de 9,4 mois pour le bras bevacizumab (risque relatif = 0,89, IC 97,5 % = [0,73 ; 1.08], p=0,1871), les résultats correspondant dans le bras traité par XELOX étant de 7,4 vs 9,3 mois (risque relatif = 0,77, IC 97,5 % = [0,63 ; 0,94], p=0,0026).", "truncated": false}, "before_length": 332, "before_sha256": "95226098bfa912ca883d7785fdbb5c1d6f6f9adf9725e952325e994ff7aead2e", "change_kind": "content", "change_operations": [{"after_end": 37, "after_start": 35, "before_end": 35, "before_start": 35, "kind": "insert"}, {"after_end": 38, "after_start": 38, "before_end": 38, "before_start": 36, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b29e1bf5f2cc49fac5514069", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1208}
{"after": {"end": 35, "start": 0, "text": "Tel: 0800 9999 000 (+31 23 5153153)", "truncated": false}, "after_length": 35, "after_sha256": "52e92ac1d067259b9fece48e0e06ad1c09748623062f243703b5d4f40455bd17", "annex": "IIIA", "before": {"end": 36, "start": 0, "text": "Tel: 0800 9999 000 (+ 31 23 5153153)", "truncated": false}, "before_length": 36, "before_sha256": "08802d516c69cefe10e1332d399e866d902441cca33557fa68396eaecaf1d321", "change_kind": "content", "change_operations": [{"after_end": 21, "after_start": 21, "before_end": 22, "before_start": 21, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b2d64f0cb044707f1f05ead0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3419}
{"after": {"end": 276, "start": 0, "text": "Les exigences relatives à la soumission des PSURs pour ce médicament sont définies dans la liste des dates de référence pour l’Union (liste EURD) prévue à l’article 107c(7), de la directive 2001/83/CE et ses actualisations publiées sur le portail Web européen des médicaments.", "truncated": false}, "after_length": 276, "after_sha256": "1fcc48626534d40c25423dbfa19723abd74bbb115cd4291945e0f733602c7518", "annex": "II", "before": {"end": 274, "start": 0, "text": "Les exigences relatives à la soumission des PSURs pour ce médicament sont définies dans la liste des dates de référence pour l’Union (liste EURD) prévue à Article 107c(7), de la directive 2001/83/CE et ses actualisations publiées sur le portail Web européen des médicaments.", "truncated": false}, "before_length": 274, "before_sha256": "0b2a74f96f3e9245866ce78d7243d38fd949b33dd41c077c0e8ff216db22c177", "change_kind": "content", "change_operations": [{"after_end": 158, "after_start": 155, "before_end": 156, "before_start": 155, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 3}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b2f78f1a4bac4347d471189e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 395}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "Tel: +44 (0)1304 616161", "truncated": false}, "before_length": 23, "before_sha256": "eba81e6ccdbae471c024a5ba77d9ec9e0617a3c443fd22205a626861e87fbd8c", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 23, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 23, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b30bce94c1ccdac5c35902fc", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 8586}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "Tel: +351 21 901 31 62", "truncated": false}, "before_length": 22, "before_sha256": "4fed4b1633437ec1d2d291235f0428ccd51ae54dd7bf54f0dfd0a7def72a4a1d", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 22, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 22, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b325a05a0f3b11ebc3c12d9a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1098}
{"after": {"end": 617, "start": 0, "text": "Les informations relatives à la sécurité d’emploi ont été observées dans 3 études cliniques en ouvert dans lesquelles l’éladocagène exuparvovec a été administré à 30 patients atteints d’un déficit en AADC, âgés de 19 mois à 8,5 ans lors de l’administration. Les patients ont été suivis pendant une durée médiane de 59,3 mois (minimum de 11,8 mois à maximum de 5,7 ans). Vingt-sept patients traités dans le cadre des études cliniques ont participé à une étude de suivi à long terme. La durée du suivi à partir de l’administration de la thérapie génique était comprise entre 51,6 et 126,5 mois (environ 4,3 à 10,5 ans).", "truncated": false}, "after_length": 617, "after_sha256": "2a56e9de1486245021b8f584a6a4e5e3c7a6770b7cc1ca1efa7e83b9c8579619", "annex": "I", "before": {"end": 614, "start": 0, "text": "Les informations relatives à la sécurité d’emploi ont été observées dans 3 études cliniques en ouvert dans lesquelles l’éladocagène exuparvovec a été administré à 30 patients atteints d’un déficit en AADC, âgés de 19 mois à 8,5 ans lors de l’administration. Les patients ont été suivis pendant une durée médiane de 59,3 mois (minimum de 11,8 mois à maximum de 5,7 ans). Vingt-six patients traités dans le cadre des études cliniques ont participé à une étude de suivi à long terme. La durée du suivi à partir de l’administration de la thérapie génique était comprise entre 27,2 et 126,5 mois (environ 2 à 10,5 ans).", "truncated": false}, "before_length": 614, "before_sha256": "72c13d54119577c9c2daedfc21ac5e3465e089b15ef2c9013ffa17b52259b56d", "change_kind": "content", "change_operations": [{"after_end": 380, "after_start": 377, "before_end": 379, "before_start": 377, "kind": "replace"}, {"after_end": 575, "after_start": 573, "before_end": 574, "before_start": 572, "kind": "replace"}, {"after_end": 577, "after_start": 576, "before_end": 576, "before_start": 575, "kind": "replace"}, {"after_end": 604, "after_start": 601, "before_end": 601, "before_start": 600, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 9}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b33debe0e0004e8b118c122b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005352", "medicine_name": "Upstaza", "medicine_slug": "upstaza", "observed_at": "2026-10-12T13:36:09Z", "pipeline_version": "2.0.0", "presentation_label": "Upstaza 2,8 × 1011 génomes de vecteur (vg)/0,5 mL, solution pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "42d7861913c7c415a9acf1067eeb3f9f1287a4e4718affc1402af95754bd6fed", "source_snapshot_id": "source-1e1e567efddae34509b5de34", "source_updated_at": "2026-06-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/upstaza-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 187}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "info@mundipharma.de", "truncated": false}, "before_length": 19, "before_sha256": "7352e6d7ce28cc7bc279a48fb87c85d0a241093368a041e0a8e1ef75be4fce99", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 19, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 19, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b3c7d6bd40fa25673627ea10", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1069}
{"after": {"end": 19, "start": 0, "text": "Tel.: +371 67025300", "truncated": false}, "after_length": 19, "after_sha256": "9d56d23b23e1cc8fe2e91dfd2c53e6e0d7c450088c854b2bc903cc7de0211cce", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Tel.: + 371 67025300", "truncated": false}, "before_length": 20, "before_sha256": "4827747deaf690f224c8bd3d87c76b9541304a06d0d293efd223d7eb4b6cb8df", "change_kind": "content", "change_operations": [{"after_end": 7, "after_start": 7, "before_end": 8, "before_start": 7, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b3d203102ee1b473b609f516", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3608}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "II", "before": {"end": 41, "start": 0, "text": "Post-authorisation efficacy study (PAES):", "truncated": false}, "before_length": 41, "before_sha256": "1890f494cd50fe77ca6af252d3feb760a06206050f2e7d192fbe4d150dd8cbb1", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 41, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 41, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b3e20fb8183195c5942a7136", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:33Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "21d66bf1e9a74479f577de09da3cf8517d65c1ce1b1d8bbdfe4bc38f79410def", "source_snapshot_id": "source-2c39c998fdaf05159687c016", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 471}
{"after": {"end": 12, "start": 0, "text": "Peu fréquent", "truncated": false}, "after_length": 12, "after_sha256": "6e64f57ace8d183e17323cc2a26bda7c8b3267b36fae0a791f83766d5d214380", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 12, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 12}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b3e8f65e1a685c21993d93af", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:18Z", "pipeline_version": "2.0.0", "presentation_label": "IMJUDO 20 mg/ml, solution à diluer pour perfusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "2437ab76633f46c9eee5e002e5c7a7caba6367f59567d750be0eb67c74d1db4e", "source_snapshot_id": "source-7f4d129b0a0fd2d3684d27c5", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 834}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 132, "start": 0, "text": "de la dysfonction érectile comme le sildénafil, le tadalafil, le vardénafil. Ne prenez pas ces médicaments en même temps qu’Adempas.", "truncated": false}, "before_length": 132, "before_sha256": "90e13e8e581898be78e21d48541293f0ac138ca7a5b51dd2cb20d20d6103d155", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 132, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 132, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b4082775cedde35252cbc186", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2855}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 33, "start": 0, "text": "United Kingdom (Northern Ireland)", "truncated": false}, "before_length": 33, "before_sha256": "9379d82927cdb505cfb186e912177065e56a1314de3a2b914ebbb8b5fe21525a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 33, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 33, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b4140d8490ffbf5268c91ccc", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 8584}
{"after": {"end": 106, "start": 0, "text": "Augmentation de la médiane de SSP de 5,6 mois, risque relatif 0,421 (p< 0,0001, IC 95 % : [0,343 ; 0,516])", "truncated": false}, "after_length": 106, "after_sha256": "af3c8d19cb4289c89512652d9c9de7e4b2ef0a9492f448a899f8ed3a4248eb33", "annex": "I", "before": {"end": 106, "start": 0, "text": "Augmentation de la médiane de PFS de 5,6 mois, risque relatif 0,421 (p< 0,0001, IC 95 % : [0,343 ; 0,516])", "truncated": false}, "before_length": 106, "before_sha256": "d2e66e3448f0cb2d7763a6073b07142bb5872169dc26721953a22bd4c6955252", "change_kind": "content", "change_operations": [{"after_end": 32, "after_start": 30, "before_end": 30, "before_start": 30, "kind": "insert"}, {"after_end": 33, "after_start": 33, "before_end": 33, "before_start": 31, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b4206ec342447faba0c2d0be", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1319}
{"after": {"end": 7, "start": 0, "text": "anxiété", "truncated": false}, "after_length": 7, "after_sha256": "bb4d69af9bd35aaa6143da40cabb4f28e43ef2f7221c418a1975536573e0bf80", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 7, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 7}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b42e8572de04781c021dce72", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "9ac80b0d56ebad4970f7a8335a177613af59ef25517bcd0bdd3397c207cc1bac", "source_snapshot_id": "source-c11aa9e32420f125a88005bc", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2741}
{"after": {"end": 20, "start": 0, "text": "Tel: +386 1 520 4201", "truncated": false}, "after_length": 20, "after_sha256": "4bc9aa9751d0ed5412a51f1a97aa4bd5b6851a9385ea852b8e407689ba7fe597", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Tel: + 386 1 5204201", "truncated": false}, "before_length": 20, "before_sha256": "03fc8248ffd9e4d5d179a7355c42c921061db83dc6ab440084c3885eeef938e0", "change_kind": "content", "change_operations": [{"after_end": 6, "after_start": 6, "before_end": 7, "before_start": 6, "kind": "delete"}, {"after_end": 16, "after_start": 15, "before_end": 16, "before_start": 16, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b44d2a812d36d73f3e0701b7", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3574}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 18, "start": 0, "text": "medis.lt@medis.com", "truncated": false}, "before_length": 18, "before_sha256": "728d3d606791c6b09f567fff9013bcbe51b504b37bbdcf449ccd76825c396355", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 18, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 18, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b451136fdc851ef7d7e779cb", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1151}
{"after": {"end": 117, "start": 0, "text": "Use your Terrosa Pen only as prescribed by your doctor, in this instructions for use and the Terrosa package leaflet.", "truncated": false}, "after_length": 117, "after_sha256": "5bea87cd25842021e58fcd3e5eeca226f64d4a6fa89c9a50627e38fac84565bc", "annex": "IIIA", "before": {"end": 117, "start": 0, "text": "Use your Terrosa Pen only as prescribed by your doctor, in this Instructions for use and the Terrosa package leaflet.", "truncated": false}, "before_length": 117, "before_sha256": "d1dd10a03a7e6e0b540ae1f0d02f8963e6fe1f0c2f9b15f5ccd82d845e02aa98", "change_kind": "content", "change_operations": [{"after_end": 65, "after_start": 64, "before_end": 65, "before_start": 64, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b46a047b23ffb113e9d79ce5", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2096}
{"after": {"end": 275, "start": 0, "text": "Une analyse non stratifiée de la SSP (évaluée par les investigateurs) a été réalisée sans censurer les traitements hors protocole avant progression de la maladie. Les résultats de ces analyses étaient très similaires à ceux de la survie sans progression du critère principal.", "truncated": false}, "after_length": 275, "after_sha256": "41d6b7eb5fd3c3952b0880766e47b889b4b8bb1453f090aacb8691c3ea2b65c5", "annex": "I", "before": {"end": 275, "start": 0, "text": "Une analyse non stratifiée de la PFS (évaluée par les investigateurs) a été réalisée sans censurer les traitements hors protocole avant progression de la maladie. Les résultats de ces analyses étaient très similaires à ceux de la survie sans progression du critère principal.", "truncated": false}, "before_length": 275, "before_sha256": "0fa806eed98c4a6e1c9ef41e1617b1e0ded2ee457a7258fb01011e07ee58a41e", "change_kind": "content", "change_operations": [{"after_end": 35, "after_start": 33, "before_end": 33, "before_start": 33, "kind": "insert"}, {"after_end": 36, "after_start": 36, "before_end": 36, "before_start": 34, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b498d75c694dc1a16867acf4", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1457}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 14, "start": 0, "text": "Mundipharma AB", "truncated": false}, "before_length": 14, "before_sha256": "6cf8d25c6640dec825037c0530131ec0c883b9dff60d21efb53dd7e9d7f8c9d1", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b4c7605a1d78e35294ca4d9e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1154}
{"after": {"end": 97, "start": 0, "text": "le kétoconazole, le posaconazole, l’itraconazole, utilisés pour traiter des infections fongiques.", "truncated": false}, "after_length": 97, "after_sha256": "a94167610bc3b5f572ca235063f6e3ad8f8ba3b8cd0991e89bdc2a6bcb999ec9", "annex": "IIIA", "before": {"end": 80, "start": 0, "text": "des infections fongiques comme le kétoconazole, le posaconazole, l’itraconazole.", "truncated": false}, "before_length": 80, "before_sha256": "1e6739885a5088453c57a13b4d76d86926fd193c092dd939ff746f6bdc279fde", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 31, "before_start": 0, "kind": "delete"}, {"after_end": 96, "after_start": 48, "before_end": 79, "before_start": 79, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 31, "chars_inserted": 48}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b4c76a7166f408d92555e85a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2857}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 15, "start": 0, "text": "Mundipharma A/S", "truncated": false}, "before_length": 15, "before_sha256": "7e6d90255964287fd1353c1e83065108e556222b86a42d15fa103f15e7a960cf", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 15, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 15, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b4d9fff840daa6b1230138a0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1043}
{"after": {"end": 57, "start": 0, "text": "ciclosporin, to prevent rejection of transplanted organs.", "truncated": false}, "after_length": 57, "after_sha256": "1b858c8c9d864d5e6d9e84c3f129509cb9d49327e4ba2105b189a3f3772c037b", "annex": "IIIA", "before": {"end": 64, "start": 0, "text": "preventing rejection of transplanted organs such as ciclosporin.", "truncated": false}, "before_length": 64, "before_sha256": "e1aa0190f123ffdd65a9578c00537d3cac3b18ee3f16dcee643c6a902d1f2003", "change_kind": "content", "change_operations": [{"after_end": 16, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}, {"after_end": 23, "after_start": 23, "before_end": 10, "before_start": 7, "kind": "delete"}, {"after_end": 56, "after_start": 56, "before_end": 63, "before_start": 43, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 23, "chars_inserted": 16}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b55af171569f7216d2a746e1", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3207}
{"after": {"end": 20, "start": 0, "text": "Tlf. +45 45 17 48 00", "truncated": false}, "after_length": 20, "after_sha256": "67b288680491a1d528179a2d435c44abca139afef48fda220fd7248c69d054e7", "annex": "IIIA", "before": {"end": 16, "start": 0, "text": "Tlf. 45 17 48 00", "truncated": false}, "before_length": 16, "before_sha256": "2c753979d855ade591464b5a15bb9d48b8bd926cbc650fac958308a656578a91", "change_kind": "content", "change_operations": [{"after_end": 9, "after_start": 5, "before_end": 5, "before_start": 5, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b59da5147b06eb984353950b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1028}
{"after": {"end": 20, "start": 0, "text": "Tlf.: +45 44 201 100", "truncated": false}, "after_length": 20, "after_sha256": "a342c892cb893e888e9b98929ab7ba413528a3b19847cefc774fcc7b2c91291e", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "Tlf: +45 44 201 100", "truncated": false}, "before_length": 19, "before_sha256": "c639c1fe70f9701d8cecb70d89ff79995abd4e41911073143438fc69a41a0363", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b5bdc24d161c1ffdcb33e18e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9928}
{"after": {"end": 16, "start": 0, "text": "Belgique/Belgien", "truncated": false}, "after_length": 16, "after_sha256": "285fbbb0fb545626c1ab2137e927e36673874e494048cabaa6015adaed72c06a", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 16, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 16}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b604c021b698568349a603a4", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000112", "medicine_name": "Twinrix Adult", "medicine_slug": "twinrix-adult", "observed_at": "2026-10-12T13:29:23Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "cfad5fb0086c9b5d6a36b454f3f546373def1f56cded73e0652b498d02d68e41", "source_snapshot_id": "source-17627897b0874bf1160c7372", "source_updated_at": "2026-08-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/twinrix-adult-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 922}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "II", "before": {"end": 16, "start": 0, "text": "F-21800 Quétigny", "truncated": false}, "before_length": 16, "before_sha256": "e393247770ad1ee36b125cf979b9ce2c2d14084175a073225284f9650aa5bca6", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 16, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 16, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b6963e65f8a9547317573643", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000174", "medicine_name": "Plavix", "medicine_slug": "plavix", "observed_at": "2026-10-12T19:27:50Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "3818c2e3c9979bf5f8be3f164dfce187fccfccf62bbd1e3227c64ca7c00ad02f", "source_snapshot_id": "source-4aff1b64c7cf58337d33ecfa", "source_updated_at": "2025-07-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/plavix-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 789}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Tel: +353 1 206 3800", "truncated": false}, "before_length": 20, "before_sha256": "b76fef5190d612d91d8ee1c3f52c40e30fcc7f25541faffe2a0c00e33c8cb7c1", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 20, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 20, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b6976587bb91d7ce3f3ee5b5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1134}
{"after": {"end": 222, "start": 0, "text": "If no liquid appears, repeat step G up to four times until some liquid appears at the needle tip. Do not repeat step G more than four times, but follow the instructions given under Troubleshooting section on the back page.", "truncated": false}, "after_length": 222, "after_sha256": "9ab5d403306e1c51bc0a50aea89645893fea06919722f5a821c58401ea37bb56", "annex": "IIIA", "before": {"end": 184, "start": 0, "text": "If no drops emerge, repeat step G until you see some drops. Do not repeat step G more than four times, but follow the instructions given under Troubleshooting section on the back page.", "truncated": false}, "before_length": 184, "before_sha256": "2c619f17dedd847faf57c6c875703937c7c6f44c39a5a4eaf013489315f5e783", "change_kind": "content", "change_operations": [{"after_end": 11, "after_start": 6, "before_end": 6, "before_start": 6, "kind": "insert"}, {"after_end": 18, "after_start": 12, "before_end": 7, "before_start": 7, "kind": "insert"}, {"after_end": 19, "after_start": 19, "before_end": 10, "before_start": 8, "kind": "delete"}, {"after_end": 20, "after_start": 20, "before_end": 18, "before_start": 11, "kind": "delete"}, {"after_end": 54, "after_start": 37, "before_end": 35, "before_start": 35, "kind": "insert"}, {"after_end": 58, "after_start": 58, "before_end": 47, "before_start": 39, "kind": "delete"}, {"after_end": 69, "after_start": 64, "before_end": 53, "before_start": 53, "kind": "insert"}, {"after_end": 76, "after_start": 70, "before_end": 54, "before_start": 54, "kind": "insert"}, {"after_end": 95, "after_start": 77, "before_end": 56, "before_start": 55, "kind": "replace"}, {"after_end": 96, "after_start": 96, "before_end": 58, "before_start": 57, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 19, "chars_inserted": 57}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b6a40e6abb1d03a4d5d41309", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2019}
{"after": {"end": 119, "start": 0, "text": "Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu", "truncated": false}, "after_length": 119, "after_sha256": "0f2b81ab8009e1a279ca008eb6e21bdb2e532de63aef52b62bdac980c49555d4", "annex": "IIIA", "before": {"end": 118, "start": 0, "text": "Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu", "truncated": false}, "before_length": 118, "before_sha256": "d114210a3c6f4b6710e22609ee80410ff17f5efd93b30ab72728a60b65635068", "change_kind": "technical", "change_operations": [{"after_end": 99, "after_start": 98, "before_end": 98, "before_start": 98, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b6fd9850b2c78d7c87014381", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12173}
{"after": {"end": 13, "start": 0, "text": "Hermeslaan 11", "truncated": false}, "after_length": 13, "after_sha256": "6426889eacea87c88f1e0405aad54515d8a889ca0f1b2ab39e2039040651e7d3", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "administrative", "change_operations": [{"after_end": 13, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 13}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b7195bfe1853915dfb9c37d5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004310", "medicine_name": "Daptomycin Hospira", "medicine_slug": "daptomycin-hospira", "observed_at": "2026-10-12T19:09:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "e544a64f1681af82ba143ddd0cfa7cca4ef0de691ed43076b92bb75f66ec7f7b", "source_snapshot_id": "source-a214fce23bf43c3222026b3d", "source_updated_at": "2025-09-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/daptomycin-hospira-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2000}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "Tel: +386 158969 00", "truncated": false}, "before_length": 19, "before_sha256": "4cd23e9bc09f4d7f9f6c0d56d2ed6523e2e88ecb6a8bb6fc53cde3b5c9caec06", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 19, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 19, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b76fe16871fa616528f5f806", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1127}
{"after": {"end": 46, "start": 0, "text": "Do not use this pen, contact customer service.", "truncated": false}, "after_length": 46, "after_sha256": "d0eef22a61843e8e1ba634fd308a0fab81f33e175e22fac3fb7bd5e32b6704d9", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Do not use this pen.", "truncated": false}, "before_length": 20, "before_sha256": "01b905053879eaea7fdc5aab942d257a461128b493d86ee78d47a1001b9513bf", "change_kind": "content", "change_operations": [{"after_end": 45, "after_start": 19, "before_end": 19, "before_start": 19, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 26}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b7c612a07b168b5f624e77a2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2144}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 18, "start": 0, "text": "organizační složka", "truncated": false}, "before_length": 18, "before_sha256": "ea36ce099264fdab294e69d74c985f3b15bc858dbf7ace60b68b6ec5844f892f", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 18, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 18, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b7ddfb2eba8730b355fe82e8", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1050}
{"after": {"end": 21, "start": 0, "text": "Block 2 Miesian Plaza", "truncated": false}, "after_length": 21, "after_sha256": "99b504ac4fff9020da29e00aeb786f0975177380626e2b3347bd3fbd75afeeba", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 21, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 21}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b7eec17252f21c49c38c224e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2184}
{"after": {"end": 13, "start": 0, "text": "1932 Zaventem", "truncated": false}, "after_length": 13, "after_sha256": "cffe4475a5de91da7a3a6363a4d41ccfd1405766d95ae182d89bf39b29686221", "annex": "IIIA", "before": {"end": 13, "start": 0, "text": "1930 Zaventem", "truncated": false}, "before_length": 13, "before_sha256": "ed9ea9385e3e50f6278214da5d7483a8543c36d1261df263d35022c5936c74db", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 4, "before_start": 3, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b8073165cbd70a0b5a292f6f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004310", "medicine_name": "Daptomycin Hospira", "medicine_slug": "daptomycin-hospira", "observed_at": "2026-10-12T19:09:33Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3242bb93d94dc3b7e86b89af5160c6986e8caa2e4f8d73bf8a634a557420452a", "source_snapshot_id": "source-dd7a18b7c210239223fa10ad", "source_updated_at": "2025-09-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/daptomycin-hospira-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1591}
{"after": {"end": 257, "start": 0, "text": "Update of section 4.4 of the SmPC to amend the current warning regarding Psychiatric disorders and update of section 4.8 of the SmPC to add the adverse reactions anxiety and mood altered with a frequency uncommon. The Package leaflet is updated accordingly.", "truncated": false}, "after_length": 257, "after_sha256": "7f72633932e6dbc57635d8eccbd0d64d9ba4785ca3f96303ba1a660ce1d36113", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 257, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 257}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b8134421dc86d5c91dc8b647", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:30Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "35ab6716aa09492c14ac6849111486ec47235c0bc65ef055350de950f316c5e6", "source_snapshot_id": "source-f20a60110d1f8fef5225317d", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2345}
{"after": {"end": 19, "start": 0, "text": "hungary_msd@msd.com", "truncated": false}, "after_length": 19, "after_sha256": "4ffcdd5eaf215819b6063b291e957577af48205584cf794ece9fd17a4802c6e1", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "hungary_msd@merck.com", "truncated": false}, "before_length": 21, "before_sha256": "da92e6e80d6625405a462b85c1135580d63c6c4a9e76a7c5be0eef07e90aee85", "change_kind": "content", "change_operations": [{"after_end": 15, "after_start": 13, "before_end": 17, "before_start": 13, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b8152088072cd541669f1464", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3086}
{"after": {"end": 222, "start": 0, "text": "SARSCoV2 LP.8.1 mRNA is a single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2 (LP.8.1).", "truncated": false}, "after_length": 222, "after_sha256": "34702b06ced8532f02c99c53ba6f0d9246957c70857b7198ecc1a68c44cdf2f6", "annex": "I", "before": {"end": 218, "start": 0, "text": "SARSCoV2 JN.1 mRNA is a single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2 (JN.1).", "truncated": false}, "before_length": 218, "before_sha256": "0d381fc8903b4f22dddd09d2a5acd3deafe7e871d820987d8fd1c338bc0022f8", "change_kind": "administrative", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}, {"after_end": 218, "after_start": 214, "before_end": 214, "before_start": 212, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b824dcc011611fa178cda0c1", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12869}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "• a compatible pen needle", "truncated": false}, "before_length": 25, "before_sha256": "18085f47cf798ee6c653801d669468dcd807cc02d0661d672ac7e33ef4bdcb60", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 25, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 25, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b82a8ca0bf1e047e2f4b05e9", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2032}
{"after": {"end": 41, "start": 0, "text": "GlaxoSmithKline Pharmaceuticals s.a./n.v.", "truncated": false}, "after_length": 41, "after_sha256": "78a50ede7f6f749aad8e46d5c904e76d599a24803810e6aa82ac2a4623d14d3b", "annex": "IIIA", "before": {"end": 37, "start": 0, "text": "GlaxoSmithKline Pharmaceuticals SA/NV", "truncated": false}, "before_length": 37, "before_sha256": "76a8c323880ceb0f3084587deeb6993db7df1bb7006480e529e3b2bdcc2fb11c", "change_kind": "content", "change_operations": [{"after_end": 36, "after_start": 32, "before_end": 34, "before_start": 32, "kind": "replace"}, {"after_end": 41, "after_start": 37, "before_end": 37, "before_start": 35, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b879bd8cb33d9951f5e6dc0a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000112", "medicine_name": "Twinrix Adult", "medicine_slug": "twinrix-adult", "observed_at": "2026-10-12T13:29:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "bc8ba3adecfe04d3079e5b502251cec982d6197257fe3b7ec3a22dc5f2ace654", "source_snapshot_id": "source-8439a1a319b62d1bd67256a4", "source_updated_at": "2026-08-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/twinrix-adult-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 879}
{"after": {"end": 20, "start": 0, "text": "dpoc_austria@msd.com", "truncated": false}, "after_length": 20, "after_sha256": "fffcced0c5785d318bead68b726572c8df5f6a7f283341dbbaa2c0e000b9f45e", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "dpoc_austria@merck.com", "truncated": false}, "before_length": 22, "before_sha256": "24a76a21b822b2b605efa994eaf3b0998f214621c2a7d0ab97cd100c212f6bc9", "change_kind": "content", "change_operations": [{"after_end": 16, "after_start": 14, "before_end": 18, "before_start": 14, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b881371e121991f2f7e90a87", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3039}
{"after": {"end": 13, "start": 0, "text": "1 Terrosa Pen", "truncated": false}, "after_length": 13, "after_sha256": "d3cea9978d0e4145df170a7cae0e0f9786a8b65b1978c54e74ecfc91fb3782d9", "annex": "IIIA", "before": {"end": 15, "start": 0, "text": "1 stylo Terrosa", "truncated": false}, "before_length": 15, "before_sha256": "e4868bbc85be6a5b5131db298941f01b1a3ea9a668cdd04162cda3b26cda76fb", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 2, "before_end": 8, "before_start": 2, "kind": "delete"}, {"after_end": 13, "after_start": 9, "before_end": 15, "before_start": 15, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b88e91e5ecc55a650e1dc8ba", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1257}
{"after": {"end": 3, "start": 0, "text": "0,6", "truncated": false}, "after_length": 3, "after_sha256": "272f4c9ea6eecffeb390b073584702240b57abe97f30d1ef36fd641c63e623b8", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 3, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 3}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b8a8321c65dce80837f1a4bc", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:18Z", "pipeline_version": "2.0.0", "presentation_label": "IMJUDO 20 mg/ml, solution à diluer pour perfusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "2437ab76633f46c9eee5e002e5c7a7caba6367f59567d750be0eb67c74d1db4e", "source_snapshot_id": "source-7f4d129b0a0fd2d3684d27c5", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 835}
{"after": {"end": 40, "start": 0, "text": "If you take more Adempas than you should", "truncated": false}, "after_length": 40, "after_sha256": "b7521df8470f1763894cb0771d6e79055cdca29105020e0d666125d172aa283b", "annex": "IIIA", "before": {"end": 39, "start": 0, "text": "If you use more Adempas than you should", "truncated": false}, "before_length": 39, "before_sha256": "038cc403c51c3cf7e271c8d3866d67cb3551f69ae89332e0cc532f7bf5ba6542", "change_kind": "content", "change_operations": [{"after_end": 10, "after_start": 7, "before_end": 9, "before_start": 7, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 3}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b8bd60a25fdc97c1cfa78a97", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3270}
{"after": {"end": 17, "start": 0, "text": "msdpolska@msd.com", "truncated": false}, "after_length": 17, "after_sha256": "1b250a519a0f233f4e354eb6c7114ba65293ff16c0041901602d11e2c6c3498c", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "msdpolska@merck.com", "truncated": false}, "before_length": 19, "before_sha256": "5690867ba2de57367aef5787dfb5119647492569c1acc32aee4d6aec5daced2d", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 11, "before_end": 15, "before_start": 11, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b8d24f86cecee5554989ab87", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3136}
{"after": {"end": 310, "start": 0, "text": "Le titulaire de l’autorisation de mise sur le marché veille à ce que, dans chaque État membre où l’etanercept est commercialisé, tous les professionnels de santé qui sont censés prescrire l’etanercept et tous les patients qui sont censés l’utiliser aient accès aumatériel éducationnel suivant ou le reçoivent :", "truncated": false}, "after_length": 310, "after_sha256": "a92b5ac8844164a537bdc7e75097e0015c1e6bb568918105f975d054dd01e5ab", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "administrative", "change_operations": [{"after_end": 310, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 310}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b8e2ecccda1467017692ac4b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6657}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 18, "start": 0, "text": "medis.hu@medis.com", "truncated": false}, "before_length": 18, "before_sha256": "cef2304db43cba5f54fe3172d255c50ce282b9e19214c53b510003d3b94a344d", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 18, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 18, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b8e64f4246e1c37c7a1d1431", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1056}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Tel: +353 1 206 3800", "truncated": false}, "before_length": 20, "before_sha256": "b76fef5190d612d91d8ee1c3f52c40e30fcc7f25541faffe2a0c00e33c8cb7c1", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 20, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 20, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b8ecde0ba3dccc8574cdb4a1", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1065}
{"after": {"end": 33, "start": 0, "text": "Atteinte de la fonction cardiaque", "truncated": false}, "after_length": 33, "after_sha256": "7b5fa86ef708d55ad7bb042aaa1ceff318f67ef62b67a149cd2404ede5c7b4dd", "annex": "I", "before": {"end": 22, "start": 0, "text": "Insuffisance cardiaque", "truncated": false}, "before_length": 22, "before_sha256": "0daba53df1d834c99c85ada39650137d5bde6374cd9dcd2fa3308545480fc6cb", "change_kind": "content", "change_operations": [{"after_end": 5, "after_start": 0, "before_end": 1, "before_start": 0, "kind": "replace"}, {"after_end": 15, "after_start": 6, "before_end": 4, "before_start": 2, "kind": "replace"}, {"after_end": 17, "after_start": 16, "before_end": 9, "before_start": 5, "kind": "replace"}, {"after_end": 23, "after_start": 19, "before_end": 12, "before_start": 11, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 8, "chars_inserted": 19}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b913883cb0c605e497f93d51", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002640", "medicine_name": "Cometriq", "medicine_slug": "cometriq", "observed_at": "2026-10-12T19:00:55Z", "pipeline_version": "2.0.0", "presentation_label": "COMETRIQ 20 mg, gélules COMETRIQ 80 mg, gélules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "c7f8aa8da9127064263770c4aed5506128bacd0c40693b863c48a757d735203e", "source_snapshot_id": "source-e4fa0b9c95a2e427d4c95a33", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/cometriq-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 102}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "Tel: +44 (0)1304 616161", "truncated": false}, "before_length": 23, "before_sha256": "eba81e6ccdbae471c024a5ba77d9ec9e0617a3c443fd22205a626861e87fbd8c", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 23, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 23, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b94ff98fa9cb8fe17bee98e1", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 10166}
{"after": {"end": 141, "start": 0, "text": "Utilisez votre Terrosa Pen uniquement de la manière prescrite par votre médecin, dans ces instructions d’utilisation et la notice de Terrosa.", "truncated": false}, "after_length": 141, "after_sha256": "f0b5b17e12d77b80631592bd3c22a3e83bcc4c582636f6042d3a2c93d4d51756", "annex": "IIIA", "before": {"end": 143, "start": 0, "text": "Utilisez votre stylo Terrosa uniquement de la manière prescrite par votre médecin, dans ces instructions d’utilisation et la notice de Terrosa.", "truncated": false}, "before_length": 143, "before_sha256": "b48bf2a5f76a4e1f41a78f7809ff172f89823cbcc35cfbaa081ed209ec33116b", "change_kind": "content", "change_operations": [{"after_end": 15, "after_start": 15, "before_end": 21, "before_start": 15, "kind": "delete"}, {"after_end": 26, "after_start": 22, "before_end": 28, "before_start": 28, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b95123dae0dbed9757319555", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2082}
{"after": {"end": 19, "start": 0, "text": "Tel: +46 77 5700488", "truncated": false}, "after_length": 19, "after_sha256": "a968f6c96e435fb9594d06eee9f260814621b5e791fe61e1569bed42d6c801a6", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Tel: + 46 77 5700488", "truncated": false}, "before_length": 20, "before_sha256": "cb17614fcd82c944ba52cdd6413741cfa9e5ecd4d08eb5b092e244324255c763", "change_kind": "content", "change_operations": [{"after_end": 6, "after_start": 6, "before_end": 7, "before_start": 6, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b95beb22ec13080a021f96f0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3507}
{"after": {"end": 129, "start": 0, "text": "Après examen de la recommandation du PRAC, le CHMP approuve les conclusions générales du PRAC et les motifs de sa recommandation.", "truncated": false}, "after_length": 129, "after_sha256": "7f742dd4d84dfcd3eaee344b865d2447706c76828f7b7aeaa1db7fa5791f3aec", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 129, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 129}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b9ac5b1127d45e6ccee0c030", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "9ac80b0d56ebad4970f7a8335a177613af59ef25517bcd0bdd3397c207cc1bac", "source_snapshot_id": "source-c11aa9e32420f125a88005bc", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2744}
{"after": {"end": 64, "start": 0, "text": "Medicines whose effect may be influenced by Adempas, for example", "truncated": false}, "after_length": 64, "after_sha256": "90dc9243508ce89b284a6623436aa075942531b30e3ad5b57483c0d37793a92f", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 64, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 64}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b9e07d8534ef326cf78132b4", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2786}
{"after": {"end": 19, "start": 0, "text": "Sími: +354 535 7000", "truncated": false}, "after_length": 19, "after_sha256": "4147b258aaf4f6d0d9b2ae441e0fa1eb5f0dadfd4e4fea070a7673c7133bf389", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Sími: + 354 535 7000", "truncated": false}, "before_length": 20, "before_sha256": "66fcdd056ccfbc5ba6d0c26580292977898106c90655c78208bc87c3d941892c", "change_kind": "content", "change_operations": [{"after_end": 7, "after_start": 7, "before_end": 8, "before_start": 7, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-b9efb88e990331faa4bd276a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3483}
{"after": {"end": 20, "start": 0, "text": "Tlf: +47 32 20 73 00", "truncated": false}, "after_length": 20, "after_sha256": "554d3014d2516702d0c22a89fb65d9c24ed800d14c36df4bf39ee1ecab71c124", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tlf: + 47 32 20 73 00", "truncated": false}, "before_length": 21, "before_sha256": "e1f6d02c8ded918450f2e8f65b84556d21d9f9644984ce9e4a7da61d7a6ac88f", "change_kind": "content", "change_operations": [{"after_end": 6, "after_start": 6, "before_end": 7, "before_start": 6, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ba1906e3f9e9ee411c62c7cd", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3028}
{"after": {"end": 54, "start": 0, "text": "avez des problèmes de cœur ou de circulation sanguine,", "truncated": false}, "after_length": 54, "after_sha256": "cb2948a430b907b03d9104fb709a2168eaa02f2070ccf548d45313da8426d8a9", "annex": "IIIA", "before": {"end": 54, "start": 0, "text": "avez des problèmes de cœur ou de circulation sanguine.", "truncated": false}, "before_length": 54, "before_sha256": "bed87af282a729f57dda47327904a64a8528f4232f26a866daa1dc534c043734", "change_kind": "content", "change_operations": [{"after_end": 54, "after_start": 53, "before_end": 54, "before_start": 53, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ba1b813c9d5d5db4dda15c3e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2829}
{"after": {"end": 50, "start": 0, "text": "90 mmHg ou plus si vous êtes âgé(e) de 6 à 11 ans,", "truncated": false}, "after_length": 50, "after_sha256": "a9f3b6467af9e2aab30a1084cc98d94f5ebeea71850ede435cc01512f254d0de", "annex": "IIIA", "before": {"end": 50, "start": 0, "text": "90 mmHg ou plus si vous êtes âgé(e) de 6 à 12 ans,", "truncated": false}, "before_length": 50, "before_sha256": "d95e47a2baf14015972b611c4461be7215d6834f07af7cba1327fdfd50cd5fdf", "change_kind": "content", "change_operations": [{"after_end": 45, "after_start": 44, "before_end": 45, "before_start": 44, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ba491441efd2103fb47c313e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3257}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 47, "start": 0, "text": "Les coordonnées du prescripteur de l’etanercept", "truncated": false}, "before_length": 47, "before_sha256": "df97d1eb078749427f0e076143a2c3e2700cf33c35d50a56405e972141a2371f", "change_kind": "unassigned", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 47, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 47, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ba63d19606a61e5c7989a57f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6670}
{"after": {"end": 1126, "start": 0, "text": "L'aprémilast est associé à une augmentation du risque d'affections psychiatriques telles que l’insomnie, l’anxiété, une humeur modifiée et la dépression. Depuis la commercialisation, la survenue d’idées et de comportements suicidaires, y compris de suicides, a été observée chez des patients présentant, ou non, des antécédents de dépression (voir rubrique 4.8). Les risques et bénéfices quant à l'instauration ou la poursuite du traitement par l’aprémilast doivent être attentivement évalués si les patients présentent des symptômes psychiatriques, ou des antécédents d'affections psychiatriques, ou s’ils sont traités de façon concomitante par des médicaments susceptibles de causer des événements psychiatriques. Les patients et soignants doivent être avertis du fait qu'ils doivent informer le médecin en cas d'idées suicidaires ou de tout changement de comportement ou d'humeur. Si les patients présentent de nouveaux symptômes psychiatriques, ou que des symptômes existants s'aggravent, ou si des idées suicidaires ou une tentative de suicide sont identifiées, il est recommandé d'arrêter le traitement par l’aprémilast.", "truncated": false}, "after_length": 1126, "after_sha256": "4a30fb4e4a4db9cf8bfdf7a28f4ceb5f2434e41d24f1ea4a7e3b6b5325fe13fd", "annex": "I", "before": {"end": 1094, "start": 0, "text": "L'aprémilast est associé à une augmentation du risque d'affections psychiatriques telles que l’insomnie et la dépression. Depuis la commercialisation, la survenue d’idées et de comportements suicidaires, y compris de suicides, a été observée chez des patients présentant, ou non, des antécédents de dépression (voir rubrique 4.8). Les risques et bénéfices quant à l'instauration ou la poursuite du traitement par l’aprémilast doivent être attentivement évalués si les patients présentent des symptômes psychiatriques, ou des antécédents d'affections psychiatriques, ou s’ils sont traités de façon concomitante par des médicaments susceptibles de causer des événements psychiatriques. Les patients et soignants doivent être avertis du fait qu'ils doivent informer le médecin en cas d'idées suicidaires ou de tout changement de comportement ou d'humeur. Si les patients présentent de nouveaux symptômes psychiatriques, ou que des symptômes existants s'aggravent, ou si des idées suicidaires ou une tentative de suicide sont identifiées, il est recommandé d'arrêter le traitement par l’aprémilast.", "truncated": false}, "before_length": 1094, "before_sha256": "2c9802b7f2d4ed2010c6583b1525564c73837b74cca8e069d94734bed19181f0", "change_kind": "content", "change_operations": [{"after_end": 135, "after_start": 103, "before_end": 103, "before_start": 103, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 32}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ba7fbcf8a64e776014b97850", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:31Z", "pipeline_version": "2.0.0", "presentation_label": "Otezla 10 mg comprimés pelliculés Otezla 20 mg comprimés pelliculés Otezla 30 mg comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "9ac80b0d56ebad4970f7a8335a177613af59ef25517bcd0bdd3397c207cc1bac", "source_snapshot_id": "source-c11aa9e32420f125a88005bc", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 231}
{"after": {"end": 2, "start": 0, "text": "SC", "truncated": false}, "after_length": 2, "after_sha256": "32da6721804f1dd3226c0551970304ebf1059ec19a27451426541027861c9388", "annex": "IIIA", "before": {"end": 17, "start": 0, "text": "Voie sous-cutanée", "truncated": false}, "before_length": 17, "before_sha256": "2c39e73e194fa4f0fa51aa54d98a94765b3fcf21e9faf5848d5728b740ab316d", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 0, "before_end": 17, "before_start": 0, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 17, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-bab04e24982612c00dce0f37", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 7713}
{"after": {"end": 20, "start": 0, "text": "Tlf.: +45 44 201 100", "truncated": false}, "after_length": 20, "after_sha256": "a342c892cb893e888e9b98929ab7ba413528a3b19847cefc774fcc7b2c91291e", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "Tlf: +45 44 201 100", "truncated": false}, "before_length": 19, "before_sha256": "c639c1fe70f9701d8cecb70d89ff79995abd4e41911073143438fc69a41a0363", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-bae437d8c474527585e8b8ba", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 8429}
{"after": {"end": 138, "start": 0, "text": "The following adverse reactions should be added under the SOC ‘Psychiatric disorders’ with a frequency uncommon: anxiety and mood altered.", "truncated": false}, "after_length": 138, "after_sha256": "eba8e53ef8fb354ee995bd16bbf3866829eb1c19c375ae95146a97f6aef26999", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 138, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 138}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-bb2847226a6d677cf6faa92f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:30Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "35ab6716aa09492c14ac6849111486ec47235c0bc65ef055350de950f316c5e6", "source_snapshot_id": "source-f20a60110d1f8fef5225317d", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2361}
{"after": {"end": 25, "start": 0, "text": "Tél: +33 (0)1 80 46 40 40", "truncated": false}, "after_length": 25, "after_sha256": "8039903c80fe171d38545fabfbccd20dc939429edfd9799a4e988d97cb003cb2", "annex": "IIIA", "before": {"end": 43, "start": 0, "text": "Information médicale : +33 (01) 80 46 40 40", "truncated": false}, "before_length": 43, "before_sha256": "df678051bfcb8012d45176bb2f3c160f423b0fbd10cd5eecb1351ab1554f5987", "change_kind": "content", "change_operations": [{"after_end": 1, "after_start": 0, "before_end": 13, "before_start": 0, "kind": "replace"}, {"after_end": 2, "after_start": 2, "before_end": 18, "before_start": 14, "kind": "delete"}, {"after_end": 3, "after_start": 3, "before_end": 21, "before_start": 19, "kind": "delete"}, {"after_end": 12, "after_start": 11, "before_end": 29, "before_start": 29, "kind": "insert"}, {"after_end": 13, "after_start": 13, "before_end": 31, "before_start": 30, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 20, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-bb38be8d2b3af079e24d7598", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3550}
{"after": {"end": 23, "start": 0, "text": "Tél/Tel: +32(0)27766211", "truncated": false}, "after_length": 23, "after_sha256": "310414d79c9777caccca375508ba76843df9171e9155179f4e97323d11721dd0", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "Tel/Tél: +32(0)27766211", "truncated": false}, "before_length": 23, "before_sha256": "82d40bdddb183e889f9263d7731dc3a0880c8dc29905ebd8ad88a6249c7e7dba", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 1, "before_end": 2, "before_start": 1, "kind": "replace"}, {"after_end": 6, "after_start": 5, "before_end": 6, "before_start": 5, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-bb5173c516f6a47334295b22", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3075}
{"after": {"end": 232, "start": 0, "text": "Des analyses de la SSP en sous-groupe, par stade de la maladie et statut de l’exérèse, sont résumées dans le Tableau 19. Ces résultats démontrent une robustesse de l’analyse primaire de la SSP telle que présentée dans le Tableau 18.", "truncated": false}, "after_length": 232, "after_sha256": "08f6fa3dc69d53681a8a3e6c6e5f1a092ee113ee517b6d364a47ea9780b01177", "annex": "I", "before": {"end": 232, "start": 0, "text": "Des analyses de la PFS en sous-groupe, par stade de la maladie et statut de l’exérèse, sont résumées dans le Tableau 19. Ces résultats démontrent une robustesse de l’analyse primaire de la PFS telle que présentée dans le Tableau 18.", "truncated": false}, "before_length": 232, "before_sha256": "c668aecdc3ecaade54bdb30bb58876fb8f90d572b02efe1ba23522ce68920361", "change_kind": "content", "change_operations": [{"after_end": 21, "after_start": 19, "before_end": 19, "before_start": 19, "kind": "insert"}, {"after_end": 22, "after_start": 22, "before_end": 22, "before_start": 20, "kind": "delete"}, {"after_end": 191, "after_start": 189, "before_end": 189, "before_start": 189, "kind": "insert"}, {"after_end": 192, "after_start": 192, "before_end": 192, "before_start": 190, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-bb77f8158d48e397b0c13f47", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1908}
{"after": {"end": 66, "start": 0, "text": "Do not remove your Cartridge needle cap until instructed to do so.", "truncated": false}, "after_length": 66, "after_sha256": "5f44ff5490f870fad33f2b50b532b02a5e5205ddaf7d4ee09777ad6f91bdcde2", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 66, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 66}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-bb7f6a8b874f2bd272169dc7", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12193}
{"after": {"end": 31, "start": 0, "text": "Survie sans progression (SSP) 1", "truncated": false}, "after_length": 31, "after_sha256": "e419a0ec99784082db7b9bb628238e9071e65c7b8d6460057d832981835c9fec", "annex": "I", "before": {"end": 31, "start": 0, "text": "Survie sans progression (PFS) 1", "truncated": false}, "before_length": 31, "before_sha256": "e6f901163b89b3c511f2316a990359470b2775e61f2107db1a4cc7883381fe74", "change_kind": "content", "change_operations": [{"after_end": 27, "after_start": 25, "before_end": 25, "before_start": 25, "kind": "insert"}, {"after_end": 28, "after_start": 28, "before_end": 28, "before_start": 26, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-bbd572fb7e424c50082c8e60", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1723}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 11, "start": 0, "text": "Pack sizes:", "truncated": false}, "before_length": 11, "before_sha256": "07375f0ab9b15bd634c57af28cbd49f2c87f26ea59100ce8f19efd4876374f96", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 11, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 11, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-bbda2e2c95b8d31c4d1a12d2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12885}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 7, "start": 0, "text": "Latvija", "truncated": false}, "before_length": 7, "before_sha256": "50b862d01712827e01a8c925a1ee290539baab7a60d18941f764c691cee16618", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 7, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-bbea954ffb290232ec2efaaa", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1158}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 41, "start": 0, "text": "Mundipharma Corporation (Ireland) Limited", "truncated": false}, "before_length": 41, "before_sha256": "1508b8eae555a7f920ad3f9f7dc0b3f86d6bca3f7a3f44b91a1699e58db6295c", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 41, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 41, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-bbeb364e6f9367438e2f86e8", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1047}
{"after": {"end": 33, "start": 0, "text": "Table 2. Spikevax LP.8.1 posology", "truncated": false}, "after_length": 33, "after_sha256": "f76fb267ecb1b7a3b032c4f09ff5a2bfad4e88d01ec0d0d69f62e780b6e4f354", "annex": "I", "before": {"end": 31, "start": 0, "text": "Table 2. Spikevax JN.1 posology", "truncated": false}, "before_length": 31, "before_sha256": "a1fdf55b52ee5f5445f56b07b34957bc6fbe65160eda8908909d19010c3936b2", "change_kind": "content", "change_operations": [{"after_end": 22, "after_start": 18, "before_end": 20, "before_start": 18, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-bc0762549291111e36ca2f30", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5468}
{"after": {"end": 106, "start": 0, "text": "• votre Terrosa Pen et une nouvelle cartouche Terrosa/votre Terrosa Pen avec une cartouche Terrosa insérée", "truncated": false}, "after_length": 106, "after_sha256": "d150e076bfb446e289cff4bd90f6cc2199670de621a9b5e70e3102a56ae4d01b", "annex": "IIIA", "before": {"end": 110, "start": 0, "text": "• votre stylo Terrosa et une nouvelle cartouche Terrosa/votre stylo Terrosa avec une cartouche Terrosa insérée", "truncated": false}, "before_length": 110, "before_sha256": "ad488696d61d0950bcc37fcdfaaff68194b5caad18a6b5fe6aababb36faad2c6", "change_kind": "content", "change_operations": [{"after_end": 8, "after_start": 8, "before_end": 14, "before_start": 8, "kind": "delete"}, {"after_end": 19, "after_start": 15, "before_end": 21, "before_start": 21, "kind": "insert"}, {"after_end": 60, "after_start": 60, "before_end": 68, "before_start": 62, "kind": "delete"}, {"after_end": 71, "after_start": 67, "before_end": 75, "before_start": 75, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 12, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-bc13046f87f640030a597661", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1955}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 119, "start": 0, "text": "For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:", "truncated": false}, "before_length": 119, "before_sha256": "96e8e519927e4ccd767c33018abc0bb77c29439563f16049ac8a6e6cef005737", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 119, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 119, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-bc160c8f20acac0a5023720b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1012}
{"after": {"end": 24, "start": 0, "text": "dpoc_czechslovak@msd.com", "truncated": false}, "after_length": 24, "after_sha256": "337ee03ecaecb8e917a1c5d342c556aebf19918c2dc3ac63cf08adeafa748373", "annex": "IIIA", "before": {"end": 26, "start": 0, "text": "dpoc_czechslovak@merck.com", "truncated": false}, "before_length": 26, "before_sha256": "a4642d78bee1d644f5eed542e84f756d52a7869d19900b6efa351b35ef1062c2", "change_kind": "content", "change_operations": [{"after_end": 20, "after_start": 18, "before_end": 22, "before_start": 18, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-bc21bddeca880fb05af1eac1", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3395}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 5, "start": 0, "text": "Malta", "truncated": false}, "before_length": 5, "before_sha256": "71e9eb10755c8232974d186a560f7658a1ccbdd3097877dfa1ad3436af90d46a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 5, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 5, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-bc49c0c6132243682fc789b9", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1063}
{"after": {"end": 76, "start": 0, "text": "Motifs de la modification des termes des autorisations de mise sur le marché", "truncated": false}, "after_length": 76, "after_sha256": "b8904e769d0eef449c6beb8fcd3a2f01b60b7adc8e52435aff32eb2da2d61795", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 76, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 76}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-bc75bf78b91d5fee91deb34a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3406}
{"after": {"end": 76, "start": 0, "text": "Spikevax LP.8.1 should be administered by a trained healthcare professional.", "truncated": false}, "after_length": 76, "after_sha256": "bc5705c6d71222acd314f08cba983ef323cb281a3760a7e893abc7a34aa30f07", "annex": "I", "before": {"end": 74, "start": 0, "text": "Spikevax JN.1 should be administered by a trained healthcare professional.", "truncated": false}, "before_length": 74, "before_sha256": "78156f669ccae840560b80e37952f39f3bf5b107b6063f712249e2d06460bd35", "change_kind": "administrative", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-bca113b088a174aeb99dfdbd", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13028}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 14, "start": 0, "text": "Pfizer Limited", "truncated": false}, "before_length": 14, "before_sha256": "faadd350d247ecbb0e8edac0805fa3d4cdbf449fbb9a1a9614eee6624274a2f6", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-bcb0910eeaedb1472c736251", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11174}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 7, "start": 0, "text": "Germany", "truncated": false}, "before_length": 7, "before_sha256": "80db4ccdca106d37b920206331fcfe3e9e50a9e763d89b54ce3ad5ac8cf30f03", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 7, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-bcd9ba561d67e6b4610d334f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1714}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 26, "start": 0, "text": "Each vial contains 0.5 mL.", "truncated": false}, "before_length": 26, "before_sha256": "ff761ca1cf4f5d507f75b640bfdd37de1203fdc2385ef9179d1f7b2d508f9d49", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 26, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 26, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-bd4ad512ad1838e1227a6818", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.5", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6325}
{"after": {"end": 25, "start": 0, "text": "Tél: +33 (0)1 80 46 40 40", "truncated": false}, "after_length": 25, "after_sha256": "8039903c80fe171d38545fabfbccd20dc939429edfd9799a4e988d97cb003cb2", "annex": "IIIA", "before": {"end": 43, "start": 0, "text": "Information médicale : +33 (01) 80 46 40 40", "truncated": false}, "before_length": 43, "before_sha256": "df678051bfcb8012d45176bb2f3c160f423b0fbd10cd5eecb1351ab1554f5987", "change_kind": "content", "change_operations": [{"after_end": 1, "after_start": 0, "before_end": 13, "before_start": 0, "kind": "replace"}, {"after_end": 2, "after_start": 2, "before_end": 18, "before_start": 14, "kind": "delete"}, {"after_end": 3, "after_start": 3, "before_end": 21, "before_start": 19, "kind": "delete"}, {"after_end": 12, "after_start": 11, "before_end": 29, "before_start": 29, "kind": "insert"}, {"after_end": 13, "after_start": 13, "before_end": 31, "before_start": 30, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 20, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-bd9817e7203636a13c247db4", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3140}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "Tel: +44 (0)1304 616161", "truncated": false}, "before_length": 23, "before_sha256": "eba81e6ccdbae471c024a5ba77d9ec9e0617a3c443fd22205a626861e87fbd8c", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 23, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 23, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-bdde2165dff21edae7f222f5", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11616}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 114, "start": 0, "text": "erectile dysfunction such as sildenafil, tadalafil, vardenafil. Do not take these medicines together with Adempas.", "truncated": false}, "before_length": 114, "before_sha256": "5ba69ab6c42999b4230d535819f792de6116d4223c1fa84337d67919bead0dc1", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 114, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 114, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-bdde2aa36fd3953e75d36317", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3201}
{"after": {"end": 61, "start": 0, "text": "2. What you need to know before you are given Spikevax LP.8.1", "truncated": false}, "after_length": 61, "after_sha256": "cd457f13453b5d3a87adf48826cfe59280e506fbdda396edfdf16fc9a13c28f2", "annex": "I", "before": {"end": 59, "start": 0, "text": "2. What you need to know before you are given Spikevax JN.1", "truncated": false}, "before_length": 59, "before_sha256": "8419e6ddb3ee3676df5263149aef68a2957beab12729bfea3051045fc943165f", "change_kind": "administrative", "change_operations": [{"after_end": 59, "after_start": 55, "before_end": 57, "before_start": 55, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-bdf6dd907942f0ca6b83a800", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12616}
{"after": {"end": 4, "start": 0, "text": "1 ml", "truncated": false}, "after_length": 4, "after_sha256": "4103eeeca6e2548f11a7718ff403283afec588e4fb6e5622d0ed558b3d903b7b", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "1 ml water for injections", "truncated": false}, "before_length": 25, "before_sha256": "53bace9b82f7ee7e58335e0c77f95ec02d6803dc9840be083b8785c2b292d523", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 4, "before_end": 25, "before_start": 4, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 21, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-be814b897d305c19c4f0a50b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6999}
{"after": {"end": 243, "start": 0, "text": "Le critère principal était la survie sans progression (SSP), évaluée par les investigateurs selon RECIST 1.0 mis à jour. Les critères supplémentaires comprenaient la réponse objective, la durée de la réponse, la survie globale et la tolérance.", "truncated": false}, "after_length": 243, "after_sha256": "55e043042254a670922f3c75e0803108be91fff921e3aee54a8849678b98acb8", "annex": "I", "before": {"end": 243, "start": 0, "text": "Le critère principal était la survie sans progression (PFS), évaluée par les investigateurs selon RECIST 1.0 mis à jour. Les critères supplémentaires comprenaient la réponse objective, la durée de la réponse, la survie globale et la tolérance.", "truncated": false}, "before_length": 243, "before_sha256": "79a9deeaaf1368da2c4ae42b755db902a21d89477373aef2f0cbf52a87e8bd52", "change_kind": "content", "change_operations": [{"after_end": 57, "after_start": 55, "before_end": 55, "before_start": 55, "kind": "insert"}, {"after_end": 58, "after_start": 58, "before_end": 58, "before_start": 56, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-bead7fd112ba4d7ae3bfe146", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1970}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 17, "start": 0, "text": "Byk-Gulden-Str. 2", "truncated": false}, "before_length": 17, "before_sha256": "5dc95d013d793b6958719e5db82aa51cd0c1864e2e8bc9bfcf2cfded1a05eba6", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 17, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 17, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-bf17f023fcc39d1fa5515196", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1207}
{"after": {"end": 245, "start": 0, "text": "Sur la base des conclusions scientifiques relatives à bevacizumab, le CHMP estime que le rapport bénéfice-risque des médicaments contenant du bevacizumab demeure inchangé, sous réserve des modifications proposées des informations sur le produit.", "truncated": false}, "after_length": 245, "after_sha256": "dc77c1660fb88787a7a1eb4164974384cc7da3bcbc4c0d0db72f7a1833126aa7", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 245, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 245}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-bf70f7611e8365baf7d0993a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3408}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 150, "start": 0, "text": "One dose (0.5 mL) contains 50 micrograms of SARSCoV2 JN.1 mRNA, a COVID-19 mRNA Vaccine (nucleoside modified) (embedded in SM102 lipid nanoparticles).", "truncated": false}, "before_length": 150, "before_sha256": "5002274f8d3b4b236e71cf4c0912e38700fb96a5b72356174022c45feb63f4e6", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 150, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 150, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-bfe734a97ddaab0d5fca6f60", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12859}
{"after": {"end": 25, "start": 0, "text": "Tel: +49 (0)89 36044 8701", "truncated": false}, "after_length": 25, "after_sha256": "76a5baaa61395f016fced6d58ba2f7d813c34e258f9cb9ec8535af61c1b1aaf2", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "Tel: + 49 (0)89 360448701", "truncated": false}, "before_length": 25, "before_sha256": "2f356779a4495e7e76f16001e1d565254865df88ad1783cab9de20e20f154a8a", "change_kind": "content", "change_operations": [{"after_end": 6, "after_start": 6, "before_end": 7, "before_start": 6, "kind": "delete"}, {"after_end": 21, "after_start": 20, "before_end": 21, "before_start": 21, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c05cbd9055368878309fdd57", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000112", "medicine_name": "Twinrix Adult", "medicine_slug": "twinrix-adult", "observed_at": "2026-10-12T13:29:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "bc8ba3adecfe04d3079e5b502251cec982d6197257fe3b7ec3a22dc5f2ace654", "source_snapshot_id": "source-8439a1a319b62d1bd67256a4", "source_updated_at": "2026-08-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/twinrix-adult-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 914}
{"after": {"end": 30, "start": 0, "text": "Critère principal d’évaluation", "truncated": false}, "after_length": 30, "after_sha256": "3373edb2659568cb971a98b7db33ed5cd595d251fed752d68070deb4bb505b64", "annex": "I", "before": {"end": 17, "start": 0, "text": "Critère principal", "truncated": false}, "before_length": 17, "before_sha256": "ea2563482c25678aad44a4c2940b0955b84d276182b52a7842254cdf24cf27c9", "change_kind": "content", "change_operations": [{"after_end": 30, "after_start": 17, "before_end": 17, "before_start": 17, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 13}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c067ca513589e4bb75ecd466", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2143}
{"after": {"end": 74, "start": 0, "text": "* Do not use the prefilled syringe to deliver a partial volume of 0.25 mL.", "truncated": false}, "after_length": 74, "after_sha256": "75e296bff3c238176d513ed450c19057750a20263b5a3152d3b7a7c0a0d4190e", "annex": "I", "before": {"end": 94, "start": 0, "text": "* Do not use the single-dose vial or prefilled syringe to deliver a partial volume of 0.25 mL.", "truncated": false}, "before_length": 94, "before_sha256": "34a3dd6a9a278560b1c455186ca0846462be29c70b70a4dd2f194f53b65e7df3", "change_kind": "administrative", "change_operations": [{"after_end": 17, "after_start": 17, "before_end": 37, "before_start": 17, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 20, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c0b31caa68b0b7f880ece667", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13230}
{"after": {"end": 20, "start": 0, "text": "Tel.: +36 1 888 5300", "truncated": false}, "after_length": 20, "after_sha256": "b83b25ec254a4166b3f210dedbd33d8e207b4ceaadec1095ccd49882767eb509", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tel.: + 36 1 888 5300", "truncated": false}, "before_length": 21, "before_sha256": "e840a2e7dcac912eac697222649c523cf85354b94f2ef4174a7e446b7bf36b6f", "change_kind": "content", "change_operations": [{"after_end": 7, "after_start": 7, "before_end": 8, "before_start": 7, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c10c102671a0f97e89ef4a07", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3495}
{"after": {"end": 602, "start": 0, "text": "L’etanercept est absorbé lentement depuis le site d’injection sous-cutanée, atteignant une concentration maximale environ 48 heures après administration unique. La biodisponibilité absolue est de 76 %. Avec deux doses par semaine, on peut s’attendre à ce que les concentrations à l’état d’équilibre représentent environ deux fois celles que l’on mesure après administration unique. Après l’administration unique par voie sous-cutanée de 25 mg d’Enbrel, la concentration sérique maximale moyenne observée chez les volontaires sains était de 1,65 0,66 g/mL, l’aire sous la courbe étant de 235 96,6 gh/mL.", "truncated": false}, "after_length": 602, "after_sha256": "6314a3bd2887cae2045cf42f95c84f67356ea2b9322450cf13aa4ed9554aeb12", "annex": "I", "before": {"end": 602, "start": 0, "text": "L’etanercept est absorbé lentement depuis le site d’injection sous-cutanée, atteignant une concentration maximale environ 48 heures après administration unique. La biodisponibilité absolue est de 76 %. Avec deux doses par semaine, on peut s’attendre à ce que les concentrations à l’état d’équilibre représentent environ deux fois celles que l’on mesure après administration unique. Après l’administration unique par voie sous-cutanée de 25 mg d’Enbrel, la concentration sérique maximale moyenne observée chez les volontaires sains était de 1,65 0,66 g/ml, l’aire sous la courbe étant de 235 96,6 gh/ml.", "truncated": false}, "before_length": 602, "before_sha256": "81e459b6de61f15e830aa6aeb2c4613af244d2ce10df117a49329704f0752546", "change_kind": "content", "change_operations": [{"after_end": 554, "after_start": 553, "before_end": 554, "before_start": 553, "kind": "replace"}, {"after_end": 601, "after_start": 600, "before_end": 601, "before_start": 600, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c13d3c762582183032c7208f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg poudre pour solution injectable", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1031}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IV", "before": {"end": 22, "start": 0, "text": "Scientific conclusions", "truncated": false}, "before_length": 22, "before_sha256": "48a176450b72da083aae0c461d4b9485bc052767229342ad7b9f3b91fb4b3641", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 22, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 22, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c14aeeaef97e4904ebe6bc51", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3423}
{"after": {"end": 41, "start": 0, "text": "GlaxoSmithKline Pharmaceuticals s.a./n.v.", "truncated": false}, "after_length": 41, "after_sha256": "78a50ede7f6f749aad8e46d5c904e76d599a24803810e6aa82ac2a4623d14d3b", "annex": "IIIA", "before": {"end": 37, "start": 0, "text": "GlaxoSmithKline Pharmaceuticals SA/NV", "truncated": false}, "before_length": 37, "before_sha256": "76a8c323880ceb0f3084587deeb6993db7df1bb7006480e529e3b2bdcc2fb11c", "change_kind": "content", "change_operations": [{"after_end": 36, "after_start": 32, "before_end": 34, "before_start": 32, "kind": "replace"}, {"after_end": 41, "after_start": 37, "before_end": 37, "before_start": 35, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c14b9636cbb0fb2473ad5211", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000112", "medicine_name": "Twinrix Adult", "medicine_slug": "twinrix-adult", "observed_at": "2026-10-12T13:29:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "bc8ba3adecfe04d3079e5b502251cec982d6197257fe3b7ec3a22dc5f2ace654", "source_snapshot_id": "source-8439a1a319b62d1bd67256a4", "source_updated_at": "2026-08-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/twinrix-adult-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 891}
{"after": {"end": 19, "start": 0, "text": "The Video includes:", "truncated": false}, "after_length": 19, "after_sha256": "2b50805cd102b41a18f508da77f490577943c44d48e0c808dc2912ae7a44e26a", "annex": "II", "before": {"end": 25, "start": 0, "text": "The Video should include:", "truncated": false}, "before_length": 25, "before_sha256": "e711050d01fec7b8839e9deaccc973021d578809337046ea59977dfcbb73f22a", "change_kind": "content", "change_operations": [{"after_end": 10, "after_start": 10, "before_end": 17, "before_start": 10, "kind": "delete"}, {"after_end": 18, "after_start": 17, "before_end": 24, "before_start": 24, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c169a6f170c623064c56d25f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:33Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "21d66bf1e9a74479f577de09da3cf8517d65c1ce1b1d8bbdfe4bc38f79410def", "source_snapshot_id": "source-2c39c998fdaf05159687c016", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 453}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IV", "before": {"end": 22, "start": 0, "text": "Scientific conclusions", "truncated": false}, "before_length": 22, "before_sha256": "48a176450b72da083aae0c461d4b9485bc052767229342ad7b9f3b91fb4b3641", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 22, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 22, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c1992814ae6add8d9999bedb", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2528}
{"after": {"end": 190, "start": 0, "text": "présentez une augmentation de la pression sanguine dans vos poumons associée à une formation de tissu cicatriciel dans les poumons de cause inconnue, appelée fibrose pulmonaire idiopathique.", "truncated": false}, "after_length": 190, "after_sha256": "2725c7a1fa7b8d8d0e2fe59929f41a8e67789773b186cdd7a2f71dc799e256a3", "annex": "IIIA", "before": {"end": 190, "start": 0, "text": "présentez une augmentation de la pression sanguine dans les poumons associée à une formation de tissu cicatriciel dans les poumons de cause inconnue, appelée fibrose pulmonaire idiopathique.", "truncated": false}, "before_length": 190, "before_sha256": "30dc9725bef1733632a0e70cb98dcb512d164bdd1f021e9088ce97fe170f3f2a", "change_kind": "content", "change_operations": [{"after_end": 58, "after_start": 56, "before_end": 58, "before_start": 56, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c19f442fd6549e31c549f78f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3259}
{"after": {"end": 31, "start": 0, "text": "5. How to store Spikevax LP.8.1", "truncated": false}, "after_length": 31, "after_sha256": "69d7031073c7cdc1f34f34230886d976eab1bf2748c5a9e7ad0fe3f5cc3f110f", "annex": "I", "before": {"end": 29, "start": 0, "text": "5. How to store Spikevax JN.1", "truncated": false}, "before_length": 29, "before_sha256": "782b9b49bf033b74025af660a19fd43f757e8f445d982877897cabbd93033f32", "change_kind": "administrative", "change_operations": [{"after_end": 29, "after_start": 25, "before_end": 27, "before_start": 25, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c1b55c5a8ad029d6045cd8d6", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12619}
{"after": {"end": 152, "start": 0, "text": "One dose (0.5 mL) contains 50 micrograms of SARSCoV2 LP.8.1 mRNA, a COVID-19 mRNA Vaccine (nucleoside modified) (embedded in SM102 lipid nanoparticles).", "truncated": false}, "after_length": 152, "after_sha256": "bc89e92bb9dc7a442ee1777369b6e3ed45b46bd4cebd14f5676463f54e37b043", "annex": "I", "before": {"end": 150, "start": 0, "text": "One dose (0.5 mL) contains 50 micrograms of SARSCoV2 JN.1 mRNA, a COVID-19 mRNA Vaccine (nucleoside modified) (embedded in SM102 lipid nanoparticles).", "truncated": false}, "before_length": 150, "before_sha256": "5002274f8d3b4b236e71cf4c0912e38700fb96a5b72356174022c45feb63f4e6", "change_kind": "administrative", "change_operations": [{"after_end": 57, "after_start": 53, "before_end": 55, "before_start": 53, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c1f790fd6549287624d16a22", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12867}
{"after": {"end": 6, "start": 0, "text": "9 (41)", "truncated": false}, "after_length": 6, "after_sha256": "661a4337da5a45b9124e2c8a883aa948806860c37388fe296424d58060cbe9f4", "annex": "I", "before": {"end": 6, "start": 0, "text": "7 (32)", "truncated": false}, "before_length": 6, "before_sha256": "5381cf2caeeb0c444d378826e402319e8afb7abc2f842250a25d2f9e776cc61e", "change_kind": "content", "change_operations": [{"after_end": 1, "after_start": 0, "before_end": 1, "before_start": 0, "kind": "replace"}, {"after_end": 5, "after_start": 3, "before_end": 5, "before_start": 3, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 3, "chars_inserted": 3}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c203cc477208b54ba1f1db79", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005352", "medicine_name": "Upstaza", "medicine_slug": "upstaza", "observed_at": "2026-10-12T13:36:09Z", "pipeline_version": "2.0.0", "presentation_label": "Upstaza 2,8 × 1011 génomes de vecteur (vg)/0,5 mL, solution pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "42d7861913c7c415a9acf1067eeb3f9f1287a4e4718affc1402af95754bd6fed", "source_snapshot_id": "source-1e1e567efddae34509b5de34", "source_updated_at": "2026-06-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/upstaza-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 347}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "Tel: + 370 68735006", "truncated": false}, "before_length": 19, "before_sha256": "0b71bb823ba1803c0344337fdda95e0fb541d57f42a05bdf33012e3406feabf1", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 19, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 19, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c20e6f2068f9ca6ec861894e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1150}
{"after": {"end": 505, "start": 0, "text": "Compte tenu des données disponibles concernant l’anxiété et une humeur modifiée issues des rapports spontanés, incluant dans certains cas une corrélation temporelle étroite et un déchallenge positif, et compte tenu du potentiel effet de classe, le PRAC considère qu’un lien de causalité entre l’aprémilast et ces effets indésirables est au moins une possibilité raisonnable. Le PRAC a conclu que les informations sur le produit des médicaments contenant l’aprémilast doivent être modifiées en conséquence.", "truncated": false}, "after_length": 505, "after_sha256": "d67999cadfaa6f6ca1052afbe3197d73f53689bb9ed9289f40bc95d6976573f5", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 505, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 505}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c22cbd2e4414c5eed890cded", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "9ac80b0d56ebad4970f7a8335a177613af59ef25517bcd0bdd3397c207cc1bac", "source_snapshot_id": "source-c11aa9e32420f125a88005bc", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2715}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 18, "start": 0, "text": "medis.ro@medis.com", "truncated": false}, "before_length": 18, "before_sha256": "10bcfb4a98edb8b9489af20261809c7c33f79ad3fed38294101e21ae5cfff776", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 18, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 18, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c248df644314ad107d28d158", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1114}
{"after": {"end": 75, "start": 0, "text": "Spikevax LP.8.1 50 micrograms dispersion for injection in prefilled syringe", "truncated": false}, "after_length": 75, "after_sha256": "b642f3a1efc0a8ed8ce0e5dd97a5f30427a98c8bf512813984ee7e9626347d6e", "annex": "IIIA", "before": {"end": 73, "start": 0, "text": "Spikevax JN.1 50 micrograms dispersion for injection in prefilled syringe", "truncated": false}, "before_length": 73, "before_sha256": "5150a8374dbe88d379a7e4130ac03fb7d42655ab8e494e1e9be5e8cd5d5f84c5", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c25c8a0ded9b3566e9df96c0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9200}
{"after": {"end": 242, "start": 0, "text": "Do not stop using this medicine without talking to your doctor first. If you stop taking this medicine, your disease may worsen. If you have not taken this medicine for 3 days or more, please tell your doctor before you start taking it again.", "truncated": false}, "after_length": 242, "after_sha256": "ddf9fcfda9b587e6cc7bedb21958bf1fed15f272fdb0f9396f91482530b594ac", "annex": "IIIA", "before": {"end": 245, "start": 0, "text": "Do not stop using this medicine without talking to your doctor first. If you stop to taking this medicine, your disease may worsen. If you have not taken this medicine for 3 days or more, please tell your doctor before you start taking it again.", "truncated": false}, "before_length": 245, "before_sha256": "9f33aa9623920ab3f900176e80fb0cc107a6f29d105f8fc1360ec2717bd11069", "change_kind": "content", "change_operations": [{"after_end": 83, "after_start": 83, "before_end": 86, "before_start": 83, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 3, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c27989ca9d010a4647378ac3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3277}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "infomed@mundipharma.fr", "truncated": false}, "before_length": 22, "before_sha256": "83463da2089fc71aeedc706e29f711dec2b50ebe78b9338f2858bff9317f376b", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 22, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 22, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c2a5babd59bdcf6957ca43bc", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1093}
{"after": {"end": 221, "start": 0, "text": "Please contact the doctor if you took more Adempas than you should and if you notice any side effects (see section 4). If your blood pressure drops (which can make you feel dizzy) you may need immediate medical attention.", "truncated": false}, "after_length": 221, "after_sha256": "f4a8426d399bf3ffca70f2e10352c1e3f8ce5a612b7906cb45619c7d96903d16", "annex": "IIIA", "before": {"end": 226, "start": 0, "text": "Please contact the doctor if you took more Adempas than you should and if you notice any side effects (see section 4). If your blood pressure drops (which can make you feel dizzy) then you may need immediate medical attention.", "truncated": false}, "before_length": 226, "before_sha256": "9490f7d05c262bf5e3373ae0f2741acad314b627264dcf553cc2fde62e47e706", "change_kind": "content", "change_operations": [{"after_end": 180, "after_start": 180, "before_end": 185, "before_start": 180, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 5, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c2ba1dee06ff3128fcd63300", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2844}
{"after": {"end": 35, "start": 0, "text": "Other medicines and Spikevax LP.8.1", "truncated": false}, "after_length": 35, "after_sha256": "24ab35532795a6ec9cac7c8680a68819da87b33c1fb4ce6cc98a42c7dbcf110a", "annex": "I", "before": {"end": 33, "start": 0, "text": "Other medicines and Spikevax JN.1", "truncated": false}, "before_length": 33, "before_sha256": "7e8ff28eba77465f199a91de056481275d48bf363a188d8d82248d79ca2cb601", "change_kind": "administrative", "change_operations": [{"after_end": 33, "after_start": 29, "before_end": 31, "before_start": 29, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c2da4c8039ea476e0573c30f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12669}
{"after": {"end": 13, "start": 0, "text": "Leusderend 16", "truncated": false}, "after_length": 13, "after_sha256": "af1e1fecef744f092123851cb8459b03d91077081e50b99a8caaeae83326dc44", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 13}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c2dcebbc81e896fdd5414244", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1023}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 12, "start": 0, "text": "15°C to 25°C", "truncated": false}, "before_length": 12, "before_sha256": "b57c2b618e71e3e42c038965c231cecdb8049c3d82d00aa02012ac70ea91f351", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 12, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 12, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c2febb2c6e4528028c96e9c9", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6400}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 81, "start": 0, "text": "the outer carton should have been marked with the new discard date at 2°C to 8°C.", "truncated": false}, "before_length": 81, "before_sha256": "a156a465c6d980d8654f2b0b1b7462dcda11501b80593373c3d931c36d4014ef", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 81, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 81, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c325cda4eb9181ac4b884aaa", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13105}
{"after": {"end": 1304, "start": 0, "text": "Elasomeran and elasomeran/imelasomeran both contain mRNA encapsulated in lipid nanoparticles. The mRNA encodes for the full-length SARS-CoV-2 spike protein modified with 2 proline substitutions within the heptad repeat 1 domain (S-2P) to stabilise the spike protein into a prefusion conformation. After intramuscular injection, cells at the injection site and the draining lymph nodes take up the lipid nanoparticle, effectively delivering the mRNA sequence into cells for translation into viral protein. The delivered mRNA does not enter the cellular nucleus or interact with the genome, is nonreplicating, and is expressed transiently mainly by dendritic cells and subcapsular sinus macrophages. The expressed, membrane-bound spike protein of SARS-CoV-2 is then recognised by immune cells as a foreign antigen. This elicits both T-cell and B-cell responses to generate neutralising antibodies, which may contribute to protection against COVID-19. The nucleoside-modified mRNA in elasomeran/davesomeran, andusomeran, SARSCoV2 JN.1 mRNA and SARSCoV2 LP.8.1 mRNA is formulated in lipid particles, which enable delivery of the nucleoside-modified mRNA into host cells to allow expression of the SARS-CoV-2 S antigen. The vaccine elicits an immune response to the S antigen, which protects against COVID-19.", "truncated": false}, "after_length": 1304, "after_sha256": "cfee14b4d19dc625296f3e1eca7b32f50d683cfc54d252361be112cf3d63a00f", "annex": "I", "before": {"end": 1282, "start": 0, "text": "Elasomeran and elasomeran/imelasomeran both contain mRNA encapsulated in lipid nanoparticles. The mRNA encodes for the full-length SARS-CoV-2 spike protein modified with 2 proline substitutions within the heptad repeat 1 domain (S-2P) to stabilise the spike protein into a prefusion conformation. After intramuscular injection, cells at the injection site and the draining lymph nodes take up the lipid nanoparticle, effectively delivering the mRNA sequence into cells for translation into viral protein. The delivered mRNA does not enter the cellular nucleus or interact with the genome, is nonreplicating, and is expressed transiently mainly by dendritic cells and subcapsular sinus macrophages. The expressed, membrane-bound spike protein of SARS-CoV-2 is then recognised by immune cells as a foreign antigen. This elicits both T-cell and B-cell responses to generate neutralising antibodies, which may contribute to protection against COVID-19. The nucleoside-modified mRNA in elasomeran/davesomeran, andusomeran and SARSCoV2 JN.1 mRNA is formulated in lipid particles, which enable delivery of the nucleoside-modified mRNA into host cells to allow expression of the SARS-CoV-2 S antigen. The vaccine elicits an immune response to the S antigen, which protects against COVID-19.", "truncated": false}, "before_length": 1282, "before_sha256": "0b4e4e6e44888a9d3df8a7fc1c8ba18d6246f9b95460bf52cd5de859f3470a65", "change_kind": "content", "change_operations": [{"after_end": 1036, "after_start": 1016, "before_end": 1016, "before_start": 1016, "kind": "insert"}, {"after_end": 1054, "after_start": 1050, "before_end": 1032, "before_start": 1030, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 24}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c33073b9b62c50b140402b83", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5837}
{"after": {"end": 82, "start": 0, "text": "Ne retirez pas le capuchon de l’aiguille de votre cartouche avant d’y être invité.", "truncated": false}, "after_length": 82, "after_sha256": "4efc275eff93858ba39b142bdc9148420570c9fb75ef5c58993a6ba93f94ff76", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 82, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 82}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c333414af0401df30867071f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11779}
{"after": {"end": 567, "start": 0, "text": "Le temps moyen pendant lequel des concentrations plasmatiques supérieures ou égales à la moitié de la Cmax sont maintenues, est plus long avec la voie nasale comparativement à la voie intramusculaire (intranasal, 2 mg, 1.27h, intramusculaire, 0.4 mg 1.09h). Une durée d'action plus longue avec la voie intra-nasale est peut donc être anticipée. Si la durée d’action de l’agoniste opioïde dépasse celui de la naloxone par voie intranasale, les effets de l’agoniste opioïde peuvent réapparaître, nécessitant une deuxième administration de naloxone par voie intranasale.", "truncated": false}, "after_length": 567, "after_sha256": "3305885843df928b0ac8bfcc70c075f23607e13366609897a84e6ae185729c4e", "annex": "I", "before": {"end": 562, "start": 0, "text": "Le temps moyen pendant lequel des concentrations plasmatiques supérieures ou égales à la moitié de la Cmax sont maintenues, est plus long avec la voie nasale comparativement à la voie intramusculaire (intranasal, 2 mg, 1.27h, intramusculaire, 0.4 mg 1.09h). Une durée d'action plus longue avec la voie intra-nasale est donc être anticipée. Si la durée d’action de l’agoniste opioïde dépasse celui de la naloxone par voie intranasale, les effets de l’agoniste opioïde peuvent réapparaître, nécessitant une deuxième administration de naloxone par voie intranasale.", "truncated": false}, "before_length": 562, "before_sha256": "45d64d92c40462d0430c916e22afe09c15ec193f41c4b4a8fb41a3c0b9ac43c5", "change_kind": "content", "change_operations": [{"after_end": 324, "after_start": 319, "before_end": 319, "before_start": 319, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 5}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c34e5df1abc85ea308a55189", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "Nyxoid 1,8 mg, solution pour pulvérisation nasale en récipient unidose", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 257}
{"after": {"end": 274, "start": 0, "text": "However, no effects on the breastfed newborn/infant are anticipated. Data from women who were breastfeeding after vaccination with Spikevax (original) have not shown a risk for adverse effects in breastfed newborns/infants. Spikevax LP.8.1 can be given during breastfeeding.", "truncated": false}, "after_length": 274, "after_sha256": "e9c124f9a222913e44d6bb373bb39f98d4ba43912c3e7ae5e73170010129d7b9", "annex": "I", "before": {"end": 272, "start": 0, "text": "However, no effects on the breastfed newborn/infant are anticipated. Data from women who were breastfeeding after vaccination with Spikevax (original) have not shown a risk for adverse effects in breastfed newborns/infants. Spikevax JN.1 can be given during breastfeeding.", "truncated": false}, "before_length": 272, "before_sha256": "642c6316a7e1a12ac3338885f29ea364fffaade093344d9663214acda8150577", "change_kind": "administrative", "change_operations": [{"after_end": 237, "after_start": 233, "before_end": 235, "before_start": 233, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c358539818da4adc835ba901", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12680}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 282, "start": 0, "text": "high blood pressure in lung arteries, as you must not take certain medicines such as sildenafil, tadalafil together with Adempas. Other medicines for high blood pressure in the lung arteries, such as bosentan and iloprost, can be used with Adempas, but you should inform the doctor.", "truncated": false}, "before_length": 282, "before_sha256": "bbe40912bf1c0a84c3bcac212ffb6c78e1f9c07955a98402cbdcdb35f9c48cad", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 282, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 282, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c36bc8dff915b1b9e197a578", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3200}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 94, "start": 0, "text": "Etanercept treatment may increase the risk of infection and congestive heart failure in adults", "truncated": false}, "before_length": 94, "before_sha256": "4c5c9b045111d38d368ed3914f4a9022240c143efad08c25d46ef433b998a076", "change_kind": "unassigned", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 94, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 94, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c3ef9fa82a731e0f6ad7cfa0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6582}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 7, "start": 0, "text": "Germany", "truncated": false}, "before_length": 7, "before_sha256": "80db4ccdca106d37b920206331fcfe3e9e50a9e763d89b54ce3ad5ac8cf30f03", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 7, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c3f4de587a217b057d92d4bc", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2182}
{"after": {"end": 149, "start": 0, "text": "Des informations détaillées sur ce médicament sont disponibles sur le site Internet de l’Agence européenne des médicaments https://www.ema.europa.eu.", "truncated": false}, "after_length": 149, "after_sha256": "a1acb9aa232f00c2eb00b3365a65ce2956955c19113dd6804463f091d9a7c50e", "annex": "I", "before": {"end": 148, "start": 0, "text": "Des informations détaillées sur ce médicament sont disponibles sur le site Internet de l’Agence européenne des médicaments http://www.ema.europa.eu.", "truncated": false}, "before_length": 148, "before_sha256": "b3ed3a5671f00ce0b2a633df1e24ea3eefb4c50cd082005c6212150c2a70d104", "change_kind": "technical", "change_operations": [{"after_end": 128, "after_start": 127, "before_end": 127, "before_start": 127, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c402e0ddc447f73133686581", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg, solution injectable en cartouche distributrice de dose Enbrel 50 mg, solution injectable en cartouche distributrice de dose", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "10", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6575}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 15, "start": 0, "text": "Medis RO S.R.L.", "truncated": false}, "before_length": 15, "before_sha256": "1caf96d7205ab5e6dbca0d3ca067e94bb07d3dafc2838cd6702bac4b82047b6a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 15, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 15, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c4274cb9aa0dec8f0489c81f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1112}
{"after": {"end": 50, "start": 0, "text": "1. What Spikevax LP.8.1 is and what it is used for", "truncated": false}, "after_length": 50, "after_sha256": "bb19f8c86fcc61d9b18f2acd20b1005ae82efc6b9981e8191bee1dd6c356a226", "annex": "I", "before": {"end": 48, "start": 0, "text": "1. What Spikevax JN.1 is and what it is used for", "truncated": false}, "before_length": 48, "before_sha256": "fda4b8f277afb7d6ebc82f9b889c70510b1a81c6e58f7cb1cdbec4998ea3579d", "change_kind": "administrative", "change_operations": [{"after_end": 21, "after_start": 17, "before_end": 19, "before_start": 17, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c460e28ea8c7424ad0514b33", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12623}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "info@mundipharma.nl", "truncated": false}, "before_length": 19, "before_sha256": "f601339a5851491b7ab1e06c9ac38eabff98b5665d314730b6204165ee158589", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 19, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 19, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c4b4ae39c6b6e77858a4ae39", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1058}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 190, "start": 0, "text": "Patient Cards are provided to etanercept prescribing physicians for distribution to patients receiving etanercept. This card provides the following important safety information for patients:", "truncated": false}, "before_length": 190, "before_sha256": "75d71b12bfee4fbfee6b211d4c12b3fa45c5628d4fd5a5506eeedb2a96e282a0", "change_kind": "unassigned", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 190, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 190, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c4d04cde6a7b9e4fb3a38ffc", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6581}
{"after": {"end": 111, "start": 0, "text": "stop using Adempas at least 24 hours before you start using sildenafil or tadalafil, if you are adult or child.", "truncated": false}, "after_length": 111, "after_sha256": "14da47e198371326894537c6326637ba3a0c305e6fa8dcbb6d1fb899ce38e000", "annex": "IIIA", "before": {"end": 84, "start": 0, "text": "stop using Adempas at least 24 hours before you start using sildenafil or tadalafil.", "truncated": false}, "before_length": 84, "before_sha256": "3cd4e3e89e235683c1a9fd3cb2500942fa947c0eea119cb0639644e8152c68aa", "change_kind": "content", "change_operations": [{"after_end": 110, "after_start": 83, "before_end": 83, "before_start": 83, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 27}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c59df11250d02e203a39e434", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2859}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 38, "start": 0, "text": "Thaw temperature (at room temperature)", "truncated": false}, "before_length": 38, "before_sha256": "026c45281369b19ddeec659566dbab7b878d204f7a1ae9e40f2ae994b9e80346", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 38, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 38, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c5c49dfbe788c880ab7f2317", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13091}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 13, "start": 0, "text": "Carte Patient", "truncated": false}, "before_length": 13, "before_sha256": "553c2099e8e0089c27222d14a714bdbeab3b7852e613d201f2630411e16d5020", "change_kind": "unassigned", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 13, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 13, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c5c7230f000d3b00b75990e0", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6665}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 24, "start": 0, "text": "Tél/Tel: +32 2 358 54 68", "truncated": false}, "before_length": 24, "before_sha256": "41a8515e0ad87e2db6e34f58a5b4db10b75995776214e98d6be98b1aa31eee38", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 24, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 24, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c5f53849846b1087d190f42b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1016}
{"after": {"end": 114, "start": 0, "text": "Chaque présentation contient 10 mg d’etanercept. Après reconstitution, la solution contient 10 mg/mL d’etanercept.", "truncated": false}, "after_length": 114, "after_sha256": "48386d3e88d60da17c2ab0990799c854ad1fcfaa539575585ef522bca7d5ebda", "annex": "I", "before": {"end": 114, "start": 0, "text": "Chaque présentation contient 10 mg d’etanercept. Après reconstitution, la solution contient 10 mg/ml d’etanercept.", "truncated": false}, "before_length": 114, "before_sha256": "1b5ee59a3ebad6ce53be951d4b8d6c655355aacc93c830c4d0c3058a88f9c159", "change_kind": "content", "change_operations": [{"after_end": 100, "after_start": 99, "before_end": 100, "before_start": 99, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c61d2f827a765cb5fb8c7808", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 10 mg poudre et solvant pour solution injectable pour usage pédiatrique", "presentation_occurrence": 5, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "2", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 4565}
{"after": {"end": 326, "start": 0, "text": "- Les autres composants sont : acide citrique anhydre (E 330), arôme fraise, hypromellose, mannitol (E 421), cellulose microcristalline et carmellose sodique, benzoate de sodium (E 211) (voir à la fin de la rubrique 2 pour plus d’informations sur le benzoate de sodium et le sodium), sucralose (E 955), gomme xanthane (E 415).", "truncated": false}, "after_length": 326, "after_sha256": "d8686b98f4c134c0ff31ead4ce7fe5c637c1d71079cb8ed1312c21ce06da8b02", "annex": "IIIA", "before": {"end": 333, "start": 0, "text": "- Les autres composants sont : acide citrique anhydre (E 330) ; arôme fraise ; hypromellose ; mannitol (E 421) ; cellulose microcristalline et carmellose sodique ; benzoate de sodium (E 211) (voir à la fin de la rubrique 2 pour plus d’informations sur le benzoate de sodium et le sodium) ; sucralose (E 955) ; gomme xanthane (E 415).", "truncated": false}, "before_length": 333, "before_sha256": "02be9e854d4449290606a9a6effac94b2e06857543569ade221ee1402ec3ef5f", "change_kind": "content", "change_operations": [{"after_end": 62, "after_start": 61, "before_end": 63, "before_start": 61, "kind": "replace"}, {"after_end": 76, "after_start": 75, "before_end": 78, "before_start": 76, "kind": "replace"}, {"after_end": 90, "after_start": 89, "before_end": 93, "before_start": 91, "kind": "replace"}, {"after_end": 108, "after_start": 107, "before_end": 112, "before_start": 110, "kind": "replace"}, {"after_end": 158, "after_start": 157, "before_end": 163, "before_start": 161, "kind": "replace"}, {"after_end": 283, "after_start": 282, "before_end": 289, "before_start": 287, "kind": "replace"}, {"after_end": 302, "after_start": 301, "before_end": 309, "before_start": 307, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 7}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c62614da5a0bd5a67fe775de", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3444}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 26, "start": 0, "text": "Medis Pharma Lithuania UAB", "truncated": false}, "before_length": 26, "before_sha256": "1016178a7e6ddebf9ca5f1ab2b491b24607475ceededd18bdcff956f1d201890", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 26, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 26, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c657dc9b18e1d6330b3bd7cc", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1061}
{"after": {"end": 198, "start": 0, "text": "Spikevax LP.8.1 is a white to off-white dispersion. It may contain white or translucent productrelated particulates. Do not administer if vaccine is discoloured or contains other particulate matter.", "truncated": false}, "after_length": 198, "after_sha256": "ccf5e59e0ae33f0518b496363820ac5f20393ec7dfb73ad5ae725a09dd80cfc9", "annex": "I", "before": {"end": 196, "start": 0, "text": "Spikevax JN.1 is a white to off-white dispersion. It may contain white or translucent productrelated particulates. Do not administer if vaccine is discoloured or contains other particulate matter.", "truncated": false}, "before_length": 196, "before_sha256": "f0d2400a3fb023ef263db802dc33f78aeddc313e6d9f42f4bef61842da6a402f", "change_kind": "administrative", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c66c8afff519028286b1d5a2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13036}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 33, "start": 0, "text": "United Kingdom (Northern Ireland)", "truncated": false}, "before_length": 33, "before_sha256": "9379d82927cdb505cfb186e912177065e56a1314de3a2b914ebbb8b5fe21525a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 33, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 33, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c67277ef86306b66ab3aeb95", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 10550}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 16, "start": 0, "text": "EU/1/20/1507/026", "truncated": false}, "before_length": 16, "before_sha256": "dc53bb262ec1549e3aaf16f4ab9777390081dd29149c398f0e6e4b3f576f8960", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 16, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 16, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c6ba039c746b2bfcb2f73d8d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "8", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6483}
{"after": {"end": 243, "start": 0, "text": "Do not stop taking this medicine without talking to your doctor first. If you stop taking this medicine, your disease may worsen. If you have not taken this medicine for 3 days or more, please tell your doctor before you start taking it again.", "truncated": false}, "after_length": 243, "after_sha256": "cfd0331e54e462abfd9393ec968240242e15878ad456ef38a220c8aeceb39890", "annex": "IIIA", "before": {"end": 246, "start": 0, "text": "Do not stop taking this medicine without talking to your doctor first. If you stop to taking this medicine, your disease may worsen. If you have not taken this medicine for 3 days or more, please tell your doctor before you start taking it again.", "truncated": false}, "before_length": 246, "before_sha256": "cd38b58170f21d37be2d7479c6430ce6971d9b99f3291570f291c21035e3af1c", "change_kind": "content", "change_operations": [{"after_end": 84, "after_start": 84, "before_end": 87, "before_start": 84, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 3, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c6d529ce0f4bfc1fc3292989", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2850}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 23, "start": 0, "text": "Single-dose 0.5 mL vial", "truncated": false}, "before_length": 23, "before_sha256": "dc1099e9e6243e6d95ba783ad4ebee8a7557a17ecc98a043c619f2fc67f48401", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 23, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 23, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c6e3b6f7cea8437dc0ba077a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12853}
{"after": {"end": 99, "start": 0, "text": "Augmentation de la médiane de SSP 2,9 mois, risque relatif 0,69 (p=0,0002, IC 95 % : [0,56 ; 0,84])", "truncated": false}, "after_length": 99, "after_sha256": "df9c86dec112cbc0b4bf17d54f4fa41aa6e92e61e75def0a0af225527236144b", "annex": "I", "before": {"end": 99, "start": 0, "text": "Augmentation de la médiane de PFS 2,9 mois, risque relatif 0,69 (p=0,0002, IC 95 % : [0,56 ; 0,84])", "truncated": false}, "before_length": 99, "before_sha256": "f92e1e631c5ada1294f46f7b24fb479890baa72985583473fe3a7f06ce53d551", "change_kind": "content", "change_operations": [{"after_end": 32, "after_start": 30, "before_end": 30, "before_start": 30, "kind": "insert"}, {"after_end": 33, "after_start": 33, "before_end": 33, "before_start": 31, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c6ef3f505d1ff179eb3a57d6", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1321}
{"after": {"end": 25, "start": 0, "text": "50-58 Baggot Street Lower", "truncated": false}, "after_length": 25, "after_sha256": "2b6052bef6a7051ce20b776d1525055c417fc02e59b9e559cd21b7aa4c7859f0", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "administrative", "change_operations": [{"after_end": 25, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 25}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c70884450fd54903f53dc8aa", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "Qdenga poudre et solvant pour solution injectable. Qdenga poudre et solvant pour solution injectable en seringue pré-remplie Vaccin tétravalent contre la dengue (vivant, atténué)", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 976}
{"after": {"end": 20, "start": 0, "text": "dpoc.croatia@msd.com", "truncated": false}, "after_length": 20, "after_sha256": "e6060fe9f944bc26788eae6c6fde884372f9d1fb19a754bedfaa7c027a1b33e8", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "croatia_info@merck.com", "truncated": false}, "before_length": 22, "before_sha256": "759280e179a26a0343b8a3e77f7b95e8375fadcd491da4367ac6580767a10fbf", "change_kind": "content", "change_operations": [{"after_end": 5, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}, {"after_end": 12, "after_start": 12, "before_end": 12, "before_start": 7, "kind": "delete"}, {"after_end": 16, "after_start": 14, "before_end": 18, "before_start": 14, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 9, "chars_inserted": 7}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c7ce70de18a4360a5b7e289b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3063}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 29, "start": 0, "text": "Puh/Tel: + 358 (0)9 8520 2065", "truncated": false}, "before_length": 29, "before_sha256": "18eaa0a9ec1bb9b7b1d51c6daf02e6bb688d8af44de55f4a319e425bea49457c", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 29, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 29, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c7dae8e9a8679cf974510926", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1145}
{"after": {"end": 98, "start": 0, "text": "inflammation des muscles provoquant des douleurs ou des raideurs (pseudopolyarthrite rhizomélique)", "truncated": false}, "after_length": 98, "after_sha256": "714713bcaa6533d567ca1b1e6120884b207d983355e458022f2ea9086d20d0d5", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 98, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 98}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c7e33811b9c2afb65b1c2a08", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:18Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "2437ab76633f46c9eee5e002e5c7a7caba6367f59567d750be0eb67c74d1db4e", "source_snapshot_id": "source-7f4d129b0a0fd2d3684d27c5", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2280}
{"after": {"end": 82, "start": 0, "text": "Ne retirez pas le capuchon de l’aiguille de votre cartouche avant d’y être invité.", "truncated": false}, "after_length": 82, "after_sha256": "4efc275eff93858ba39b142bdc9148420570c9fb75ef5c58993a6ba93f94ff76", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 82, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 82}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c7ed944f522bebfff17ef32b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12330}
{"after": {"end": 11, "start": 0, "text": "Terrosa Pen", "truncated": false}, "after_length": 11, "after_sha256": "e4a38ee0dfaf8dd8b67929bec214019b621f6cae95f5af8d024eb02323be413c", "annex": "IIIA", "before": {"end": 13, "start": 0, "text": "Stylo Terrosa", "truncated": false}, "before_length": 13, "before_sha256": "39b1b47600411d061478c82f5f8da099bdf064994e323aa6f0f145b05129b745", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 6, "before_start": 0, "kind": "delete"}, {"after_end": 11, "after_start": 7, "before_end": 13, "before_start": 13, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c8139d3bffa38bbaae5ed2e1", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1929}
{"after": {"end": 26, "start": 0, "text": "<QR code> + www.nyxoid.com", "truncated": false}, "after_length": 26, "after_sha256": "1f54c7bd12c6d46c42e83d2bd6146613feadf70e6b2a0e8ba1700a1598bcf47d", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 26, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 26}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c829e80b7e087e904948bea8", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:33Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "21d66bf1e9a74479f577de09da3cf8517d65c1ce1b1d8bbdfe4bc38f79410def", "source_snapshot_id": "source-2c39c998fdaf05159687c016", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 863}
{"after": {"end": 130, "start": 0, "text": "Taking into account the PRAC Assessment Report on the PSUR(s) for tremelimumab, the scientific conclusions of PRAC are as follows:", "truncated": false}, "after_length": 130, "after_sha256": "805dcbe6c7135261b9b9ce03543f00323496ae1660a9cc77d53fd49b32e2627a", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 130, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 130}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c8d72727103c6a5223a35e03", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2538}
{"after": {"end": 9, "start": 0, "text": "Oral use.", "truncated": false}, "after_length": 9, "after_sha256": "3cb600334d66cfc50b70bcea280eaeb9fc125e589d372d56f3fae261332b8ee9", "annex": "IIIA", "before": {"end": 8, "start": 0, "text": "Oral use", "truncated": false}, "before_length": 8, "before_sha256": "1a1f6c65b762e8cde9480afdbb709dcfb59c2d46c38f5d3112c9f605bcbdf25f", "change_kind": "content", "change_operations": [{"after_end": 9, "after_start": 8, "before_end": 8, "before_start": 8, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c8ffd1df57caff73105cb6b5", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2075}
{"after": {"end": 105, "start": 0, "text": "CONCLUSIONS SCIENTIFIQUES ET MOTIFS DE LA MODIFICATION DES TERMES DES AUTORISATIONS DE MISE SUR LE MARCHÉ", "truncated": false}, "after_length": 105, "after_sha256": "986a5a8167262a2e1b34885d8bf0d8f1d06f2dd4da8ab0f4d7bedc4081ef8b90", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 105, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 105}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c91a819920ccf42670570dd0", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:32:00Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "3ff8cd4d67d22ba799aa348aeda944d6d896a16dcf54b030db101cbc095fc8ad", "source_snapshot_id": "source-a79a7cba8bf5dbc72fd40574", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3513}
{"after": {"end": 303, "start": 0, "text": "• de la comparaison des incidences constatées entre les bras de traitement des essais cliniques (avec une différence d’au moins 10 % par rapport au groupe témoin pour les effets de grade 1-5 NCI-CTCAE ou une différence d’au moins 2 % par rapport au groupe témoin pour les effets de grade 3-5 NCI-CTCAE),", "truncated": false}, "after_length": 303, "after_sha256": "00c93a36f172290fd12d89b40e1b12e130ebe86802c25be03efd6083a45256a5", "annex": "I", "before": {"end": 314, "start": 0, "text": "• de la comparaison des incidences constatées entre les bras de traitement des essais cliniques (avec une différence d’au moins 10 % par rapport au groupe témoin pour les effets de grade 1-5 NCI-CTCAE ou une différence supérieure d’au moins 2 % par rapport au groupe témoin pour les effets de grade 3-5 NCI-CTCAE),", "truncated": false}, "before_length": 314, "before_sha256": "2246c2aaeee9bdb3abb9e32e0bfa33c676f1eac073d50289cf634f064ed28952", "change_kind": "content", "change_operations": [{"after_end": 219, "after_start": 219, "before_end": 230, "before_start": 219, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 11, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c93a29ab4682674e2a5ac2cf", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 327}
{"after": {"end": 139, "start": 0, "text": "Compte tenu du rapport d’évaluation du PRAC sur les PSUR concernant bevacizumab, les conclusions scientifiques du PRAC sont les suivantes :", "truncated": false}, "after_length": 139, "after_sha256": "8b838a2517e083e0e8e7232793f151812e88f098b31c0d71fd01e417b114c353", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 139, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 139}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c97528d1385e99f8a40ca373", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3400}
{"after": {"end": 326, "start": 0, "text": "Verify that the product name of the pre-filled syringe is Spikevax LP.8.1. If the product name is Spikevax 50 micrograms, Spikevax bivalent Original/Omicron BA.1, Spikevax bivalent Original/Omicron BA.4-5, Spikevax XBB.1.5 or Spikevax JN.1, please make reference to the Summary of Product Characteristics for that formulation.", "truncated": false}, "after_length": 326, "after_sha256": "10fcb18e1faecdc5010e19cd2827989b6bf204cbdd4a362d50b022a01f7b57f5", "annex": "I", "before": {"end": 309, "start": 0, "text": "Verify that the product name of the pre-filled syringe is Spikevax JN.1. If the product name is Spikevax 50 micrograms, Spikevax bivalent Original/Omicron BA.1, Spikevax bivalent Original/Omicron BA.4-5 or Spikevax XBB.1.5, please make reference to the Summary of Product Characteristics for that formulation.", "truncated": false}, "before_length": 309, "before_sha256": "f8df2d454faac8c0c1f7a471f5680b03801d6b65c664b4f03dd434a972a06a24", "change_kind": "content", "change_operations": [{"after_end": 71, "after_start": 67, "before_end": 69, "before_start": 67, "kind": "replace"}, {"after_end": 205, "after_start": 204, "before_end": 205, "before_start": 202, "kind": "replace"}, {"after_end": 239, "after_start": 222, "before_end": 222, "before_start": 222, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 5, "chars_inserted": 22}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c9861871ee87ee1511807f44", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6447}
{"after": {"end": 108, "start": 0, "text": "Each pre-filled syringe contains 0.5 mL. One dose (0.5 mL) contains 50 micrograms of SARS-CoV-2 LP.8.1 mRNA.", "truncated": false}, "after_length": 108, "after_sha256": "797ee6c41611c9e1078225244ec99db06539687a3d811a97f4df9e958dbad736", "annex": "IIIA", "before": {"end": 106, "start": 0, "text": "Each pre-filled syringe contains 0.5 mL. One dose (0.5 mL) contains 50 micrograms of SARS-CoV-2 JN.1 mRNA.", "truncated": false}, "before_length": 106, "before_sha256": "e84534769392ae8697691051e963a79e630393e90eaa3daf1a6d542d406c323f", "change_kind": "content", "change_operations": [{"after_end": 100, "after_start": 96, "before_end": 98, "before_start": 96, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-c995840c1ffe1e28d42b7a21", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9206}
{"after": {"end": 325, "start": 0, "text": "Deux larges études de phase III avaient pour objectif d’évaluer l’effet d’Avastin en association à deux chimiothérapies distinctes, avec comme critère principal : la Survie Sans Progression (SSP). Une amélioration cliniquement pertinente et statistiquement significative de la SSP a été observée dans chacune des deux études.", "truncated": false}, "after_length": 325, "after_sha256": "0a9d30cb26abfd09ffc4089f64db42e2147d61e1fff5471e956846a8c44bc59d", "annex": "I", "before": {"end": 325, "start": 0, "text": "Deux larges études de phase III avaient pour objectif d’évaluer l’effet d’Avastin en association à deux chimiothérapies distinctes, avec comme critère principal : la Survie Sans Progression (PFS). Une amélioration cliniquement pertinente et statistiquement significative de la PFS a été observée dans chacune des deux études.", "truncated": false}, "before_length": 325, "before_sha256": "3e0fe48719def7a9fc15da3f2d7936d4f2628121ec71b1b40efc6f2a7b625b57", "change_kind": "content", "change_operations": [{"after_end": 193, "after_start": 191, "before_end": 191, "before_start": 191, "kind": "insert"}, {"after_end": 194, "after_start": 194, "before_end": 194, "before_start": 192, "kind": "delete"}, {"after_end": 279, "after_start": 277, "before_end": 277, "before_start": 277, "kind": "insert"}, {"after_end": 280, "after_start": 280, "before_end": 280, "before_start": 278, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ca28dd439393db33606a353f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1314}
{"after": {"end": 43, "start": 0, "text": "Pfizer Healthcare Ireland Unlimited Company", "truncated": false}, "after_length": 43, "after_sha256": "1f203777a0ec6fed9c840d52631b6a74c7e25b5d318485d8147e2404f52dc981", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "Pfizer Healthcare Ireland", "truncated": false}, "before_length": 25, "before_sha256": "4beeea9b6d0c491f03a9511d9f9576b9c75cbcdcfd736e4934f768fdded936f5", "change_kind": "content", "change_operations": [{"after_end": 43, "after_start": 25, "before_end": 25, "before_start": 25, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 18}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ca52084b9b415b561c0c34be", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11720}
{"after": {"end": 148, "start": 0, "text": "Des informations détaillées sur ce médicament sont disponibles sur le site internet de l’Agence européenne des médicaments https://www.ema.europa.eu", "truncated": false}, "after_length": 148, "after_sha256": "0144d9770eb4c4153d7e7b1c9dec56544610f245adee115432038125fa622184", "annex": "IIIA", "before": {"end": 147, "start": 0, "text": "Des informations détaillées sur ce médicament sont disponibles sur le site internet de l’Agence européenne des médicaments http://www.ema.europa.eu", "truncated": false}, "before_length": 147, "before_sha256": "d0dd4118d52714b2cfcf09f73f7031efc575f51b70183bf3d601893b6bf4e936", "change_kind": "technical", "change_operations": [{"after_end": 128, "after_start": 127, "before_end": 127, "before_start": 127, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ca803ca6b8fd0d17bbbc5681", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11183}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 13, "start": 0, "text": "Configuration", "truncated": false}, "before_length": 13, "before_sha256": "b332c3492d5eb10a118eb6d8b0dcd689bc2477ce2ae16b303753b942b54377bc", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 13, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 13, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ca81a790e96396c27ed9cdaf", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13086}
{"after": {"end": 31, "start": 0, "text": "Pseudopolyarthrite rhizomélique", "truncated": false}, "after_length": 31, "after_sha256": "d860661d954418bf68c7201eda21f3030d7a099f3ab30ffd2e6028edc3cc01da", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 31, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 31}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ca8b8a9d742b21b7fffb954d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:18Z", "pipeline_version": "2.0.0", "presentation_label": "IMJUDO 20 mg/ml, solution à diluer pour perfusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "2437ab76633f46c9eee5e002e5c7a7caba6367f59567d750be0eb67c74d1db4e", "source_snapshot_id": "source-7f4d129b0a0fd2d3684d27c5", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 830}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 16, "start": 0, "text": "EU/1/20/1507/024", "truncated": false}, "before_length": 16, "before_sha256": "42a4750a4faed6116a9f558850b5ac45c15debdae91b4c8ef87d72f6d6e48104", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 16, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 16, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ca9a42c78300f620a06fd60e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "8", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6481}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 28, "start": 0, "text": "Mundipharma Farmacêutica Lda", "truncated": false}, "before_length": 28, "before_sha256": "92b5c1da95eda2f54f4735853a1250cd9cb07176a9c2d50fe2ecbe0500e6711a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 28, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 28, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-caab8acf5a6db744cd0a91ed", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1097}
{"after": {"end": 18, "start": 0, "text": "dpoccyprus@msd.com", "truncated": false}, "after_length": 18, "after_sha256": "492fae7e6db021703bcb80e4b139bc2be78a7e6cf4c6056a9314c70cfe643716", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "malta_info@merck.com", "truncated": false}, "before_length": 20, "before_sha256": "d0529053ac5f753b95c76e02b64d46efbc0d61183bea7de30faa0abc218a9e1c", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 0, "before_end": 9, "before_start": 0, "kind": "replace"}, {"after_end": 10, "after_start": 3, "before_end": 10, "before_start": 10, "kind": "insert"}, {"after_end": 14, "after_start": 12, "before_end": 16, "before_start": 12, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 13, "chars_inserted": 11}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-caadbaa691ec00f4634ce4e5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3096}
{"after": {"end": 428, "start": 0, "text": "L’objectif principal d’amélioration de la SSP a été atteint. Les patientes ayant reçu du bevacizumab à la dose de 7,5 mg/kg toutes les 3 semaines en association à la chimiothérapie et ayant continué à recevoir du bevacizumab seul pendant 18 cycles au maximum, ont eu une amélioration de la SSP statistiquement significative comparée aux patientes traitées par chimiothérapie seule (carboplatine et paclitaxel) en première ligne.", "truncated": false}, "after_length": 428, "after_sha256": "a28fcd178e6f634c8aefb50532899232d0bfe37579c7111d8a8cf5c8d8efe170", "annex": "I", "before": {"end": 428, "start": 0, "text": "L’objectif principal d’amélioration de la PFS a été atteint. Les patientes ayant reçu du bevacizumab à la dose de 7,5 mg/kg toutes les 3 semaines en association à la chimiothérapie et ayant continué à recevoir du bevacizumab seul pendant 18 cycles au maximum, ont eu une amélioration de la PFS statistiquement significative comparée aux patientes traitées par chimiothérapie seule (carboplatine et paclitaxel) en première ligne.", "truncated": false}, "before_length": 428, "before_sha256": "36c1ee744e6c660b0566296525dcb10973318a4ec101c191a4783db3d0b93cf0", "change_kind": "content", "change_operations": [{"after_end": 44, "after_start": 42, "before_end": 42, "before_start": 42, "kind": "insert"}, {"after_end": 45, "after_start": 45, "before_end": 45, "before_start": 43, "kind": "delete"}, {"after_end": 292, "after_start": 290, "before_end": 290, "before_start": 290, "kind": "insert"}, {"after_end": 293, "after_start": 293, "before_end": 293, "before_start": 291, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-cb1f0eb1762657b4344c5e1e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1864}
{"after": {"end": 19, "start": 0, "text": "Sími: +354 535 7000", "truncated": false}, "after_length": 19, "after_sha256": "4147b258aaf4f6d0d9b2ae441e0fa1eb5f0dadfd4e4fea070a7673c7133bf389", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Sími: + 354 535 7000", "truncated": false}, "before_length": 20, "before_sha256": "66fcdd056ccfbc5ba6d0c26580292977898106c90655c78208bc87c3d941892c", "change_kind": "content", "change_operations": [{"after_end": 7, "after_start": 7, "before_end": 8, "before_start": 7, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-cb48cd3da4dd2b335fd64949", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3082}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 13, "start": 0, "text": "Medis, d.o.o.", "truncated": false}, "before_length": 13, "before_sha256": "fda955bff0c409b008f998853f0a76bfdb681c029b0ff98b4bb6e9cc5ca14663", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 13, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 13, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-cb54d15ddc5f56a6ee928413", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1117}
{"after": {"end": 130, "start": 0, "text": "Les évènements indésirables d’intensité sévère pouvant être fréquents (peuvent affecter jusqu’à une personne sur 10) comprennent :", "truncated": false}, "after_length": 130, "after_sha256": "c5054cfe8a58b9b96ce23c9c2ed583a7b58bf693bf892ecff1987cbeb4839b6d", "annex": "IIIA", "before": {"end": 127, "start": 0, "text": "Les évènements indésirables d’intensité sévère pouvant être fréquents (peut affecter jusqu’à une personne sur 10) comprennent :", "truncated": false}, "before_length": 127, "before_sha256": "100be9401b11af5dd8b4fd1088663d8bdbaa9f954b8e0301125702cb323da5eb", "change_kind": "content", "change_operations": [{"after_end": 77, "after_start": 74, "before_end": 74, "before_start": 74, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 3}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-cb59b9e098f9bd71144a92bf", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3117}
{"after": {"end": 117, "start": 0, "text": "Si vous avez des questions concernant l’utilisation du Terrosa Pen, suivez les instructions données dans le tableau :", "truncated": false}, "after_length": 117, "after_sha256": "3c1a5404a5139efb5bc472c390d8eeed06d4f51fcf4111dbe4f9e78f4fd7d8e6", "annex": "IIIA", "before": {"end": 119, "start": 0, "text": "Si vous avez des questions concernant l’utilisation du stylo Terrosa, suivez les instructions données dans le tableau :", "truncated": false}, "before_length": 119, "before_sha256": "7ec5acf0b14803f4f4189edf4a3e922e907a1586a921812f25c532bcc23ac8d0", "change_kind": "content", "change_operations": [{"after_end": 55, "after_start": 55, "before_end": 61, "before_start": 55, "kind": "delete"}, {"after_end": 66, "after_start": 62, "before_end": 68, "before_start": 68, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-cb6250f109d084d10f3de660", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2106}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 5, "start": 0, "text": "Malta", "truncated": false}, "before_length": 5, "before_sha256": "71e9eb10755c8232974d186a560f7658a1ccbdd3097877dfa1ad3436af90d46a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 5, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 5, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-cb70ebebfb97a2c9bb5e71a3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1046}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 80, "start": 0, "text": "Within this period, up to 36 hours may be used for transportation at 2°C to 8°C.", "truncated": false}, "before_length": 80, "before_sha256": "d6b13ce6bf20090178cfd334596098ea2c5ce7f26aeb382f0412270c81eb8297", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 80, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 80, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-cb7b6fc835b694eff8cd6d0d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13107}
{"after": {"end": 52, "start": 0, "text": "le millepertuis, utilisé pour traiter la dépression.", "truncated": false}, "after_length": 52, "after_sha256": "d07cd097c53bd3ab4869753c049529d3d83be39dc2674eb80a40f98958778754", "annex": "IIIA", "before": {"end": 42, "start": 0, "text": "de la dépression tels que le millepertuis.", "truncated": false}, "before_length": 42, "before_sha256": "7d82720f9f8eab55abf64d5d1a94d3b4209c8fd15beff345943423cb2fae10e6", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 26, "before_start": 0, "kind": "delete"}, {"after_end": 51, "after_start": 15, "before_end": 41, "before_start": 41, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 26, "chars_inserted": 36}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-cb8ad8515c00716a9926606a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2860}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 17, "start": 0, "text": "Medis Hungary Kft", "truncated": false}, "before_length": 17, "before_sha256": "1788967aa4a6065efb54b66c922a89e6f9d8cf865cf32093aaf092afd11fc6de", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 17, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 17, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-cba3569896b94950d3008439", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1039}
{"after": {"end": 74, "start": 0, "text": "* Do not use the prefilled syringe to deliver a partial volume of 0.25 mL.", "truncated": false}, "after_length": 74, "after_sha256": "75e296bff3c238176d513ed450c19057750a20263b5a3152d3b7a7c0a0d4190e", "annex": "I", "before": {"end": 94, "start": 0, "text": "* Do not use the single-dose vial or prefilled syringe to deliver a partial volume of 0.25 mL.", "truncated": false}, "before_length": 94, "before_sha256": "34a3dd6a9a278560b1c455186ca0846462be29c70b70a4dd2f194f53b65e7df3", "change_kind": "content", "change_operations": [{"after_end": 17, "after_start": 17, "before_end": 37, "before_start": 17, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 20, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-cbb9b4ff0ba59d2de0c928e3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5501}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 230, "start": 0, "text": "Head control (Sta Q10)Standing with support (Loc Q28)Sitting unassisted (Sta Q14) Walking with assistance (Loc Q34)Head control (Sta Q10)Standing with support (Loc Q28)Sitting unassisted (Sta Q14) Walking with assistance (Loc Q34)", "truncated": false}, "before_length": 230, "before_sha256": "ceca58c5eeb4ea3d2edaefd2c39a21d866181aded2ed5512b141fbef238850b9", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 230, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 230, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-cbbe933c85e6086d5646fe08", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005352", "medicine_name": "Upstaza", "medicine_slug": "upstaza", "observed_at": "2026-10-12T13:36:07Z", "pipeline_version": "2.0.0", "presentation_label": "Upstaza 2.8 × 1011 vector genomes (vg)/0.5 mL solution for infusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8561a0c5aed752dd415d30acef76bf620ad205d702080a0bca765e086873fe20", "source_snapshot_id": "source-4b712d5f9e4e2e8cd620aa93", "source_updated_at": "2026-06-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/upstaza-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 350}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 7, "start": 0, "text": "România", "truncated": false}, "before_length": 7, "before_sha256": "633e193d7e05828a893d02a6273755ed0d417cc14abf5ecfc2b6328c71ddcc7e", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 7, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-cbcd53a2c2e8646b2d7bdc7e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1120}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 11, "start": 0, "text": "Hoge Wei 10", "truncated": false}, "before_length": 11, "before_sha256": "ba5c0cab58e83e9dc6ec41e55e6acc00077e1be63c8a1ed970723221f2f12ba4", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 11, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 11, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-cbe0c623c05c97eec4180665", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004310", "medicine_name": "Daptomycin Hospira", "medicine_slug": "daptomycin-hospira", "observed_at": "2026-10-12T19:09:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e544a64f1681af82ba143ddd0cfa7cca4ef0de691ed43076b92bb75f66ec7f7b", "source_snapshot_id": "source-a214fce23bf43c3222026b3d", "source_updated_at": "2025-09-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/daptomycin-hospira-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1599}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 192, "start": 0, "text": "Votre médecin vous remettra également une Carte Patient qui comportera des informations importantes de sécurité d’emploi que vous devez connaître, avant et pendant votre traitement par Enbrel.", "truncated": false}, "before_length": 192, "before_sha256": "a9b61621aee7f348e503c6ef13da6f1d4dc6f2a4d953f840016b3daaebeecd6a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 192, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 192, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-cc11fbcb6e6ee1b84da284a5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 10824}
{"after": {"end": 149, "start": 0, "text": "Des informations détaillées sur ce médicament sont disponibles sur le site Internet de l’Agence européenne des médicaments https://www.ema.europa.eu.", "truncated": false}, "after_length": 149, "after_sha256": "a1acb9aa232f00c2eb00b3365a65ce2956955c19113dd6804463f091d9a7c50e", "annex": "IIIA", "before": {"end": 148, "start": 0, "text": "Des informations détaillées sur ce médicament sont disponibles sur le site Internet de l’Agence européenne des médicaments http://www.ema.europa.eu.", "truncated": false}, "before_length": 148, "before_sha256": "b3ed3a5671f00ce0b2a633df1e24ea3eefb4c50cd082005c6212150c2a70d104", "change_kind": "technical", "change_operations": [{"after_end": 128, "after_start": 127, "before_end": 127, "before_start": 127, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-cc19c84d9f5781ea3da43368", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11759}
{"after": {"end": 480, "start": 0, "text": "Enbrel est reconstitué avec 1 mL d’eau pour préparations injectables avant utilisation, et administration de l’injection sous-cutanée. La solution doit être limpide et incolore à jaune pâle ou brun pâle, sans amas, flocons ou particules visibles. Il se peut que de la mousse reste dans le flacon – c’est normal. Enbrel ne doit pas être utilisé si toute la poudre du flacon ne s’est pas dissoute dans les 10 minutes. Si tel est le cas, recommencez l’opération avec un autre flacon.", "truncated": false}, "after_length": 480, "after_sha256": "67d89ed136c3a82698fd5611839841ebbf54de6510667b7a37aa360c1743d4b2", "annex": "I", "before": {"end": 480, "start": 0, "text": "Enbrel est reconstitué avec 1 ml d’eau pour préparations injectables avant utilisation, et administration de l’injection sous-cutanée. La solution doit être limpide et incolore à jaune pâle ou brun pâle, sans amas, flocons ou particules visibles. Il se peut que de la mousse reste dans le flacon – c’est normal. Enbrel ne doit pas être utilisé si toute la poudre du flacon ne s’est pas dissoute dans les 10 minutes. Si tel est le cas, recommencez l’opération avec un autre flacon.", "truncated": false}, "before_length": 480, "before_sha256": "b661190a86ff22a0d7cca54059817078b7201c2424d40f030a4e15d25a45675b", "change_kind": "content", "change_operations": [{"after_end": 32, "after_start": 31, "before_end": 32, "before_start": 31, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-cc7de485b9561943d72f68ed", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 10 mg poudre et solvant pour solution injectable pour usage pédiatrique", "presentation_occurrence": 5, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5410}
{"after": {"end": 8, "start": 0, "text": "Dublin 2", "truncated": false}, "after_length": 8, "after_sha256": "b9d41e7d3be3ec3e12457949fb5c2f7be98290b5d2919e8b974df9c98fab02b9", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "administrative", "change_operations": [{"after_end": 8, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ccacea3de516ac78b45b8e41", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "Qdenga poudre et solvant pour solution injectable. Qdenga poudre et solvant pour solution injectable en seringue pré-remplie Vaccin tétravalent contre la dengue (vivant, atténué)", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 977}
{"after": {"end": 154, "start": 0, "text": "Le Terrosa Pen est un dispositif médical non stérile, réutilisable, destiné à l'administration sous-cutanée de Terrosa à partir de cartouches compatibles.", "truncated": false}, "after_length": 154, "after_sha256": "0f9a9cfcba26350ee2fdd5006232ca8991b2daaf1676db674385986c7e7c36f0", "annex": "IIIA", "before": {"end": 156, "start": 0, "text": "Le stylo Terrosa est un dispositif médical non stérile, réutilisable, destiné à l'administration sous-cutanée de Terrosa à partir de cartouches compatibles.", "truncated": false}, "before_length": 156, "before_sha256": "8b727b4231155169dffefcbcc20a8f20516f77a4612fd5efbd91e4cb60104310", "change_kind": "content", "change_operations": [{"after_end": 3, "after_start": 3, "before_end": 9, "before_start": 3, "kind": "delete"}, {"after_end": 14, "after_start": 10, "before_end": 16, "before_start": 16, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ccbba1ce402095170b96e35d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1934}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 26, "start": 0, "text": "Each vial contains 0.5 mL.", "truncated": false}, "before_length": 26, "before_sha256": "ff761ca1cf4f5d507f75b640bfdd37de1203fdc2385ef9179d1f7b2d508f9d49", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 26, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 26, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ccfc74942e25e33cddd68c61", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12888}
{"after": {"end": 37, "start": 0, "text": "No special requirements for disposal.", "truncated": false}, "after_length": 37, "after_sha256": "66322e10cdd185f1c5bebf08a0f67109793fd18a17f19346bd0e25ab242839b0", "annex": "I", "before": {"end": 24, "start": 0, "text": "No special requirements.", "truncated": false}, "before_length": 24, "before_sha256": "b00325b129158a76d9b33e14327037803608660d4eb1f1502c3e1400e7389f7d", "change_kind": "content", "change_operations": [{"after_end": 36, "after_start": 23, "before_end": 23, "before_start": 23, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 13}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-cd9e0a4d08f52ba6ceca5052", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "Fycompa 2 mg filmcoated tablets Fycompa 4 mg filmcoated tablets Fycompa 6 mg filmcoated tablets Fycompa 8 mg filmcoated tablets Fycompa 10 mg filmcoated tablets Fycompa 12 mg filmcoated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 819}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "Tel: +34 91 3821870", "truncated": false}, "before_length": 19, "before_sha256": "117ebc6bfe06f8e0b5ae2e854e665f02a5c68de0b64f7ffb83bee1e039844483", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 19, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 19, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-cded7e61b2e1065a01ce5240", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1082}
{"after": {"end": 18, "start": 0, "text": "msdromania@msd.com", "truncated": false}, "after_length": 18, "after_sha256": "5820201082e5902b1d6a84673e62d34f129a4dc7106dc8e5e365973da4db652f", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "msdromania@merck.com", "truncated": false}, "before_length": 20, "before_sha256": "ed43025368036055834b7ab01c906dfab567b905345a39d35f9d1f659762c1b4", "change_kind": "content", "change_operations": [{"after_end": 14, "after_start": 12, "before_end": 16, "before_start": 12, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ce0d8eb15af9823ec6c4d0c2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3068}
{"after": {"end": 291, "start": 0, "text": "Caution: If the cartridge contains less than 80 microliters, the dose knob cannot be turned clockwise up to the arrow sign. In this case, remove the pen needle, according to step \"3. Removing the pen needle\", change the cartridge and proceed with priming according the pen preparation steps.", "truncated": false}, "after_length": 291, "after_sha256": "62d7b8738bf232ba02760712357d3168c47ec157c25624c6ad267274aa35c108", "annex": "IIIA", "before": {"end": 240, "start": 0, "text": "Note: If the cartridge contains less than 80 microliters, the dose knob cannot be turned clockwise up to the arrow sign. In this case, remove the pen needle, change the cartridge and proceed with priming according the pen preparation steps.", "truncated": false}, "before_length": 240, "before_sha256": "773beb01d25ba3bb004da37837e6d78a62535eaa55b528f4fbed226dd4a38965", "change_kind": "content", "change_operations": [{"after_end": 5, "after_start": 0, "before_end": 1, "before_start": 0, "kind": "replace"}, {"after_end": 7, "after_start": 6, "before_end": 4, "before_start": 2, "kind": "replace"}, {"after_end": 207, "after_start": 159, "before_end": 156, "before_start": 156, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 3, "chars_inserted": 54}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ce32442ca50c7266aed3a01d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2058}
{"after": {"end": 22, "start": 0, "text": "Insuffisance cardiaque", "truncated": false}, "after_length": 22, "after_sha256": "0daba53df1d834c99c85ada39650137d5bde6374cd9dcd2fa3308545480fc6cb", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 22, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 22}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ce69c6f82e7b818319897ee1", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002640", "medicine_name": "Cometriq", "medicine_slug": "cometriq", "observed_at": "2026-10-12T19:00:55Z", "pipeline_version": "2.0.0", "presentation_label": "COMETRIQ 20 mg, gélules COMETRIQ 80 mg, gélules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "c7f8aa8da9127064263770c4aed5506128bacd0c40693b863c48a757d735203e", "source_snapshot_id": "source-e4fa0b9c95a2e427d4c95a33", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/cometriq-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 143}
{"after": {"end": 98, "start": 0, "text": "Tableau 17 Résultats de la SSP1 par stade de la maladie et statut de l’exérèse de l’étude GOG-0218", "truncated": false}, "after_length": 98, "after_sha256": "3f65a00de6dda6b85d5f65da84a078da1884f0c578bddea6d004c023990b2c6c", "annex": "I", "before": {"end": 98, "start": 0, "text": "Tableau 17 Résultats de la PFS1 par stade de la maladie et statut de l’exérèse de l’étude GOG-0218", "truncated": false}, "before_length": 98, "before_sha256": "090d70cc0196f8767aa2f32020fd0fb91148df06bf4c656539261e6103866b0d", "change_kind": "content", "change_operations": [{"after_end": 29, "after_start": 27, "before_end": 27, "before_start": 27, "kind": "insert"}, {"after_end": 30, "after_start": 30, "before_end": 30, "before_start": 28, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ce6b4f23d6f1991d6d4846e4", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1792}
{"after": {"end": 105, "start": 0, "text": "Spikevax LP.8.1 should be administered at least 3 months after the most recent dose of a COVID19 vaccine.", "truncated": false}, "after_length": 105, "after_sha256": "cb920377c5c8e39d8da8bd46b2b786bee15ae3279003e504ae149a68404dcdd7", "annex": "I", "before": {"end": 103, "start": 0, "text": "Spikevax JN.1 should be administered at least 3 months after the most recent dose of a COVID19 vaccine.", "truncated": false}, "before_length": 103, "before_sha256": "1ffe43d37772f8deefe1797a49307dc26bb46874b29c0b434dbf982941e47645", "change_kind": "administrative", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ce765386311bd57356192f58", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12708}
{"after": {"end": 1, "start": 0, "text": "-", "truncated": false}, "after_length": 1, "after_sha256": "3973e022e93220f9212c18d0d0c543ae7c309e46640da93a4a0314de999f5112", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 1, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ced302223fb041fb9f2cd03e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "IMJUDO 20 mg/ml concentrate for solution for infusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 840}
{"after": {"end": 968, "start": 0, "text": "Compte tenu du mécanisme d’action du trémélimumab en association avec le durvalumab, d’autres effets indésirables à médiation immunitaire potentiels peuvent survenir. Les effets indésirables à médiation immunitaire suivants ont été observés chez des patients traités par trémélimumab en association avec le durvalumab ou avec le durvalumab et la chimiothérapie : myasthénie grave, myélite transverse, myosite, polymyosite, rhabdomyolyse, méningite, encéphalite, syndrome de GuillainBarré, thrombopénie immunitaire, cystite non infectieuse, arthrite à médiation immunitaire, uvéite et pseudopolyarthrite rhizomélique (voir rubrique 4.8). Les patients doivent être surveillés afin de déceler tous signes et symptômes et pris en charge conformément aux recommandations de la rubrique 4.2. Des corticoïdes doivent être administrés à la dose initiale de 1 à 2 mg/kg/jour de prednisone ou équivalent, suivie d'une réduction progressive de la posologie pour les grades 2 à 4.", "truncated": false}, "after_length": 968, "after_sha256": "30e1ee396dd6bfbbe1deb227caa8b4d54685ded8367a0ab7be4bf71572ae8c00", "annex": "I", "before": {"end": 935, "start": 0, "text": "Compte tenu du mécanisme d’action du trémélimumab en association avec le durvalumab, d’autres effets indésirables à médiation immunitaire potentiels peuvent survenir. Les effets indésirables à médiation immunitaire suivants ont été observés chez des patients traités par trémélimumab en association avec le durvalumab ou avec le durvalumab et la chimiothérapie : myasthénie grave, myélite transverse, myosite, polymyosite, rhabdomyolyse, méningite, encéphalite, syndrome de GuillainBarré, thrombopénie immunitaire, cystite non infectieuse, arthrite à médiation immunitaire et uvéite (voir rubrique 4.8). Les patients doivent être surveillés afin de déceler tous signes et symptômes et pris en charge conformément aux recommandations de la rubrique 4.2. Des corticoïdes doivent être administrés à la dose initiale de 1 à 2 mg/kg/jour de prednisone ou équivalent, suivie d'une réduction progressive de la posologie pour les grades 2 à 4.", "truncated": false}, "before_length": 935, "before_sha256": "4aa1bb78350e6d6eab0d26ecefd3c8434db59f9bd7011686379aa0d897b9e96d", "change_kind": "content", "change_operations": [{"after_end": 573, "after_start": 572, "before_end": 575, "before_start": 572, "kind": "replace"}, {"after_end": 614, "after_start": 579, "before_end": 581, "before_start": 581, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 3, "chars_inserted": 36}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-cf5de1e7193370523aea2872", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:18Z", "pipeline_version": "2.0.0", "presentation_label": "IMJUDO 20 mg/ml, solution à diluer pour perfusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "2437ab76633f46c9eee5e002e5c7a7caba6367f59567d750be0eb67c74d1db4e", "source_snapshot_id": "source-7f4d129b0a0fd2d3684d27c5", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 315}
{"after": {"end": 12, "start": 0, "text": "Rubrique 4.4", "truncated": false}, "after_length": 12, "after_sha256": "ebfdd3ad71c8c2d9dfb46af1bc89271f8401bd6dd6e0dbb59c7fb8bd0fad0ca9", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 12, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 12}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-cf976cebe500aa4238e79edb", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "9ac80b0d56ebad4970f7a8335a177613af59ef25517bcd0bdd3397c207cc1bac", "source_snapshot_id": "source-c11aa9e32420f125a88005bc", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2723}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 16, "start": 0, "text": "EU/1/20/1507/019", "truncated": false}, "before_length": 16, "before_sha256": "3ad3afe0d1592ccf2fb18122de8512d5dab0a7282f8e60fc72fd8a6060143160", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 16, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 16, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d02a62e15dec192364d0c637", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "8", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6476}
{"after": {"end": 196, "start": 0, "text": "Les modifications des informations sur le produit des médicaments contenant l’aprémilast indiquées ci-après sont recommandées (nouveau texte souligné et en caractères gras, texte supprimé barré) :", "truncated": false}, "after_length": 196, "after_sha256": "b1fb4749a27308523c3929e2120c941a478a1a510e672bec9835fbfc848deff0", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 196, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 196}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d02fbe040945fc75485468f5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "9ac80b0d56ebad4970f7a8335a177613af59ef25517bcd0bdd3397c207cc1bac", "source_snapshot_id": "source-c11aa9e32420f125a88005bc", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2719}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 8, "start": 0, "text": "Hrvatska", "truncated": false}, "before_length": 8, "before_sha256": "08c5546cc42a9be9368bdd6a99ed02c97b9163c173b1e97dd49b785cb49740bc", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 8, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 8, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d034c969161a3ec391e03d86", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1100}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IV", "before": {"end": 141, "start": 0, "text": "Compte tenu du rapport d’évaluation du PRAC sur les PSUR concernant le pérampanel, les conclusions scientifiques du CHMP sont les suivantes :", "truncated": false}, "before_length": 141, "before_sha256": "4893374472d679944f3912faa38c6dff0476b4f56f381482a1b76c038407238b", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 141, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 141, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d04be642e05e8990237325ae", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:32:00Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "3ff8cd4d67d22ba799aa348aeda944d6d896a16dcf54b030db101cbc095fc8ad", "source_snapshot_id": "source-a79a7cba8bf5dbc72fd40574", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3518}
{"after": {"end": 16, "start": 0, "text": "EU/1/20/1507/032", "truncated": false}, "after_length": 16, "after_sha256": "b8f53054882bd555445732de31725872ce16497e168a1e65e368987fc957281f", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "administrative", "change_operations": [{"after_end": 16, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 16}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d11f193beaeb9106a3136960", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "8", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6485}
{"after": {"end": 11, "start": 0, "text": "Vistor ehf.", "truncated": false}, "after_length": 11, "after_sha256": "7b79f0f888fc32453606a29b908677d0b6c13a510070ab26fe31e12b995d77fe", "annex": "IIIA", "before": {"end": 10, "start": 0, "text": "Vistor hf.", "truncated": false}, "before_length": 10, "before_sha256": "4b40dfc2a19551f982dad779994a624f3432207c4666bbd66f0ec59c2f229b32", "change_kind": "content", "change_operations": [{"after_end": 8, "after_start": 7, "before_end": 7, "before_start": 7, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d137cc513d3dd6a15e2bcb44", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000112", "medicine_name": "Twinrix Adult", "medicine_slug": "twinrix-adult", "observed_at": "2026-10-12T13:29:23Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "cfad5fb0086c9b5d6a36b454f3f546373def1f56cded73e0652b498d02d68e41", "source_snapshot_id": "source-17627897b0874bf1160c7372", "source_updated_at": "2026-08-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/twinrix-adult-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1005}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 177, "start": 0, "text": "0.5 mL dispersion in a (type 1 glass or type 1 equivalent glass) single-dose vial with a stopper (chlorobutyl rubber) and a blue flip-off plastic cap with seal (aluminium seal).", "truncated": false}, "before_length": 177, "before_sha256": "c65e194965360b7e8af52bcf39f1265322b664d622918e46ecb4a7761dd7bed9", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 177, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 177, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d17466cd834f5064a8029b36", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.5", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6320}
{"after": {"end": 2, "start": 0, "text": "SC", "truncated": false}, "after_length": 2, "after_sha256": "32da6721804f1dd3226c0551970304ebf1059ec19a27451426541027861c9388", "annex": "IIIA", "before": {"end": 16, "start": 0, "text": "Subcutaneous use", "truncated": false}, "before_length": 16, "before_sha256": "363fd22613abec178143cdac0b1a34f04ee8ccdaa7d6988b3722fa7540374cde", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 1, "before_end": 16, "before_start": 1, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 15, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d1815df0ca97dbaf120ff340", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6979}
{"after": {"end": 69, "start": 0, "text": "Spikevax LP.8.1 50 mcg dispersion for injection in pre-filled syringe", "truncated": false}, "after_length": 69, "after_sha256": "061edcb2f9fa1ab0efb0fdb65179d780211123fca9d875cd7eaa84ad97b023bb", "annex": "I", "before": {"end": 67, "start": 0, "text": "Spikevax JN.1 50 mcg dispersion for injection in pre-filled syringe", "truncated": false}, "before_length": 67, "before_sha256": "9ccb296dec556dfe398a4e4d1c45d4d966207c5afe4fae527b7ef00ca62e569b", "change_kind": "administrative", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d19a7353cce0766e9fb15721", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12861}
{"after": {"end": 18, "start": 0, "text": "Tel: +370 80000334", "truncated": false}, "after_length": 18, "after_sha256": "070182b732687ebecc53ca52625433b3770e4308764e233923df1e0a7c41a74f", "annex": "IIIA", "before": {"end": 18, "start": 0, "text": "Tel. +370 80000334", "truncated": false}, "before_length": 18, "before_sha256": "4314c1144c8dfc9482f2713af5a057f582377362046ebe71b893a47f80699370", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 4, "before_start": 3, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d1a10bf8ab30e60bbf62a99d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000112", "medicine_name": "Twinrix Adult", "medicine_slug": "twinrix-adult", "observed_at": "2026-10-12T13:29:23Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "cfad5fb0086c9b5d6a36b454f3f546373def1f56cded73e0652b498d02d68e41", "source_snapshot_id": "source-17627897b0874bf1160c7372", "source_updated_at": "2026-08-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/twinrix-adult-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 916}
{"after": {"end": 21, "start": 0, "text": "Block 2 Miesian Plaza", "truncated": false}, "after_length": 21, "after_sha256": "99b504ac4fff9020da29e00aeb786f0975177380626e2b3347bd3fbd75afeeba", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "administrative", "change_operations": [{"after_end": 21, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 21}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d1f684d0ead25a9270797899", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "Qdenga poudre et solvant pour solution injectable. Qdenga poudre et solvant pour solution injectable en seringue pré-remplie Vaccin tétravalent contre la dengue (vivant, atténué)", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 975}
{"after": {"end": 295, "start": 0, "text": "• Un effet indésirable neurologique rare appelé Syndrome d’encéphalopathie postérieure réversible (SEPR) a été associé au traitement par Avastin. Si vous avez mal à la tête, des troubles de la vision, une confusion ou une convulsion avec ou sans hypertension artérielle, consultez votre médecin.", "truncated": false}, "after_length": 295, "after_sha256": "a24b733b36228fdd9fbe5987502112c01981f9092058a29e4829fce5fe19dcb2", "annex": "IIIA", "before": {"end": 292, "start": 0, "text": "• Un effet indésirable neurologique rare appelé Syndrome d’encéphalopathie postérieure réversible (SEPR) a été associé au traitement par Avastin. Si vous avez mal à la tête, des troubles de la vision, une confusion ou une attaque avec ou sans hypertension artérielle, consultez votre médecin.", "truncated": false}, "before_length": 292, "before_sha256": "e7dbe2e1a64208216d8bead4eacdb94a766793fd28669ba86828ef352052df8c", "change_kind": "content", "change_operations": [{"after_end": 226, "after_start": 222, "before_end": 227, "before_start": 222, "kind": "replace"}, {"after_end": 232, "after_start": 227, "before_end": 229, "before_start": 228, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 9}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d1fc886554ef4871e15171f3", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3017}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "Tel: +39 02 3182881", "truncated": false}, "before_length": 19, "before_sha256": "6f9e6ac8eafb4bbd7cd7d97ab4e13855ff3f41c067de37fccc45629f603eab76", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 19, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 19, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d225a3ad9492a188ab0316a8", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1141}
{"after": {"end": 336, "start": 0, "text": "les dérivés nitrés ou des produits dits « donneurs de monoxyde d’azote » tels que le nitrite d’amyle. Ces médicaments sont souvent utilisés pour traiter la pression sanguine élevée, les douleurs thoraciques d’origine cardiaque ou autres maladies du cœur. Cela comprend également les drogues à usage récréatif telles que les « poppers ».", "truncated": false}, "after_length": 336, "after_sha256": "48318973b9b906d4e5ba4140ee90fb0ceb16b3b7cb490f87da107b39afb435ba", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 336, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 336}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d229e6d7be0ffa91673b53dd", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2851}
{"after": {"end": 41, "start": 0, "text": "EU/1/20/1507/036 (paper inner tray of 10)", "truncated": false}, "after_length": 41, "after_sha256": "19368a871179b073c558d02134dc2ed8bc16fd8ebcccec05da46d608c422b0c7", "annex": "IIIA", "before": {"end": 41, "start": 0, "text": "EU/1/20/1507/026 (paper inner tray of 10)", "truncated": false}, "before_length": 41, "before_sha256": "340a8e258104f718ff43c78b07d70c8fcf61639342bc6086d8462a92975c26d8", "change_kind": "content", "change_operations": [{"after_end": 15, "after_start": 14, "before_end": 15, "before_start": 14, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d2301b45499cfdde53c16949", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9267}
{"after": {"end": 86, "start": 0, "text": "The CHMP recommends that the terms of the marketing authorisation(s) should be varied.", "truncated": false}, "after_length": 86, "after_sha256": "58ed8da449860435afd7d26d286a000f65c5901b49253a30ae46cbbcbca82784", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 86, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 86}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d2390ed99c1c6ad6391cdbb6", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2548}
{"after": {"end": 28, "start": 0, "text": "Tel.: +49 (0) 89 20 300 4500", "truncated": false}, "after_length": 28, "after_sha256": "2f47e24ea3b89eb99468dc43a719db1159dc130a0e2b969c67c6b5887bc5696f", "annex": "IIIA", "before": {"end": 27, "start": 0, "text": "Tel: +49 (0) 89 20 300 4500", "truncated": false}, "before_length": 27, "before_sha256": "3ec0c7ac949c3c79f60152bd053a52d41d0b7662db4cc5cb04f12ee2390fd91d", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d2801779399136bc62abd5a6", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3510}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 7, "start": 0, "text": "Lietuva", "truncated": false}, "before_length": 7, "before_sha256": "5109820f748796128b8bafd3806d05511bc89ad77fc3cda960facf37a639bc7f", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 7, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d2ad333a4e52157621497fdd", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1034}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 9, "start": 0, "text": "Allemagne", "truncated": false}, "before_length": 9, "before_sha256": "6b58dbd6a994339b48d8446597da22402857b3409613459c7e3a293788fbe66a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 9, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 9, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d2d8469281246860e565d623", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2175}
{"after": {"end": 40, "start": 0, "text": "EU/1/20/1507/032 (cyclic olefin polymer)", "truncated": false}, "after_length": 40, "after_sha256": "568199336bd8e8766d5b74079bfbdc0756f80a5f96a051a1cd79ea1328a841ee", "annex": "IIIA", "before": {"end": 40, "start": 0, "text": "EU/1/20/1507/020 (cyclic olefin polymer)", "truncated": false}, "before_length": 40, "before_sha256": "67d9a7d84edf92df5b30a60a971a4754efc3ba14fbf84eebf36e7cba2a7746da", "change_kind": "content", "change_operations": [{"after_end": 15, "after_start": 14, "before_end": 14, "before_start": 14, "kind": "insert"}, {"after_end": 16, "after_start": 16, "before_end": 16, "before_start": 15, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d2e29d9e38c40d1d065383cc", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9121}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "Tel: +44 (0)1304 616161", "truncated": false}, "before_length": 23, "before_sha256": "eba81e6ccdbae471c024a5ba77d9ec9e0617a3c443fd22205a626861e87fbd8c", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 23, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 23, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d31e9030b43104f5c3b5cba2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9015}
{"after": {"end": 21, "start": 0, "text": "Block 2 Miesian Plaza", "truncated": false}, "after_length": 21, "after_sha256": "99b504ac4fff9020da29e00aeb786f0975177380626e2b3347bd3fbd75afeeba", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 21, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 21}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d348324fe3480e6cd127c48b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1342}
{"after": {"end": 134, "start": 0, "text": "Detailed information on this medicinal product is available on the website of the European Medicines Agency https://www.ema.europa.eu.", "truncated": false}, "after_length": 134, "after_sha256": "9f2a855337f11701b0cd4191c51820fa5a70b201b2e0721ba6acd34544486f89", "annex": "I", "before": {"end": 133, "start": 0, "text": "Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.", "truncated": false}, "before_length": 133, "before_sha256": "eabdb61a543e11ee016c5c43ada549964199ddf9e287a2eb3256e15d4a87fe4a", "change_kind": "technical", "change_operations": [{"after_end": 113, "after_start": 112, "before_end": 112, "before_start": 112, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d392c51f249e74294fc773cc", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg solution for injection in pre-filled syringe Enbrel 50 mg solution for injection in pre-filled syringe", "presentation_occurrence": 3, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "10", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3359}
{"after": {"end": 503, "start": 0, "text": "Dans tous les essais cliniques, une hémorragie cutanéo-muqueuse a été observée chez jusqu’à 50 % des patients traités par Avastin. Il s’agissait la plupart du temps d’épistaxis de Grade 1 selon les critères du NCI-CTCAE v.3 d’une durée de moins de 5 minutes, disparaissant sans traitement et qui ne justifiaient pas de modifications du traitement par Avastin. Les données cliniques de pharmacovigilance suggèrent que l’incidence des hémorragies cutanéo-muqueuses (ex : épistaxis) serait dose dépendante.", "truncated": false}, "after_length": 503, "after_sha256": "740f548cf9007217f01cb8715cd08d3e1ae9bc0952e712e7521f454af65c850c", "annex": "I", "before": {"end": 498, "start": 0, "text": "Dans tous les essais cliniques, une hémorragie cutanéo-muqueuse a été observée jusqu’à 50 % des patients traités par Avastin. Il s’agissait la plupart du temps d’épistaxis de Grade 1 selon les critères du NCI-CTCAE v.3 d’une durée de moins de 5 minutes, disparaissant sans traitement et qui ne justifiaient pas de modifications du traitement par Avastin. Les données cliniques de pharmacovigilance suggèrent que l’incidence des hémorragies cutanéo-muqueuses (ex : épistaxis) serait dose dépendante.", "truncated": false}, "before_length": 498, "before_sha256": "6cfa0a613c42196271f28b4476f9c6b055b04d135f3413ee427fc0b6086a9881", "change_kind": "content", "change_operations": [{"after_end": 84, "after_start": 79, "before_end": 79, "before_start": 79, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 5}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d3af69cadb8d3e29d234203c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 791}
{"after": {"end": 820, "start": 0, "text": "Avant de débuter un traitement par Enbrel, une recherche de tuberculose active ou inactive (« latente ») doit être effectuée chez tous les patients. Cette recherche doit comprendre un entretien médical détaillé portant sur les antécédents personnels de tuberculose ou sur d’éventuels contacts antérieurs avec un patient tuberculeux et sur un traitement immunosuppresseur ancien et/ou en cours. Des tests de dépistage appropriés (par exemple, test dermique à la tuberculine et radiographie pulmonaire) doivent être effectués chez tous les patients (conformément aux recommandations locales). Il est recommandé de noter ces tests sur la Carte Patient.Il est rappelé aux prescripteurs que le test dermique à la tuberculine peut s’avérer faussement négatif, en particulier chez un patient sévèrement malade ou immunodéprimé.", "truncated": false}, "after_length": 820, "after_sha256": "c1085a0d66f8062ce1c56adacb6b10b198d3e78f185084f25522e1fb47a13a05", "annex": "I", "before": {"end": 821, "start": 0, "text": "Avant de débuter un traitement par Enbrel, une recherche de tuberculose active ou inactive (« latente ») doit être effectuée chez tous les patients. Cette recherche doit comprendre un entretien médical détaillé portant sur les antécédents personnels de tuberculose ou sur d’éventuels contacts antérieurs avec un patient tuberculeux et sur un traitement immunosuppresseur ancien et/ou en cours. Des tests de dépistage appropriés (par exemple, test dermique à la tuberculine et radiographie pulmonaire) doivent être effectués chez tous les patients (conformément aux recommandations locales). Il est recommandé de noter ces tests sur la Carte Patient. Il est rappelé aux prescripteurs que le test dermique à la tuberculine peut s’avérer faussement négatif, en particulier chez un patient sévèrement malade ou immunodéprimé.", "truncated": false}, "before_length": 821, "before_sha256": "4bcf845ebd7a8f31523064d283cdafd1aeaa4ecf16cf571690d54c5cb2c1ec82", "change_kind": "content", "change_operations": [{"after_end": 649, "after_start": 649, "before_end": 650, "before_start": 649, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d3e1b22ca58f6836c15682ae", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 10 mg poudre et solvant pour solution injectable pour usage pédiatrique", "presentation_occurrence": 5, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 4654}
{"after": {"end": 50, "start": 0, "text": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection", "truncated": false}, "after_length": 50, "after_sha256": "8c0d5490a68da1e449c0490ed0defe0da9d9d8c2d6ae11271b883fa7dfd5a64a", "annex": "I", "before": {"end": 48, "start": 0, "text": "Spikevax JN.1 0.1 mg/mL dispersion for injection", "truncated": false}, "before_length": 48, "before_sha256": "f251c20d6a11d153458ca69aaf22627ccbe0cce3064c14f8eb27faf9c2c0f105", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d3f5259b4bcace2495f2202b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "1", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5399}
{"after": {"end": 122, "start": 0, "text": "Having reviewed the PRAC recommendation, the CHMP agrees with the PRAC overall conclusions and grounds for recommendation.", "truncated": false}, "after_length": 122, "after_sha256": "095a3b724a58255112d0ae23e9c65e77959b40571fcaaf1946c9da9f699beeda", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 122, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 122}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d4135692f53b1a8ab582bec0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:18Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "89a938df5e41f86548301270084e3d1ecf171802e24b5429f62e3bede7ee32dd", "source_snapshot_id": "source-b71aeee5a07abebc34c02e28", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3430}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 34, "start": 0, "text": "EGIS Pharmaceuticals PLC atstovybė", "truncated": false}, "before_length": 34, "before_sha256": "10293ba397b571536dae2db03491721455ce79670e43c6a0834c8626388d7b9c", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 34, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 34, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d43fd923378042114983e2f8", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1019}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 14, "start": 0, "text": "78467 Konstanz", "truncated": false}, "before_length": 14, "before_sha256": "ee960a86a16086f43d4c7f3f51bd93d39025d5227fb1a6f1c825d1015754ff53", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d44914b0708c81817f840d08", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1208}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 32, "start": 0, "text": "Mundipharma Gesellschaft m.b.H.,", "truncated": false}, "before_length": 32, "before_sha256": "bbfa033123b5282f87503ec9344a52a3ae5eee16c0337a64e37aa2fd94bc739f", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 32, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 32, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d456a1b44f89bd9a51cb02af", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1034}
{"after": {"end": 7, "start": 0, "text": "17 (77)", "truncated": false}, "after_length": 7, "after_sha256": "95d4e49ee1812236931bb91218f01c09f1e0fe34a5eec20fd88a457f2a1a80d0", "annex": "I", "before": {"end": 7, "start": 0, "text": "16 (73)", "truncated": false}, "before_length": 7, "before_sha256": "436e980a2c225ff8334b0ed687ee08af099979fdb3666e58b8fcbff2b9172d6f", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 1, "before_end": 2, "before_start": 1, "kind": "replace"}, {"after_end": 6, "after_start": 5, "before_end": 6, "before_start": 5, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d494dc1198baf83f109a5f12", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005352", "medicine_name": "Upstaza", "medicine_slug": "upstaza", "observed_at": "2026-10-12T13:36:09Z", "pipeline_version": "2.0.0", "presentation_label": "Upstaza 2,8 × 1011 génomes de vecteur (vg)/0,5 mL, solution pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "42d7861913c7c415a9acf1067eeb3f9f1287a4e4718affc1402af95754bd6fed", "source_snapshot_id": "source-1e1e567efddae34509b5de34", "source_updated_at": "2026-06-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/upstaza-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 334}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 52, "start": 0, "text": "Spikevax JN.1 50 micrograms dispersion for injection", "truncated": false}, "before_length": 52, "before_sha256": "597e6a2a3b4949004d4fc05201b82efef68b5595489c6b3279e0567739db5110", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 52, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 52, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d4b4ef09692d8ca09289de61", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "1", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5400}
{"after": {"end": 19, "start": 0, "text": "hungary_msd@msd.com", "truncated": false}, "after_length": 19, "after_sha256": "4ffcdd5eaf215819b6063b291e957577af48205584cf794ece9fd17a4802c6e1", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "hungary_msd@merck.com", "truncated": false}, "before_length": 21, "before_sha256": "da92e6e80d6625405a462b85c1135580d63c6c4a9e76a7c5be0eef07e90aee85", "change_kind": "content", "change_operations": [{"after_end": 15, "after_start": 13, "before_end": 17, "before_start": 13, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d4cdca93ab244ad32ff10512", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3496}
{"after": {"end": 69, "start": 0, "text": "4. During dose dialling the pen does not provide an audible clicking.", "truncated": false}, "after_length": 69, "after_sha256": "e6d2e720f995725db96c6d073e8ce42a05dc59cf8895b91c39ab2e0251f207e6", "annex": "IIIA", "before": {"end": 67, "start": 0, "text": "4. During dose dialling the pen does not provide an audible signal.", "truncated": false}, "before_length": 67, "before_sha256": "424f9737d7a47c3b78d32cba51d1d7a9cbe57deefa4d76a8eb256b0b62f5959f", "change_kind": "content", "change_operations": [{"after_end": 62, "after_start": 60, "before_end": 61, "before_start": 60, "kind": "replace"}, {"after_end": 67, "after_start": 63, "before_end": 62, "before_start": 62, "kind": "insert"}, {"after_end": 68, "after_start": 68, "before_end": 66, "before_start": 63, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 6}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d4fb57b1bc109d25e692315d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2131}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 11, "start": 0, "text": "Hoge Wei 10", "truncated": false}, "before_length": 11, "before_sha256": "ba5c0cab58e83e9dc6ec41e55e6acc00077e1be63c8a1ed970723221f2f12ba4", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 11, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 11, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d5151b140c06950868896d7a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004310", "medicine_name": "Daptomycin Hospira", "medicine_slug": "daptomycin-hospira", "observed_at": "2026-10-12T19:09:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "e544a64f1681af82ba143ddd0cfa7cca4ef0de691ed43076b92bb75f66ec7f7b", "source_snapshot_id": "source-a214fce23bf43c3222026b3d", "source_updated_at": "2025-09-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/daptomycin-hospira-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2001}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "infomed@mundipharma.es", "truncated": false}, "before_length": 22, "before_sha256": "b804f6d6d90771ef4472b0befaaa07ffaa6334b73b084d8dd8578760f78b2dc5", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 22, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 22, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d5abb5f879349b489181a7c8", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1083}
{"after": {"end": 175, "start": 0, "text": "The Terrosa Pen can be used by self-injecting patients above the age of 18 years, healthcare professionals, caregivers or third parties such as, for instance, adult relatives.", "truncated": false}, "after_length": 175, "after_sha256": "2912bb0d1343baf0ab275c56bab9d1be755826e7c69351d91457682e53ba4e0e", "annex": "IIIA", "before": {"end": 163, "start": 0, "text": "The Terrosa Pen can be used by self-injecting patients above the age of 18 years, healthcare professionals or third parties such as, for instance, adult relatives.", "truncated": false}, "before_length": 163, "before_sha256": "f567efd901e7f725f3a83a5a65d5a98b362c336323251d3a12ee2c39cb2a3960", "change_kind": "content", "change_operations": [{"after_end": 118, "after_start": 106, "before_end": 106, "before_start": 106, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 12}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d5d41f60b0aded1e97f8a443", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2097}
{"after": {"end": 332, "start": 0, "text": "La date de péremption figurant sur l’étiquette de la cartouche doit toujours être vérifiée avant d’insérer la cartouche dans le Terrosa Pen. Afin d’éviter toute erreur médicamenteuse, il convient de s’assurer au moment d’utiliser une nouvelle cartouche que la date du jour est antérieure d’au moins 28 jours à sa date de péremption.", "truncated": false}, "after_length": 332, "after_sha256": "ab272402a36ee61be07f6ee6af2dd5f295cd0cdd414b12415872738a05a6cadf", "annex": "I", "before": {"end": 334, "start": 0, "text": "La date de péremption figurant sur l’étiquette de la cartouche doit toujours être vérifiée avant d’insérer la cartouche dans le stylo Terrosa. Afin d’éviter toute erreur médicamenteuse, il convient de s’assurer au moment d’utiliser une nouvelle cartouche que la date du jour est antérieure d’au moins 28 jours à sa date de péremption.", "truncated": false}, "before_length": 334, "before_sha256": "38c83dc354914119eedb991c32045c5805b64718e58ad7831c0121b949814bce", "change_kind": "content", "change_operations": [{"after_end": 128, "after_start": 128, "before_end": 134, "before_start": 128, "kind": "delete"}, {"after_end": 139, "after_start": 135, "before_end": 141, "before_start": 141, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d5fa6c102a85db885c39d018", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "Terrosa 20 microgrammes/80 microlitres solution injectable", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 469}
{"after": {"end": 20, "start": 0, "text": "dpoc.croatia@msd.com", "truncated": false}, "after_length": 20, "after_sha256": "e6060fe9f944bc26788eae6c6fde884372f9d1fb19a754bedfaa7c027a1b33e8", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "croatia_info@merck.com", "truncated": false}, "before_length": 22, "before_sha256": "759280e179a26a0343b8a3e77f7b95e8375fadcd491da4367ac6580767a10fbf", "change_kind": "content", "change_operations": [{"after_end": 5, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}, {"after_end": 12, "after_start": 12, "before_end": 12, "before_start": 7, "kind": "delete"}, {"after_end": 16, "after_start": 14, "before_end": 18, "before_start": 14, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 9, "chars_inserted": 7}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d60156443ceeb7ac2dc7a4c9", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3150}
{"after": {"end": 78, "start": 0, "text": "Les médicaments dont les effets peuvent être modifiés par Adempas, par exemple", "truncated": false}, "after_length": 78, "after_sha256": "2c128712da46e5544914c9132b3fd8a314973ee72b247151cf27a7cb6c0d2d79", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 78, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 78}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d652d90c4c48d463a2d415b2", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2867}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IV", "before": {"end": 72, "start": 0, "text": "Grounds for the variation to the terms of the marketing authorisation(s)", "truncated": false}, "before_length": 72, "before_sha256": "3186bdadc3d2480c65b477145e6ff994610239d4243371f493c1f2ab110ec5da", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 72, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 72, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d65a3b14095565d90a4deae6", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2533}
{"after": {"end": 185, "start": 0, "text": "Spikevax LP.8.1 is supplied in a single-dose, pre-filled syringe (without needle) containing 0.5 mL (50 micrograms of SARS-CoV-2 LP.8.1 mRNA) and must be thawed prior to administration.", "truncated": false}, "after_length": 185, "after_sha256": "e3da0fe016ac07fe533760ce2e39c5fa80d4bb98ca76a52cf5e8c848eb373a6c", "annex": "I", "before": {"end": 181, "start": 0, "text": "Spikevax JN.1 is supplied in a single-dose, pre-filled syringe (without needle) containing 0.5 mL (50 micrograms of SARS-CoV-2 JN.1 mRNA) and must be thawed prior to administration.", "truncated": false}, "before_length": 181, "before_sha256": "89a4e0d26e9c9faa196b0610b7431824640a3d39b361446b8c24e5d545571a2e", "change_kind": "administrative", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}, {"after_end": 133, "after_start": 129, "before_end": 129, "before_start": 127, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d65d06f1a506caf4bbef7ec8", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13117}
{"after": {"end": 360, "start": 0, "text": "L’analyse de la SSP déterminée par le comité de revue indépendant (traitements hors protocole censurés) a montré un risque relatif stratifié de 0,62 (IC 95 % : 0,50-0,77, valeur de p du test du log-rank unilatéral < 0,0001) quand le bras CPB15+ est comparé au bras CPP, avec une médiane de SSP de 13,1 mois dans le bras CPP et de 19,1 mois dans le bras CPB15+.", "truncated": false}, "after_length": 360, "after_sha256": "fee460689dd59b4697070c34d2c2a1914155cb18e68dee39ef6b2869b5c43722", "annex": "I", "before": {"end": 360, "start": 0, "text": "L’analyse de la PFS déterminée par le comité de revue indépendant (traitements hors protocole censurés) a montré un risque relatif stratifié de 0,62 (IC 95 % : 0,50-0,77, valeur de p du test du log-rank unilatéral < 0,0001) quand le bras CPB15+ est comparé au bras CPP, avec une médiane de PFS de 13,1 mois dans le bras CPP et de 19,1 mois dans le bras CPB15+.", "truncated": false}, "before_length": 360, "before_sha256": "8425641e1568466c569dc4baa89e83d7abe6beda464997edf14e975dca9c4b63", "change_kind": "content", "change_operations": [{"after_end": 18, "after_start": 16, "before_end": 16, "before_start": 16, "kind": "insert"}, {"after_end": 19, "after_start": 19, "before_end": 19, "before_start": 17, "kind": "delete"}, {"after_end": 292, "after_start": 290, "before_end": 290, "before_start": 290, "kind": "insert"}, {"after_end": 293, "after_start": 293, "before_end": 293, "before_start": 291, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d675f947c8136af79f845a53", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1788}
{"after": {"end": 84, "start": 0, "text": "Reusable pen injector to be used with Terrosa cartridges for subcutaneous injections", "truncated": false}, "after_length": 84, "after_sha256": "d60b6cbfe4aed4bc83db36a2d83a8378221213c1553cb6e76b537b5b291e7212", "annex": "IIIA", "before": {"end": 85, "start": 0, "text": "Re-usable pen injector to be used with Terrosa cartridges for subcutaneous injections", "truncated": false}, "before_length": 85, "before_sha256": "a684020daafbdc75fd4496d71b1fcb2d3bc939984fda2a6e2ab221e7196259a5", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 2, "before_end": 3, "before_start": 2, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d678f23b62a06221b3fb09a3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1941}
{"after": {"end": 225, "start": 0, "text": "1 Les investigateurs ont évalué l’analyse de la SSP spécifiée au protocole GOG (données de progression CA 125 et traitements hors protocole avant progression de la maladie non censurés) à la date du 25 février 2010 (cut-off).", "truncated": false}, "after_length": 225, "after_sha256": "08def08db9043c10589700843d60741e618bb09867aa7c6c147f8033543feab0", "annex": "I", "before": {"end": 225, "start": 0, "text": "1 Les investigateurs ont évalué l’analyse de la PFS spécifiée au protocole GOG (données de progression CA 125 et traitements hors protocole avant progression de la maladie non censurés) à la date du 25 février 2010 (cut-off).", "truncated": false}, "before_length": 225, "before_sha256": "387bac484598daee2f6d7e2b3bc512ed2b444d21b255fd3de3f7e419970ca866", "change_kind": "content", "change_operations": [{"after_end": 50, "after_start": 48, "before_end": 48, "before_start": 48, "kind": "insert"}, {"after_end": 51, "after_start": 51, "before_end": 51, "before_start": 49, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d6a001b16baac0e4e3cda1f3", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1845}
{"after": {"end": 13, "start": 0, "text": "Hermeslaan 11", "truncated": false}, "after_length": 13, "after_sha256": "6426889eacea87c88f1e0405aad54515d8a889ca0f1b2ab39e2039040651e7d3", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 13}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d6a3cb6057dc555634e9d88a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004310", "medicine_name": "Daptomycin Hospira", "medicine_slug": "daptomycin-hospira", "observed_at": "2026-10-12T19:09:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e544a64f1681af82ba143ddd0cfa7cca4ef0de691ed43076b92bb75f66ec7f7b", "source_snapshot_id": "source-a214fce23bf43c3222026b3d", "source_updated_at": "2025-09-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/daptomycin-hospira-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1598}
{"after": {"end": 15, "start": 0, "text": "Humeur modifiée", "truncated": false}, "after_length": 15, "after_sha256": "2b29d9b1fc3679985a45e56310367a96c24aa9d8cd6414ccdaf1df0b1efa75b5", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 15, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 15}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d6f9ef264bae53977ff4d76a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:31Z", "pipeline_version": "2.0.0", "presentation_label": "Otezla 10 mg comprimés pelliculés Otezla 20 mg comprimés pelliculés Otezla 30 mg comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "9ac80b0d56ebad4970f7a8335a177613af59ef25517bcd0bdd3397c207cc1bac", "source_snapshot_id": "source-c11aa9e32420f125a88005bc", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 340}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "office@mundipharma.pl", "truncated": false}, "before_length": 21, "before_sha256": "81c5ffb99abd461b2b46bd9426bde7f8bc683221226fbaf15a52f3407e427ad3", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 21, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 21, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d76daf19ae2be4edf9d441c2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1088}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 16, "start": 0, "text": "EU/1/20/1507/025", "truncated": false}, "before_length": 16, "before_sha256": "fdce0182c9ac131da7b1d1e5cdc4d0d8dcea8a120cfe77ee03199b710aebf2fd", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 16, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 16, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d7acbd46932301c40e0744b6", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "8", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6482}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 20, "start": 0, "text": "10 single-dose vials", "truncated": false}, "before_length": 20, "before_sha256": "389860e7b0c5930334ac8ab3f137b5fb5c8e0748f5a28c351a21dcaee30126f4", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 20, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 20, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d7b740a335052f8dcc29b923", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12887}
{"after": {"end": 122, "start": 0, "text": "Having reviewed the PRAC recommendation, the CHMP agrees with the PRAC overall conclusions and grounds for recommendation.", "truncated": false}, "after_length": 122, "after_sha256": "095a3b724a58255112d0ae23e9c65e77959b40571fcaaf1946c9da9f699beeda", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 122, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 122}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d7f5cac880f262bbba8cb5b7", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:30Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "35ab6716aa09492c14ac6849111486ec47235c0bc65ef055350de950f316c5e6", "source_snapshot_id": "source-f20a60110d1f8fef5225317d", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2372}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 17, "start": 0, "text": "1 hour 45 minutes", "truncated": false}, "before_length": 17, "before_sha256": "91cdd6a52d7d436f49753a82ebbf2f903deeae52be8c0c29e2c10f042b87c186", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 17, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 17, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d81de845c990b92e06ae7ea0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13100}
{"after": {"end": 43, "start": 0, "text": "8 seringues pré-remplies de 1 mL de solvant", "truncated": false}, "after_length": 43, "after_sha256": "d2d86571b6e20edf8d34c99c6483f4b81bc4697bed10f51b96d374311031d16a", "annex": "IIIA", "before": {"end": 43, "start": 0, "text": "8 seringues pré-remplies de 1 ml de solvant", "truncated": false}, "before_length": 43, "before_sha256": "b2f992ae20726855abae279950618340bd2fa45bd8c9aa60bbe29f549f773e41", "change_kind": "content", "change_operations": [{"after_end": 32, "after_start": 31, "before_end": 32, "before_start": 31, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d8297a0592afd42dd87b8e83", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6926}
{"after": {"end": 27, "start": 0, "text": "erlotinib, to treat cancer.", "truncated": false}, "after_length": 27, "after_sha256": "a999d7283f966898d2be9a537bb4297108bfa5217d31f6fdd0090d1cd65584be", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 27, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 27}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d837fbe09f77930d84d404c4", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2788}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "info@mundipharma.be", "truncated": false}, "before_length": 19, "before_sha256": "fc5e5b98df902cc2264e183a9bf7b097d1330cde86581ebd0467522133fb8584", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 19, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 19, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d852dc633c04926429626ca7", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1032}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "III", "before": {"end": 14, "start": 0, "text": "Delpharm Dijon", "truncated": false}, "before_length": 14, "before_sha256": "488aa9484cf024ead28202226d4252020932466c3441a2c99248d9d96918b046", "change_kind": "unassigned", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d87ab44c60e280191b6ae78c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000174", "medicine_name": "Plavix", "medicine_slug": "plavix", "observed_at": "2026-10-12T19:26:25Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "8d1630f20e7a86728cac32eaccf248b0a0e88d4d9a2a9cfa6e6429b883e20247", "source_snapshot_id": "source-77d6cc5bd19bd71f20e22a8e", "source_updated_at": "2025-07-14", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/plavix-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1549}
{"after": {"end": 2, "start": 0, "text": "SC", "truncated": false}, "after_length": 2, "after_sha256": "32da6721804f1dd3226c0551970304ebf1059ec19a27451426541027861c9388", "annex": "IIIA", "before": {"end": 17, "start": 0, "text": "Voie sous-cutanée", "truncated": false}, "before_length": 17, "before_sha256": "2c39e73e194fa4f0fa51aa54d98a94765b3fcf21e9faf5848d5728b740ab316d", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 0, "before_end": 17, "before_start": 0, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 17, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d87ce89685d9e11ec5e6d7e5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 7385}
{"after": {"end": 152, "start": 0, "text": "do not start Adempas for at least 24 hours after your last dose of sildenafil and at least 48 hours after your last dose of tadalafil, if you are adult.", "truncated": false}, "after_length": 152, "after_sha256": "e5e992500a7a2a8c03cb17311ceb220bd262111b26d5dc990ae1d57c3e6e4a82", "annex": "IIIA", "before": {"end": 134, "start": 0, "text": "do not start Adempas for at least 24 hours after your last dose of sildenafil and at least 48 hours after your last dose of tadalafil.", "truncated": false}, "before_length": 134, "before_sha256": "76e7cef14aefd617bf2d2b3345b9a219917d1b227f6449e3fa445110ba4108bd", "change_kind": "content", "change_operations": [{"after_end": 151, "after_start": 133, "before_end": 133, "before_start": 133, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 18}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d89c4aab1fab59035c23d388", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2855}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 18, "start": 0, "text": "medis.si@medis.com", "truncated": false}, "before_length": 18, "before_sha256": "32ce83723f0e7c81efbc7b4c51505dc3014cc642bd846a12847ce5a003709876", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 18, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 18, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d8ab36b057e01119a1a845e9", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1128}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 11, "start": 0, "text": "Takeda GmbH", "truncated": false}, "before_length": 11, "before_sha256": "94e4e4fc81542d4a8a0deb904c666e74cf300a1075af4d0d2e564a29e287bafb", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 11, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 11, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d8f89dfea2e31526724039ef", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2172}
{"after": {"end": 468, "start": 0, "text": "Les analyses statistiques ont été réalisées indépendamment pour : 1) les patients traités par capécitabine en association à Avastin ou au placebo ; 2) les patients traités par une chimiothérapie à base de taxanes ou d’anthracyclines en association à Avastin ou au placebo. Le critère principal était la Survie Sans Progression (SSP) basé sur l’évaluation de l’investigateur. Par ailleurs, le critère principal était également évalué par un Comité de Revue Indépendant.", "truncated": false}, "after_length": 468, "after_sha256": "d165c440016313dfcfe31c337214d585a50bf9d2b62ca2ff57d7ae1a2f6c0488", "annex": "I", "before": {"end": 468, "start": 0, "text": "Les analyses statistiques ont été réalisées indépendamment pour : 1) les patients traités par capécitabine en association à Avastin ou au placebo ; 2) les patients traités par une chimiothérapie à base de taxanes ou d’anthracyclines en association à Avastin ou au placebo. Le critère principal était la Survie Sans Progression (PFS) basé sur l’évaluation de l’investigateur. Par ailleurs, le critère principal était également évalué par un Comité de Revue Indépendant.", "truncated": false}, "before_length": 468, "before_sha256": "57c83cb3fa07a958ef5cd621535a71e3b3478537335213be30967de6c9440166", "change_kind": "content", "change_operations": [{"after_end": 330, "after_start": 328, "before_end": 328, "before_start": 328, "kind": "insert"}, {"after_end": 331, "after_start": 331, "before_end": 331, "before_start": 329, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d9072f87010edffbc804e04e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1412}
{"after": {"end": 10, "start": 0, "text": "50 mg/1 mL", "truncated": false}, "after_length": 10, "after_sha256": "a558007d4fff152f6cb4735b3ad12424e7cbc5a180e2d6aaf96494264fd38aaf", "annex": "IIIA", "before": {"end": 10, "start": 0, "text": "50 mg/1 ml", "truncated": false}, "before_length": 10, "before_sha256": "d29bca9bc6337ef8c0e27e23812ffbcfa8ebe5505134dbf116ff9f4ee101b05e", "change_kind": "content", "change_operations": [{"after_end": 10, "after_start": 9, "before_end": 10, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d99500450a8c729bc671373e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 7405}
{"after": {"end": 70, "start": 0, "text": "Conserver le flacon dans l'emballage extérieur, à l'abri de la lumière", "truncated": false}, "after_length": 70, "after_sha256": "dbcad915dff15478d74b99def52aa5d8b19e1d1216ad9d07530c5a8c5cc59c7e", "annex": "IIIA", "before": {"end": 80, "start": 0, "text": "Conserver le flacon dans l’emballage extérieur afin de le protéger de la lumière", "truncated": false}, "before_length": 80, "before_sha256": "614ec3b3fb3662cdd1f6566029d740a09943b455b8fd05ab3d30c0dc1f154c94", "change_kind": "content", "change_operations": [{"after_end": 27, "after_start": 26, "before_end": 27, "before_start": 26, "kind": "replace"}, {"after_end": 47, "after_start": 46, "before_end": 46, "before_start": 46, "kind": "insert"}, {"after_end": 49, "after_start": 48, "before_end": 54, "before_start": 47, "kind": "replace"}, {"after_end": 54, "after_start": 51, "before_end": 59, "before_start": 56, "kind": "replace"}, {"after_end": 56, "after_start": 55, "before_end": 66, "before_start": 60, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 17, "chars_inserted": 7}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d999d99d4e24e93b3d94d65b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2829}
{"after": {"end": 51, "start": 0, "text": "95 mmHg ou plus si vous êtes âgé(e) de 12 à 17 ans.", "truncated": false}, "after_length": 51, "after_sha256": "8f64477afcadc6494815353a14ec1b3f6b3589931bb5114751491e2d5750395f", "annex": "IIIA", "before": {"end": 76, "start": 0, "text": "95 mmHg ou plus si vous êtes âgé(e) de plus de 12 ans et de moins de 18 ans.", "truncated": false}, "before_length": 76, "before_sha256": "a99385fd5f72d41ce53985205065438e7102094c321c34872a5da7e5d2264848", "change_kind": "content", "change_operations": [{"after_end": 39, "after_start": 39, "before_end": 47, "before_start": 39, "kind": "delete"}, {"after_end": 43, "after_start": 42, "before_end": 68, "before_start": 50, "kind": "replace"}, {"after_end": 46, "after_start": 45, "before_end": 71, "before_start": 70, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 27, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-d9dfd97f1a12bfc48645af70", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3258}
{"after": {"end": 19, "start": 0, "text": "Mundipharma DC B.V.", "truncated": false}, "after_length": 19, "after_sha256": "e3293d50ef13895d680c96110997100aa9ea415c79a538edde8c542ffb4f7ce6", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 19, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 19}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-da1be3db91986a4d583c0422", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1022}
{"after": {"end": 360, "start": 0, "text": "The vaccine is shipped and supplied frozen or thawed. If the vaccine is frozen, thaw each pre-filled syringe before use following the instructions below. Syringes may be thawed in the blister packs (each blister containing 1 or 2 pre-filled syringes, depending on pack size) or in the carton itself, either in the refrigerator or at room temperature (Table 5).", "truncated": false}, "after_length": 360, "after_sha256": "69c5b3bf14309704b83026d935fe807b19bb2f9c91b8047148486a9a55c12f54", "annex": "I", "before": {"end": 360, "start": 0, "text": "The vaccine is shipped and supplied frozen or thawed. If the vaccine is frozen, thaw each pre-filled syringe before use following the instructions below. Syringes may be thawed in the blister packs (each blister containing 1 or 2 pre-filled syringes, depending on pack size) or in the carton itself, either in the refrigerator or at room temperature (Table 6).", "truncated": false}, "before_length": 360, "before_sha256": "9cc511799ec7d978a72b045a46b15e22e2f870b85030a295faab7c40417b4132", "change_kind": "administrative", "change_operations": [{"after_end": 358, "after_start": 357, "before_end": 358, "before_start": 357, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-da2e3d3a02fbb1348335e52a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13122}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 10, "start": 0, "text": "2°C to 8°C", "truncated": false}, "before_length": 10, "before_sha256": "81d810716acbe950b41556ad0d6f83327c0c94aaaad43647bd6107d8f320a304", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 10, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 10, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-da5bda2fe9e2616c0684a75f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6398}
{"after": {"end": 172, "start": 0, "text": "This document is the approved product information for COMETRIQ, with the changes since the previous procedure affecting the product information (EMA/VR/0000263255) tracked.", "truncated": false}, "after_length": 172, "after_sha256": "602221c879e5ed75a2307ca4c1f6b30f9c032f35cccb9cd354876483c4c27fbf", "annex": "", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 172, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 172}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-da6df92f7d49b17cbed1d226", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002640", "medicine_name": "Cometriq", "medicine_slug": "cometriq", "observed_at": "2026-10-12T19:00:48Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "9a013f64c372a20a7dfcfd0a30d84c365e558413e28c71df200098486d1db15b", "source_snapshot_id": "source-a2dc64012a0e2142a7477fbb", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/cometriq-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Sími: + 354 540 8000", "truncated": false}, "before_length": 20, "before_sha256": "a7506b4a5595314995c42e298571584be2588dc0ed55a3beeea4c2d5fe939c85", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 20, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 20, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-da88a42e04b2d82b91214d3d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1123}
{"after": {"end": 45, "start": 0, "text": "90 mmHg or more if you are 6 to 11 years old,", "truncated": false}, "after_length": 45, "after_sha256": "310abe146eeaa2989c4655608923df18aafa96a607535276fe984ca2f2c375c2", "annex": "IIIA", "before": {"end": 54, "start": 0, "text": "90 mmHg or more if your age is between 6 and 12 years,", "truncated": false}, "before_length": 54, "before_sha256": "9128e5d9cd864b5ced5ad3e6613cf8d89493c9196199047f89901fb89d845f9a", "change_kind": "content", "change_operations": [{"after_end": 22, "after_start": 22, "before_end": 23, "before_start": 22, "kind": "delete"}, {"after_end": 25, "after_start": 24, "before_end": 26, "before_start": 25, "kind": "replace"}, {"after_end": 26, "after_start": 26, "before_end": 38, "before_start": 27, "kind": "delete"}, {"after_end": 31, "after_start": 29, "before_end": 44, "before_start": 41, "kind": "replace"}, {"after_end": 34, "after_start": 33, "before_end": 47, "before_start": 46, "kind": "replace"}, {"after_end": 44, "after_start": 40, "before_end": 53, "before_start": 53, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 17, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-dab0bef08c12b803c2943bbb", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2733}
{"after": {"end": 163, "start": 0, "text": "antacids such as aluminium hydroxide / magnesium hydroxide, to treat indigestion or heartburn. Take antacids at least 2 hours before or 1 hour after using Adempas.", "truncated": false}, "after_length": 163, "after_sha256": "232e7f1d9186d9d59d3c81d5e0bcc0af889d462df398316f3a0354a8630eff6b", "annex": "IIIA", "before": {"end": 178, "start": 0, "text": "to treat stomach disease or heartburn called antacids such as aluminium hydroxide / magnesium hydroxide used. Take antacids at least 2 hours before or 1 hour after using Adempas.", "truncated": false}, "before_length": 178, "before_sha256": "7edc11ee235d6e956c076bad1354e3de55001ae8c03b1d201b1281ef2dea3bc0", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 45, "before_start": 0, "kind": "delete"}, {"after_end": 59, "after_start": 58, "before_end": 103, "before_start": 103, "kind": "insert"}, {"after_end": 90, "after_start": 60, "before_end": 104, "before_start": 104, "kind": "insert"}, {"after_end": 93, "after_start": 91, "before_end": 108, "before_start": 105, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 48, "chars_inserted": 33}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-db251e36e640691396c9a8cd", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2784}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "II", "before": {"end": 108, "start": 0, "text": "The Effectiveness of Nyxoid (intranasal naloxone) Administration by Lay People in Reversing Opioid Overdose.", "truncated": false}, "before_length": 108, "before_sha256": "dac1934c4ffa1f615e45a1f8e233af7642c35953279f4a3bcb20da9d50b28ac6", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 108, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 108, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-db9f04be0c8a0d64386a89ee", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:33Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "21d66bf1e9a74479f577de09da3cf8517d65c1ce1b1d8bbdfe4bc38f79410def", "source_snapshot_id": "source-2c39c998fdaf05159687c016", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 472}
{"after": {"end": 20, "start": 0, "text": "dpoc_austria@msd.com", "truncated": false}, "after_length": 20, "after_sha256": "fffcced0c5785d318bead68b726572c8df5f6a7f283341dbbaa2c0e000b9f45e", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "dpoc_austria@merck.com", "truncated": false}, "before_length": 22, "before_sha256": "24a76a21b822b2b605efa994eaf3b0998f214621c2a7d0ab97cd100c212f6bc9", "change_kind": "content", "change_operations": [{"after_end": 16, "after_start": 14, "before_end": 18, "before_start": 14, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-dbbec572b02d7d4a87aeb168", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3440}
{"after": {"end": 72, "start": 0, "text": "Medicines that can change the level of Adempas in the blood, for example", "truncated": false}, "after_length": 72, "after_sha256": "9a68e5dde529571b769db702358a8f94c7e0ef480f831e6d1ce1f35f856588cc", "annex": "IIIA", "before": {"end": 131, "start": 0, "text": "The following medicines can increase the level of Adempas in the blood which increases the risk of side effects. Medicines to treat", "truncated": false}, "before_length": 131, "before_sha256": "ecac7fc682e6191c8816ed75cde4a493fcef85e34348db690dc5dc2381182215", "change_kind": "content", "change_operations": [{"after_end": 1, "after_start": 0, "before_end": 15, "before_start": 0, "kind": "replace"}, {"after_end": 15, "after_start": 10, "before_end": 24, "before_start": 24, "kind": "insert"}, {"after_end": 22, "after_start": 19, "before_end": 29, "before_start": 28, "kind": "replace"}, {"after_end": 24, "after_start": 23, "before_end": 35, "before_start": 30, "kind": "replace"}, {"after_end": 60, "after_start": 59, "before_end": 70, "before_start": 70, "kind": "insert"}, {"after_end": 63, "after_start": 61, "before_end": 80, "before_start": 71, "kind": "replace"}, {"after_end": 64, "after_start": 64, "before_end": 103, "before_start": 81, "kind": "delete"}, {"after_end": 71, "after_start": 66, "before_end": 107, "before_start": 105, "kind": "replace"}, {"after_end": 72, "after_start": 72, "before_end": 131, "before_start": 108, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 77, "chars_inserted": 18}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-dc796574b3cb71f76c06c4b6", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3202}
{"after": {"end": 147, "start": 0, "text": "Si vous prenez ces médicaments, vous pourriez présenter davantage d’effets indésirables ou Adempas pourrait ne pas fonctionner comme il le devrait.", "truncated": false}, "after_length": 147, "after_sha256": "df9f9a30684e1cb28bca8d44598158614396f705c8795c551f97a7f79e05e7f6", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 147, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 147}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-dc82ae1e6d4089fb87418e94", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2866}
{"after": {"end": 211, "start": 0, "text": "SARSCoV2 LP.8.1 mRNA has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under section 4.8 may temporarily affect the ability to drive or use machines.", "truncated": false}, "after_length": 211, "after_sha256": "ffbe445e35478a3bee6f5421748119f4a721afa1e9a9c04675d99c673cb60e6f", "annex": "I", "before": {"end": 209, "start": 0, "text": "SARSCoV2 JN.1 mRNA has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under section 4.8 may temporarily affect the ability to drive or use machines.", "truncated": false}, "before_length": 209, "before_sha256": "e004263fcd9c433e1e881dc050416ee5932772011493bf16e963dcfe38fea71d", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-dc8cfcc534b5a69f8acd7981", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.7", "section_type": "driving", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5633}
{"after": {"end": 54, "start": 0, "text": "Takeda Pharmaceuticals International AG Ireland Branch", "truncated": false}, "after_length": 54, "after_sha256": "81709515d3af1f0e4041ce3c760d8fc81fefa358805810b0b53a84e121d5efa6", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 54, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 54}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-dc9b1507e5ef8bc8c97079b3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2183}
{"after": {"end": 9, "start": 0, "text": "Oral use.", "truncated": false}, "after_length": 9, "after_sha256": "3cb600334d66cfc50b70bcea280eaeb9fc125e589d372d56f3fae261332b8ee9", "annex": "IIIA", "before": {"end": 8, "start": 0, "text": "Oral use", "truncated": false}, "before_length": 8, "before_sha256": "1a1f6c65b762e8cde9480afdbb709dcfb59c2d46c38f5d3112c9f605bcbdf25f", "change_kind": "content", "change_operations": [{"after_end": 9, "after_start": 8, "before_end": 8, "before_start": 8, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-dcedd715a1df6ecf750e813d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2329}
{"after": {"end": 25, "start": 0, "text": "Make sure you have ready:", "truncated": false}, "after_length": 25, "after_sha256": "9854f96b8a28346bc317e0d005839bb20566a4a6a13afe4ec7782fb8430ae198", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 25, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 25}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-dcf039b04396d99e425e1b43", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1969}
{"after": {"end": 40, "start": 0, "text": "Conservation et entretien du Terrosa Pen", "truncated": false}, "after_length": 40, "after_sha256": "c21d7558834575c1e0c3303d1ac549fedc23528fda2d3e7305feed9773d05c55", "annex": "IIIA", "before": {"end": 42, "start": 0, "text": "Conservation et entretien du stylo Terrosa", "truncated": false}, "before_length": 42, "before_sha256": "b94dd1d7397410df91f197b0ac1b3f6412c839de092f5e7bfc9afe69a88629b3", "change_kind": "content", "change_operations": [{"after_end": 29, "after_start": 29, "before_end": 35, "before_start": 29, "kind": "delete"}, {"after_end": 40, "after_start": 36, "before_end": 42, "before_start": 42, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-dd2c2f6b701c92224d49c249", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3592d072525ce11938f51086292e3c38e99222a1bf24f3425d6dc450b4800681", "source_snapshot_id": "source-f0f93eac2429d0d09a8d9b8d", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2088}
{"after": {"end": 18, "start": 0, "text": "Tel: +372 614 4200", "truncated": false}, "after_length": 18, "after_sha256": "7d3522618730b1de908f19c99d5ea234b90d83a5325dd2ec72bca1ef54fabcae", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "Tel: + 372 614 4200", "truncated": false}, "before_length": 19, "before_sha256": "6c17b65f6dae7b7eb8a66b70911f988e73da3c441a896be83003ab51482ef3fd", "change_kind": "content", "change_operations": [{"after_end": 6, "after_start": 6, "before_end": 7, "before_start": 6, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-dd31798a40b8202f913a7260", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3424}
{"after": {"end": 38, "start": 0, "text": "erlotinib, gefitinib, to treat cancer.", "truncated": false}, "after_length": 38, "after_sha256": "396bf8d8ba27e1b456460c2d12688afb4508d224774b66e37b52eccd0cf94a5d", "annex": "IIIA", "before": {"end": 36, "start": 0, "text": "cancer such as erlotinib, gefitinib.", "truncated": false}, "before_length": 36, "before_sha256": "d5fb14120c9c0fa7064768d76536801578a1b90b302236b272991e0fcaf781dc", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 15, "before_start": 0, "kind": "delete"}, {"after_end": 37, "after_start": 20, "before_end": 35, "before_start": 35, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 15, "chars_inserted": 17}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-dd3ceaaf7537c48243785c74", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2781}
{"after": {"end": 72, "start": 0, "text": "Grounds for the variation to the terms of the marketing authorisation(s)", "truncated": false}, "after_length": 72, "after_sha256": "3186bdadc3d2480c65b477145e6ff994610239d4243371f493c1f2ab110ec5da", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 72, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 72}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-dd4a2a579e767d08e474c009", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:30Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "35ab6716aa09492c14ac6849111486ec47235c0bc65ef055350de950f316c5e6", "source_snapshot_id": "source-f20a60110d1f8fef5225317d", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2374}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "Τηλ: +357 22 815656", "truncated": false}, "before_length": 19, "before_sha256": "5711b6725bbda0d41ed024cf91909a0abf0deae86b71ee0bb202fca2c9265537", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 19, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 19, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-dd7a86d435da685a804a7df4", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1150}
{"after": {"end": 1126, "start": 0, "text": "L'aprémilast est associé à une augmentation du risque d'affections psychiatriques telles que l’insomnie, l’anxiété, une humeur modifiée et la dépression. Depuis la commercialisation, la survenue d’idées et de comportements suicidaires, y compris de suicides, a été observée chez des patients présentant, ou non, des antécédents de dépression (voir rubrique 4.8). Les risques et bénéfices quant à l'instauration ou la poursuite du traitement par l’aprémilast doivent être attentivement évalués si les patients présentent des symptômes psychiatriques, ou des antécédents d'affections psychiatriques, ou s’ils sont traités de façon concomitante par des médicaments susceptibles de causer des événements psychiatriques. Les patients et soignants doivent être avertis du fait qu'ils doivent informer le médecin en cas d'idées suicidaires ou de tout changement de comportement ou d'humeur. Si les patients présentent de nouveaux symptômes psychiatriques, ou que des symptômes existants s'aggravent, ou si des idées suicidaires ou une tentative de suicide sont identifiées, il est recommandé d'arrêter le traitement par l’aprémilast.", "truncated": false}, "after_length": 1126, "after_sha256": "4a30fb4e4a4db9cf8bfdf7a28f4ceb5f2434e41d24f1ea4a7e3b6b5325fe13fd", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 1126, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1126}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-dd95f55ed92b9f8167665050", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "9ac80b0d56ebad4970f7a8335a177613af59ef25517bcd0bdd3397c207cc1bac", "source_snapshot_id": "source-c11aa9e32420f125a88005bc", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2729}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 14, "start": 0, "text": "78467 Konstanz", "truncated": false}, "before_length": 14, "before_sha256": "ee960a86a16086f43d4c7f3f51bd93d39025d5227fb1a6f1c825d1015754ff53", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ddafb38244b6977df07663d2", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2174}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "Tel: +44 (0)1304 616161", "truncated": false}, "before_length": 23, "before_sha256": "eba81e6ccdbae471c024a5ba77d9ec9e0617a3c443fd22205a626861e87fbd8c", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 23, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 23, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ddbae733ae9e3ccac9da54d7", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9691}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 17, "start": 0, "text": "Byk-Gulden-Str. 2", "truncated": false}, "before_length": 17, "before_sha256": "5dc95d013d793b6958719e5db82aa51cd0c1864e2e8bc9bfcf2cfded1a05eba6", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 17, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 17, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ddd7c450965a563fd3c652da", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1208}
{"after": {"end": 74, "start": 0, "text": "1, rue de la Vierge, Ambarès & Lagrave, F-33565 Carbon Blanc cedex, France", "truncated": false}, "after_length": 74, "after_sha256": "14a8d5719db7e3ae2c03a3bde8c651b53274b008cb6172a9ff8e53df45aed953", "annex": "III", "before": {"end": 77, "start": 0, "text": "1, rue de la Vierge, Ambarès & Lagrave, F-33565 Carbon Blanc cedex, France ou", "truncated": false}, "before_length": 77, "before_sha256": "3fad7048d2fcac7a3d79b04ae89aab59e1d3a14ebb3a98abe20af0a6cce4f8bf", "change_kind": "unassigned", "change_operations": [{"after_end": 74, "after_start": 74, "before_end": 77, "before_start": 74, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 3, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ddf50ebe425eefe3335f362a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000174", "medicine_name": "Plavix", "medicine_slug": "plavix", "observed_at": "2026-10-12T19:26:25Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "8d1630f20e7a86728cac32eaccf248b0a0e88d4d9a2a9cfa6e6429b883e20247", "source_snapshot_id": "source-77d6cc5bd19bd71f20e22a8e", "source_updated_at": "2025-07-14", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/plavix-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1548}
{"after": {"end": 19, "start": 0, "text": "Tel.: +371 67025300", "truncated": false}, "after_length": 19, "after_sha256": "9d56d23b23e1cc8fe2e91dfd2c53e6e0d7c450088c854b2bc903cc7de0211cce", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Tel.: + 371 67025300", "truncated": false}, "before_length": 20, "before_sha256": "4827747deaf690f224c8bd3d87c76b9541304a06d0d293efd223d7eb4b6cb8df", "change_kind": "content", "change_operations": [{"after_end": 7, "after_start": 7, "before_end": 8, "before_start": 7, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-de05d5060c1176c3b2f77cf3", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3198}
{"after": {"end": 20, "start": 0, "text": "Tel: +385 1 6611 333", "truncated": false}, "after_length": 20, "after_sha256": "ac17f5de7a55b551146b4e13e2e182c0c768e2407d11ada47b7ea50ccc88e7a9", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tel: + 385 1 6611 333", "truncated": false}, "before_length": 21, "before_sha256": "832fb9e4a0309ac207ea1cddc7b0f0d314eb5cd3eac51bc4ad14b8ef55b1e935", "change_kind": "content", "change_operations": [{"after_end": 6, "after_start": 6, "before_end": 7, "before_start": 6, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-de0769404e40b94767d1c98b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3559}
{"after": {"end": 16, "start": 0, "text": "EU/1/20/1507/035", "truncated": false}, "after_length": 16, "after_sha256": "ca38cdb9a485d16272a176be5c3f39300f5ea0ae4ffe2a2b1f0fc2161c464c22", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "administrative", "change_operations": [{"after_end": 16, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 16}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-de2329d08697f334bee9a2bd", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "8", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6488}
{"after": {"end": 119, "start": 0, "text": "Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu", "truncated": false}, "after_length": 119, "after_sha256": "0f2b81ab8009e1a279ca008eb6e21bdb2e532de63aef52b62bdac980c49555d4", "annex": "IIIA", "before": {"end": 118, "start": 0, "text": "Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu", "truncated": false}, "before_length": 118, "before_sha256": "d114210a3c6f4b6710e22609ee80410ff17f5efd93b30ab72728a60b65635068", "change_kind": "technical", "change_operations": [{"after_end": 99, "after_start": 98, "before_end": 98, "before_start": 98, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-de2d9aecbf58f804b459aef5", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 10561}
{"after": {"end": 69, "start": 0, "text": "maux de tête (fréquent : pouvant concerner jusqu’à 1 personne sur 10)", "truncated": false}, "after_length": 69, "after_sha256": "00efd936d5964d23e6b12a93e5b410f8f402fff80945f240bb850050bd878fdc", "annex": "IIIA", "before": {"end": 69, "start": 0, "text": "maux de tête (Fréquent : pouvant concerner jusqu’à 1 personne sur 10)", "truncated": false}, "before_length": 69, "before_sha256": "fb58bfadb13a736549d49ee1e01c17fb4569909992839a82df96989895f62b10", "change_kind": "content", "change_operations": [{"after_end": 15, "after_start": 14, "before_end": 15, "before_start": 14, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-de3f9228728c26b31ab64abf", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3392}
{"after": {"end": 459, "start": 0, "text": "In view of available data on hyaline occlusive glomerular microangiopathy reported in the literature, including in some cases a positive de-challenge and in view of a plausible mechanism of action, the PRAC considers a causal relationship between bevacizumab and hyaline occlusive glomerular microangiopathy is at least a reasonable possibility. The PRAC concluded that the product information of products containing bevacizumab should be amended accordingly.", "truncated": false}, "after_length": 459, "after_sha256": "4be488e55eb9021bc0be5d7fbec9d4f35ae73a286ab79da35d6be0dad3020925", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 459, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 459}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-de591cdcf2613501bf4e4aa5", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:18Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "89a938df5e41f86548301270084e3d1ecf171802e24b5429f62e3bede7ee32dd", "source_snapshot_id": "source-b71aeee5a07abebc34c02e28", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3428}
{"after": {"end": 268, "start": 0, "text": "The MAH shall ensure that in each Member State where etanercept is marketed, all healthcare professionals who are expected to prescribe etanercept and all patients who are expected to use etanercept have access to/are provided with the following educational materials:", "truncated": false}, "after_length": 268, "after_sha256": "fa60c85a994ba18d8e1407894e470ab6031ea190d712b5a326d33a056085f372", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 268, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 268}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-de5c6129d77f033c967dfde3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6569}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 6, "start": 0, "text": "Κύπρος", "truncated": false}, "before_length": 6, "before_sha256": "7f8ef8a379e33810aefd13f344f489d85e8902de6fdcd1b46a4e856985b5e14e", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 6, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-de7727d36017b0033d1e49a1", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1148}
{"after": {"end": 7, "start": 0, "text": "Ireland", "truncated": false}, "after_length": 7, "after_sha256": "02bf1dfa9a0365a86223f0e4ac9eaa0517b06b2e9273790f719feda656a247ae", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 7, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 7}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-de8ceac0c3698fcc9e416558", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1720}
{"after": {"end": 11, "start": 0, "text": "Voie orale.", "truncated": false}, "after_length": 11, "after_sha256": "dd303ff5eaeb3946adedda2cb1cc0525b4d6b7561b2450d515addd890456afe9", "annex": "IIIA", "before": {"end": 10, "start": 0, "text": "Voie orale", "truncated": false}, "before_length": 10, "before_sha256": "b21e8d51c5cf6ffc46ec58c52f7fd9782e18be932f51e39153050c410cb9b1b2", "change_kind": "content", "change_operations": [{"after_end": 11, "after_start": 10, "before_end": 10, "before_start": 10, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-de97c2d7251e0a548aa91ee9", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:32:00Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3ff8cd4d67d22ba799aa348aeda944d6d896a16dcf54b030db101cbc095fc8ad", "source_snapshot_id": "source-a79a7cba8bf5dbc72fd40574", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2276}
{"after": {"end": 7, "start": 0, "text": "Irlande", "truncated": false}, "after_length": 7, "after_sha256": "a8cdfff5dbbda1b070a2acb339b6f0aa20b6230d9b5500c9ce066eaa89bc9a64", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "administrative", "change_operations": [{"after_end": 7, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 7}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-dee1610e7be5ca8de9a73a4d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "Qdenga poudre et solvant pour solution injectable. Qdenga poudre et solvant pour solution injectable en seringue pré-remplie Vaccin tétravalent contre la dengue (vivant, atténué)", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 979}
{"after": {"end": 19, "start": 0, "text": "dpoc.greece@msd.com", "truncated": false}, "after_length": 19, "after_sha256": "d96a401106c51f4f8693adaf45abc406ae4e520f06826181cac8e7fb34e045be", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Dpoc_greece@merck.com", "truncated": false}, "before_length": 21, "before_sha256": "0e58b408798c0d2dce72f7f9b6fbca9c33c77ce71bb2d3fbab6c0b153e44fc5e", "change_kind": "content", "change_operations": [{"after_end": 1, "after_start": 0, "before_end": 1, "before_start": 0, "kind": "replace"}, {"after_end": 5, "after_start": 4, "before_end": 5, "before_start": 4, "kind": "replace"}, {"after_end": 15, "after_start": 13, "before_end": 17, "before_start": 13, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-df170b9f4a425d1f4392ffaa", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3435}
{"after": {"end": 184, "start": 0, "text": "Des cas d’anomalies fœtales chez des femmes traitées par bevacizumab seul ou en association à des chimiothérapies connues pour être embryotoxiques ont été observés (voir rubrique 4.6).", "truncated": false}, "after_length": 184, "after_sha256": "026ffaa54be29591dee4ff40dfed3ad95d9ea06f413f1cabcd59a9654e2666bc", "annex": "I", "before": {"end": 185, "start": 0, "text": "Des cas d’anomalies fœtales chez des femmes traitées par bevacizumab seul ou en association à des chimiothérapies connues pour être embryotoxiques ont été observées (voir rubrique 4.6).", "truncated": false}, "before_length": 185, "before_sha256": "6b10d6d2ba8cdff6fb36edc313956bc02b1adab77ef79d1cc5d8265d0cb9afbd", "change_kind": "content", "change_operations": [{"after_end": 162, "after_start": 162, "before_end": 163, "before_start": 162, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-df1fd044c8d2bc013689fbf0", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 885}
{"after": {"end": 65, "start": 0, "text": "Handling instructions for the Spikevax LP.8.1 pre-filled syringes", "truncated": false}, "after_length": 65, "after_sha256": "f15c62005f4fa94e386cf6f905b17df972ad4565198cc4c1a1f77f08377cc021", "annex": "I", "before": {"end": 63, "start": 0, "text": "Handling instructions for the Spikevax JN.1 pre-filled syringes", "truncated": false}, "before_length": 63, "before_sha256": "168f456b2e3e7a2c30ccdf73704a9be7ebf39b3799db788a2bc437f7c766d364", "change_kind": "content", "change_operations": [{"after_end": 43, "after_start": 39, "before_end": 41, "before_start": 39, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-df3bf11927b68d188de3e531", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6449}
{"after": {"end": 246, "start": 0, "text": "Vérifiez la présence de signes de surdosage, comme : aucune réaction au toucher ou au bruit, respiration lente et irrégulière ou absence de respiration, ronflement, halètement, déglutition, ongles ou lèvre bleus ou violets, pupilles très petites.", "truncated": false}, "after_length": 246, "after_sha256": "fce158b41e41a1037c5ce4756dd76c004a666a0c348822dc3bd1b63170a92a5c", "annex": "IIIA", "before": {"end": 223, "start": 0, "text": "Vérifiez la présence de signes de surdosage, comme : aucune réaction au toucher ou au bruit, respiration lente et irrégulière ou absence de respiration, ronflement, halètement, déglutition, ongles ou lèvre bleus ou violets.", "truncated": false}, "before_length": 223, "before_sha256": "cb5a3a635c609a0c38c2f0e8ea3295a04d2231af74d4ff54201fc0529df9416b", "change_kind": "content", "change_operations": [{"after_end": 245, "after_start": 222, "before_end": 222, "before_start": 222, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 23}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-df516fc8dc824a73ac28e876", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 832}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "Teл.: + 359 2 962 13 56", "truncated": false}, "before_length": 23, "before_sha256": "bfb4a42942146d3ccf5bea091cf10ea2e677a3059cc805c633c7ec4fe1347908", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 23, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 23, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-df778fd82963836d8802910d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1041}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 33, "start": 0, "text": "United Kingdom (Northern Ireland)", "truncated": false}, "before_length": 33, "before_sha256": "9379d82927cdb505cfb186e912177065e56a1314de3a2b914ebbb8b5fe21525a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 33, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 33, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-dfab445a243e5574ae1b10ef", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9575}
{"after": {"end": 21, "start": 0, "text": "Tel.: +351 21 4465700", "truncated": false}, "after_length": 21, "after_sha256": "81a4c4002df1418d2222d806783560055518461831297fdd2d0c5bfb5f673696", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Tel: + 351 214465700", "truncated": false}, "before_length": 20, "before_sha256": "4a3d7a7c5925473eef92c2cd7a2e616c5dd3e20a042ab127910a184d9dfd503d", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}, {"after_end": 7, "after_start": 7, "before_end": 7, "before_start": 6, "kind": "delete"}, {"after_end": 14, "after_start": 13, "before_end": 13, "before_start": 13, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-dffa163bee5408ce5d4dc92f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3458}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "Make sure you have ready:", "truncated": false}, "before_length": 25, "before_sha256": "9854f96b8a28346bc317e0d005839bb20566a4a6a13afe4ec7782fb8430ae198", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 25, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 25, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e00e02b71932d8067152434b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2030}
{"after": {"end": 832, "start": 0, "text": "La sécurité et l’efficacité d’Enbrel à la dose de 50 mg (deux injections de 25 mg par voie SC) administrée une fois par semaine ont été évaluées au cours d’une étude en double aveugle, contrôlée contre placebo chez 420 patients atteints de PR active. Dans cette étude, 53 patients ont reçu du placebo, 214 patients ont reçu 50 mg d’Enbrel une fois par semaine et 153 patients ont reçu 25 mg d’Enbrel deux fois par semaine. Les profils d’efficacité et de sécurité des deux schémas posologiques d’Enbrel ont été similaires à la semaine 8 sur les signes et symptômes de la PR ; à la semaine 16, la comparabilité (non-infériorité) entre les deux schémas posologiques n’a pas été démontrée. Il a été démontré que l’administration d’une injection unique de 50 mg/mL d’Enbrel était bioéquivalente à deux injections simultanées de 25 mg/mL.", "truncated": false}, "after_length": 832, "after_sha256": "3c6968677a619a0eebf5f8aab69f4cff9a1e97f6c34158f798d678c99c003e58", "annex": "I", "before": {"end": 832, "start": 0, "text": "La sécurité et l’efficacité d’Enbrel à la dose de 50 mg (deux injections de 25 mg par voie SC) administrée une fois par semaine ont été évaluées au cours d’une étude en double aveugle, contrôlée contre placebo chez 420 patients atteints de PR active. Dans cette étude, 53 patients ont reçu du placebo, 214 patients ont reçu 50 mg d’Enbrel une fois par semaine et 153 patients ont reçu 25 mg d’Enbrel deux fois par semaine. Les profils d’efficacité et de sécurité des deux schémas posologiques d’Enbrel ont été similaires à la semaine 8 sur les signes et symptômes de la PR ; à la semaine 16, la comparabilité (non-infériorité) entre les deux schémas posologiques n’a pas été démontrée. Il a été démontré que l’administration d’une injection unique de 50 mg/ml d’Enbrel était bioéquivalente à deux injections simultanées de 25 mg/ml.", "truncated": false}, "before_length": 832, "before_sha256": "a07da594b281e0fcd36bd16281164fda6a3bebb1a4052dee60a320c7abb04e78", "change_kind": "content", "change_operations": [{"after_end": 759, "after_start": 758, "before_end": 759, "before_start": 758, "kind": "replace"}, {"after_end": 831, "after_start": 830, "before_end": 831, "before_start": 830, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e0a518c52f4a947c19f9e8de", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg, solution injectable en cartouche distributrice de dose Enbrel 50 mg, solution injectable en cartouche distributrice de dose", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6061}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tlf: + 47 67 51 89 00", "truncated": false}, "before_length": 21, "before_sha256": "7c43090a27c13dac0bc43320de0895010db2bed3594a32688343af9caeaf0ceb", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 21, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 21, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e0eb9c2290b7fb167ab873f8", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1082}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "II", "before": {"end": 115, "start": 0, "text": "Le titulaire de l’autorisation de mise sur le marché réalisera, selon le calendrier indiqué, les mesures ci-après :", "truncated": false}, "before_length": 115, "before_sha256": "97c2200eb1c6c2fc54a2af2b4f391c48f671addd41b64d06efb06e812162ed7c", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 115, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 115, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e11a3621529538b4f6c47c10", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 469}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 18, "start": 0, "text": "Medis Adria d.o.o.", "truncated": false}, "before_length": 18, "before_sha256": "9b45905f5bb1f7f631c00c103a5a406afd1cae41339f56b79ed37f9802cbeca4", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 18, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 18, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e1549a98a82ee1ce684da18e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1113}
{"after": {"end": 270, "start": 0, "text": "Spikevax LP.8.1 is a vaccine used to prevent COVID-19 caused by SARSCoV2. It is given to adults and children aged 6 months and older. The active substance in Spikevax LP.8.1 is mRNA encoding the SARSCoV2 spike protein. The mRNA is embedded in SM-102 lipid nanoparticles.", "truncated": false}, "after_length": 270, "after_sha256": "c0534689e86c4703382f52fb7ef4c45a8c4180ffccf6b7190609901e1971338c", "annex": "I", "before": {"end": 266, "start": 0, "text": "Spikevax JN.1 is a vaccine used to prevent COVID-19 caused by SARSCoV2. It is given to adults and children aged 6 months and older. The active substance in Spikevax JN.1 is mRNA encoding the SARSCoV2 spike protein. The mRNA is embedded in SM-102 lipid nanoparticles.", "truncated": false}, "before_length": 266, "before_sha256": "9129cf3bf50387276548c016c024f563ad4df527c3c2f60dda2631e736378eb7", "change_kind": "administrative", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}, {"after_end": 171, "after_start": 167, "before_end": 167, "before_start": 165, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e1906afa54704351cc8c42a7", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12625}
{"after": {"end": 178, "start": 0, "text": "Data beyond the Month 60 and Month 12 timepoints in Study AADC-010 and Study AADC-011, respectively, were collected in the long-term follow-up Study AADC-1602 as indicated below.", "truncated": false}, "after_length": 178, "after_sha256": "88c8adfe1938599edd74e96d6d6140915776c52f2bb1c25101833e93137d3333", "annex": "I", "before": {"end": 219, "start": 0, "text": "Data beyond the Month 60 and Month 12 timepoints in Study AADC-010 and Study AADC-011, respectively, were collected in the long-term follow-up Study AADC-1602 as indicated below, with a data cutoff date of 16 June 2023.", "truncated": false}, "before_length": 219, "before_sha256": "9667fd2f5a94226ab46e688d36ba72ef2e6bd953ae7e79718ff6382974a7cef9", "change_kind": "content", "change_operations": [{"after_end": 177, "after_start": 177, "before_end": 218, "before_start": 177, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 41, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e192a55c52e1de1d9492ff28", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005352", "medicine_name": "Upstaza", "medicine_slug": "upstaza", "observed_at": "2026-10-12T13:36:07Z", "pipeline_version": "2.0.0", "presentation_label": "Upstaza 2.8 × 1011 vector genomes (vg)/0.5 mL solution for infusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8561a0c5aed752dd415d30acef76bf620ad205d702080a0bca765e086873fe20", "source_snapshot_id": "source-4b712d5f9e4e2e8cd620aa93", "source_updated_at": "2026-06-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/upstaza-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 282}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IV", "before": {"end": 236, "start": 0, "text": "On the basis of the scientific conclusions for perampanel the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing perampanel is unchanged subject to the proposed changes to the product information", "truncated": false}, "before_length": 236, "before_sha256": "a1f4dbe73d901782db389b8f100ba994091e97e73f177a04bba849e8743f1072", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 236, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 236, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e1a634cccf09cc9843c9ded3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3433}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 35, "start": 0, "text": "Mundipharma Pharmaceuticals Limited", "truncated": false}, "before_length": 35, "before_sha256": "c9f3bc818698700e6aea923854537c9e902c0d2d4a55bc83c3346f2abbcfd880", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 35, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 35, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e1c01afbe279d948b7310f55", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1133}
{"after": {"end": 20, "start": 0, "text": "Tel. +370 5 2780 247", "truncated": false}, "after_length": 20, "after_sha256": "be9916884a39997d225e35a54dcbad608c2f1450d383ed91a2b2c37447acf059", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Tel + 370 5 2780 247", "truncated": false}, "before_length": 20, "before_sha256": "efbdd6098836fb2d599921d1b729194cb12c4277b6ed9ce6d128aeedf65638c9", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}, {"after_end": 6, "after_start": 6, "before_end": 6, "before_start": 5, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e1f92f9767164b2f3da7029a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2978}
{"after": {"end": 148, "start": 0, "text": "Des informations détaillées sur ce médicament sont disponibles sur le site internet de l’Agence européenne des médicaments https://www.ema.europa.eu", "truncated": false}, "after_length": 148, "after_sha256": "0144d9770eb4c4153d7e7b1c9dec56544610f245adee115432038125fa622184", "annex": "I", "before": {"end": 147, "start": 0, "text": "Des informations détaillées sur ce médicament sont disponibles sur le site internet de l’Agence européenne des médicaments http://www.ema.europa.eu", "truncated": false}, "before_length": 147, "before_sha256": "d0dd4118d52714b2cfcf09f73f7031efc575f51b70183bf3d601893b6bf4e936", "change_kind": "technical", "change_operations": [{"after_end": 128, "after_start": 127, "before_end": 127, "before_start": 127, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e2099dbef24bf251a845e2c2", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 10 mg poudre et solvant pour solution injectable pour usage pédiatrique", "presentation_occurrence": 5, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "10", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5438}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 43, "start": 0, "text": "The vaccine comes ready to use once thawed.", "truncated": false}, "before_length": 43, "before_sha256": "a4f540004da2311077aa0ae1cd291686425e5d1fb0dbdf3f249e9192732dcfc9", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 43, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 43, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e2184923d9d1df921545ac7e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13075}
{"after": {"end": 17, "start": 0, "text": "msdpolska@msd.com", "truncated": false}, "after_length": 17, "after_sha256": "1b250a519a0f233f4e354eb6c7114ba65293ff16c0041901602d11e2c6c3498c", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "msdpolska@merck.com", "truncated": false}, "before_length": 19, "before_sha256": "5690867ba2de57367aef5787dfb5119647492569c1acc32aee4d6aec5daced2d", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 11, "before_end": 15, "before_start": 11, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e219dd0f9d47c016ee123fca", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3049}
{"after": {"end": 218, "start": 0, "text": "Close observation for at least 15 minutes is recommended following vaccination. Subsequent doses of Spikevax LP.8.1 should not be given to those who have experienced anaphylaxis to a prior dose of any Spikevax vaccine.", "truncated": false}, "after_length": 218, "after_sha256": "63232632940cf41ed0cbc83f7e6de82d7375d3910e634f57ac684988c0070bfb", "annex": "I", "before": {"end": 216, "start": 0, "text": "Close observation for at least 15 minutes is recommended following vaccination. Subsequent doses of Spikevax JN.1 should not be given to those who have experienced anaphylaxis to a prior dose of any Spikevax vaccine.", "truncated": false}, "before_length": 216, "before_sha256": "c51cb3afd80f57c12c4ca10d20626c6929da5b222261c1e09850ea2e6de7b65d", "change_kind": "content", "change_operations": [{"after_end": 113, "after_start": 109, "before_end": 111, "before_start": 109, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e220aa34335c3b07d6fce2c5", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5563}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "nordics@mundipharma.dk", "truncated": false}, "before_length": 22, "before_sha256": "f439d81e92f339fb15af44387dc1531c6265af6c724b25a05f18a5ab6acd0f1e", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 22, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 22, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e2581bd9713938defb319846", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1068}
{"after": {"end": 25, "start": 0, "text": "50-58 Baggot Street Lower", "truncated": false}, "after_length": 25, "after_sha256": "2b6052bef6a7051ce20b776d1525055c417fc02e59b9e559cd21b7aa4c7859f0", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 25, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 25}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e2837a6cb7c51e5494cc94e7", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1717}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IV", "before": {"end": 69, "start": 0, "text": "Le CHMP approuve les conclusions scientifiques formulées par le PRAC.", "truncated": false}, "before_length": 69, "before_sha256": "90c7bcf5bda957d755e24ac4a267c2580e64de699683322d8f07b6bc87a9570e", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 69, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 69, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e2a9d9869c0b649ab0d1df35", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:32:00Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "3ff8cd4d67d22ba799aa348aeda944d6d896a16dcf54b030db101cbc095fc8ad", "source_snapshot_id": "source-a79a7cba8bf5dbc72fd40574", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3522}
{"after": {"end": 129, "start": 0, "text": "Les instructions relatives à l’enregistrement du nom de marque et du numéro de lot du médicament afin d’en assurer la traçabilité", "truncated": false}, "after_length": 129, "after_sha256": "8cf8fd038e391835323b04d3328446de9913e56536257130c2dd3a92ab062615", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 129, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 129}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e2c7305c21560c949dcd87dd", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6663}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "Tel: +386 158969 00", "truncated": false}, "before_length": 19, "before_sha256": "4cd23e9bc09f4d7f9f6c0d56d2ed6523e2e88ecb6a8bb6fc53cde3b5c9caec06", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 19, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 19, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e302dbf03fecbecab87e6e36", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1118}
{"after": {"end": 22, "start": 0, "text": "medicalinfo.nl@msd.com", "truncated": false}, "after_length": 22, "after_sha256": "578550b051823e92654f0b1dd2f62a8da0f4aa2c1bad41b233b8e6951a41272c", "annex": "IIIA", "before": {"end": 24, "start": 0, "text": "medicalinfo.nl@merck.com", "truncated": false}, "before_length": 24, "before_sha256": "cc3a8af00f6f52af5b0956221d649740a16b082158e556d4b49a01bcba8e6a99", "change_kind": "content", "change_operations": [{"after_end": 18, "after_start": 16, "before_end": 20, "before_start": 16, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e31cd20c2f6d78b1fe91ce28", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3420}
{"after": {"end": 226, "start": 0, "text": "cc Cet effet indésirable n’a pas été observé dans l’étude POSEIDON mais des cas ont été rapportés chez des patients traités par trémélimumab en association au durvalumab dans des études cliniques en dehors de l’étude POSEIDON.", "truncated": false}, "after_length": 226, "after_sha256": "f51788e9bbb88226ebaf8b1469397814de299a23ff779607347e70b60a60273a", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 226, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 226}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e35842f781f6af16800ea9a8", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:18Z", "pipeline_version": "2.0.0", "presentation_label": "IMJUDO 20 mg/ml, solution à diluer pour perfusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "2437ab76633f46c9eee5e002e5c7a7caba6367f59567d750be0eb67c74d1db4e", "source_snapshot_id": "source-7f4d129b0a0fd2d3684d27c5", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 924}
{"after": {"end": 2, "start": 0, "text": "SC", "truncated": false}, "after_length": 2, "after_sha256": "32da6721804f1dd3226c0551970304ebf1059ec19a27451426541027861c9388", "annex": "IIIA", "before": {"end": 17, "start": 0, "text": "Voie sous-cutanée", "truncated": false}, "before_length": 17, "before_sha256": "2c39e73e194fa4f0fa51aa54d98a94765b3fcf21e9faf5848d5728b740ab316d", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 0, "before_end": 17, "before_start": 0, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 17, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e3a7ed20846bec0642d51ad3", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 7053}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 2, "start": 0, "text": "16", "truncated": false}, "before_length": 2, "before_sha256": "b17ef6d19c7a5b1ee83b907c595526dcb1eb06db8227d650d5dda0a9f4ce8cd9", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 2, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e44f9e88cc8a415f845c7b12", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005352", "medicine_name": "Upstaza", "medicine_slug": "upstaza", "observed_at": "2026-10-12T13:36:07Z", "pipeline_version": "2.0.0", "presentation_label": "Upstaza 2.8 × 1011 vector genomes (vg)/0.5 mL solution for infusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8561a0c5aed752dd415d30acef76bf620ad205d702080a0bca765e086873fe20", "source_snapshot_id": "source-4b712d5f9e4e2e8cd620aa93", "source_updated_at": "2026-06-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/upstaza-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 331}
{"after": {"end": 632, "start": 0, "text": "Les caractéristiques des concentrations sériques moyennes à l’état d’équilibre chez les patients atteints de PR étaient une Cmax de 2,4 mg/l vs 2,6 mg/l, une Cmin de 1,2 mg/l vs 1,4 mg/l, et une ASC partielle de 297 mgh/l vs 316 mgh/l pour la dose de 50 mg d’Enbrel une fois par semaine (n = 21) vs 25 mg d’Enbrel deux fois par semaine (n = 16) respectivement. Dans une étude en ouvert, croisée, avec administration unique de deux posologies différentes chez des volontaires sains, il a été démontré que l’administration d’une injection unique de 50 mg/mL d’etanercept était bioéquivalente à deux injections simultanées de 25 mg/mL.", "truncated": false}, "after_length": 632, "after_sha256": "a314719d36f9cbee570762008a9dbbdc562da2fa0fcbf7079b1f1d65515aa5c9", "annex": "I", "before": {"end": 632, "start": 0, "text": "Les caractéristiques des concentrations sériques moyennes à l’état d’équilibre chez les patients atteints de PR étaient une Cmax de 2,4 mg/l vs 2,6 mg/l, une Cmin de 1,2 mg/l vs 1,4 mg/l, et une ASC partielle de 297 mgh/l vs 316 mgh/l pour la dose de 50 mg d’Enbrel une fois par semaine (n = 21) vs 25 mg d’Enbrel deux fois par semaine (n = 16) respectivement. Dans une étude en ouvert, croisée, avec administration unique de deux posologies différentes chez des volontaires sains, il a été démontré que l’administration d’une injection unique de 50 mg/ml d’etanercept était bioéquivalente à deux injections simultanées de 25 mg/ml.", "truncated": false}, "before_length": 632, "before_sha256": "8c065fd129119e22879a2173b5d388342b9c02f7cde21405d481a9d61753f047", "change_kind": "content", "change_operations": [{"after_end": 555, "after_start": 554, "before_end": 555, "before_start": 554, "kind": "replace"}, {"after_end": 631, "after_start": 630, "before_end": 631, "before_start": 630, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e466e9e7ed457d6859478a1d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 10 mg poudre et solvant pour solution injectable pour usage pédiatrique", "presentation_occurrence": 5, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5347}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 393, "start": 0, "text": "If transport at -50°C to -15°C is not feasible, available data support transportation of one or more thawed single-dose vials in liquid state for up to 36 hours at 2°C to 8°C (within the 30 days or 14 days shelf life, respectively, at 2°C to 8°C). Once thawed and transported in liquid state at 2°C to 8°C, single-dose vials should not be refrozen and should be stored at 2°C to 8°C until use.", "truncated": false}, "before_length": 393, "before_sha256": "4663e056b45578084232fa9caf61b42ed782bdd5776aa1cb3882099f3f01c9d6", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 393, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 393, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e48d9e963ce471404b6d3b84", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.4", "section_type": "storage", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6298}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 73, "start": 0, "text": "Table 9. Thawing instructions for single-dose vials and carton before use", "truncated": false}, "before_length": 73, "before_sha256": "72459dd0fb308ca791fc5ace81d4177f078c2f31aa31a159284d0135fa5aea22", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 73, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 73, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e494d57bfa19219ecf7245c9", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6388}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "Slovenská republika", "truncated": false}, "before_length": 19, "before_sha256": "8667151da5d74cf45a2b263a2f7b38e944fd51f34b51e08d79151f123b8f10b2", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 19, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 19, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e4a9e648aa245f7999cd0a3b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1126}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IV", "before": {"end": 99, "start": 0, "text": "SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S)", "truncated": false}, "before_length": 99, "before_sha256": "4d43e1a4109e8a776bcf1a5f90e9a1bc3b91d0b8306edf4d773e154de56fdd42", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 99, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 99, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e4e3fdf6785765c9e8b34763", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3420}
{"after": {"end": 135, "start": 0, "text": "g Includes immune thrombocytopenia, pancreatitis, cystitis noninfective, immune-mediated arthritis, uveitis and polymyalgia rheumatica.", "truncated": false}, "after_length": 135, "after_sha256": "8c3da0117ac92e84ba4d19bfc237cb250a330248a562226e1104e5220873c4b6", "annex": "I", "before": {"end": 112, "start": 0, "text": "g Includes immune thrombocytopenia, pancreatitis, cystitis noninfective, immune-mediated arthritis, and uveitis.", "truncated": false}, "before_length": 112, "before_sha256": "2118eb6fb50e35e3105ebc15e47b0bf89bdbc741c32f677ed8432eeeacc37644", "change_kind": "content", "change_operations": [{"after_end": 100, "after_start": 100, "before_end": 104, "before_start": 100, "kind": "delete"}, {"after_end": 134, "after_start": 107, "before_end": 111, "before_start": 111, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 27}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e516d40d131490f8223e6c0b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "IMJUDO 20 mg/ml concentrate for solution for infusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 221}
{"after": {"end": 25, "start": 0, "text": "Conclusions scientifiques", "truncated": false}, "after_length": 25, "after_sha256": "b9dba41fa3c9d3b642cfe755c989781c6765c2e1667b80c2d6fb1f02a6cb6463", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 25, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 25}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e5444b22264d0a7a1fd2e49f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "9ac80b0d56ebad4970f7a8335a177613af59ef25517bcd0bdd3397c207cc1bac", "source_snapshot_id": "source-c11aa9e32420f125a88005bc", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2709}
{"after": {"end": 22, "start": 0, "text": "Teл.: +359 2 819 37 37", "truncated": false}, "after_length": 22, "after_sha256": "f99d9da7522776c9e193c3d902a0bfac1449878008698e67a70066d46f048b40", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "Teл.: + 359 2 819 37 37", "truncated": false}, "before_length": 23, "before_sha256": "c607221a5f8b9a53eea2b30c436402b48449ce353ad88bc41c01cdb4f8bb48e8", "change_kind": "content", "change_operations": [{"after_end": 7, "after_start": 7, "before_end": 8, "before_start": 7, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e568004de735627d52446466", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3384}
{"after": {"end": 30, "start": 0, "text": "Critère principal d’évaluation", "truncated": false}, "after_length": 30, "after_sha256": "3373edb2659568cb971a98b7db33ed5cd595d251fed752d68070deb4bb505b64", "annex": "I", "before": {"end": 17, "start": 0, "text": "Critère principal", "truncated": false}, "before_length": 17, "before_sha256": "ea2563482c25678aad44a4c2940b0955b84d276182b52a7842254cdf24cf27c9", "change_kind": "content", "change_operations": [{"after_end": 30, "after_start": 17, "before_end": 17, "before_start": 17, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 13}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e57aa3e38f63a2de3ebd36ae", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1175}
{"after": {"end": 122, "start": 0, "text": "Having reviewed the PRAC recommendation, the CHMP agrees with the PRAC overall conclusions and grounds for recommendation.", "truncated": false}, "after_length": 122, "after_sha256": "095a3b724a58255112d0ae23e9c65e77959b40571fcaaf1946c9da9f699beeda", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 122, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 122}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e5812043f461a1bba615ec12", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2542}
{"after": {"end": 62, "start": 0, "text": "Avastin n’est pas formulé pour une utilisation intravitréenne.", "truncated": false}, "after_length": 62, "after_sha256": "b7a018c16d8e56467b57c419322d1d416240d21dd119d2042ea94fbe71d2df35", "annex": "I", "before": {"end": 63, "start": 0, "text": "Avastin n’est pas formulé pour une utilisation intra-vitréenne.", "truncated": false}, "before_length": 63, "before_sha256": "12a79fba011ac15d3d3997a30fddce8c2a073f02aaa96399b4d9833c069620f5", "change_kind": "content", "change_operations": [{"after_end": 52, "after_start": 52, "before_end": 53, "before_start": 52, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e5db1fcfebeeb55a95e087cf", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 247}
{"after": {"end": 105, "start": 0, "text": "Spikevax LP.8.1 should be administered at least 3 months after the most recent dose of a COVID19 vaccine.", "truncated": false}, "after_length": 105, "after_sha256": "cb920377c5c8e39d8da8bd46b2b786bee15ae3279003e504ae149a68404dcdd7", "annex": "I", "before": {"end": 103, "start": 0, "text": "Spikevax JN.1 should be administered at least 3 months after the most recent dose of a COVID19 vaccine.", "truncated": false}, "before_length": 103, "before_sha256": "1ffe43d37772f8deefe1797a49307dc26bb46874b29c0b434dbf982941e47645", "change_kind": "administrative", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e61b0f0ace2dc02f22b8241b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13189}
{"after": {"end": 90, "start": 0, "text": "Le CHMP recommande que les termes des autorisations de mise sur le marché soient modifiés.", "truncated": false}, "after_length": 90, "after_sha256": "961d393e9b2806d1f75b6baac0b9ff03a6e5dee1077163ba7bb8df3cc8385934", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 90, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 90}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e633d392b6536cab8789b609", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3410}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "Tel: + 31 (0)33 450 82 70", "truncated": false}, "before_length": 25, "before_sha256": "c3bd4c4339096aa6c189d1dce364189e2604277f9761e06e2d64868ce9742c04", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 25, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 25, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e6490cb3dff1ced673baeeba", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1073}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 20, "start": 0, "text": "For single-use only.", "truncated": false}, "before_length": 20, "before_sha256": "f7b36887a4d8d6c0230c11c845772064907c62d5d036ebc2ec7a8d66cdc325df", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 20, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 20, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e687c8c623cb6583d5bc58b3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "2", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5433}
{"after": {"end": 225, "start": 0, "text": "les anti-acides comme l’hydroxyde d’aluminium / l’hydroxyde de magnésium, utilisés pour traiter l’indigestion ou les brûlures d’estomac. Prenez les anti-acides au moins 2 heures avant ou 1 heure après l’utilisation d’Adempas.", "truncated": false}, "after_length": 225, "after_sha256": "e0d7e5129a6c20a4d49ad08d94a62d9d418f4ff73e80e136e6ba4814e56d685c", "annex": "IIIA", "before": {"end": 218, "start": 0, "text": "des maladies de l’estomac ou des brûlures d’estomac appelés anti-acides comme l’hydroxyde d’aluminium / l’hydroxyde de magnésium. Prenez les anti-acides au moins 2 heures avant ou 1 heure après l’utilisation d’Adempas.", "truncated": false}, "before_length": 218, "before_sha256": "03c20bbc3f5295f16e6daa8b297e5478c224fdda4517c1acf54043db01478348", "change_kind": "content", "change_operations": [{"after_end": 1, "after_start": 0, "before_end": 1, "before_start": 0, "kind": "replace"}, {"after_end": 2, "after_start": 2, "before_end": 58, "before_start": 2, "kind": "delete"}, {"after_end": 135, "after_start": 72, "before_end": 128, "before_start": 128, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 57, "chars_inserted": 64}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e688fb16a5a2899dffdbcf3f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3307}
{"after": {"end": 145, "start": 0, "text": "One dose (0.5 mL) contains 50 micrograms of SARSCoV2 LP.8.1 mRNA, a COVID19 mRNA Vaccine (nucleoside modified) (embedded in lipid nanoparticles).", "truncated": false}, "after_length": 145, "after_sha256": "7b73ed4334cf57ac73142541e7981150e2d96786f22e9ca9f81005e977b9e222", "annex": "I", "before": {"end": 143, "start": 0, "text": "One dose (0.5 mL) contains 50 micrograms of SARSCoV2 JN.1 mRNA, a COVID19 mRNA Vaccine (nucleoside modified) (embedded in lipid nanoparticles).", "truncated": false}, "before_length": 143, "before_sha256": "59aec4ee6835dd582a93dffc8976603649dfe92fb8f9cfefbbdb72454c4dc65a", "change_kind": "content", "change_operations": [{"after_end": 57, "after_start": 53, "before_end": 55, "before_start": 53, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e6e0870d07b72f6c9cb9c56f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "2", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5443}
{"after": {"end": 13, "start": 0, "text": "1932 Zaventem", "truncated": false}, "after_length": 13, "after_sha256": "cffe4475a5de91da7a3a6363a4d41ccfd1405766d95ae182d89bf39b29686221", "annex": "II", "before": {"end": 13, "start": 0, "text": "1930 Zaventem", "truncated": false}, "before_length": 13, "before_sha256": "ed9ea9385e3e50f6278214da5d7483a8543c36d1261df263d35022c5936c74db", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 4, "before_start": 3, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e723229611dbc73e3d544a29", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004310", "medicine_name": "Daptomycin Hospira", "medicine_slug": "daptomycin-hospira", "observed_at": "2026-10-12T19:09:33Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "3242bb93d94dc3b7e86b89af5160c6986e8caa2e4f8d73bf8a634a557420452a", "source_snapshot_id": "source-dd7a18b7c210239223fa10ad", "source_updated_at": "2025-09-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/daptomycin-hospira-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1017}
{"after": {"end": 76, "start": 0, "text": "Unopened multidose vial (Spikevax LP.8.1 0.1 mg/mL dispersion for injection)", "truncated": false}, "after_length": 76, "after_sha256": "0a62216a29957c3890df885a888e40473a837e423e04aa2141911bf114612d14", "annex": "I", "before": {"end": 74, "start": 0, "text": "Unopened multidose vial (Spikevax JN.1 0.1 mg/mL dispersion for injection)", "truncated": false}, "before_length": 74, "before_sha256": "58686d95095225a81e02bae175a0a72fa469ad232ae6fe73f16a464162b5e8c0", "change_kind": "content", "change_operations": [{"after_end": 38, "after_start": 34, "before_end": 36, "before_start": 34, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e744ed0ecb64464b6737c67c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.3", "section_type": "storage", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6219}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 7, "start": 0, "text": "România", "truncated": false}, "before_length": 7, "before_sha256": "633e193d7e05828a893d02a6273755ed0d417cc14abf5ecfc2b6328c71ddcc7e", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 7, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e776457e7282d7b1b36f3dac", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1111}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 33, "start": 0, "text": "United Kingdom (Northern Ireland)", "truncated": false}, "before_length": 33, "before_sha256": "9379d82927cdb505cfb186e912177065e56a1314de3a2b914ebbb8b5fe21525a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 33, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 33, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e78ec25f48604e7f317f263b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000112", "medicine_name": "Twinrix Adult", "medicine_slug": "twinrix-adult", "observed_at": "2026-10-12T13:29:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "bc8ba3adecfe04d3079e5b502251cec982d6197257fe3b7ec3a22dc5f2ace654", "source_snapshot_id": "source-8439a1a319b62d1bd67256a4", "source_updated_at": "2026-08-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/twinrix-adult-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1004}
{"after": {"end": 30, "start": 0, "text": "Survie sans progression (SSP)*", "truncated": false}, "after_length": 30, "after_sha256": "b0ed4560a023955031516d6301bac7a6ab066f26a350f36cfc9c96008a0daff8", "annex": "I", "before": {"end": 30, "start": 0, "text": "Survie sans progression (PFS)*", "truncated": false}, "before_length": 30, "before_sha256": "2467145ec0f426eeb0ff24ac47a104ccfb4dfe9f3b906c9cd98b13a3276196c0", "change_kind": "content", "change_operations": [{"after_end": 27, "after_start": 25, "before_end": 25, "before_start": 25, "kind": "insert"}, {"after_end": 28, "after_start": 28, "before_end": 28, "before_start": 26, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e791fd3d73f80cf459dc0f8d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2144}
{"after": {"end": 73, "start": 0, "text": "- If an overdose is suspected Nyxoid should be given as soon as possible.", "truncated": false}, "after_length": 73, "after_sha256": "b1af7ec648622d6b232bdfed67335f05e99a898539920e5d1790cbcbd556450d", "annex": "IIIA", "before": {"end": 53, "start": 0, "text": "- If an overdose is suspected Nyxoid should be given.", "truncated": false}, "before_length": 53, "before_sha256": "95b4154df25cec306acccd517ea3f4fb6e2840e5b1e61152331406a5109eaa7f", "change_kind": "content", "change_operations": [{"after_end": 72, "after_start": 52, "before_end": 52, "before_start": 52, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 20}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e7ebaf53da26203a842a41c7", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:33Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "21d66bf1e9a74479f577de09da3cf8517d65c1ce1b1d8bbdfe4bc38f79410def", "source_snapshot_id": "source-2c39c998fdaf05159687c016", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 829}
{"after": {"end": 98, "start": 0, "text": "Le CHMP recommande que les termes de la/des autorisation(s) de mise sur le marché soient modifiés.", "truncated": false}, "after_length": 98, "after_sha256": "814445cd01b1f96232572044ddd66f4350cafdd933e820b4d83b946474ffc969", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 98, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 98}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e7f781e94fac4f14dcaffd99", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "9ac80b0d56ebad4970f7a8335a177613af59ef25517bcd0bdd3397c207cc1bac", "source_snapshot_id": "source-c11aa9e32420f125a88005bc", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2750}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 18, "start": 0, "text": "1 single-dose vial", "truncated": false}, "before_length": 18, "before_sha256": "1affd6db765a6968ad5115033d17409302823e2ce547d08312d93d249661e887", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 18, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 18, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e7f95f2724d9199b4bc74f30", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.5", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6323}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 17, "start": 0, "text": "Byk-Gulden-Str. 2", "truncated": false}, "before_length": 17, "before_sha256": "5dc95d013d793b6958719e5db82aa51cd0c1864e2e8bc9bfcf2cfded1a05eba6", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 17, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 17, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e86a58851c4163172a43ecc1", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "e569f524f020f028a35c6c220bddf3a6cc7a4f6893b39b6f03a30cff5b214377", "source_snapshot_id": "source-a31ad98ca731add8030b2c11", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1713}
{"after": {"end": 767, "start": 0, "text": "If you are pregnant or think you may be pregnant, tell your doctor, nurse or pharmacist before you receive this vaccine. No data are available yet regarding the use of Spikevax LP.8.1 during pregnancy. However, a large amount of information from pregnant women vaccinated with Spikevax (original) during the second and third trimester have not shown negative effects on the pregnancy or the newborn baby. While information on effects on pregnancy or the newborn baby after vaccination during the first trimester is limited, no increased risk for miscarriage has been seen. Since differences between the two products are only related to the spike protein in the vaccine, and there are no clinically meaningful differences, Spikevax LP.8.1 can be used during pregnancy.", "truncated": false}, "after_length": 767, "after_sha256": "e47be8bf8a0f24c7afedd084e61bd33286cd7b8084e05ebeb1e74f7bc98bde60", "annex": "I", "before": {"end": 763, "start": 0, "text": "If you are pregnant or think you may be pregnant, tell your doctor, nurse or pharmacist before you receive this vaccine. No data are available yet regarding the use of Spikevax JN.1 during pregnancy. However, a large amount of information from pregnant women vaccinated with Spikevax (original) during the second and third trimester have not shown negative effects on the pregnancy or the newborn baby. While information on effects on pregnancy or the newborn baby after vaccination during the first trimester is limited, no increased risk for miscarriage has been seen. Since differences between the two products are only related to the spike protein in the vaccine, and there are no clinically meaningful differences, Spikevax JN.1 can be used during pregnancy.", "truncated": false}, "before_length": 763, "before_sha256": "64557b676e4d824f68cf39eff4edfecbe09fa6c1404f30ba7bc83c7ddf36da28", "change_kind": "administrative", "change_operations": [{"after_end": 181, "after_start": 177, "before_end": 179, "before_start": 177, "kind": "replace"}, {"after_end": 735, "after_start": 731, "before_end": 731, "before_start": 729, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e86f9a40663bedef4163d963", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12676}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 16, "start": 0, "text": "EU/1/20/1507/023", "truncated": false}, "before_length": 16, "before_sha256": "d4e1e59f0e7e37e2fc18ac534b8f64dac69a3023c6b6cf66f5b53b434c491e81", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 16, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 16, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e8d246edd661880c65512467", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "8", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6480}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 170, "start": 0, "text": "Within the period of 9 months, after removal from the freezer, single-dose vials may be stored refrigerated at 2°C to 8°C, protected from light, for a maximum of 30 days.", "truncated": false}, "before_length": 170, "before_sha256": "1df81f2f4f7a192ee90ecf415fbfaec2e3f9cc4565444d4c00bef2954f354902", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 170, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 170, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e903734d9a5d15f98ed705d7", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.3", "section_type": "storage", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6245}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "II", "before": {"end": 59, "start": 0, "text": "o Memory stick for HCP use to train, if WiFi not accessible", "truncated": false}, "before_length": 59, "before_sha256": "0a59ad4bd73a0397851314de34dc4d1611e08e0f54eeca84cf5aa00ba9770522", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 59, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 59, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e908d9dd4349070aa38daf44", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:33Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "21d66bf1e9a74479f577de09da3cf8517d65c1ce1b1d8bbdfe4bc38f79410def", "source_snapshot_id": "source-2c39c998fdaf05159687c016", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 461}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 33, "start": 0, "text": "United Kingdom (Northern Ireland)", "truncated": false}, "before_length": 33, "before_sha256": "9379d82927cdb505cfb186e912177065e56a1314de3a2b914ebbb8b5fe21525a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 33, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 33, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e94871ec97d777c955c051e3", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 11173}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Tel: +40 744 777 258", "truncated": false}, "before_length": 20, "before_sha256": "2f8518807aac1374d3d8dd7c6368398c16e4c209bdb5c605dcdf3de7b1a6874f", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 20, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 20, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e98c5ca86351c6bf3179462e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1122}
{"after": {"end": 134, "start": 0, "text": "Detailed information on this medicinal product is available on the website of the European Medicines Agency https://www.ema.europa.eu.", "truncated": false}, "after_length": 134, "after_sha256": "9f2a855337f11701b0cd4191c51820fa5a70b201b2e0721ba6acd34544486f89", "annex": "I", "before": {"end": 133, "start": 0, "text": "Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.", "truncated": false}, "before_length": 133, "before_sha256": "eabdb61a543e11ee016c5c43ada549964199ddf9e287a2eb3256e15d4a87fe4a", "change_kind": "technical", "change_operations": [{"after_end": 113, "after_start": 112, "before_end": 112, "before_start": 112, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e9a6db7346b6f1035c91da60", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg powder for solution for injection", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "10", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1123}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "Tel: +44 (0)1304 616161", "truncated": false}, "before_length": 23, "before_sha256": "eba81e6ccdbae471c024a5ba77d9ec9e0617a3c443fd22205a626861e87fbd8c", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 23, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 23, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-e9b1c982bc2b3ba45831dbf5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9099}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 6, "start": 0, "text": "Κύπρος", "truncated": false}, "before_length": 6, "before_sha256": "7f8ef8a379e33810aefd13f344f489d85e8902de6fdcd1b46a4e856985b5e14e", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 6, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ea5d98241ef172900aafb704", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1139}
{"after": {"end": 37, "start": 0, "text": "St. John’s Wort, to treat depression.", "truncated": false}, "after_length": 37, "after_sha256": "c65491c42b0e77c12917a8d6e7ce7701b4d3f76af5da04ad99883ca4ca919fb7", "annex": "IIIA", "before": {"end": 35, "start": 0, "text": "depression such as St. John’s Wort.", "truncated": false}, "before_length": 35, "before_sha256": "c6ca9212f5b5a19d813161b53399a45d1a7b73ae24cc5df4ef1e68707378853e", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 19, "before_start": 0, "kind": "delete"}, {"after_end": 36, "after_start": 15, "before_end": 34, "before_start": 34, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 19, "chars_inserted": 21}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ea6b409c52d1dc638f576eed", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2779}
{"after": {"end": 189, "start": 0, "text": "have pulmonary veno-occlusive disease, a disease which makes you feel short of breath because fluid builds up in the lungs. He or she may decide to provide you with an alternative medicine.", "truncated": false}, "after_length": 189, "after_sha256": "4ed6f13b3b4c712664c8e89a0c1ad084aacf08e3a0eb249be58f6d9c20333a56", "annex": "IIIA", "before": {"end": 189, "start": 0, "text": "have pulmonary veno-occlusive disease, a disease which makes you feel short of breath because fluid builds-up in the lungs. He or she may decide to provide you with an alternative medicine.", "truncated": false}, "before_length": 189, "before_sha256": "a1f2d1d257f6dd70fcfc9fc1c5690d3a61f045adee4fa9fa773b532aa47b78b8", "change_kind": "content", "change_operations": [{"after_end": 107, "after_start": 106, "before_end": 107, "before_start": 106, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ea73192fdfe22a683d412da6", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3172}
{"after": {"end": 152, "start": 0, "text": "One dose (0.5 mL) contains 50 micrograms of SARSCoV2 LP.8.1 mRNA, a COVID-19 mRNA Vaccine (nucleoside modified) (embedded in SM102 lipid nanoparticles).", "truncated": false}, "after_length": 152, "after_sha256": "bc89e92bb9dc7a442ee1777369b6e3ed45b46bd4cebd14f5676463f54e37b043", "annex": "I", "before": {"end": 150, "start": 0, "text": "One dose (0.5 mL) contains 50 micrograms of SARSCoV2 JN.1 mRNA, a COVID-19 mRNA Vaccine (nucleoside modified) (embedded in SM102 lipid nanoparticles).", "truncated": false}, "before_length": 150, "before_sha256": "5002274f8d3b4b236e71cf4c0912e38700fb96a5b72356174022c45feb63f4e6", "change_kind": "administrative", "change_operations": [{"after_end": 57, "after_start": 53, "before_end": 55, "before_start": 53, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ea877c4c1d033fab2f164d1d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12848}
{"after": {"end": 25, "start": 0, "text": "50-58 Baggot Street Lower", "truncated": false}, "after_length": 25, "after_sha256": "2b6052bef6a7051ce20b776d1525055c417fc02e59b9e559cd21b7aa4c7859f0", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 25, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 25}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ea9353ef73c0dea7cad4bd08", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1342}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 41, "start": 0, "text": "Mundipharma Corporation (Ireland) Limited", "truncated": false}, "before_length": 41, "before_sha256": "1508b8eae555a7f920ad3f9f7dc0b3f86d6bca3f7a3f44b91a1699e58db6295c", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 41, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 41, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-eaf4698c323e30c75252fb14", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1064}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 8, "start": 0, "text": "Hrvatska", "truncated": false}, "before_length": 8, "before_sha256": "08c5546cc42a9be9368bdd6a99ed02c97b9163c173b1e97dd49b785cb49740bc", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 8, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 8, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-eaf55563acd71d2b776b39a3", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1112}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 12, "start": 0, "text": "15°C to 25°C", "truncated": false}, "before_length": 12, "before_sha256": "b57c2b618e71e3e42c038965c231cecdb8049c3d82d00aa02012ac70ea91f351", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 12, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 12, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-eb5bbfcdd539d15172ee7d50", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13096}
{"after": {"end": 12, "start": 0, "text": "mood changes", "truncated": false}, "after_length": 12, "after_sha256": "d7e4c9d288b9c049fdb2f6bc959674ac45d768b169f611bb3a5d0d49a8426f48", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 12, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 12}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-eb746f6248e8fa7155b877b0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:30Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "35ab6716aa09492c14ac6849111486ec47235c0bc65ef055350de950f316c5e6", "source_snapshot_id": "source-f20a60110d1f8fef5225317d", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2103}
{"after": {"end": 21, "start": 0, "text": "Tel.: +421 2 58282010", "truncated": false}, "after_length": 21, "after_sha256": "32c933770f90d44663e373be0c519eb7428907366f1868c6a270ab7f76ac5d6c", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tel: + 421 2 58282010", "truncated": false}, "before_length": 21, "before_sha256": "90cacf7d3ec61fa882ae694eb785acb84b5a4d5dc4e01a35b7899e1f2403cc28", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}, {"after_end": 7, "after_start": 7, "before_end": 7, "before_start": 6, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ebc57600c33403dcf5bf94a2", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3583}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 26, "start": 0, "text": "mundipharma@mundipharma.bg", "truncated": false}, "before_length": 26, "before_sha256": "5c8cedae416243cb8959a3ac77d76d67a4127baef6c6dc6eb3c2d590f7a0241c", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 26, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 26, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ec20e9fd04c2dc9e752410a2", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1042}
{"after": {"end": 82, "start": 0, "text": "Adempas is for oral use. Take your Adempas dose 3 times a day, every 6 to 8 hours.", "truncated": false}, "after_length": 82, "after_sha256": "c0f26cc5935d46337420b24b03268ec2f41b41357362da3e688990fefa44098d", "annex": "IIIA", "before": {"end": 176, "start": 0, "text": "Adempas is for oral use. Each Adempas dose has to be swallowed. The patient must swallow the full dose of medicine. Use Adempas 3 times daily, approximately every 6 to 8 hours.", "truncated": false}, "before_length": 176, "before_sha256": "284bf6cc1eb8c97b3fcaa9608dc7d46ce6dfe11360204d9c0b68e4f0d9f6a055", "change_kind": "content", "change_operations": [{"after_end": 26, "after_start": 25, "before_end": 26, "before_start": 25, "kind": "replace"}, {"after_end": 34, "after_start": 27, "before_end": 29, "before_start": 27, "kind": "replace"}, {"after_end": 48, "after_start": 48, "before_end": 128, "before_start": 43, "kind": "delete"}, {"after_end": 58, "after_start": 56, "before_end": 136, "before_start": 136, "kind": "insert"}, {"after_end": 60, "after_start": 60, "before_end": 140, "before_start": 138, "kind": "delete"}, {"after_end": 62, "after_start": 62, "before_end": 156, "before_start": 142, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 104, "chars_inserted": 10}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ec30d77f4afb4c39fc0b6417", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3262}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "Tel: +44 (0)1304 616161", "truncated": false}, "before_length": 23, "before_sha256": "eba81e6ccdbae471c024a5ba77d9ec9e0617a3c443fd22205a626861e87fbd8c", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 23, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 23, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ec7e2e088d9ba2770f97b65b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 8521}
{"after": {"end": 15, "start": 0, "text": "Cardiac Failure", "truncated": false}, "after_length": 15, "after_sha256": "7356f7db99e5120eece3b8718f00ff6118cecca06b27656bab282a194bfcb5db", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 15, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 15}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ec80a8be6f80e246c60f0447", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002640", "medicine_name": "Cometriq", "medicine_slug": "cometriq", "observed_at": "2026-10-12T19:00:48Z", "pipeline_version": "2.0.0", "presentation_label": "COMETRIQ 20 mg hard capsules COMETRIQ 80 mg hard capsules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "9a013f64c372a20a7dfcfd0a30d84c365e558413e28c71df200098486d1db15b", "source_snapshot_id": "source-a2dc64012a0e2142a7477fbb", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/cometriq-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 142}
{"after": {"end": 800, "start": 0, "text": "Les patients atteints de psoriasis en plaques pédiatrique (âgés de 4 à 17 ans) ont reçu 0,8 mg/kg (jusqu’à une dose maximale de 50 mg par semaine) d’etanercept une fois par semaine jusqu’à 48 semaines. Les concentrations sériques moyennes à l’état d’équilibre ont varié de 1,6 à 2,1 g/mL aux semaines 12, 24 et 48. Ces concentrations moyennes chez les patients atteints de psoriasis en plaques pédiatrique ont été similaires aux concentrations observées chez les patients atteints d’arthrite juvénile idiopathique (traités par 0,4 mg/kg d’etanercept deux fois par semaine, jusqu’à une dose maximale de 50 mg par semaine). Ces concentrations moyennes étaient similaires à celles observées chez les patients adultes atteints de psoriasis en plaques traités par 25 mg d’etanercept deux fois par semaine.", "truncated": false}, "after_length": 800, "after_sha256": "45cec5f493545419a45e5abbb1dd4ac0a9e852e76d7b20b526414eed5d33951b", "annex": "I", "before": {"end": 800, "start": 0, "text": "Les patients atteints de psoriasis en plaques pédiatrique (âgés de 4 à 17 ans) ont reçu 0,8 mg/kg (jusqu’à une dose maximale de 50 mg par semaine) d’etanercept une fois par semaine jusqu’à 48 semaines. Les concentrations sériques moyennes à l’état d’équilibre ont varié de 1,6 à 2,1 g/ml aux semaines 12, 24 et 48. Ces concentrations moyennes chez les patients atteints de psoriasis en plaques pédiatrique ont été similaires aux concentrations observées chez les patients atteints d’arthrite juvénile idiopathique (traités par 0,4 mg/kg d’etanercept deux fois par semaine, jusqu’à une dose maximale de 50 mg par semaine). Ces concentrations moyennes étaient similaires à celles observées chez les patients adultes atteints de psoriasis en plaques traités par 25 mg d’etanercept deux fois par semaine.", "truncated": false}, "before_length": 800, "before_sha256": "fe7d3d907bc892858ed04c3fdbb1d64ae7c6b7ed8a81004a623298b1197fad7e", "change_kind": "content", "change_operations": [{"after_end": 287, "after_start": 286, "before_end": 287, "before_start": 286, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ece8fe54afb45db03b3b133a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg solution injectable en stylo pré-rempli Enbrel 50 mg solution injectable en stylo pré-rempli", "presentation_occurrence": 4, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 4462}
{"after": {"end": 22, "start": 0, "text": "Teл.: +359 2 819 37 37", "truncated": false}, "after_length": 22, "after_sha256": "f99d9da7522776c9e193c3d902a0bfac1449878008698e67a70066d46f048b40", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "Teл.: + 359 2 819 37 37", "truncated": false}, "before_length": 23, "before_sha256": "c607221a5f8b9a53eea2b30c436402b48449ce353ad88bc41c01cdb4f8bb48e8", "change_kind": "content", "change_operations": [{"after_end": 7, "after_start": 7, "before_end": 8, "before_start": 7, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ecebc3656b77645cb2ed4dd4", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3070}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 170, "start": 0, "text": "Pour toute information complémentaire concernant ce médicament, veuillez prendre contact avec le représentant local du titulaire de l’autorisation de mise sur le marché :", "truncated": false}, "before_length": 170, "before_sha256": "3d33a6b4a45572c6d201e5b64d04d70230f33eb5f235e4cf7ed24c3872500500", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 170, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 170, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ed35ca49c387def2e1fc5ea1", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1027}
{"after": {"end": 219, "start": 0, "text": "Les autres composants sont le citrate trisodique dihydraté (E331), le chlorure de sodium, l’acide chlorhydrique (E507), l’hydroxyde de sodium (E524) et l’eau purifiée (voir la rubrique 2 « Nyxoid contient du sodium » ).", "truncated": false}, "after_length": 219, "after_sha256": "e3f4d935e7ec76c744872a23625d4b7464c4f06e9ba589413fb209598bc69650", "annex": "IIIA", "before": {"end": 223, "start": 0, "text": "Les autres composants sont le citrate trisodique dihydraté (E331), le chlorure de sodium, l’acide chlorhydrique (E507), l’hydroxyde de sodium (E524) et l’eau purifiée (voir « Nyxoid contient du sodium » dans la rubrique 2).", "truncated": false}, "before_length": 223, "before_sha256": "adbe2db3326444e5feba7c4bac96d832b16bee3025b0212cc92f52cb806a787a", "change_kind": "content", "change_operations": [{"after_end": 187, "after_start": 173, "before_end": 173, "before_start": 173, "kind": "insert"}, {"after_end": 217, "after_start": 217, "before_end": 221, "before_start": 203, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 18, "chars_inserted": 14}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ed43d8cd31840485614c19c2", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 967}
{"after": {"end": 41, "start": 0, "text": "GlaxoSmithKline Pharmaceuticals s.a./n.v.", "truncated": false}, "after_length": 41, "after_sha256": "78a50ede7f6f749aad8e46d5c904e76d599a24803810e6aa82ac2a4623d14d3b", "annex": "IIIA", "before": {"end": 37, "start": 0, "text": "GlaxoSmithKline Pharmaceuticals SA/NV", "truncated": false}, "before_length": 37, "before_sha256": "76a8c323880ceb0f3084587deeb6993db7df1bb7006480e529e3b2bdcc2fb11c", "change_kind": "content", "change_operations": [{"after_end": 36, "after_start": 32, "before_end": 34, "before_start": 32, "kind": "replace"}, {"after_end": 41, "after_start": 37, "before_end": 37, "before_start": 35, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ed70899b77ff75b70e25beec", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000112", "medicine_name": "Twinrix Adult", "medicine_slug": "twinrix-adult", "observed_at": "2026-10-12T13:29:23Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "cfad5fb0086c9b5d6a36b454f3f546373def1f56cded73e0652b498d02d68e41", "source_snapshot_id": "source-17627897b0874bf1160c7372", "source_updated_at": "2026-08-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/twinrix-adult-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 921}
{"after": {"end": 99, "start": 0, "text": "Pen may only be used on one patient, otherwise there is a risk of transmitting infectious diseases.", "truncated": false}, "after_length": 99, "after_sha256": "63cf70aa35e2fe9fbb4f6737f53405c4ce709587a30dd583df631791ef298a98", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 99, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 99}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ed76d1134d84f1a74865eab9", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2101}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 13, "start": 0, "text": "Suomi/Finland", "truncated": false}, "before_length": 13, "before_sha256": "5bea43a11ae0d0e9706443422f6eb9b6107624ceb18d16ec89005011c62699dd", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 13, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 13, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ed850307b7e3760614a7e962", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1143}
{"after": {"end": 36, "start": 0, "text": "atrial fibrillation, cardiac failure", "truncated": false}, "after_length": 36, "after_sha256": "fca7b2eed19cc2b77a5ac31b5df3bc5b9b651e784af122d5e0729e9eb165c01a", "annex": "I", "before": {"end": 19, "start": 0, "text": "atrial fibrillation", "truncated": false}, "before_length": 19, "before_sha256": "09417dacb7279d009a24f83e37178b27a9d76a30bc65832ba5bb7c00ac6240d5", "change_kind": "content", "change_operations": [{"after_end": 36, "after_start": 19, "before_end": 19, "before_start": 19, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 17}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-edc2a684e8cd106926b41247", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002640", "medicine_name": "Cometriq", "medicine_slug": "cometriq", "observed_at": "2026-10-12T19:00:48Z", "pipeline_version": "2.0.0", "presentation_label": "COMETRIQ 20 mg hard capsules COMETRIQ 80 mg hard capsules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "9a013f64c372a20a7dfcfd0a30d84c365e558413e28c71df200098486d1db15b", "source_snapshot_id": "source-a2dc64012a0e2142a7477fbb", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/cometriq-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 263}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IV", "before": {"end": 514, "start": 0, "text": "In view of the 18 cases of psychotic disorders from clinical trials including 10 cases with positive dechallenge, the literature (2 case reports), spontaneous reports including in 10 cases a close temporal relationship, a positive dechallenge in 6 cases and rechallenge in 1 case, the PRAC considers a causal relationship between perampanel and psychotic disorder is at least a reasonable possibility. The PRAC concluded that the product information of products containing perampanel should be amended accordingly.", "truncated": false}, "before_length": 514, "before_sha256": "58ad20e31f4b4a747cf28d7630c82edc688de59c2127e9ceeea9a60eed389600", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 514, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 514, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ee45c37df5a5fdf33bffc909", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3427}
{"after": {"end": 244, "start": 0, "text": "Si vous avez pris plus de Fycompa que vous n’auriez dû, vous devez contacter immédiatement votre médecin. Vous pourrez présenter une confusion, une agitation, un comportement agressif, des vomissements et une diminution du niveau de conscience.", "truncated": false}, "after_length": 244, "after_sha256": "c0f7dc5e9202f7b81fb193f8181d882c8860d6ef94e8af45ee34607a50225e4c", "annex": "IIIA", "before": {"end": 226, "start": 0, "text": "Si vous avez pris plus de Fycompa que vous n’auriez dû, vous devez contacter immédiatement votre médecin. Vous pourrez présenter une confusion, une agitation, un comportement agressif et une diminution du niveau de conscience.", "truncated": false}, "before_length": 226, "before_sha256": "131d0bacfe9d91a3e52ee4ec1a2e3ebcc1ace873373f089f9001618755c89a43", "change_kind": "content", "change_operations": [{"after_end": 201, "after_start": 183, "before_end": 183, "before_start": 183, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 18}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ee76b312d3a2b05e6cc1cd37", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:32:00Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3ff8cd4d67d22ba799aa348aeda944d6d896a16dcf54b030db101cbc095fc8ad", "source_snapshot_id": "source-a79a7cba8bf5dbc72fd40574", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3259}
{"after": {"end": 746, "start": 0, "text": "Les symptômes peuvent notamment être : le syndrome de sevrage comporte, impatiences, irritabilité, hyperesthésie (augmentation de la sensibilité de la peau), nausées (malaise), vomissements, douleur gastro-intestinale (crampes d’estomac), spasmes musculaires (contractions soudaines de vos muscles, courbatures), dysphorie (mauvaise humeur ou sensation d’humeur inconfortable), insomnie (difficulté à dormir), anxiété, hyperhidrose (sudation excessive), horripilation (chair de poule, frissonnements, tremblements), tachycardie (fréquence cardiaque rapide), pression artérielle augmentée, bâillements, pyrexie (fièvre). Des modifications comportementales notamment, comportement violent, nervosité et excitation, peuvent également être observées.", "truncated": false}, "after_length": 746, "after_sha256": "bb19eb2559348ce9c9895acba544a76f76a0684aae0aa1fa952df47e8ab0f3d2", "annex": "IIIA", "before": {"end": 746, "start": 0, "text": "Les symptômes peuvent notamment être : le syndrome de sevrage comporte, impatiences, irritabilité, hyperesthésie (augmentation de la sensibilité de la peau), nausées (malaise), vomissements, douleur gastro-intestinale (crampes d’estomac), spasmes musculaires (contractions soudaines de vos muscles, courbatures), dysphorie (mauvaise humeur ou sensation d’humeur inconfortable), insomnie (difficulté à dormir), anxiété, hyperhidrose (sudation excessive), horripilation (chair de poule, frissonnements, tremblements), tachycardie (fréquence cardiaque rapide), pression artérielle augmentée, bâillements, pyrexie (fièvre). Des modifications comportementales,notamment, comportement violent, nervosité et excitation, peuvent également être observées.", "truncated": false}, "before_length": 746, "before_sha256": "d297d0a18051fa8265702de8b0291734ed717545fda2a7417dc503ed06a9cb4a", "change_kind": "content", "change_operations": [{"after_end": 655, "after_start": 654, "before_end": 655, "before_start": 654, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ee92c851a75d138552fb6fb7", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 916}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 206, "start": 0, "text": "Thaw each singledose vial before use following the instructions below. Each single-dose vial or the carton containing 1 or 10 vials may be thawed either in the refrigerator or at room temperature (Table 9).", "truncated": false}, "before_length": 206, "before_sha256": "37e7f706407021ec731dd70e6ba936e25091a59806083ca1788c0cc9e15b8958", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 206, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 206, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ee953b2da1ba8f6ed915b162", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6386}
{"after": {"end": 7, "start": 0, "text": "Anxiété", "truncated": false}, "after_length": 7, "after_sha256": "64dac2ef570eda7c463cd428c932183eb82404e684a6d322f060d9e9e6ddc7dd", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 7, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 7}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-eed8b89ea6f39726e9a4b82f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:31Z", "pipeline_version": "2.0.0", "presentation_label": "Otezla 10 mg comprimés pelliculés Otezla 20 mg comprimés pelliculés Otezla 30 mg comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "9ac80b0d56ebad4970f7a8335a177613af59ef25517bcd0bdd3397c207cc1bac", "source_snapshot_id": "source-c11aa9e32420f125a88005bc", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 337}
{"after": {"end": 22, "start": 0, "text": "Tel.: +48 22 549 51 00", "truncated": false}, "after_length": 22, "after_sha256": "b4f3ff473cb9a7a642bf71f33b5b5948d208175e4d85b587f2a38e81caf1a4cb", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tel: +48 22 549 51 00", "truncated": false}, "before_length": 21, "before_sha256": "222e9a202ca5b1cde4fca3b2b78aaf332f0c1aa8b98e03455889987c3316067a", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ef0c68b9416563fb9198183c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3545}
{"after": {"end": 9, "start": 0, "text": "Oral use.", "truncated": false}, "after_length": 9, "after_sha256": "3cb600334d66cfc50b70bcea280eaeb9fc125e589d372d56f3fae261332b8ee9", "annex": "IIIA", "before": {"end": 8, "start": 0, "text": "Oral use", "truncated": false}, "before_length": 8, "before_sha256": "1a1f6c65b762e8cde9480afdbb709dcfb59c2d46c38f5d3112c9f605bcbdf25f", "change_kind": "content", "change_operations": [{"after_end": 9, "after_start": 8, "before_end": 8, "before_start": 8, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ef0d59529a0b844b6fbbddcc", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2202}
{"after": {"end": 43, "start": 0, "text": "Pfizer Healthcare Ireland Unlimited Company", "truncated": false}, "after_length": 43, "after_sha256": "1f203777a0ec6fed9c840d52631b6a74c7e25b5d318485d8147e2404f52dc981", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "Pfizer Healthcare Ireland", "truncated": false}, "before_length": 25, "before_sha256": "4beeea9b6d0c491f03a9511d9f9576b9c75cbcdcfd736e4934f768fdded936f5", "change_kind": "content", "change_operations": [{"after_end": 43, "after_start": 25, "before_end": 25, "before_start": 25, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 18}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ef2e08b9d1f633a7e603fcfa", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9069}
{"after": {"end": 24, "start": 0, "text": "dpoc_czechslovak@msd.com", "truncated": false}, "after_length": 24, "after_sha256": "337ee03ecaecb8e917a1c5d342c556aebf19918c2dc3ac63cf08adeafa748373", "annex": "IIIA", "before": {"end": 26, "start": 0, "text": "dpoc_czechslovak@merck.com", "truncated": false}, "before_length": 26, "before_sha256": "a4642d78bee1d644f5eed542e84f756d52a7869d19900b6efa351b35ef1062c2", "change_kind": "content", "change_operations": [{"after_end": 20, "after_start": 18, "before_end": 22, "before_start": 18, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ef5229b026c693cf4120d49f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3584}
{"after": {"end": 8, "start": 0, "text": "5 years.", "truncated": false}, "after_length": 8, "after_sha256": "7356e46f8cc0a2899bfb048ea70dbf22ed0316799145cff9c2aa5d4c8e9e90be", "annex": "I", "before": {"end": 7, "start": 0, "text": "5 years", "truncated": false}, "before_length": 7, "before_sha256": "9d8ee593ed5c2c983448eea1e88bb245e17c47bc37e26cc510e72c263f6e104c", "change_kind": "content", "change_operations": [{"after_end": 8, "after_start": 7, "before_end": 7, "before_start": 7, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ef7b803ef08f7cf83c301dfa", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "Fycompa 2 mg filmcoated tablets Fycompa 4 mg filmcoated tablets Fycompa 6 mg filmcoated tablets Fycompa 8 mg filmcoated tablets Fycompa 10 mg filmcoated tablets Fycompa 12 mg filmcoated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.3", "section_type": "storage", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 787}
{"after": {"end": 6, "start": 0, "text": "Notice", "truncated": false}, "after_length": 6, "after_sha256": "65659145569b894bd67d06e685509c2decc5b2ac5e18700c085a253506b0fb75", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 6, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 6}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ef8f051062daef904bb2f1e9", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "9ac80b0d56ebad4970f7a8335a177613af59ef25517bcd0bdd3397c207cc1bac", "source_snapshot_id": "source-c11aa9e32420f125a88005bc", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2735}
{"after": {"end": 31, "start": 0, "text": "5. How to store Spikevax LP.8.1", "truncated": false}, "after_length": 31, "after_sha256": "69d7031073c7cdc1f34f34230886d976eab1bf2748c5a9e7ad0fe3f5cc3f110f", "annex": "I", "before": {"end": 29, "start": 0, "text": "5. How to store Spikevax JN.1", "truncated": false}, "before_length": 29, "before_sha256": "782b9b49bf033b74025af660a19fd43f757e8f445d982877897cabbd93033f32", "change_kind": "administrative", "change_operations": [{"after_end": 29, "after_start": 25, "before_end": 27, "before_start": 25, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-efa7920b1a319ca1b5639314", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12821}
{"after": {"end": 340, "start": 0, "text": "Les analyses secondaires de SSP, basées sur l’évaluation d’un Comité de Revue Indépendant (CRI) et sur les évaluations de la réponse « sous-traitement », ont confirmé la supériorité significative du bénéfice clinique pour les patients traités avec Avastin (voir analyses de sous-groupe du Tableau 7), comme observé lors de l’analyse poolée.", "truncated": false}, "after_length": 340, "after_sha256": "a9a37aca06512ca90d1679cea587f3653ea6a483a7942b88a512e38c556a5bc8", "annex": "I", "before": {"end": 340, "start": 0, "text": "Les analyses secondaires de PFS, basées sur l’évaluation d’un Comité de Revue Indépendant (CRI) et sur les évaluations de la réponse « sous-traitement », ont confirmé la supériorité significative du bénéfice clinique pour les patients traités avec Avastin (voir analyses de sous-groupe du Tableau 7), comme observé lors de l’analyse poolée.", "truncated": false}, "before_length": 340, "before_sha256": "b663fe96aab8483ebb1fad3f810cc3e1429de090f7504d37f04e04eebbe77e98", "change_kind": "content", "change_operations": [{"after_end": 30, "after_start": 28, "before_end": 28, "before_start": 28, "kind": "insert"}, {"after_end": 31, "after_start": 31, "before_end": 31, "before_start": 29, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-efacb62e1f4beb3ddbb031d1", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1162}
{"after": {"end": 222, "start": 0, "text": "SARSCoV2 LP.8.1 mRNA is a single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2 (LP.8.1).", "truncated": false}, "after_length": 222, "after_sha256": "34702b06ced8532f02c99c53ba6f0d9246957c70857b7198ecc1a68c44cdf2f6", "annex": "I", "before": {"end": 218, "start": 0, "text": "SARSCoV2 JN.1 mRNA is a single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2 (JN.1).", "truncated": false}, "before_length": 218, "before_sha256": "0d381fc8903b4f22dddd09d2a5acd3deafe7e871d820987d8fd1c338bc0022f8", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}, {"after_end": 218, "after_start": 214, "before_end": 214, "before_start": 212, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-efe5ae761f6ee4f151e0a326", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "2", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5445}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "customercontactuk@gsk.com", "truncated": false}, "before_length": 25, "before_sha256": "73834f2ec2786ba4565d1820e07d2bb38952e8214867b143e05286042d58b0b0", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 25, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 25, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f041bc436499b99099787bf8", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000112", "medicine_name": "Twinrix Adult", "medicine_slug": "twinrix-adult", "observed_at": "2026-10-12T13:29:23Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "cfad5fb0086c9b5d6a36b454f3f546373def1f56cded73e0652b498d02d68e41", "source_snapshot_id": "source-17627897b0874bf1160c7372", "source_updated_at": "2026-08-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/twinrix-adult-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1034}
{"after": {"end": 311, "start": 0, "text": "L’analyse primaire de la SSP évaluée par les investigateurs à la date du 28 février 2010 (cut-off) montre un risque relatif non stratifié de 0,79 (IC 95 % : 0,68 ; 0,91, valeur du p du test du log-rank bilatéral 0,0010) avec une médiane de SSP de 16,0 mois dans le bras CP et de 18,3 mois dans le bras CPB 7,5+.", "truncated": false}, "after_length": 311, "after_sha256": "f2fe6616f946aa0d857e3c493124b105626f5f4102fadae0ef414702d35841e0", "annex": "I", "before": {"end": 311, "start": 0, "text": "L’analyse primaire de la PFS évaluée par les investigateurs à la date du 28 février 2010 (cut-off) montre un risque relatif non stratifié de 0,79 (IC 95 % : 0,68 ; 0,91, valeur du p du test du log-rank bilatéral 0,0010) avec une médiane de PFS de 16,0 mois dans le bras CP et de 18,3 mois dans le bras CPB 7,5+.", "truncated": false}, "before_length": 311, "before_sha256": "b3fc4fe6aac0b0031a362946ae51ca70faed9a88835f23dbedb03d91c7486201", "change_kind": "content", "change_operations": [{"after_end": 27, "after_start": 25, "before_end": 25, "before_start": 25, "kind": "insert"}, {"after_end": 28, "after_start": 28, "before_end": 28, "before_start": 26, "kind": "delete"}, {"after_end": 242, "after_start": 240, "before_end": 240, "before_start": 240, "kind": "insert"}, {"after_end": 243, "after_start": 243, "before_end": 243, "before_start": 241, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f086d7c532c625578e7800dc", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1906}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 27, "start": 0, "text": "Mundipharma Ges.m.b.H.-o.z.", "truncated": false}, "before_length": 27, "before_sha256": "9029483ca33dfc6da671293b2cd5f39021da794ad7ae13578dd56a22e674b430", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 27, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 27, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f0bff0ec7388352b14fee8ce", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1136}
{"after": {"end": 19, "start": 0, "text": "Tel.: +371 67025300", "truncated": false}, "after_length": 19, "after_sha256": "9d56d23b23e1cc8fe2e91dfd2c53e6e0d7c450088c854b2bc903cc7de0211cce", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Tel.: + 371 67025300", "truncated": false}, "before_length": 20, "before_sha256": "4827747deaf690f224c8bd3d87c76b9541304a06d0d293efd223d7eb4b6cb8df", "change_kind": "content", "change_operations": [{"after_end": 7, "after_start": 7, "before_end": 8, "before_start": 7, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f0fd2698db9cf692cd99a46f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3111}
{"after": {"end": 445, "start": 0, "text": "In view of available data on anxiety and mood altered from spontaneous reports, including in some cases a close temporal relationship, a positive de-challenge and in view of the potential class effect, the PRAC considers that a causal relationship between apremilast and these adverse reactions is at least a reasonable possibility. The PRAC concluded that the product information of products containing apremilast should be amended accordingly.", "truncated": false}, "after_length": 445, "after_sha256": "26c429c08083f0e1460b36542e28f6e2532dfc0a596566789da86941bb50c1fa", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 445, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 445}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f10f64858e1bf6e5a8863348", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:30Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "35ab6716aa09492c14ac6849111486ec47235c0bc65ef055350de950f316c5e6", "source_snapshot_id": "source-f20a60110d1f8fef5225317d", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2343}
{"after": {"end": 77, "start": 0, "text": "Vérifiez que votre seringue contient 1 mL d'eau pour préparations injectables", "truncated": false}, "after_length": 77, "after_sha256": "7787a69762eda82d0d4f3de92fc7717b5e85c4279127f97b0f8f51480378484d", "annex": "IIIA", "before": {"end": 77, "start": 0, "text": "Vérifiez que votre seringue contient 1 ml d'eau pour préparations injectables", "truncated": false}, "before_length": 77, "before_sha256": "0bbc3815d32ac3905fb0aabbc187d754d23ae861fc9d8b3f813fc9f3dbfa71f8", "change_kind": "content", "change_operations": [{"after_end": 41, "after_start": 40, "before_end": 41, "before_start": 40, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f18499da1c6b613acc022908", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 8637}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 14, "start": 0, "text": "Pfizer Limited", "truncated": false}, "before_length": 14, "before_sha256": "faadd350d247ecbb0e8edac0805fa3d4cdbf449fbb9a1a9614eee6624274a2f6", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f1c1830f36b170da46efbe64", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 8585}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 6, "start": 0, "text": "Ísland", "truncated": false}, "before_length": 6, "before_sha256": "5801902efe8b92c2ace1332f4cca2ea1fcb704712e2fe7ca66654d2a826e8451", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 6, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f250874aad2e11a8dc286d7b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1130}
{"after": {"end": 244, "start": 0, "text": "Si vous avez pris plus de Fycompa que vous n’auriez dû, vous devez contacter immédiatement votre médecin. Vous pourrez présenter une confusion, une agitation, un comportement agressif, des vomissements et une diminution du niveau de conscience.", "truncated": false}, "after_length": 244, "after_sha256": "c0f7dc5e9202f7b81fb193f8181d882c8860d6ef94e8af45ee34607a50225e4c", "annex": "IIIA", "before": {"end": 226, "start": 0, "text": "Si vous avez pris plus de Fycompa que vous n’auriez dû, vous devez contacter immédiatement votre médecin. Vous pourrez présenter une confusion, une agitation, un comportement agressif et une diminution du niveau de conscience.", "truncated": false}, "before_length": 226, "before_sha256": "131d0bacfe9d91a3e52ee4ec1a2e3ebcc1ace873373f089f9001618755c89a43", "change_kind": "content", "change_operations": [{"after_end": 201, "after_start": 183, "before_end": 183, "before_start": 183, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 18}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f2dc5dcf804d2923b797f28e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:32:00Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3ff8cd4d67d22ba799aa348aeda944d6d896a16dcf54b030db101cbc095fc8ad", "source_snapshot_id": "source-a79a7cba8bf5dbc72fd40574", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2798}
{"after": {"end": 29, "start": 0, "text": "Survie sans progression (SSP)", "truncated": false}, "after_length": 29, "after_sha256": "617193974d6682c85a8af219a6f2b06ff66ff3e0e9b29cabebd5d5998461e7d8", "annex": "I", "before": {"end": 29, "start": 0, "text": "Survie sans progression (PFS)", "truncated": false}, "before_length": 29, "before_sha256": "8f5b37d99ddf529df1ca72d62d3cc355e8dee70624f1335d36a06a6f71013027", "change_kind": "content", "change_operations": [{"after_end": 27, "after_start": 25, "before_end": 25, "before_start": 25, "kind": "insert"}, {"after_end": 28, "after_start": 28, "before_end": 28, "before_start": 26, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f30db1886fa97b8d63064fff", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1870}
{"after": {"end": 9, "start": 0, "text": "Oral use.", "truncated": false}, "after_length": 9, "after_sha256": "3cb600334d66cfc50b70bcea280eaeb9fc125e589d372d56f3fae261332b8ee9", "annex": "IIIA", "before": {"end": 8, "start": 0, "text": "Oral use", "truncated": false}, "before_length": 8, "before_sha256": "1a1f6c65b762e8cde9480afdbb709dcfb59c2d46c38f5d3112c9f605bcbdf25f", "change_kind": "content", "change_operations": [{"after_end": 9, "after_start": 8, "before_end": 8, "before_start": 8, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f30f450715d654ad898cf675", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2459}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 33, "start": 0, "text": "United Kingdom (Northern Ireland)", "truncated": false}, "before_length": 33, "before_sha256": "9379d82927cdb505cfb186e912177065e56a1314de3a2b914ebbb8b5fe21525a", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 33, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 33, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f325aa630e4becd11cb99af5", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 8519}
{"after": {"end": 470, "start": 0, "text": "Le critère principal était la survie sans progression (SSP) basée sur l’évaluation de la progression de la maladie par les investigateurs, à partir de scanners, du taux du marqueur CA 125 ou d’une détérioration symptomatique durant le protocole. Par ailleurs, une analyse pré-définie des données censurant les événements de progression définis sur la base de l’augmentation du CA 125 a été conduite, ainsi qu’une revue indépendante de la SSP déterminée par les scanners.", "truncated": false}, "after_length": 470, "after_sha256": "83fbe88110c3e5d2221d56cbb773564d09be14ab6ede8f3a8afed13c1e2e73bb", "annex": "I", "before": {"end": 470, "start": 0, "text": "Le critère principal était la survie sans progression (PFS) basée sur l’évaluation de la progression de la maladie par les investigateurs, à partir de scanners, du taux du marqueur CA 125 ou d’une détérioration symptomatique durant le protocole. Par ailleurs, une analyse pré-définie des données censurant les événements de progression définis sur la base de l’augmentation du CA 125 a été conduite, ainsi qu’une revue indépendante de la PFS déterminée par les scanners.", "truncated": false}, "before_length": 470, "before_sha256": "9f8bebaccc3968e449ecba9474e523bd981c596a21b4175e2a6dbdf394ecc0d4", "change_kind": "content", "change_operations": [{"after_end": 57, "after_start": 55, "before_end": 55, "before_start": 55, "kind": "insert"}, {"after_end": 58, "after_start": 58, "before_end": 58, "before_start": 56, "kind": "delete"}, {"after_end": 440, "after_start": 438, "before_end": 438, "before_start": 438, "kind": "insert"}, {"after_end": 441, "after_start": 441, "before_end": 441, "before_start": 439, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f347962bd3786ae7898771c9", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1713}
{"after": {"end": 51, "start": 0, "text": "bosentan, to treat pulmonary arterial hypertension.", "truncated": false}, "after_length": 51, "after_sha256": "4e9f73fbe1e293057fdbe2df3475f8930983032e714230de509bf7f990c258ac", "annex": "IIIA", "before": {"end": 37, "start": 0, "text": "nausea, vomiting such as granisetron.", "truncated": false}, "before_length": 37, "before_sha256": "3b2a9217d93f10feb0f615225268d54ae08fcbdfc92aefa170d87ea742960f09", "change_kind": "content", "change_operations": [{"after_end": 24, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}, {"after_end": 28, "after_start": 26, "before_end": 21, "before_start": 2, "kind": "replace"}, {"after_end": 46, "after_start": 30, "before_end": 23, "before_start": 23, "kind": "insert"}, {"after_end": 47, "after_start": 47, "before_end": 29, "before_start": 24, "kind": "delete"}, {"after_end": 48, "after_start": 48, "before_end": 34, "before_start": 30, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 28, "chars_inserted": 42}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f34c9b02c8f33272a36ffe94", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2783}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "medinfo@mundipharma.pt", "truncated": false}, "before_length": 22, "before_sha256": "5459a27479d0597a7c1b1ca3825cab8fd8337cfb671df321accb79b7a7f908a8", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 22, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 22, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f3b7a7abf6bf0a9da3f81588", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1111}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 11, "start": 0, "text": "Takeda GmbH", "truncated": false}, "before_length": 11, "before_sha256": "94e4e4fc81542d4a8a0deb904c666e74cf300a1075af4d0d2e564a29e287bafb", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 11, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 11, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f4019e90a18ad66b48b7bc5b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1711}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 82, "start": 0, "text": "Do not shake or dilute. Swirl the vial gently after thawing and before withdrawal.", "truncated": false}, "before_length": 82, "before_sha256": "3bb837cece84c3915e889590ec4b81fff9fd0027a19fcfcb8995398702a7d3f8", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 82, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 82, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f429c34f831512ea15e37905", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 13077}
{"after": {"end": 84, "start": 0, "text": "Motifs de la modification des termes de la/des autorisation(s) de mise sur le marché", "truncated": false}, "after_length": 84, "after_sha256": "4ae2391ae7d822fcc157b2047bb5fc98dea0742b977efc28a87cde01dda2e02a", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 84, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 84}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f42ef952149a79da2e46b3f8", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "9ac80b0d56ebad4970f7a8335a177613af59ef25517bcd0bdd3397c207cc1bac", "source_snapshot_id": "source-c11aa9e32420f125a88005bc", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2746}
{"after": {"end": 134, "start": 0, "text": "Detailed information on this medicinal product is available on the website of the European Medicines Agency https://www.ema.europa.eu.", "truncated": false}, "after_length": 134, "after_sha256": "9f2a855337f11701b0cd4191c51820fa5a70b201b2e0721ba6acd34544486f89", "annex": "I", "before": {"end": 133, "start": 0, "text": "Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.", "truncated": false}, "before_length": 133, "before_sha256": "eabdb61a543e11ee016c5c43ada549964199ddf9e287a2eb3256e15d4a87fe4a", "change_kind": "technical", "change_operations": [{"after_end": 113, "after_start": 112, "before_end": 112, "before_start": 112, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f4383d7f44a11c24f1ff4bbd", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg powder and solvent for solution for injection", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "10", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2231}
{"after": {"end": 22, "start": 0, "text": "medicalinfo.nl@msd.com", "truncated": false}, "after_length": 22, "after_sha256": "578550b051823e92654f0b1dd2f62a8da0f4aa2c1bad41b233b8e6951a41272c", "annex": "IIIA", "before": {"end": 24, "start": 0, "text": "medicalinfo.nl@merck.com", "truncated": false}, "before_length": 24, "before_sha256": "cc3a8af00f6f52af5b0956221d649740a16b082158e556d4b49a01bcba8e6a99", "change_kind": "content", "change_operations": [{"after_end": 18, "after_start": 16, "before_end": 20, "before_start": 16, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f48e1b0b5f9fe6ee53914386", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3106}
{"after": {"end": 20, "start": 0, "text": "Tlf.: +45 44 201 100", "truncated": false}, "after_length": 20, "after_sha256": "a342c892cb893e888e9b98929ab7ba413528a3b19847cefc774fcc7b2c91291e", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "Tlf: +45 44 201 100", "truncated": false}, "before_length": 19, "before_sha256": "c639c1fe70f9701d8cecb70d89ff79995abd4e41911073143438fc69a41a0363", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f4a000e2b39dc19200466513", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9598}
{"after": {"end": 52, "start": 0, "text": "ff Inclut réaction liée à la perfusion et urticaire.", "truncated": false}, "after_length": 52, "after_sha256": "176452c88762e04d1dc073ec171cf1ffe5f3bfc57105352d85a3b8e7aefe949d", "annex": "I", "before": {"end": 52, "start": 0, "text": "ee Inclut réaction liée à la perfusion et urticaire.", "truncated": false}, "before_length": 52, "before_sha256": "7bbb1dc9ae35552061b01e3e59142d3c0cdc2ce2615d83ce6fb90f024d00d6af", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 0, "before_end": 2, "before_start": 0, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f4c65192064f96809a9a823f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:18Z", "pipeline_version": "2.0.0", "presentation_label": "IMJUDO 20 mg/ml, solution à diluer pour perfusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "2437ab76633f46c9eee5e002e5c7a7caba6367f59567d750be0eb67c74d1db4e", "source_snapshot_id": "source-7f4d129b0a0fd2d3684d27c5", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 927}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 158, "start": 0, "text": "Spikevax JN.1 is a white to off white dispersion supplied in a glass single-dose vial with a rubber stopper and blue flip-off plastic cap with aluminium seal.", "truncated": false}, "before_length": 158, "before_sha256": "ff7f398710cec20d8cd4c52a10f8544e41dd47ed954bd4be78545790ad17fa91", "change_kind": "administrative", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 158, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 158, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f4d22463d749b5fd0384a997", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12883}
{"after": {"end": 76, "start": 0, "text": "Les médicaments pouvant modifier le taux d’Adempas dans le sang, par exemple", "truncated": false}, "after_length": 76, "after_sha256": "82ac6fc73748ae9487fe9aaa1bd1cf09a188f7b8825284a1c8c2dddade82fcb3", "annex": "IIIA", "before": {"end": 120, "start": 0, "text": "Les médicaments suivants peuvent augmenter le taux d’Adempas dans le sang ce qui augmente le risque d’effets secondaires", "truncated": false}, "before_length": 120, "before_sha256": "3c3b89e0fbd88e6bc92c727b1e475bd6114848eaa077d1881fc1d2bfd18f9d1c", "change_kind": "content", "change_operations": [{"after_end": 18, "after_start": 16, "before_end": 17, "before_start": 16, "kind": "replace"}, {"after_end": 19, "after_start": 19, "before_end": 19, "before_start": 18, "kind": "delete"}, {"after_end": 23, "after_start": 23, "before_end": 24, "before_start": 23, "kind": "delete"}, {"after_end": 24, "after_start": 24, "before_end": 36, "before_start": 25, "kind": "delete"}, {"after_end": 30, "after_start": 25, "before_end": 40, "before_start": 37, "kind": "replace"}, {"after_end": 64, "after_start": 63, "before_end": 73, "before_start": 73, "kind": "insert"}, {"after_end": 69, "after_start": 65, "before_end": 75, "before_start": 74, "kind": "replace"}, {"after_end": 72, "after_start": 70, "before_end": 84, "before_start": 76, "kind": "replace"}, {"after_end": 74, "after_start": 73, "before_end": 90, "before_start": 85, "kind": "replace"}, {"after_end": 76, "after_start": 76, "before_end": 120, "before_start": 92, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 59, "chars_inserted": 15}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f4eb48cd72af8cb1e8371667", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2856}
{"after": {"end": 220, "start": 0, "text": "les anti-acides comme l’hydroxyde d’aluminium / l’hydroxyde de magnésium, utilisés pour traiter l’indigestion ou les brûlures d’estomac. Prenez les anti-acides au moins 2 heures avant ou 1 heure après la prise d’Adempas.", "truncated": false}, "after_length": 220, "after_sha256": "a1d4944d0c363d5b48c187c4120091ae487ccbb0f38de4c73cd7ea853e31a837", "annex": "IIIA", "before": {"end": 242, "start": 0, "text": "pour traiter des maladies de l’estomac ou des brûlures d’estomac, des anti-acides comme l’hydroxyde d’aluminium / l’hydroxyde de magnésium sont utilisés. Prenez les anti-acides au moins 2 heures avant ou 1 heure après l’utilisation d’Adempas.", "truncated": false}, "before_length": 242, "before_sha256": "e58e16a360d4cf4e9f71ca4cf86876256b04fed61a9b9de6330d9229a6529eaa", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 19, "before_start": 0, "kind": "delete"}, {"after_end": 1, "after_start": 1, "before_end": 67, "before_start": 20, "kind": "delete"}, {"after_end": 73, "after_start": 72, "before_end": 143, "before_start": 138, "kind": "replace"}, {"after_end": 135, "after_start": 82, "before_end": 152, "before_start": 152, "kind": "insert"}, {"after_end": 206, "after_start": 202, "before_end": 224, "before_start": 219, "kind": "replace"}, {"after_end": 209, "after_start": 208, "before_end": 231, "before_start": 226, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 81, "chars_inserted": 59}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f527d175eec2201427e35221", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2865}
{"after": {"end": 89, "start": 0, "text": "Les résultats de SSP pour chaque chimiothérapie de l’indication sont résumés ci-dessous :", "truncated": false}, "after_length": 89, "after_sha256": "fcb41062481493026c1c543fb23bd6f7d169d1b9b6d65bb20c059a7bd15be6e0", "annex": "I", "before": {"end": 89, "start": 0, "text": "Les résultats de PFS pour chaque chimiothérapie de l’indication sont résumés ci-dessous :", "truncated": false}, "before_length": 89, "before_sha256": "21dfcce110b7a623547a2057fba9512ff4aaf03154a3451d27dac7d89c4263b2", "change_kind": "content", "change_operations": [{"after_end": 19, "after_start": 17, "before_end": 17, "before_start": 17, "kind": "insert"}, {"after_end": 20, "after_start": 20, "before_end": 20, "before_start": 18, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f528571ae1511a652d73d43e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1316}
{"after": {"end": 728, "start": 0, "text": "Enbrel est reconstitué avec 1 mL d’eau pour préparations injectables avant utilisation, et administration de l’injection sous-cutanée. Enbrel ne contient aucun agent conservateur antibactérien, et les solutions préparées avec de l’eau pour préparations injectables doivent donc être administrées le plus vite possible, au plus tard dans les six heures qui suivent la reconstitution. La solution doit être limpide et incolore à jaune pâle ou brun pâle, sans amas, flocons ou particules visibles. Il se peut que de la mousse reste dans le flacon – c’est normal. Enbrel ne doit pas être utilisé si toute la poudre du flacon ne s’est pas dissoute dans les 10 minutes. Si tel est le cas, recommencez l’opération avec un autre flacon.", "truncated": false}, "after_length": 728, "after_sha256": "a7ad294936da0dac6665f55aa0bbbd8496142f742eb105fd5b9c7379ff55f653", "annex": "I", "before": {"end": 728, "start": 0, "text": "Enbrel est reconstitué avec 1 ml d’eau pour préparations injectables avant utilisation, et administration de l’injection sous-cutanée. Enbrel ne contient aucun agent conservateur antibactérien, et les solutions préparées avec de l’eau pour préparations injectables doivent donc être administrées le plus vite possible, au plus tard dans les six heures qui suivent la reconstitution. La solution doit être limpide et incolore à jaune pâle ou brun pâle, sans amas, flocons ou particules visibles. Il se peut que de la mousse reste dans le flacon – c’est normal. Enbrel ne doit pas être utilisé si toute la poudre du flacon ne s’est pas dissoute dans les 10 minutes. Si tel est le cas, recommencez l’opération avec un autre flacon.", "truncated": false}, "before_length": 728, "before_sha256": "987c3784f2b47ae2aeaad61ac9dbbda35cb1b54cef25dbd34a1fbe0eee0a1c18", "change_kind": "content", "change_operations": [{"after_end": 32, "after_start": 31, "before_end": 32, "before_start": 31, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f53785b6bb45e65c071a14d2", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg poudre et solvant pour solution injectable", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2233}
{"after": {"end": 150, "start": 0, "text": "avez une pression sanguine basse avant de commencer le traitement par Adempas. Pour débuter Adempas, votre pression artérielle systolique doit être de", "truncated": false}, "after_length": 150, "after_sha256": "2503e139c5d118c26ecf8aa3ecf85940b381cbe486544cc0884d35cd1a2e0343", "annex": "IIIA", "before": {"end": 152, "start": 0, "text": "avez une pression sanguine basse avant de prendre Adempas pour la première fois. Pour débuter Adempas, votre pression artérielle systolique doit être de", "truncated": false}, "before_length": 152, "before_sha256": "de644e15a17b5698dff5bdedbef63385c8071ff48a77da4918e39bedf5f29e17", "change_kind": "content", "change_operations": [{"after_end": 46, "after_start": 42, "before_end": 44, "before_start": 42, "kind": "replace"}, {"after_end": 50, "after_start": 48, "before_end": 47, "before_start": 46, "kind": "replace"}, {"after_end": 53, "after_start": 51, "before_end": 48, "before_start": 48, "kind": "insert"}, {"after_end": 69, "after_start": 54, "before_end": 49, "before_start": 49, "kind": "insert"}, {"after_end": 76, "after_start": 76, "before_end": 78, "before_start": 56, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 25, "chars_inserted": 23}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f537ac011ae7b844cf50d3ce", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2813}
{"after": {"end": 50, "start": 0, "text": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection", "truncated": false}, "after_length": 50, "after_sha256": "8c0d5490a68da1e449c0490ed0defe0da9d9d8c2d6ae11271b883fa7dfd5a64a", "annex": "I", "before": {"end": 48, "start": 0, "text": "Spikevax JN.1 0.1 mg/mL dispersion for injection", "truncated": false}, "before_length": 48, "before_sha256": "f251c20d6a11d153458ca69aaf22627ccbe0cce3064c14f8eb27faf9c2c0f105", "change_kind": "administrative", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f596d68461708a95b0c0c7f9", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12875}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 7, "start": 0, "text": "Ireland", "truncated": false}, "before_length": 7, "before_sha256": "02bf1dfa9a0365a86223f0e4ac9eaa0517b06b2e9273790f719feda656a247ae", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 7, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 7, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f5cfd5acaa7abbda3b3fa83c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1105}
{"after": {"end": 45, "start": 0, "text": "95 mmHg or more if you are12 to 17 years old.", "truncated": false}, "after_length": 45, "after_sha256": "73f3423cb71a8265f44ae61124e5c3b035bc4f63482eab8c1f596c008647716f", "annex": "IIIA", "before": {"end": 67, "start": 0, "text": "95 mmHg or more if you are older than 12 and younger than 18 years.", "truncated": false}, "before_length": 67, "before_sha256": "07b903f2a5c38f51f593fa8960a968d643756226623d39c834b51e83b2d1f092", "change_kind": "content", "change_operations": [{"after_end": 26, "after_start": 26, "before_end": 38, "before_start": 26, "kind": "delete"}, {"after_end": 30, "after_start": 29, "before_end": 46, "before_start": 41, "kind": "replace"}, {"after_end": 31, "after_start": 31, "before_end": 57, "before_start": 47, "kind": "delete"}, {"after_end": 34, "after_start": 33, "before_end": 60, "before_start": 59, "kind": "replace"}, {"after_end": 44, "after_start": 40, "before_end": 66, "before_start": 66, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 28, "chars_inserted": 6}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f5e821b37d10a9229c1ab2a8", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3166}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "België/Belgique/Belgien", "truncated": false}, "before_length": 23, "before_sha256": "4646bb1028d1508f87afd915f6c144536b764795c7df5858f4eaa35881bb797d", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 23, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 23, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f5f31c29b768c64350396227", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1014}
{"after": {"end": 20, "start": 0, "text": "Tlf.: +45 44 201 100", "truncated": false}, "after_length": 20, "after_sha256": "a342c892cb893e888e9b98929ab7ba413528a3b19847cefc774fcc7b2c91291e", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "Tlf: +45 44 201 100", "truncated": false}, "before_length": 19, "before_sha256": "c639c1fe70f9701d8cecb70d89ff79995abd4e41911073143438fc69a41a0363", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f60025ca1b145453bd260e0d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12072}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 33, "start": 0, "text": "Mundipharma Pharmaceuticals, S.L.", "truncated": false}, "before_length": 33, "before_sha256": "446fa3011719739274b4086253796403ba3069098384e7226a20327278e75f63", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 33, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 33, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f60e41aef303a5d5e0ae5afc", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1095}
{"after": {"end": 13, "start": 0, "text": "Leusderend 16", "truncated": false}, "after_length": 13, "after_sha256": "af1e1fecef744f092123851cb8459b03d91077081e50b99a8caaeae83326dc44", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 13}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f615b165c4a72d94b792ac13", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1008}
{"after": {"end": 26, "start": 0, "text": "<code QR> + www.nyxoid.com", "truncated": false}, "after_length": 26, "after_sha256": "857e06b67ebe3627553965867a0c4ede35c720f0729e026430f762a391320181", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 26, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 26}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f67d70b214290b5059e18b36", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 901}
{"after": {"end": 20, "start": 0, "text": "Tlf.: +45 44 201 100", "truncated": false}, "after_length": 20, "after_sha256": "a342c892cb893e888e9b98929ab7ba413528a3b19847cefc774fcc7b2c91291e", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "Tlf: +45 44 201 100", "truncated": false}, "before_length": 19, "before_sha256": "c639c1fe70f9701d8cecb70d89ff79995abd4e41911073143438fc69a41a0363", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f6f1a4396cdaf1186070d9cb", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 8494}
{"after": {"end": 31, "start": 0, "text": "Ne pas testez avant utilisation", "truncated": false}, "after_length": 31, "after_sha256": "e79423040f9f3fe7af8374fc1c0106b94516e755a016afe4c463b7a8f784bf52", "annex": "IIIA", "before": {"end": 31, "start": 0, "text": "Ne pas tester avant utilisation", "truncated": false}, "before_length": 31, "before_sha256": "d7b02d10253b577b4bec5447414e63090c9e2f975678cacc5ec777864dd94d3f", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 12, "before_end": 13, "before_start": 12, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f6feab2db9bd3818cde0b6ba", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 661}
{"after": {"end": 10, "start": 0, "text": "50 mg/1 mL", "truncated": false}, "after_length": 10, "after_sha256": "a558007d4fff152f6cb4735b3ad12424e7cbc5a180e2d6aaf96494264fd38aaf", "annex": "IIIA", "before": {"end": 10, "start": 0, "text": "50 mg/1 ml", "truncated": false}, "before_length": 10, "before_sha256": "d29bca9bc6337ef8c0e27e23812ffbcfa8ebe5505134dbf116ff9f4ee101b05e", "change_kind": "content", "change_operations": [{"after_end": 10, "after_start": 9, "before_end": 10, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f7130fac8b9d2961f67f7d09", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12316}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "Tel.: +36 23 801 028", "truncated": false}, "before_length": 20, "before_sha256": "7f7869949c31dd79daffcb46cd116971dd2648bfe86226cbf32dac3588a8cfa1", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 20, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 20, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f724451b6f0ac7823a8ecbda", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1040}
{"after": {"end": 189, "start": 0, "text": "have pulmonary veno-occlusive disease, a disease which makes you feel short of breath because fluid builds up in the lungs. He or she may decide to provide you with an alternative medicine.", "truncated": false}, "after_length": 189, "after_sha256": "4ed6f13b3b4c712664c8e89a0c1ad084aacf08e3a0eb249be58f6d9c20333a56", "annex": "IIIA", "before": {"end": 189, "start": 0, "text": "have pulmonary veno-occlusive disease, a disease which makes you feel short of breath because fluid builds-up in the lungs. He or she may decide to provide you with an alternative medicine.", "truncated": false}, "before_length": 189, "before_sha256": "a1f2d1d257f6dd70fcfc9fc1c5690d3a61f045adee4fa9fa773b532aa47b78b8", "change_kind": "content", "change_operations": [{"after_end": 107, "after_start": 106, "before_end": 107, "before_start": 106, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f758161c966ba7f6e47d0bc3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2740}
{"after": {"end": 25, "start": 0, "text": "Elle est disponible via :", "truncated": false}, "after_length": 25, "after_sha256": "87288ea26a1fb9afafafdcc576df540ecf2f9133d7610cc1fd94107c86518ef1", "annex": "II", "before": {"end": 31, "start": 0, "text": "Elle doit être disponible via :", "truncated": false}, "before_length": 31, "before_sha256": "653675c7bffcd1300c7965dfb5ecda46d4d621a1728634b568c0d43048d2bfc1", "change_kind": "content", "change_operations": [{"after_end": 7, "after_start": 5, "before_end": 8, "before_start": 5, "kind": "replace"}, {"after_end": 8, "after_start": 8, "before_end": 14, "before_start": 9, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 8, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f76cedc177e9ec4a0e2bf0f8", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 460}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 14, "start": 0, "text": "Pfizer Limited", "truncated": false}, "before_length": 14, "before_sha256": "faadd350d247ecbb0e8edac0805fa3d4cdbf449fbb9a1a9614eee6624274a2f6", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f78dc8b82e899728fa7c192e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 9690}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 12, "start": 0, "text": "15°C to 25°C", "truncated": false}, "before_length": 12, "before_sha256": "b57c2b618e71e3e42c038965c231cecdb8049c3d82d00aa02012ac70ea91f351", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 12, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 12, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f7c9d50c948ba555711c15bf", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6405}
{"after": {"end": 845, "start": 0, "text": "Il a été rarement rapporté que des patients traités par Avastin développent des signes et symptômes compatibles avec un Syndrome d’Encéphalopathie Postérieure Réversible (SEPR), un trouble neurologique rare, pouvant se manifester, entres autres, par les signes et symptômes suivants : convulsions, céphalées, état mental altéré, troubles de la vision, cécité corticale, avec ou sans hypertension associée. Le diagnostic de SEPR requiert une confirmation par imagerie cérébrale, de préférence par imagerie par résonance magnétique (IRM). Chez les patients qui développent un SEPR, le traitement spécifique des symptômes, incluant le contrôle de l’hypertension est recommandé ainsi que l’arrêt d’Avastin. Les conséquences en termes de tolérance d’une reprise du traitement par Avastin chez les patients ayant développé un SEPR ne sont pas connues.", "truncated": false}, "after_length": 845, "after_sha256": "79c9f00736a15e1d965ff2c02710f5eb2022367588bb3c29b805ce35cae32a87", "annex": "I", "before": {"end": 842, "start": 0, "text": "Il a été rarement rapporté que des patients traités par Avastin développent des signes et symptômes compatibles avec un Syndrome d’Encéphalopathie Postérieure Réversible (SEPR), un trouble neurologique rare, pouvant se manifester, entres autres, par les signes et symptômes suivants : attaques, céphalées, état mental altéré, troubles de la vision, cécité corticale, avec ou sans hypertension associée. Le diagnostic de SEPR requiert une confirmation par imagerie cérébrale, de préférence par imagerie par résonance magnétique (IRM). Chez les patients qui développent un SEPR, le traitement spécifique des symptômes, incluant le contrôle de l’hypertension est recommandé ainsi que l’arrêt d’Avastin. Les conséquences en termes de tolérance d’une reprise du traitement par Avastin chez les patients ayant développé un SEPR ne sont pas connues.", "truncated": false}, "before_length": 842, "before_sha256": "2871710cd6a339f15ca032e2e807ccc715e0fa12ee009080990ba12bc063f0ed", "change_kind": "content", "change_operations": [{"after_end": 289, "after_start": 285, "before_end": 290, "before_start": 285, "kind": "replace"}, {"after_end": 295, "after_start": 290, "before_end": 292, "before_start": 291, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 9}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f83e0ba459c2af81d1a9fb4f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 197}
{"after": {"end": 17, "start": 0, "text": "inform_pt@msd.com", "truncated": false}, "after_length": 17, "after_sha256": "80ea8d7772d76b760ca402228980572f0cf6dc451b408386454eb84cec35e7c8", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "inform_pt@merck.com", "truncated": false}, "before_length": 19, "before_sha256": "417a4e56160e131fb045d4a98431bae78237c04f6d71f4a97656e8299c0b43d2", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 11, "before_end": 15, "before_start": 11, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f83f2fa4d848d897a17b808a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3555}
{"after": {"end": 22, "start": 0, "text": "Tel.: +420 277 050 000", "truncated": false}, "after_length": 22, "after_sha256": "5a73afc7c7a9b40fee1c264ddd73318b7831c01ad752d8e98c531d058ff77e22", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tel: +420 233 010 111", "truncated": false}, "before_length": 21, "before_sha256": "86999b702f11fb434a8ae044a79bf67743758f2695ac34bae0355d2effa55dff", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}, {"after_end": 14, "after_start": 12, "before_end": 13, "before_start": 11, "kind": "replace"}, {"after_end": 17, "after_start": 16, "before_end": 16, "before_start": 15, "kind": "replace"}, {"after_end": 22, "after_start": 19, "before_end": 21, "before_start": 18, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 7}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f845acf83d8b2dd39997932a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3490}
{"after": {"end": 28, "start": 0, "text": "Que contient cette notice ?:", "truncated": false}, "after_length": 28, "after_sha256": "5567131b5cfaa905e7b2bebca8011ab12d65e41e8a00e5471d8eebc2f258a8f2", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "Que contient cette notice", "truncated": false}, "before_length": 25, "before_sha256": "99d35d46ce6e3a25dcecda9e8a5caa72cdadeab2d8d38c8c67783f06af54cc3a", "change_kind": "content", "change_operations": [{"after_end": 28, "after_start": 25, "before_end": 25, "before_start": 25, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 3}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f85e9379c2fd202d70a526d1", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 743}
{"after": {"end": 204, "start": 0, "text": "Aucun bénéfice cliniquement pertinent en SSP n’a été observé chez les patientes ayant reçu du bevacizumab en association à la chimiothérapie et n’ayant pas continué à recevoir du bevacizumab seul (CPB15).", "truncated": false}, "after_length": 204, "after_sha256": "f0386a6c6cf36415096cea172a73ff2c2b072bce5c18feda93fd7e81d4432252", "annex": "I", "before": {"end": 204, "start": 0, "text": "Aucun bénéfice cliniquement pertinent en PFS n’a été observé chez les patientes ayant reçu du bevacizumab en association à la chimiothérapie et n’ayant pas continué à recevoir du bevacizumab seul (CPB15).", "truncated": false}, "before_length": 204, "before_sha256": "a6a58a616e6655b2165f5a9e9642d77ac65b9eecd42fb9eae92e21095a51da7c", "change_kind": "content", "change_operations": [{"after_end": 43, "after_start": 41, "before_end": 41, "before_start": 41, "kind": "insert"}, {"after_end": 44, "after_start": 44, "before_end": 44, "before_start": 42, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f880c043340cd0f103e8867b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1717}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IV", "before": {"end": 72, "start": 0, "text": "Grounds for the variation to the terms of the marketing authorisation(s)", "truncated": false}, "before_length": 72, "before_sha256": "3186bdadc3d2480c65b477145e6ff994610239d4243371f493c1f2ab110ec5da", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 72, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 72, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f89273537a22fe80a6200a64", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:31:53Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "ea71588767c01ec0d963dcff1ec8339ebd7d99fd9f25439a3c9d9c86ca3ea916", "source_snapshot_id": "source-e3932a928cf90bf8fb14f02f", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3431}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "Τηλ: +357 22 815656", "truncated": false}, "before_length": 19, "before_sha256": "5711b6725bbda0d41ed024cf91909a0abf0deae86b71ee0bb202fca2c9265537", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 19, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 19, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f892f35cd7ff70a058a4d988", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1141}
{"after": {"end": 18, "start": 0, "text": "dpoccyprus@msd.com", "truncated": false}, "after_length": 18, "after_sha256": "492fae7e6db021703bcb80e4b139bc2be78a7e6cf4c6056a9314c70cfe643716", "annex": "IIIA", "before": {"end": 20, "start": 0, "text": "malta_info@merck.com", "truncated": false}, "before_length": 20, "before_sha256": "d0529053ac5f753b95c76e02b64d46efbc0d61183bea7de30faa0abc218a9e1c", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 0, "before_end": 9, "before_start": 0, "kind": "replace"}, {"after_end": 10, "after_start": 3, "before_end": 10, "before_start": 10, "kind": "insert"}, {"after_end": 14, "after_start": 12, "before_end": 16, "before_start": 12, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 13, "chars_inserted": 11}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f8e6f2bb56f516cc059f73ff", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3506}
{"after": {"end": 697, "start": 0, "text": "Des études de la toxicité par administration répétée chez l’animal ont révélé que le bevacizumab pourrait avoir un effet indésirable sur la fertilité des femmes (voir rubrique 5.3). Dans un essai de phase III chez des patients atteints d’un cancer colorectal en traitement adjuvant, une sous-étude a montré, chez des femmes non ménopausées, une augmentation de l’incidence de nouveaux cas d’insuffisance ovarienne dans le groupe bevacizumab comparé au groupe contrôle. Après arrêt du traitement par le bevacizumab, la fonction ovarienne s’est rétablie pour la majorité des patientes concernées. Les effets à long terme d’un traitement par bevacizumab sur la fertilité ne sont à ce jour pas connus.", "truncated": false}, "after_length": 697, "after_sha256": "50b8b69010d435e210d924ef9d7520a1a2238d8f844c290d7e103e8e143959ec", "annex": "I", "before": {"end": 697, "start": 0, "text": "Des études de la toxicité par administration répétée chez l’animal ont révélé que le bevacizumab pourrait avoir un effet indésirable sur la fertilité des femmes (voir rubrique 5.3). Dans un essai de phase III chez des patients atteints d’un cancer colorectal en traitement adjuvant, une sous-étude a montré, chez des femmes non ménopausées, une augmentation de l’incidence de nouveaux cas d’insuffisance ovarienne dans le groupe bevacizumab comparé au groupe contrôle. Après arrêt du traitement par le bevacizumab, la fonction ovarienne s’est rétablie pour la majorité des patientes concernées. Les effets à long-terme d’un traitement par bevacizumab sur la fertilité ne sont à ce jour pas connus.", "truncated": false}, "before_length": 697, "before_sha256": "ec005c9a77d7d5c272d8a9980e21ff99def3f05e8d1f1d4353351be57b24ad63", "change_kind": "content", "change_operations": [{"after_end": 613, "after_start": 612, "before_end": 613, "before_start": 612, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f9372c6fbbdd27bf3c5ef1f7", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.6", "section_type": "pregnancy", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 298}
{"after": {"end": 298, "start": 0, "text": "Carboplatine (ASC 4, Jour 1) et gemcitabine (1000 mg/m², les jours 1 et 8) en association avec Avastin (15 mg/kg, Jour 1) toutes les 3 semaines pendant 6 cycles, et jusqu’à 10 cycles, suivis d’Avastin (15 mg/kg toutes les 3 semaines) seul jusqu’à progression de la maladie ou toxicité inacceptable.", "truncated": false}, "after_length": 298, "after_sha256": "3c97b81093d671380db1a3bb84606c61ee677b010dc0c898bef3348989286e28", "annex": "I", "before": {"end": 283, "start": 0, "text": "Carboplatine (ASC 4, Jour 1) et gemcitabine (1000 mg/m², Jours 1 et 8) suivis d’Avastin (15 mg/kg, Jour 1) toutes les 3 semaines pendant 6 cycles, et jusqu’à 10 cycles, suivis d’Avastin (15 mg/kg toutes les 3 semaines) seul jusqu’à progression de la maladie ou toxicité inacceptable.", "truncated": false}, "before_length": 283, "before_sha256": "785000bb8f35bf667e0632a817fd9f5648b147fbe5de5ff9c24e3aed2393e96a", "change_kind": "content", "change_operations": [{"after_end": 62, "after_start": 57, "before_end": 58, "before_start": 57, "kind": "replace"}, {"after_end": 79, "after_start": 75, "before_end": 71, "before_start": 71, "kind": "insert"}, {"after_end": 83, "after_start": 80, "before_end": 73, "before_start": 72, "kind": "replace"}, {"after_end": 91, "after_start": 84, "before_end": 74, "before_start": 74, "kind": "insert"}, {"after_end": 94, "after_start": 92, "before_end": 77, "before_start": 75, "kind": "replace"}, {"after_end": 95, "after_start": 95, "before_end": 80, "before_start": 78, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 6, "chars_inserted": 21}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f98351dbcec336090f12e10c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1969}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 38, "start": 0, "text": "Thaw temperature (at room temperature)", "truncated": false}, "before_length": 38, "before_sha256": "026c45281369b19ddeec659566dbab7b878d204f7a1ae9e40f2ae994b9e80346", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 38, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 38, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-f9875c3772246318ea03ebb8", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6395}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 11, "start": 0, "text": "Pack sizes:", "truncated": false}, "before_length": 11, "before_sha256": "07375f0ab9b15bd634c57af28cbd49f2c87f26ea59100ce8f19efd4876374f96", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 11, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 11, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-fa0bb8088d5482395f7955ce", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.5", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6322}
{"after": {"end": 22, "start": 0, "text": "Τηλ: +30 210 98 97 300", "truncated": false}, "after_length": 22, "after_sha256": "dd162db651d0bb933c67abbcfedf7247ba30b74281375422519823d66107bf57", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "Τηλ: + 30 210 98 97 300", "truncated": false}, "before_length": 23, "before_sha256": "1997a91a04dae627a7812e41999545eae97ed698432b9af730eba8006d8fde42", "change_kind": "content", "change_operations": [{"after_end": 6, "after_start": 6, "before_end": 7, "before_start": 6, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-fa10fe025f363c9cb366429f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3033}
{"after": {"end": 74, "start": 0, "text": "As Spikevax LP.8.1 does not contain the virus, it cannot give you COVID19.", "truncated": false}, "after_length": 74, "after_sha256": "1fef653f2412cb45993ba72b05910deb8e1cb7164dca0299649a2ecf1fca40df", "annex": "I", "before": {"end": 72, "start": 0, "text": "As Spikevax JN.1 does not contain the virus, it cannot give you COVID19.", "truncated": false}, "before_length": 72, "before_sha256": "ca5e9ff18e45162219a1b060d1c684b488d1207b7bf7034ef3f708fa7820ac47", "change_kind": "administrative", "change_operations": [{"after_end": 16, "after_start": 12, "before_end": 14, "before_start": 12, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-faab01efb5ea3fe9ecb3a10c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12627}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IV", "before": {"end": 99, "start": 0, "text": "Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)", "truncated": false}, "before_length": 99, "before_sha256": "d91cfa1348faf27099fbf9ab8abbfd4f3138591ee444efb9a76342682d0ae6c8", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 99, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 99, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-fab4fe855c8c94cf75d4a54d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2502}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 16, "start": 0, "text": "Single-dose vial", "truncated": false}, "before_length": 16, "before_sha256": "e524099369c6feef1de2df0ae572b99a4dff2799165a4afd5f6a7a6e4beaef70", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 16, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 16, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-fab8ec50d72ca4f8272e799e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6397}
{"after": {"end": 76, "start": 0, "text": "Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe", "truncated": false}, "after_length": 76, "after_sha256": "6c7ff1bbd2f6d8c84f1254cce87065dac51505e1edd888622047a746e34551e6", "annex": "I", "before": {"end": 74, "start": 0, "text": "Spikevax JN.1 50 micrograms dispersion for injection in pre-filled syringe", "truncated": false}, "before_length": 74, "before_sha256": "ebe036d056b86be90e582dc3803425dce3820674579f962bd2fc8976b65c292a", "change_kind": "administrative", "change_operations": [{"after_end": 13, "after_start": 9, "before_end": 11, "before_start": 9, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 4}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-fadc0bab3cabdba2df855bcd", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 12602}
{"after": {"end": 45, "start": 0, "text": "Tel: +351 21 901 31 62 medinfo@mundipharma.pt", "truncated": false}, "after_length": 45, "after_sha256": "40a0e214d09b2a8b7f4cea7b5826b85ad17fe1fc52e034547e6f91e9778a17b5", "annex": "IIIA", "before": {"end": 46, "start": 0, "text": "Tel: +351 21 901 31 62 med.info@mundipharma.pt", "truncated": false}, "before_length": 46, "before_sha256": "ab899ca6d4aa8b9bfe95fb491baa3388577fb8e3362f2e2e92a717c02e9482af", "change_kind": "content", "change_operations": [{"after_end": 26, "after_start": 26, "before_end": 27, "before_start": 26, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-faf752134fc73de96e6002cb", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:33Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "21d66bf1e9a74479f577de09da3cf8517d65c1ce1b1d8bbdfe4bc38f79410def", "source_snapshot_id": "source-2c39c998fdaf05159687c016", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1032}
{"after": {"end": 7, "start": 0, "text": "Anxiety", "truncated": false}, "after_length": 7, "after_sha256": "7806c4ea4cdc269ec9bef57b3d8967ae6a4dcf4ba20017db416fbaab45412b66", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 7, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 7}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-faf8ac8923ea75ced84154e7", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:30Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "35ab6716aa09492c14ac6849111486ec47235c0bc65ef055350de950f316c5e6", "source_snapshot_id": "source-f20a60110d1f8fef5225317d", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2369}
{"after": {"end": 632, "start": 0, "text": "Les caractéristiques des concentrations sériques moyennes à l’état d’équilibre chez les patients atteints de PR étaient une Cmax de 2,4 mg/l vs 2,6 mg/l, une Cmin de 1,2 mg/l vs 1,4 mg/l, et une ASC partielle de 297 mgh/l vs 316 mgh/l pour la dose de 50 mg d’Enbrel une fois par semaine (n = 21) vs 25 mg d’Enbrel deux fois par semaine (n = 16) respectivement. Dans une étude en ouvert, croisée, avec administration unique de deux posologies différentes chez des volontaires sains, il a été démontré que l’administration d’une injection unique de 50 mg/mL d’etanercept était bioéquivalente à deux injections simultanées de 25 mg/mL.", "truncated": false}, "after_length": 632, "after_sha256": "a314719d36f9cbee570762008a9dbbdc562da2fa0fcbf7079b1f1d65515aa5c9", "annex": "I", "before": {"end": 632, "start": 0, "text": "Les caractéristiques des concentrations sériques moyennes à l’état d’équilibre chez les patients atteints de PR étaient une Cmax de 2,4 mg/l vs 2,6 mg/l, une Cmin de 1,2 mg/l vs 1,4 mg/l, et une ASC partielle de 297 mgh/l vs 316 mgh/l pour la dose de 50 mg d’Enbrel une fois par semaine (n = 21) vs 25 mg d’Enbrel deux fois par semaine (n = 16) respectivement. Dans une étude en ouvert, croisée, avec administration unique de deux posologies différentes chez des volontaires sains, il a été démontré que l’administration d’une injection unique de 50 mg/ml d’etanercept était bioéquivalente à deux injections simultanées de 25 mg/ml.", "truncated": false}, "before_length": 632, "before_sha256": "8c065fd129119e22879a2173b5d388342b9c02f7cde21405d481a9d61753f047", "change_kind": "content", "change_operations": [{"after_end": 555, "after_start": 554, "before_end": 555, "before_start": 554, "kind": "replace"}, {"after_end": 631, "after_start": 630, "before_end": 631, "before_start": 630, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-fb1a258ab49249eb780a37aa", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg solution injectable en stylo pré-rempli Enbrel 50 mg solution injectable en stylo pré-rempli", "presentation_occurrence": 4, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 4427}
{"after": {"end": 157, "start": 0, "text": "• Press and hold down the push button until the dose indication has returned to the start position. Keep the needle in the skin fold for a further 6 seconds.", "truncated": false}, "after_length": 157, "after_sha256": "57dc2803fc10faa7c40466ab4073915a1f44cad20fd358703e223137299a7f66", "annex": "IIIA", "before": {"end": 143, "start": 0, "text": "• Press the push button until the dose indication has returned to the start position. Keep the needle in the skin fold for a further 6 seconds.", "truncated": false}, "before_length": 143, "before_sha256": "30efbc72581aec178b52dedaf2991a3d0466d444e19ca6246b9328303519cc58", "change_kind": "content", "change_operations": [{"after_end": 22, "after_start": 8, "before_end": 8, "before_start": 8, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 14}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-fb1c85ff039858d151c58f5d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2067}
{"after": {"end": 137, "start": 0, "text": "Terrosa Pen is a non-sterile, reusable medical device intended for the subcutaneous administration of Terrosa from compatible cartridges.", "truncated": false}, "after_length": 137, "after_sha256": "435c2dd44c3f72ce330a1639773fafe869f217fd044d64cc06220612288df814", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 137, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 137}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-fb307f0b45e7472a8cc4e4e8", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1944}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 13, "start": 0, "text": "Thaw duration", "truncated": false}, "before_length": 13, "before_sha256": "1192f885dc2df1a806d7eec521b69a527d874ceba16591d76aabb6dbb7166424", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 13, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 13, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-fb39b747fe99042487feeb41", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6394}
{"after": {"end": 149, "start": 0, "text": "Des informations détaillées sur ce médicament sont disponibles sur le site internet de l’Agence européenne des médicaments https://www.ema.europa.eu.", "truncated": false}, "after_length": 149, "after_sha256": "0e6b9f35caaf0258b468a6e9a53665f0ec5536787f68eefee5f242bf64add02e", "annex": "I", "before": {"end": 148, "start": 0, "text": "Des informations détaillées sur ce médicament sont disponibles sur le site internet de l’Agence européenne des médicaments http://www.ema.europa.eu.", "truncated": false}, "before_length": 148, "before_sha256": "8781a4dba25cf8cb978f0efd517b11bd29ec42e3e0fffadb61d4b9c2e7362806", "change_kind": "technical", "change_operations": [{"after_end": 128, "after_start": 127, "before_end": 127, "before_start": 127, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-fb658b0cf8f17f60b5055e74", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg poudre et solvant pour solution injectable", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "10", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2263}
{"after": {"end": 53, "start": 0, "text": "Si vous avez pris plus d’Adempas que vous n’auriez dû", "truncated": false}, "after_length": 53, "after_sha256": "a572a3a3c2cf7624ec6774904c9ab22cb9e960f9c3b342280b2e15fd7f50190e", "annex": "IIIA", "before": {"end": 56, "start": 0, "text": "Si vous avez utilisé plus d’Adempas que vous n’auriez dû", "truncated": false}, "before_length": 56, "before_sha256": "cccb04e259bb220340d66786c8ddae4105e10402e687b576a2c4c2bc261e7d10", "change_kind": "content", "change_operations": [{"after_end": 15, "after_start": 13, "before_end": 17, "before_start": 13, "kind": "replace"}, {"after_end": 17, "after_start": 17, "before_end": 20, "before_start": 19, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 5, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-fbc74a81497bc808e9e7cbd9", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3365}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 25, "start": 0, "text": "infomedica@mundipharma.it", "truncated": false}, "before_length": 25, "before_sha256": "89c9a5a4b27d88008a794269450f6c194e44699d85a48dfda4b28a0388179c52", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 25, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 25, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-fbde46b1a6b061abf91b1196", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1133}
{"after": {"end": 128, "start": 0, "text": "Taking into account the PRAC Assessment Report on the PSUR(s) for apremilast, the scientific conclusions of PRAC are as follows:", "truncated": false}, "after_length": 128, "after_sha256": "05cd2cbf12d95718b3e47bb93cbc86b4fe5d4e593c509d53bcdb9789528a101e", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 128, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 128}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-fc0901a367e9cb70e6449715", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:30Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "35ab6716aa09492c14ac6849111486ec47235c0bc65ef055350de950f316c5e6", "source_snapshot_id": "source-f20a60110d1f8fef5225317d", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2339}
{"after": {"end": 2, "start": 0, "text": "SC", "truncated": false}, "after_length": 2, "after_sha256": "32da6721804f1dd3226c0551970304ebf1059ec19a27451426541027861c9388", "annex": "IIIA", "before": {"end": 16, "start": 0, "text": "Subcutaneous use", "truncated": false}, "before_length": 16, "before_sha256": "363fd22613abec178143cdac0b1a34f04ee8ccdaa7d6988b3722fa7540374cde", "change_kind": "content", "change_operations": [{"after_end": 2, "after_start": 1, "before_end": 16, "before_start": 1, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 15, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-fc2ad3530cab0e0c4c8d9beb", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 7616}
{"after": {"end": 456, "start": 0, "text": "Si vous ressentez un quelconque effet indésirable, parlez-en à votre médecin, votre pharmacien ou votre infirmier(ère). Cela s’applique aussi à tout effet indésirable qui ne serait pas mentionné dans cette notice. Vous pouvez également déclarer les effets indésirables directement via le système national de déclaration – voir Annexe V. En signalant les effets indésirables, vous contribuez à fournir davantage d’informations sur la sécurité du médicament.", "truncated": false}, "after_length": 456, "after_sha256": "d8d550346439bc35d018700753cb3a276a29800fe55ceeb2c003632c2111991e", "annex": "IIIA", "before": {"end": 548, "start": 0, "text": "Si vous ressentez un quelconque effet indésirable, parlez-en à votre médecin, votre pharmacien ou votre infirmier(ère). Cela s’applique aussi à tout effet indésirable qui ne serait pas mentionné dans cette notice. Vous pouvez également déclarer les effets indésirables directement via le système national de déclaration – voir Annexe V. des Centres Régionaux de Pharmacovigilance - Site internet : www.signalement-sante.gouv.fr. En signalant les effets indésirables, vous contribuez à fournir davantage d’informations sur la sécurité du médicament.", "truncated": false}, "before_length": 548, "before_sha256": "6a8a1d1e6274a0b722b6776f0ba0399e21c9d8fabe0f7d6b32644936668c9058", "change_kind": "content", "change_operations": [{"after_end": 337, "after_start": 337, "before_end": 429, "before_start": 337, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 92, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-fc61419cc6d4f459c339e0d0", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 948}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 12, "start": 0, "text": "Patient Card", "truncated": false}, "before_length": 12, "before_sha256": "b9f1d23d52aa92d0440f2d945975d6472a399b8df54492030bc43eea79e2edc1", "change_kind": "unassigned", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 12, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 12, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-fc854997b5d0fe92a2104f0b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6580}
{"after": {"end": 74, "start": 0, "text": "* Do not use the prefilled syringe to deliver a partial volume of 0.25 mL.", "truncated": false}, "after_length": 74, "after_sha256": "75e296bff3c238176d513ed450c19057750a20263b5a3152d3b7a7c0a0d4190e", "annex": "I", "before": {"end": 94, "start": 0, "text": "* Do not use the single-dose vial or prefilled syringe to deliver a partial volume of 0.25 mL.", "truncated": false}, "before_length": 94, "before_sha256": "34a3dd6a9a278560b1c455186ca0846462be29c70b70a4dd2f194f53b65e7df3", "change_kind": "content", "change_operations": [{"after_end": 17, "after_start": 17, "before_end": 37, "before_start": 17, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 20, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-fc986672629015d32b765f2b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5529}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 282, "start": 0, "text": "high blood pressure in lung arteries, as you must not take certain medicines such as sildenafil, tadalafil together with Adempas. Other medicines for high blood pressure in the lung arteries, such as bosentan and iloprost, can be used with Adempas, but you should inform the doctor.", "truncated": false}, "before_length": 282, "before_sha256": "bbe40912bf1c0a84c3bcac212ffb6c78e1f9c07955a98402cbdcdb35f9c48cad", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 282, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 282, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-fcb085a4b5b1cd377d8b01cb", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2773}
{"after": {"end": 74, "start": 0, "text": "Si un surdosage est suspecté, il faut administrer Nyxoid dès que possible.", "truncated": false}, "after_length": 74, "after_sha256": "ba91e0d84221698b06d90129522c02395fb42c10da8d6b23c7308337783cf98a", "annex": "IIIA", "before": {"end": 57, "start": 0, "text": "Si un surdosage est suspecté, il faut administrer Nyxoid.", "truncated": false}, "before_length": 57, "before_sha256": "e5b4ab12a8aa3f9a296c97f6e2c54880bc8cf48bdfd439f126002c569ccc7413", "change_kind": "content", "change_operations": [{"after_end": 73, "after_start": 56, "before_end": 56, "before_start": 56, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 17}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-fcbef8aa77afa3b10cef4e9c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:44Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "049435742bf3f7d55a09a8a975d6e623e2e30098c387b0bb5c20772f64119914", "source_snapshot_id": "source-8c3e71c3fd252de918c18218", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 833}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 31, "start": 0, "text": "Mundipharma Gesellschaft m.b.H.", "truncated": false}, "before_length": 31, "before_sha256": "e6851d5a437200a1e4e127bb5a9b932fc5c74eb39e861c56ae687ec74d8fc5ad", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 31, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 31, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-fcd018e8e8b64ba256594988", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1076}
{"after": {"end": 140, "start": 0, "text": "Compte tenu du rapport d’évaluation du PRAC sur les PSUR concernant l’aprémilast, les conclusions scientifiques du PRAC sont les suivantes :", "truncated": false}, "after_length": 140, "after_sha256": "2b76d55fc44b9d30b83704876d3e9b32718edb404ee2a0dcb9d9a0e75d67ef07", "annex": "IV", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 140, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 140}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-fcf1b3feb7881721b27b585c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:31Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "conditions", "section_type": "conditions", "source_provider": "European Medicines Agency", "source_sha256": "9ac80b0d56ebad4970f7a8335a177613af59ef25517bcd0bdd3397c207cc1bac", "source_snapshot_id": "source-c11aa9e32420f125a88005bc", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2711}
{"after": {"end": 27, "start": 0, "text": "Infusion-related reactionff", "truncated": false}, "after_length": 27, "after_sha256": "91496309069401fe5732ebf0082e02764187973ebabab8acdeea15f9c5ab7910", "annex": "I", "before": {"end": 27, "start": 0, "text": "Infusion-related reactionee", "truncated": false}, "before_length": 27, "before_sha256": "976a40924919cb45f62b878890d65162c2334d4ccaee488b3ecc951cd880bf22", "change_kind": "content", "change_operations": [{"after_end": 27, "after_start": 25, "before_end": 27, "before_start": 25, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 2, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-fd27703029e9dd1d53634777", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "IMJUDO 20 mg/ml concentrate for solution for infusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 897}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 23, "start": 0, "text": "Tel: +43 (0)1 523 25 05", "truncated": false}, "before_length": 23, "before_sha256": "1c871405cc2b2c04561b63ec0520ec0b01c5f9571be60e896ddbf90186d9c8da", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 23, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 23, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-fd80261ae034f361ca10ef73", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1077}
{"after": {"end": 32, "start": 0, "text": "•Section 4 Possible side effects", "truncated": false}, "after_length": 32, "after_sha256": "4e6bddd02ef3a2f5b336c8d0bf6cd7165b7080173f8c6322ba1f38ed07ebbe73", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "unassigned", "change_operations": [{"after_end": 32, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 32}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-fda44ca85fed576f7a97c55e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:30Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "", "section_type": "unassigned", "source_provider": "European Medicines Agency", "source_sha256": "35ab6716aa09492c14ac6849111486ec47235c0bc65ef055350de950f316c5e6", "source_snapshot_id": "source-f20a60110d1f8fef5225317d", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2365}
{"after": {"end": 76, "start": 0, "text": "Les médicaments pouvant modifier le taux d’Adempas dans le sang, par exemple", "truncated": false}, "after_length": 76, "after_sha256": "82ac6fc73748ae9487fe9aaa1bd1cf09a188f7b8825284a1c8c2dddade82fcb3", "annex": "IIIA", "before": {"end": 146, "start": 0, "text": "Les médicaments suivants peuvent augmenter le taux d’Adempas dans le sang ce qui augmente le risque d’effets secondaires. Médicaments pour traiter", "truncated": false}, "before_length": 146, "before_sha256": "a96ce52b2813be345305a619fb9810f53247cf2ba7adf935601a1cda52ecafa0", "change_kind": "content", "change_operations": [{"after_end": 18, "after_start": 16, "before_end": 17, "before_start": 16, "kind": "replace"}, {"after_end": 19, "after_start": 19, "before_end": 19, "before_start": 18, "kind": "delete"}, {"after_end": 23, "after_start": 23, "before_end": 24, "before_start": 23, "kind": "delete"}, {"after_end": 24, "after_start": 24, "before_end": 36, "before_start": 25, "kind": "delete"}, {"after_end": 30, "after_start": 25, "before_end": 40, "before_start": 37, "kind": "replace"}, {"after_end": 64, "after_start": 63, "before_end": 73, "before_start": 73, "kind": "insert"}, {"after_end": 69, "after_start": 65, "before_end": 75, "before_start": 74, "kind": "replace"}, {"after_end": 72, "after_start": 70, "before_end": 84, "before_start": 76, "kind": "replace"}, {"after_end": 74, "after_start": 73, "before_end": 90, "before_start": 85, "kind": "replace"}, {"after_end": 76, "after_start": 76, "before_end": 146, "before_start": 92, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 85, "chars_inserted": 15}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-fdbc8a5dd030a268172289e0", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3297}
{"after": {"end": 22, "start": 0, "text": "Tel.: +40 21 529 29 00", "truncated": false}, "after_length": 22, "after_sha256": "c0def45751c8a6f47b191f68953f4156d333424fdfacc770cf07669eae1210a5", "annex": "IIIA", "before": {"end": 22, "start": 0, "text": "Tel: + 40 21 529 29 00", "truncated": false}, "before_length": 22, "before_sha256": "ab360a5cc3194a1966bd86bcee0a1a2cf6cc97342e9c07c5a45039ca6bac64ef", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}, {"after_end": 7, "after_start": 7, "before_end": 7, "before_start": 6, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-fe1660819101197e39a11480", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3564}
{"after": {"end": 192, "start": 0, "text": "Votre médecin vous remettra également une Carte Patient qui comportera des informations importantes de sécurité d’emploi que vous devez connaître, avant et pendant votre traitement par Enbrel.", "truncated": false}, "after_length": 192, "after_sha256": "a9b61621aee7f348e503c6ef13da6f1d4dc6f2a4d953f840016b3daaebeecd6a", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 192, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 192}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-fe2009791eed3851e6ac0f73", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:40Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "a41dac2fc5e8b417985556dd3387a9d48be01703fe6cadaaa44d436826c3fb06", "source_snapshot_id": "source-e47ad1eb70eea40ffe6f630a", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 8726}
{"after": {"end": 22, "start": 0, "text": "Tel.: +48 22 549 51 00", "truncated": false}, "after_length": 22, "after_sha256": "b4f3ff473cb9a7a642bf71f33b5b5948d208175e4d85b587f2a38e81caf1a4cb", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tel: +48 22 549 51 00", "truncated": false}, "before_length": 21, "before_sha256": "222e9a202ca5b1cde4fca3b2b78aaf332f0c1aa8b98e03455889987c3316067a", "change_kind": "content", "change_operations": [{"after_end": 4, "after_start": 3, "before_end": 3, "before_start": 3, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 1}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-fe9582fb7d9bbb9efe168be2", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3135}
{"after": {"end": 163, "start": 0, "text": "take PDE5 inhibitors such as sildenafil, tadalafil, vardenafil. These are medicines to treat high blood pressure in lung arteries or to treat erectile dysfunction.", "truncated": false}, "after_length": 163, "after_sha256": "d52f5f7346871c8b9832ac0c45c1d8db0696c195c1a32c7991110cab2c242df3", "annex": "IIIA", "before": {"end": 154, "start": 0, "text": "take PDE5 inhibitors such as sildenafil, tadalafil, vardenafil. These are medicines to treat high blood pressure in lung arteries or erectile dysfunction.", "truncated": false}, "before_length": 154, "before_sha256": "24520b159633f1325463f1bbce5b312aac0f24934db8ff8ffac1f751701caba2", "change_kind": "content", "change_operations": [{"after_end": 142, "after_start": 133, "before_end": 133, "before_start": 133, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 9}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-fec3a50067992346b26e2468", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2726}
{"after": {"end": 17, "start": 0, "text": "msdpolska@msd.com", "truncated": false}, "after_length": 17, "after_sha256": "1b250a519a0f233f4e354eb6c7114ba65293ff16c0041901602d11e2c6c3498c", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "msdpolska@merck.com", "truncated": false}, "before_length": 19, "before_sha256": "5690867ba2de57367aef5787dfb5119647492569c1acc32aee4d6aec5daced2d", "change_kind": "content", "change_operations": [{"after_end": 13, "after_start": 11, "before_end": 15, "before_start": 11, "kind": "replace"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 4, "chars_inserted": 2}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-fecdae69440289b40b132c0d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3546}
{"after": {"end": 8, "start": 0, "text": "Dublin 2", "truncated": false}, "after_length": 8, "after_sha256": "b9d41e7d3be3ec3e12457949fb5c2f7be98290b5d2919e8b974df9c98fab02b9", "annex": "IIIA", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 8, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 8}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-fed6ab22e3ff1f5e8af986da", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005155", "medicine_name": "Qdenga", "medicine_slug": "qdenga", "observed_at": "2026-10-12T19:02:39Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b728ede91da43e090207b0b91b65c1338bc82e0b4d99aee56d00eac27d113dbf", "source_snapshot_id": "source-67edb5bf4917c536eec03461", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/qdenga-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1343}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 49, "start": 0, "text": "des nausées et vomissements comme le granisétron.", "truncated": false}, "before_length": 49, "before_sha256": "d6dfa8c4680cda58d765ba0fd2f6b28add22868d5645bf67009241065131b734", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 49, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 49, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-fee3105a4ddd05c3fe17b7a1", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3306}
{"after": {"end": 197, "start": 0, "text": "cc Adverse reaction was not observed in the POSEIDON study but was reported in patients treated with tremelimumab in combination with durvalumab in clinical studies outside of the POSEIDON dataset.", "truncated": false}, "after_length": 197, "after_sha256": "942cbd0b4086882d2e642a57ece5de6274065d2beef016f4d163f854ee5a0a04", "annex": "I", "before": {"end": 0, "start": 0, "text": "", "truncated": false}, "before_length": 0, "before_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "change_kind": "content", "change_operations": [{"after_end": 197, "after_start": 0, "before_end": 0, "before_start": 0, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 197}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-feea9a83579228ae9d7976df", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "IMJUDO 20 mg/ml concentrate for solution for infusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 932}
{"after": {"end": 30, "start": 0, "text": "Critère principal d’évaluation", "truncated": false}, "after_length": 30, "after_sha256": "3373edb2659568cb971a98b7db33ed5cd595d251fed752d68070deb4bb505b64", "annex": "I", "before": {"end": 17, "start": 0, "text": "Critère principal", "truncated": false}, "before_length": 17, "before_sha256": "ea2563482c25678aad44a4c2940b0955b84d276182b52a7842254cdf24cf27c9", "change_kind": "content", "change_operations": [{"after_end": 30, "after_start": 17, "before_end": 17, "before_start": 17, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 13}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-fef6e6c2887691ad257694ce", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2090}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 19, "start": 0, "text": "info@mundipharma.be", "truncated": false}, "before_length": 19, "before_sha256": "fc5e5b98df902cc2264e183a9bf7b097d1330cde86581ebd0467522133fb8584", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 19, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 19, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ff1efecc3ea5003d6dd0c0b6", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "c3c48c436d46e094564a4264abeb3b64ba46030a34ff73cf712ceab8909a640e", "source_snapshot_id": "source-5ec469b534c264beb55c4562", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1017}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 13, "start": 0, "text": "Icepharma hf.", "truncated": false}, "before_length": 13, "before_sha256": "b10e8b5abc79456615b7bbf170d67bdcdfb8e87e7bd69bed75dffa3ce87100cb", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 13, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 13, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ff272701de16162b125eafad", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1131}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "I", "before": {"end": 52, "start": 0, "text": "Spikevax JN.1 50 micrograms dispersion for injection", "truncated": false}, "before_length": 52, "before_sha256": "597e6a2a3b4949004d4fc05201b82efef68b5595489c6b3279e0567739db5110", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 52, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 52, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ff5d657949a72fd258fc66da", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005791", "medicine_name": "Spikevax (previously COVID-19 Vaccine Moderna)", "medicine_slug": "spikevax-previously-covid-19-vaccine-moderna", "observed_at": "2026-10-12T19:21:27Z", "pipeline_version": "2.0.0", "presentation_label": "Spikevax LP.8.1 0.1 mg/mL dispersion for injection Spikevax JN.1 50 micrograms dispersion for injection Spikevax LP.8.1 50 micrograms dispersion for injection in pre-filled syringe COVID19 mRNA Vaccine", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "2", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ee7712f3bea6ed1e7adb7ff4b59495e4c6961b92481d32d6b60668695c2bd753", "source_snapshot_id": "source-d57a5483e2d598a45f189cfa", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/spikevax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5428}
{"after": {"end": 20, "start": 0, "text": "Tel: +385 1 6611 333", "truncated": false}, "after_length": 20, "after_sha256": "ac17f5de7a55b551146b4e13e2e182c0c768e2407d11ada47b7ea50ccc88e7a9", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tel: + 385 1 6611 333", "truncated": false}, "before_length": 21, "before_sha256": "832fb9e4a0309ac207ea1cddc7b0f0d314eb5cd3eac51bc4ad14b8ef55b1e935", "change_kind": "content", "change_operations": [{"after_end": 6, "after_start": 6, "before_end": 7, "before_start": 6, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 1, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ff81bc19a398b818d85e225f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:29Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "4ed86370c90529467e65d9f8fefeb73bd06a694419a72ca009c08d841e1be751", "source_snapshot_id": "source-aef9ae0f8e0087d897d1f70f", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3149}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 14, "start": 0, "text": "Pfizer Limited", "truncated": false}, "before_length": 14, "before_sha256": "faadd350d247ecbb0e8edac0805fa3d4cdbf449fbb9a1a9614eee6624274a2f6", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 14, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 14, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ff823763b9da2f59836168b3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 6, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 10019}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 26, "start": 0, "text": "Medis Pharma Lithuania UAB", "truncated": false}, "before_length": 26, "before_sha256": "1016178a7e6ddebf9ca5f1ab2b491b24607475ceededd18bdcff956f1d201890", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 26, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 26, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ff9c95b7b035d91e01417c65", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1076}
{"after": {"end": 0, "start": 0, "text": "", "truncated": false}, "after_length": 0, "after_sha256": "e3b0c44298fc1c149afbf4c8996fb92427ae41e4649b934ca495991b7852b855", "annex": "IIIA", "before": {"end": 21, "start": 0, "text": "Tlf: + 45 45 17 48 00", "truncated": false}, "before_length": 21, "before_sha256": "4e4f97da713bcb120d3c0c35a877cad54bf9ee7e912dac4610c730c24fe928a3", "change_kind": "content", "change_operations": [{"after_end": 0, "after_start": 0, "before_end": 21, "before_start": 0, "kind": "delete"}], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 21, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-ffc0b951d7ed8f904e002b71", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "labelling", "section_type": "labelling", "source_provider": "European Medicines Agency", "source_sha256": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1059}