{"after": {"end": 370, "start": 0, "text": "No pharmacokinetic interaction was observed between rivastigmine and digoxin, warfarin, diazepam or fluoxetine in studies in healthy volunteers. The increase in prothrombin time induced by warfarin is not affected by administration of rivastigmine. No untoward effects on cardiac conduction were observed following concomitant administration of digoxin and rivastigmine.", "truncated": false}, "after_length": 370, "after_sha256": "f62050386dd67005b30d9af87a94cba968a74f706f96210f9553b544311b285e", "annex": "I", "before": {"end": 370, "start": 0, "text": "No pharmacokinetic interaction was observed between rivastigmine and digoxin, warfarin, diazepam or fluoxetine in studies in healthy volunteers. The increase in prothrombin time induced by warfarin is not affected by administration of rivastigmine. No untoward effects on cardiac conduction were observed following concomitant administration of digoxin and rivastigmine.", "truncated": false}, "before_length": 370, "before_sha256": "f62050386dd67005b30d9af87a94cba968a74f706f96210f9553b544311b285e", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00029b0c08ccb9e264a5cedd", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001029", "medicine_name": "Nimvastid", "medicine_slug": "nimvastid", "observed_at": "2026-10-12T19:24:00Z", "pipeline_version": "2.0.0", "presentation_label": "Nimvastid 1.5 mg orodispersible tablets Nimvastid 3 mg orodispersible tablets Nimvastid 4.5 mg orodispersible tablets Nimvastid 6 mg orodispersible tablets", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "fa4c6e344db60bf4064eb3cc2d76d72c0fc858894147724d88ab2d66b9f9a0dc", "source_snapshot_id": "source-775bf49790604674d3549dac", "source_updated_at": "2025-07-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nimvastid-epar-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": 625, "start": 0, "text": "Au cours du traitement par l’eptifibatide il y a une augmentation significative des taux de saignement, particulièrement au niveau de l’artère fémorale, où la gaine protectrice du cathéter est introduite. Prendre des précautions pour s’assurer que seule la paroi antérieure de l’artère fémorale est ponctionnée. Les gaines protectrices peuvent être retirées lorsque la coagulation est redevenue normale (i.e. lorsque le temps de coagulation activée (ACT) est de moins de 180 secondes, habituellement 2-6 heures après l’arrêt de l’héparine). Après retrait de la gaine protectrice, l’hémostase doit être étroitement surveillée.", "truncated": false}, "after_length": 625, "after_sha256": "a244135b56f990b5906ef357f8d3805fee5c73e16dcda8de7e46b0db25ee6fb3", "annex": "I", "before": {"end": 625, "start": 0, "text": "Au cours du traitement par l’eptifibatide il y a une augmentation significative des taux de saignement, particulièrement au niveau de l’artère fémorale, où la gaine protectrice du cathéter est introduite. Prendre des précautions pour s’assurer que seule la paroi antérieure de l’artère fémorale est ponctionnée. Les gaines protectrices peuvent être retirées lorsque la coagulation est redevenue normale (i.e. lorsque le temps de coagulation activée (ACT) est de moins de 180 secondes, habituellement 2-6 heures après l’arrêt de l’héparine). Après retrait de la gaine protectrice, l’hémostase doit être étroitement surveillée.", "truncated": false}, "before_length": 625, "before_sha256": "a244135b56f990b5906ef357f8d3805fee5c73e16dcda8de7e46b0db25ee6fb3", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-001b3dde06b64bf87d032a42", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004104", "medicine_name": "Eptifibatide Accord", "medicine_slug": "eptifibatide-accord", "observed_at": "2026-10-12T19:45:11Z", "pipeline_version": "2.0.0", "presentation_label": "Eptifibatide Accord 0,75 mg/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": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "c9be002148fa73331c72aadac205f927e043f3407cf695e63a1cbe715480600b", "source_snapshot_id": "source-9e33d5d566c95289f1a7e6a6", "source_updated_at": "2025-05-02", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/eptifibatide-accord-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 139}
{"after": {"end": 474, "start": 0, "text": "Les études NSABP B-31 et NCCTG N9831, qui ont fait l’objet d’une analyse groupée, ont évalué l’intérêt clinique de l’association d’un traitement par trastuzumab avec le paclitaxel après une chimiothérapie associant doxorubicine et cyclophosphamide (AC). En outre, l’étude NCCTG N9831 a également évalué l’ajout de façon séquentielle de trastuzumab à une chimiothérapie AC → P (paclitaxel) chez des patients atteints d’un cancer du sein précoce HER2 positif, après chirurgie.", "truncated": false}, "after_length": 474, "after_sha256": "2ec3d7151055ed855a6ea75ef134dabbc43bff06e9a317a167cfb6cf05fd58a6", "annex": "I", "before": {"end": 474, "start": 0, "text": "Les études NSABP B-31 et NCCTG N9831, qui ont fait l’objet d’une analyse groupée, ont évalué l’intérêt clinique de l’association d’un traitement par trastuzumab avec le paclitaxel après une chimiothérapie associant doxorubicine et cyclophosphamide (AC). En outre, l’étude NCCTG N9831 a également évalué l’ajout de façon séquentielle de trastuzumab à une chimiothérapie AC → P (paclitaxel) chez des patients atteints d’un cancer du sein précoce HER2 positif, après chirurgie.", "truncated": false}, "before_length": 474, "before_sha256": "2ec3d7151055ed855a6ea75ef134dabbc43bff06e9a317a167cfb6cf05fd58a6", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0027cfc6062cb14eb2886b03", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004361", "medicine_name": "Kanjinti", "medicine_slug": "kanjinti", "observed_at": "2026-10-12T19:40:38Z", "pipeline_version": "2.0.0", "presentation_label": "KANJINTI 150 mg poudre pour solution à diluer pour perfusion KANJINTI 420 mg poudre pour 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": "ea9ea0ca90af9dcbc236774255b0290bf3e784884d88a33522b45c8050f829cf", "source_snapshot_id": "source-a4621a49bcc40ac3f94d4939", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/kanjinti-epar-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": 144, "start": 0, "text": "Currently no data from clinical studies are available on re-treatment of patients with previous exposure to trastuzumab in the adjuvant setting.", "truncated": false}, "after_length": 144, "after_sha256": "4b3407b69a4c7764ee8c77e9a7ebb1c8cc24053d7600a89a6b2717786348d098", "annex": "I", "before": {"end": 144, "start": 0, "text": "Currently no data from clinical studies are available on re-treatment of patients with previous exposure to trastuzumab in the adjuvant setting.", "truncated": false}, "before_length": 144, "before_sha256": "4b3407b69a4c7764ee8c77e9a7ebb1c8cc24053d7600a89a6b2717786348d098", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0027e562316a6044923fb164", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004361", "medicine_name": "Kanjinti", "medicine_slug": "kanjinti", "observed_at": "2026-10-12T19:40:28Z", "pipeline_version": "2.0.0", "presentation_label": "KANJINTI 150 mg powder for concentrate for solution for infusion KANJINTI 420 mg powder for 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": "9f4119e69f965285688c3402ad669f6dc3298fbbaf20f5909a83d03f0f927312", "source_snapshot_id": "source-4222dc61a5c401d9ea981d06", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/kanjinti-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 174}
{"after": {"end": 191, "start": 0, "text": "Les médicaments utilisés pour fluidifier le sang tel que la warfarine. Une surveillance par votre médecin pourrait être nécessaire lorsque vous commencez ou arrêtez de prendre Nexium Control.", "truncated": false}, "after_length": 191, "after_sha256": "b2e5f5f395be37c57316e67139b028282cf5bddd0c08b056cdec1f7b773a5f10", "annex": "IIIB", "before": {"end": 191, "start": 0, "text": "Les médicaments utilisés pour fluidifier le sang tel que la warfarine. Une surveillance par votre médecin pourrait être nécessaire lorsque vous commencez ou arrêtez de prendre Nexium Control.", "truncated": false}, "before_length": 191, "before_sha256": "b2e5f5f395be37c57316e67139b028282cf5bddd0c08b056cdec1f7b773a5f10", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-002999a04919c075d2a12b53", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002618", "medicine_name": "Nexium Control", "medicine_slug": "nexium-control", "observed_at": "2026-10-12T13:36:18Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "dd192e79554a2cf904e3b717c765e723c89937d2250f85a0df30f9a56f6cb2e1", "source_snapshot_id": "source-614e91f5970645497b96d67b", "source_updated_at": "2026-06-03", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nexium-control-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1867}
{"after": {"end": 216, "start": 0, "text": "Until the cut-off date (22-Oct-2021), patients were exposed to eltrombopag for a median (Q1-Q3) duration of 6.2 months (2.3-12.0 months). The median (Q1-Q3) platelet count at baseline was 16 000/µl (7 800-28 000/µl).", "truncated": false}, "after_length": 216, "after_sha256": "878b55685e03bf1eae433639cfde968aa5d49da0be20d08e89ead022ec9c102c", "annex": "I", "before": {"end": 216, "start": 0, "text": "Until the cut-off date (22-Oct-2021), patients were exposed to eltrombopag for a median (Q1-Q3) duration of 6.2 months (2.3-12.0 months). The median (Q1-Q3) platelet count at baseline was 16 000/µl (7 800-28 000/µl).", "truncated": false}, "before_length": 216, "before_sha256": "878b55685e03bf1eae433639cfde968aa5d49da0be20d08e89ead022ec9c102c", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0029f95811eb943e8c5d4fe2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006459", "medicine_name": "Eltrombopag Accord", "medicine_slug": "eltrombopag-accord", "observed_at": "2026-10-12T19:38:22Z", "pipeline_version": "2.0.0", "presentation_label": "Eltrombopag Accord 12.5 mg film-coated tablets Eltrombopag Accord 25 mg film-coated tablets Eltrombopag Accord 50 mg film-coated tablets Eltrombopag Accord 75 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "0485f44a0e25bf9e0f930e8ce8c053598ed2a48f78476ffafefb66d9fb3e8d89", "source_snapshot_id": "source-d7e0f3276633f5a4a1cef1a4", "source_updated_at": "2025-05-20", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/eltrombopag-accord-epar-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": 394, "start": 0, "text": "Eptifibatide Accord inhibits platelet aggregation, but does not appear to affect the viability of platelets. As demonstrated in clinical trials, the incidence of thrombocytopenia was low, and similar in patients treated with eptifibatide or placebo. Thrombocytopenia, including acute profound thrombocytopenia, has been observed with eptifibatide administration post-marketing (see section 4.8)", "truncated": false}, "after_length": 394, "after_sha256": "2d34ae28f9cd584cf09ba714d65a56cca866bf3e51b6424a000b64f896b8d574", "annex": "I", "before": {"end": 394, "start": 0, "text": "Eptifibatide Accord inhibits platelet aggregation, but does not appear to affect the viability of platelets. As demonstrated in clinical trials, the incidence of thrombocytopenia was low, and similar in patients treated with eptifibatide or placebo. Thrombocytopenia, including acute profound thrombocytopenia, has been observed with eptifibatide administration post-marketing (see section 4.8)", "truncated": false}, "before_length": 394, "before_sha256": "2d34ae28f9cd584cf09ba714d65a56cca866bf3e51b6424a000b64f896b8d574", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-002d34aeb71055786e3f47e1", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004104", "medicine_name": "Eptifibatide Accord", "medicine_slug": "eptifibatide-accord", "observed_at": "2026-10-12T19:45:01Z", "pipeline_version": "2.0.0", "presentation_label": "Eptifibatide Accord 2 mg/ml 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": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "a45982959a207e1611cd67a6103370f86a234e3c45dfb3ab49b532886fe928cb", "source_snapshot_id": "source-8dd88a3db45e564c959f66e5", "source_updated_at": "2025-05-02", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/eptifibatide-accord-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 558}
{"after": {"end": 45, "start": 0, "text": "Affections de la peau et du tissu sous-cutané", "truncated": false}, "after_length": 45, "after_sha256": "cac32befbb56c4471ce1125879aeb792ac4577f86239ddf5d286857d9dfae253", "annex": "I", "before": {"end": 45, "start": 0, "text": "Affections de la peau et du tissu sous-cutané", "truncated": false}, "before_length": 45, "before_sha256": "cac32befbb56c4471ce1125879aeb792ac4577f86239ddf5d286857d9dfae253", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0030c6e94878ca27f5e9deab", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002547", "medicine_name": "Perjeta", "medicine_slug": "perjeta", "observed_at": "2026-10-12T13:39:17Z", "pipeline_version": "2.0.0", "presentation_label": "Perjeta 420 mg 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": "dfc85998efa134fbc08630f7e0f1d1183bd4fb18ec62a15b680bda3fd94b49bd", "source_snapshot_id": "source-791eb96e62fdebcce4c81ec4", "source_updated_at": "2026-04-28", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/perjeta-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 373}
{"after": {"end": 144, "start": 0, "text": "suivie par la conservation appropriée de la solution préparée pour perfusion intraveineuse afin d’assurer le maintien des conditions aseptiques.", "truncated": false}, "after_length": 144, "after_sha256": "cfc4ca017a32abe190a8d50d48dbe35c7c507193c83f5794d24faef98578ba53", "annex": "I", "before": {"end": 144, "start": 0, "text": "suivie par la conservation appropriée de la solution préparée pour perfusion intraveineuse afin d’assurer le maintien des conditions aseptiques.", "truncated": false}, "before_length": 144, "before_sha256": "cfc4ca017a32abe190a8d50d48dbe35c7c507193c83f5794d24faef98578ba53", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00320ef24ec0b7825dc22fe2", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004361", "medicine_name": "Kanjinti", "medicine_slug": "kanjinti", "observed_at": "2026-10-12T19:40:38Z", "pipeline_version": "2.0.0", "presentation_label": "KANJINTI 150 mg poudre pour solution à diluer pour perfusion KANJINTI 420 mg poudre pour 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": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ea9ea0ca90af9dcbc236774255b0290bf3e784884d88a33522b45c8050f829cf", "source_snapshot_id": "source-a4621a49bcc40ac3f94d4939", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/kanjinti-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1849}
{"after": {"end": 86, "start": 0, "text": "White to almost white powder in a capsule with brownish red cap and brownish red body.", "truncated": false}, "after_length": 86, "after_sha256": "e55b33824d4be14a8da5cc7163974adfd41163f5f71d16c1816e4829ae301d6f", "annex": "I", "before": {"end": 86, "start": 0, "text": "White to almost white powder in a capsule with brownish red cap and brownish red body.", "truncated": false}, "before_length": 86, "before_sha256": "e55b33824d4be14a8da5cc7163974adfd41163f5f71d16c1816e4829ae301d6f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0033eba830c06aefaa61e1ec", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001029", "medicine_name": "Nimvastid", "medicine_slug": "nimvastid", "observed_at": "2026-10-12T19:24:00Z", "pipeline_version": "2.0.0", "presentation_label": "Nimvastid 1.5 mg hard capsules Nimvastid 3 mg hard capsules Nimvastid 4.5 mg hard capsules Nimvastid 6 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": "3", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "fa4c6e344db60bf4064eb3cc2d76d72c0fc858894147724d88ab2d66b9f9a0dc", "source_snapshot_id": "source-775bf49790604674d3549dac", "source_updated_at": "2025-07-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nimvastid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 66}
{"after": {"end": 50, "start": 0, "text": "Date de dernier renouvellement : 30 septembre 2020", "truncated": false}, "after_length": 50, "after_sha256": "f3e35a0e0da97f0f4ede9d4d549e5a43ef194a028eeddba90fea987ba7d5ce48", "annex": "I", "before": {"end": 50, "start": 0, "text": "Date de dernier renouvellement : 30 septembre 2020", "truncated": false}, "before_length": 50, "before_sha256": "f3e35a0e0da97f0f4ede9d4d549e5a43ef194a028eeddba90fea987ba7d5ce48", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00412db20554054180c44b93", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004104", "medicine_name": "Eptifibatide Accord", "medicine_slug": "eptifibatide-accord", "observed_at": "2026-10-12T19:45:11Z", "pipeline_version": "2.0.0", "presentation_label": "Eptifibatide Accord 0,75 mg/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": "9", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "c9be002148fa73331c72aadac205f927e043f3407cf695e63a1cbe715480600b", "source_snapshot_id": "source-9e33d5d566c95289f1a7e6a6", "source_updated_at": "2025-05-02", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/eptifibatide-accord-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 444}
{"after": {"end": 52, "start": 0, "text": "General disorders and administration site conditions", "truncated": false}, "after_length": 52, "after_sha256": "9b9cf1c012d3141c3aa7593cca0d5b6c753bc487fb4023353217a2838e4bc61a", "annex": "I", "before": {"end": 52, "start": 0, "text": "General disorders and administration site conditions", "truncated": false}, "before_length": 52, "before_sha256": "9b9cf1c012d3141c3aa7593cca0d5b6c753bc487fb4023353217a2838e4bc61a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-004f0a37a14c54155d9a0e8b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002345", "medicine_name": "Revestive", "medicine_slug": "revestive", "observed_at": "2026-10-12T19:38:01Z", "pipeline_version": "2.0.0", "presentation_label": "Revestive 1.25 mg powder and solvent 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": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "0125d033ce2f8805dc45ece9b8ffa34db6682b195448a3a560e6d2483a8982b4", "source_snapshot_id": "source-8d7c3200418c650a002546aa", "source_updated_at": "2025-05-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/revestive-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 311}
{"after": {"end": 89, "start": 0, "text": "- known history of intracranial disease (neoplasm, arteriovenous malformation, aneurysm);", "truncated": false}, "after_length": 89, "after_sha256": "1ab95b580ecac31050074607f05fb1f9480da4f328c7d479ecea2566de7b3d41", "annex": "I", "before": {"end": 89, "start": 0, "text": "- known history of intracranial disease (neoplasm, arteriovenous malformation, aneurysm);", "truncated": false}, "before_length": 89, "before_sha256": "1ab95b580ecac31050074607f05fb1f9480da4f328c7d479ecea2566de7b3d41", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-005b3ba520ab24a1566e4161", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004104", "medicine_name": "Eptifibatide Accord", "medicine_slug": "eptifibatide-accord", "observed_at": "2026-10-12T19:45:01Z", "pipeline_version": "2.0.0", "presentation_label": "Eptifibatide Accord 0.75 mg/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": "4.3", "section_type": "contraindication", "source_provider": "European Medicines Agency", "source_sha256": "a45982959a207e1611cd67a6103370f86a234e3c45dfb3ab49b532886fe928cb", "source_snapshot_id": "source-8dd88a3db45e564c959f66e5", "source_updated_at": "2025-05-02", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/eptifibatide-accord-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 112}
{"after": {"end": 154, "start": 0, "text": "Pour la mercaptopurine, le manque de documentation clinique récente est un obstacle à la détermination précise de la fréquence des réactions indésirables.", "truncated": false}, "after_length": 154, "after_sha256": "7747f4ee47114a9f1e74f2edab634ecd61c7781a67cd216eeaf957105f29e4d3", "annex": "I", "before": {"end": 154, "start": 0, "text": "Pour la mercaptopurine, le manque de documentation clinique récente est un obstacle à la détermination précise de la fréquence des réactions indésirables.", "truncated": false}, "before_length": 154, "before_sha256": "7747f4ee47114a9f1e74f2edab634ecd61c7781a67cd216eeaf957105f29e4d3", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-005d9317b2c2c584a406f77c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002022", "medicine_name": "Xaluprine (previously Mercaptopurine Nova Laboratories)", "medicine_slug": "xaluprine-previously-mercaptopurine-nova-laboratories", "observed_at": "2026-10-12T19:08:05Z", "pipeline_version": "2.0.0", "presentation_label": "Xaluprine 20 mg/ml suspension orale", "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": "24d3b15ae521f391e697a4d72930da59f53e4eeefc26a100461fbfa83e960527", "source_snapshot_id": "source-22ca1025dfc29c23d7b323de", "source_updated_at": "2025-09-25", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xaluprine-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 511}
{"after": {"end": 47, "start": 0, "text": "28x1 comprimés orodispersibles: EU/1/09/525/027", "truncated": false}, "after_length": 47, "after_sha256": "2ed3aed4365d09319a758449a287852beb2ee6cc6742856350cb7f4b5caec1de", "annex": "I", "before": {"end": 47, "start": 0, "text": "28x1 comprimés orodispersibles: EU/1/09/525/027", "truncated": false}, "before_length": 47, "before_sha256": "2ed3aed4365d09319a758449a287852beb2ee6cc6742856350cb7f4b5caec1de", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-006368cfaec587b9f0f7e9fc", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/001029", "medicine_name": "Nimvastid", "medicine_slug": "nimvastid", "observed_at": "2026-10-12T19:24:04Z", "pipeline_version": "2.0.0", "presentation_label": "Nimvastid 1,5 mg gélule Nimvastid 3 mg gélule Nimvastid 4,5 mg gélule Nimvastid 6 mg gélule", "presentation_occurrence": 1, "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": "8e6eaa143ff5f69cfa4caba1806dbd754ee713f2f64ce6a1b369433c9e511b46", "source_snapshot_id": "source-655cd60c5475e58b35c5a1c3", "source_updated_at": "2025-07-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nimvastid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1672}
{"after": {"end": 47, "start": 0, "text": "60x1 comprimés orodispersibles: EU/1/09/525/035", "truncated": false}, "after_length": 47, "after_sha256": "ba9725975fadc64c978432bc74103c033123fe0dfab0becf083e9f86edcd3f9d", "annex": "I", "before": {"end": 47, "start": 0, "text": "60x1 comprimés orodispersibles: EU/1/09/525/035", "truncated": false}, "before_length": 47, "before_sha256": "ba9725975fadc64c978432bc74103c033123fe0dfab0becf083e9f86edcd3f9d", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-006a3707b9f94a43e91c27b1", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/001029", "medicine_name": "Nimvastid", "medicine_slug": "nimvastid", "observed_at": "2026-10-12T19:24:04Z", "pipeline_version": "2.0.0", "presentation_label": "Nimvastid 1,5 mg gélule Nimvastid 3 mg gélule Nimvastid 4,5 mg gélule Nimvastid 6 mg gélule", "presentation_occurrence": 1, "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": "8e6eaa143ff5f69cfa4caba1806dbd754ee713f2f64ce6a1b369433c9e511b46", "source_snapshot_id": "source-655cd60c5475e58b35c5a1c3", "source_updated_at": "2025-07-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nimvastid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1682}
{"after": {"end": 44, "start": 0, "text": "Patients with moderate dementia (MMSE 10-17)", "truncated": false}, "after_length": 44, "after_sha256": "30c5e21daeabeb0c9dc2e138f2fc5b2d18d4726701eec6a6e063ad1bde2f0d75", "annex": "I", "before": {"end": 44, "start": 0, "text": "Patients with moderate dementia (MMSE 10-17)", "truncated": false}, "before_length": 44, "before_sha256": "30c5e21daeabeb0c9dc2e138f2fc5b2d18d4726701eec6a6e063ad1bde2f0d75", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0096229bc7dd19aa51e74452", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001029", "medicine_name": "Nimvastid", "medicine_slug": "nimvastid", "observed_at": "2026-10-12T19:24:00Z", "pipeline_version": "2.0.0", "presentation_label": "Nimvastid 1.5 mg orodispersible tablets Nimvastid 3 mg orodispersible tablets Nimvastid 4.5 mg orodispersible tablets Nimvastid 6 mg orodispersible tablets", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "fa4c6e344db60bf4064eb3cc2d76d72c0fc858894147724d88ab2d66b9f9a0dc", "source_snapshot_id": "source-775bf49790604674d3549dac", "source_updated_at": "2025-07-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nimvastid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1588}
{"after": {"end": 179, "start": 0, "text": "Tremor, balance disorder, dysaesthesia, hemiparesis, migraine with aura, neuropathy peripheral, peripheral sensory neuropathy, speech disorder, toxic neuropathy, vascular headache", "truncated": false}, "after_length": 179, "after_sha256": "ec2b364df9316dfa8b95b1f2e6032d79c386305b2c930691dbaa27ca78dc3a08", "annex": "I", "before": {"end": 179, "start": 0, "text": "Tremor, balance disorder, dysaesthesia, hemiparesis, migraine with aura, neuropathy peripheral, peripheral sensory neuropathy, speech disorder, toxic neuropathy, vascular headache", "truncated": false}, "before_length": 179, "before_sha256": "ec2b364df9316dfa8b95b1f2e6032d79c386305b2c930691dbaa27ca78dc3a08", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-009e81c6cc35d0103c87ad28", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006459", "medicine_name": "Eltrombopag Accord", "medicine_slug": "eltrombopag-accord", "observed_at": "2026-10-12T19:38:22Z", "pipeline_version": "2.0.0", "presentation_label": "Eltrombopag Accord 12.5 mg film-coated tablets Eltrombopag Accord 25 mg film-coated tablets Eltrombopag Accord 50 mg film-coated tablets Eltrombopag Accord 75 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": "0485f44a0e25bf9e0f930e8ce8c053598ed2a48f78476ffafefb66d9fb3e8d89", "source_snapshot_id": "source-d7e0f3276633f5a4a1cef1a4", "source_updated_at": "2025-05-20", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/eltrombopag-accord-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 451}
{"after": {"end": 493, "start": 0, "text": "Les inhibiteurs de la pompe à protons sont associés à des cas très peu fréquents de LECS. Si des lésions se développent, notamment sur les zones cutanées exposées au soleil, et si elles s'accompagnent d'arthralgie, le patient doit consulter un médecin rapidement et le professionnel de santé doit envisager d'arrêter Nexium Control. La survenue d’un LECS après traitement par un inhibiteur de la pompe à protons peut augmenter le risque de LECS avec d'autres inhibiteurs de la pompe à protons.", "truncated": false}, "after_length": 493, "after_sha256": "aa0f50146c285d6284d27ebdb1f79a8c5a7da5aa6fa401faa12e46d644ba3764", "annex": "I", "before": {"end": 493, "start": 0, "text": "Les inhibiteurs de la pompe à protons sont associés à des cas très peu fréquents de LECS. Si des lésions se développent, notamment sur les zones cutanées exposées au soleil, et si elles s'accompagnent d'arthralgie, le patient doit consulter un médecin rapidement et le professionnel de santé doit envisager d'arrêter Nexium Control. La survenue d’un LECS après traitement par un inhibiteur de la pompe à protons peut augmenter le risque de LECS avec d'autres inhibiteurs de la pompe à protons.", "truncated": false}, "before_length": 493, "before_sha256": "aa0f50146c285d6284d27ebdb1f79a8c5a7da5aa6fa401faa12e46d644ba3764", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00a1b18d9de8b07188cdaa01", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002618", "medicine_name": "Nexium Control", "medicine_slug": "nexium-control", "observed_at": "2026-10-12T13:36:18Z", "pipeline_version": "2.0.0", "presentation_label": "Nexium Control 20 mg, comprimés gastrorésistants", "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": "dd192e79554a2cf904e3b717c765e723c89937d2250f85a0df30f9a56f6cb2e1", "source_snapshot_id": "source-614e91f5970645497b96d67b", "source_updated_at": "2026-06-03", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nexium-control-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 126}
{"after": {"end": 47, "start": 0, "text": "Description des effets indésirables spécifiques", "truncated": false}, "after_length": 47, "after_sha256": "3388b54c9b694035efcf77870048f42d8beec7e779b97b4e8cb95eb7d8e4cd6b", "annex": "I", "before": {"end": 47, "start": 0, "text": "Description des effets indésirables spécifiques", "truncated": false}, "before_length": 47, "before_sha256": "3388b54c9b694035efcf77870048f42d8beec7e779b97b4e8cb95eb7d8e4cd6b", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00a4fcb4c3d9e3b8f06a76c6", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002547", "medicine_name": "Perjeta", "medicine_slug": "perjeta", "observed_at": "2026-10-12T13:39:17Z", "pipeline_version": "2.0.0", "presentation_label": "Perjeta 420 mg 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": "dfc85998efa134fbc08630f7e0f1d1183bd4fb18ec62a15b680bda3fd94b49bd", "source_snapshot_id": "source-791eb96e62fdebcce4c81ec4", "source_updated_at": "2026-04-28", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/perjeta-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 410}
{"after": {"end": 539, "start": 0, "text": "NEOSPHERE is a phase II, multicentre, multinational randomised controlled trial with Perjeta and was conducted in 417 adult female patients with newly diagnosed, early, inflammatory or locally advanced HER2-positive breast cancer (T2-4d; primary tumour > 2cm in diameter) who had not received prior trastuzumab, chemotherapy or radiotherapy. Patients with metastases, bilateral breast cancer, clinically important cardiac risk factors (see section 4.4) or LVEF < 55% were not included. The majority of patients were less than 65 years old.", "truncated": false}, "after_length": 539, "after_sha256": "8b7fe10e3f4d5dd0a5f9f48fa3887ad7952b67f477068dd092c57137dd2d9583", "annex": "I", "before": {"end": 539, "start": 0, "text": "NEOSPHERE is a phase II, multicentre, multinational randomised controlled trial with Perjeta and was conducted in 417 adult female patients with newly diagnosed, early, inflammatory or locally advanced HER2-positive breast cancer (T2-4d; primary tumour > 2cm in diameter) who had not received prior trastuzumab, chemotherapy or radiotherapy. Patients with metastases, bilateral breast cancer, clinically important cardiac risk factors (see section 4.4) or LVEF < 55% were not included. The majority of patients were less than 65 years old.", "truncated": false}, "before_length": 539, "before_sha256": "8b7fe10e3f4d5dd0a5f9f48fa3887ad7952b67f477068dd092c57137dd2d9583", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00abebb06ba39f4fae5118fa", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002547", "medicine_name": "Perjeta", "medicine_slug": "perjeta", "observed_at": "2026-10-12T13:39:17Z", "pipeline_version": "2.0.0", "presentation_label": "Perjeta 420 mg 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "cb28465c58604d0b3ae410ab4b7f20b7947f60bdf7475f845ec18185037e8ea6", "source_snapshot_id": "source-f34b78f381a5e027cfbe1fe6", "source_updated_at": "2026-04-28", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/perjeta-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 655}
{"after": {"end": 162, "start": 0, "text": "Antécédents de réactions au site d’application suggérant une dermatite allergique de contact avec le dispositif transdermique de rivastigmine (voir rubrique 4.4).", "truncated": false}, "after_length": 162, "after_sha256": "96ccb96a363bbb41b215df21871f95c107c89df31ed99e229048cfefcbfae538", "annex": "I", "before": {"end": 162, "start": 0, "text": "Antécédents de réactions au site d’application suggérant une dermatite allergique de contact avec le dispositif transdermique de rivastigmine (voir rubrique 4.4).", "truncated": false}, "before_length": 162, "before_sha256": "96ccb96a363bbb41b215df21871f95c107c89df31ed99e229048cfefcbfae538", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00be3a84fc239b3871f8e85a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/001029", "medicine_name": "Nimvastid", "medicine_slug": "nimvastid", "observed_at": "2026-10-12T19:24:04Z", "pipeline_version": "2.0.0", "presentation_label": "Nimvastid 1,5 mg gélule Nimvastid 3 mg gélule Nimvastid 4,5 mg gélule Nimvastid 6 mg gélule", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.3", "section_type": "contraindication", "source_provider": "European Medicines Agency", "source_sha256": "8e6eaa143ff5f69cfa4caba1806dbd754ee713f2f64ce6a1b369433c9e511b46", "source_snapshot_id": "source-655cd60c5475e58b35c5a1c3", "source_updated_at": "2025-07-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nimvastid-epar-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": 434, "start": 0, "text": "In study BCIRG 006, 213/1 075 patients in the DCarbH (TCH) arm, 221/1 074 patients in the AC→DH (AC→TH) arm, and 217/1 073 in the AC→D (AC→T) arm had a Karnofsky performance status ≤ 90 (either 80 or 90). No disease-free survival (DFS) benefit was noticed in this subgroup of patients (hazard ratio = 1.16, 95% CI [0.73, 1.83] for DCarbH (TCH) versus AC→D (AC→T); hazard ratio 0.97, 95% CI [0.60, 1.55] for AC→DH (AC→TH) versus AC→D).", "truncated": false}, "after_length": 434, "after_sha256": "80e9e9616f0e20be447a3e4db18c918cdfa465bfaace8ba7c1575eb480419d39", "annex": "I", "before": {"end": 434, "start": 0, "text": "In study BCIRG 006, 213/1 075 patients in the DCarbH (TCH) arm, 221/1 074 patients in the AC→DH (AC→TH) arm, and 217/1 073 in the AC→D (AC→T) arm had a Karnofsky performance status ≤ 90 (either 80 or 90). No disease-free survival (DFS) benefit was noticed in this subgroup of patients (hazard ratio = 1.16, 95% CI [0.73, 1.83] for DCarbH (TCH) versus AC→D (AC→T); hazard ratio 0.97, 95% CI [0.60, 1.55] for AC→DH (AC→TH) versus AC→D).", "truncated": false}, "before_length": 434, "before_sha256": "80e9e9616f0e20be447a3e4db18c918cdfa465bfaace8ba7c1575eb480419d39", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00c73165d9140fd034016712", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004361", "medicine_name": "Kanjinti", "medicine_slug": "kanjinti", "observed_at": "2026-10-12T19:40:28Z", "pipeline_version": "2.0.0", "presentation_label": "KANJINTI 150 mg powder for concentrate for solution for infusion KANJINTI 420 mg powder for 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "9f4119e69f965285688c3402ad669f6dc3298fbbaf20f5909a83d03f0f927312", "source_snapshot_id": "source-4222dc61a5c401d9ea981d06", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/kanjinti-epar-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": 219, "start": 0, "text": "La sécurité et l’efficacité d’Emtricitabine/Ténofovir alafénamide Viatris chez les patients présentant des troubles sous-jacents significatifs de la fonction hépatique n’ont pas été établies (voir rubriques 4.2 et 5.2).", "truncated": false}, "after_length": 219, "after_sha256": "b445fc5d7b3be8e5f9b8b60c6bf435ec623940da912101c42e41c980e8b26728", "annex": "I", "before": {"end": 219, "start": 0, "text": "La sécurité et l’efficacité d’Emtricitabine/Ténofovir alafénamide Viatris chez les patients présentant des troubles sous-jacents significatifs de la fonction hépatique n’ont pas été établies (voir rubriques 4.2 et 5.2).", "truncated": false}, "before_length": 219, "before_sha256": "b445fc5d7b3be8e5f9b8b60c6bf435ec623940da912101c42e41c980e8b26728", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00ca04dba4b42533d03e6c51", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006469", "medicine_name": "Emtricitabine / Tenofovir alafenamide Viatris", "medicine_slug": "emtricitabine-tenofovir-alafenamide-viatris", "observed_at": "2026-10-12T13:40:17Z", "pipeline_version": "2.0.0", "presentation_label": "Emtricitabine/Ténofovir alafénamide Viatris 200 mg/10 mg, comprimés pelliculés Emtricitabine/Ténofovir alafénamide Viatris 200 mg/25 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": "f756470c4d010c80a3cc0e1d2d813c1c039c3ca68b113594de79e065fdc70412", "source_snapshot_id": "source-e58329b521b2e223a700355b", "source_updated_at": "2026-04-16", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/emtricitabine-tenofovir-alafenamide-viatris-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 131}
{"after": {"end": 499, "start": 0, "text": "La rivastigmine est un inhibiteur de l’acétyl et de la butyrylcholinestérase, de type carbamate: on estime qu’elle facilite la neurotransmission cholinergique en ralentissant la dégradation de l'acétylcholine libérée par les neurones cholinergiques intacts sur le plan fonctionnel. La rivastigmine est donc susceptible d’avoir un effet favorable sur les déficits cognitifs dépendants de ces voies cholinergiques au cours de la maladie d’Alzheimer et d’une démence associée à la maladie de Parkinson.", "truncated": false}, "after_length": 499, "after_sha256": "f271ba5e5822304ea15c00ad8b7ebc9a38b36ec5948d2112b519326252553caa", "annex": "I", "before": {"end": 499, "start": 0, "text": "La rivastigmine est un inhibiteur de l’acétyl et de la butyrylcholinestérase, de type carbamate: on estime qu’elle facilite la neurotransmission cholinergique en ralentissant la dégradation de l'acétylcholine libérée par les neurones cholinergiques intacts sur le plan fonctionnel. La rivastigmine est donc susceptible d’avoir un effet favorable sur les déficits cognitifs dépendants de ces voies cholinergiques au cours de la maladie d’Alzheimer et d’une démence associée à la maladie de Parkinson.", "truncated": false}, "before_length": 499, "before_sha256": "f271ba5e5822304ea15c00ad8b7ebc9a38b36ec5948d2112b519326252553caa", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00cfcc0ea12cafb4185ab5c0", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/001029", "medicine_name": "Nimvastid", "medicine_slug": "nimvastid", "observed_at": "2026-10-12T19:24:04Z", "pipeline_version": "2.0.0", "presentation_label": "Nimvastid 1,5 mg gélule Nimvastid 3 mg gélule Nimvastid 4,5 mg gélule Nimvastid 6 mg gélule", "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": "8e6eaa143ff5f69cfa4caba1806dbd754ee713f2f64ce6a1b369433c9e511b46", "source_snapshot_id": "source-655cd60c5475e58b35c5a1c3", "source_updated_at": "2025-07-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nimvastid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1348}
{"after": {"end": 256, "start": 0, "text": "In addition, patients could taper off concomitant ITP medicinal products and receive rescue treatments as dictated by local standard of care. More than half of all patients in each treatment group had ≥3 prior ITP therapies and 36% had a prior splenectomy.", "truncated": false}, "after_length": 256, "after_sha256": "6e3ebcb4c8dba842b70a6413b279ffb80b819208a23bcd556e4eae8124f3ff52", "annex": "I", "before": {"end": 256, "start": 0, "text": "In addition, patients could taper off concomitant ITP medicinal products and receive rescue treatments as dictated by local standard of care. More than half of all patients in each treatment group had ≥3 prior ITP therapies and 36% had a prior splenectomy.", "truncated": false}, "before_length": 256, "before_sha256": "6e3ebcb4c8dba842b70a6413b279ffb80b819208a23bcd556e4eae8124f3ff52", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00d37de81580bd573c5c3e9c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006459", "medicine_name": "Eltrombopag Accord", "medicine_slug": "eltrombopag-accord", "observed_at": "2026-10-12T19:38:22Z", "pipeline_version": "2.0.0", "presentation_label": "Eltrombopag Accord 12.5 mg film-coated tablets Eltrombopag Accord 25 mg film-coated tablets Eltrombopag Accord 50 mg film-coated tablets Eltrombopag Accord 75 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "0485f44a0e25bf9e0f930e8ce8c053598ed2a48f78476ffafefb66d9fb3e8d89", "source_snapshot_id": "source-d7e0f3276633f5a4a1cef1a4", "source_updated_at": "2025-05-20", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/eltrombopag-accord-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 794}
{"after": {"end": 142, "start": 0, "text": "Efficacité clinique et sécurité chez les patients présentant une perte osseuse associée à un traitement adjuvant par inhibiteur de l'aromatase", "truncated": false}, "after_length": 142, "after_sha256": "8aa0ebd3696fa9ee1a98ccb99395da735bfaf4debfcc24587c55d2e045e18ce3", "annex": "I", "before": {"end": 142, "start": 0, "text": "Efficacité clinique et sécurité chez les patients présentant une perte osseuse associée à un traitement adjuvant par inhibiteur de l'aromatase", "truncated": false}, "before_length": 142, "before_sha256": "8aa0ebd3696fa9ee1a98ccb99395da735bfaf4debfcc24587c55d2e045e18ce3", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00d81a26951d5075fa5e28e2", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/001120", "medicine_name": "Prolia", "medicine_slug": "prolia", "observed_at": "2026-10-12T13:28:45Z", "pipeline_version": "2.0.0", "presentation_label": "Prolia 60 mg solution injectable en seringue préremplie", "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": "30e296cc06d303605f266e9544e10515b7e5c2063a0473f5aa3595a42d18a3e1", "source_snapshot_id": "source-2924aac36bd07813fcc1891d", "source_updated_at": "2026-08-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/prolia-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 470}
{"after": {"end": 165, "start": 0, "text": "Syringes should be rinsed and washed with cold or warm water and dried completely before the next use. Store syringes in a hygienic place with the medicinal product.", "truncated": false}, "after_length": 165, "after_sha256": "1e7ec6c13cf65fa62639f67d8cfbc418b80d64a7f6d16ee176e149cfaea3ffe7", "annex": "I", "before": {"end": 165, "start": 0, "text": "Syringes should be rinsed and washed with cold or warm water and dried completely before the next use. Store syringes in a hygienic place with the medicinal product.", "truncated": false}, "before_length": 165, "before_sha256": "1e7ec6c13cf65fa62639f67d8cfbc418b80d64a7f6d16ee176e149cfaea3ffe7", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00d9f459f48734dca5c525a6", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004837", "medicine_name": "Xromi", "medicine_slug": "xromi", "observed_at": "2026-10-12T19:31:37Z", "pipeline_version": "2.0.0", "presentation_label": "Xromi 100 mg/ml oral solution", "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": "5e9826d3dd1edc48d9eb87b57c4ee7e70574bc6ce1c841b5477a3de3b9950a1e", "source_snapshot_id": "source-d10ea7497b831a802d8ae623", "source_updated_at": "2025-06-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/xromi-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 558}
{"after": {"end": 168, "start": 0, "text": "Fluid overload has been observed in clinical trials. Fluid overload adverse events occurred most frequently during the first 4 weeks of therapy and decreased over time.", "truncated": false}, "after_length": 168, "after_sha256": "7e63a98f5c8489990460fd49b0d9e0309d41e70d12e1e8b2588ba9085b2dd0d4", "annex": "I", "before": {"end": 168, "start": 0, "text": "Fluid overload has been observed in clinical trials. Fluid overload adverse events occurred most frequently during the first 4 weeks of therapy and decreased over time.", "truncated": false}, "before_length": 168, "before_sha256": "7e63a98f5c8489990460fd49b0d9e0309d41e70d12e1e8b2588ba9085b2dd0d4", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00e63d5817bd4d7b9a4ea6aa", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002345", "medicine_name": "Revestive", "medicine_slug": "revestive", "observed_at": "2026-10-12T19:38:01Z", "pipeline_version": "2.0.0", "presentation_label": "Revestive 1.25 mg powder and solvent 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": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "0125d033ce2f8805dc45ece9b8ffa34db6682b195448a3a560e6d2483a8982b4", "source_snapshot_id": "source-8d7c3200418c650a002546aa", "source_updated_at": "2025-05-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/revestive-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 164}
{"after": {"end": 489, "start": 0, "text": "Teratology studies have been performed by continuous intravenous infusion of eptifibatide in pregnant rats at total daily doses of up to 72 mg/kg/day (about 4 times the recommended maximum daily human dose on a body surface area basis) and in pregnant rabbits at total daily doses of up to 36 mg/kg/day (about 4 times the recommended maximum daily human dose on a body surface area basis). These studies revealed no evidence of impaired fertility or harm to the foetus due to eptifibatide.", "truncated": false}, "after_length": 489, "after_sha256": "650f795148b0ec80505d6284906ed15aad2e2f68f7700418d47c14e1ca90be3a", "annex": "I", "before": {"end": 489, "start": 0, "text": "Teratology studies have been performed by continuous intravenous infusion of eptifibatide in pregnant rats at total daily doses of up to 72 mg/kg/day (about 4 times the recommended maximum daily human dose on a body surface area basis) and in pregnant rabbits at total daily doses of up to 36 mg/kg/day (about 4 times the recommended maximum daily human dose on a body surface area basis). These studies revealed no evidence of impaired fertility or harm to the foetus due to eptifibatide.", "truncated": false}, "before_length": 489, "before_sha256": "650f795148b0ec80505d6284906ed15aad2e2f68f7700418d47c14e1ca90be3a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00e8f1c31eaea53e84f52094", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004104", "medicine_name": "Eptifibatide Accord", "medicine_slug": "eptifibatide-accord", "observed_at": "2026-10-12T19:45:01Z", "pipeline_version": "2.0.0", "presentation_label": "Eptifibatide Accord 2 mg/ml 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": "5.3", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a45982959a207e1611cd67a6103370f86a234e3c45dfb3ab49b532886fe928cb", "source_snapshot_id": "source-8dd88a3db45e564c959f66e5", "source_updated_at": "2025-05-02", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/eptifibatide-accord-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 798}
{"after": {"end": 40, "start": 0, "text": "Délai entre deux perfusions consécutives", "truncated": false}, "after_length": 40, "after_sha256": "d9f02ff78edb2d65d9ec46ac05c7f969ae65ab41ee4fa80b5c4ad6167cd8ccb0", "annex": "I", "before": {"end": 40, "start": 0, "text": "Délai entre deux perfusions consécutives", "truncated": false}, "before_length": 40, "before_sha256": "d9f02ff78edb2d65d9ec46ac05c7f969ae65ab41ee4fa80b5c4ad6167cd8ccb0", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00fd1d876b6085315f8cd642", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002547", "medicine_name": "Perjeta", "medicine_slug": "perjeta", "observed_at": "2026-10-12T13:39:17Z", "pipeline_version": "2.0.0", "presentation_label": "Perjeta 420 mg 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": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "dfc85998efa134fbc08630f7e0f1d1183bd4fb18ec62a15b680bda3fd94b49bd", "source_snapshot_id": "source-791eb96e62fdebcce4c81ec4", "source_updated_at": "2026-04-28", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/perjeta-epar-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": 153, "start": 0, "text": "An absolute benefit of 13 percentage points in favour of the trastuzumab arm was estimated in terms of 3 years event-free survival rate (65% versus 52%).", "truncated": false}, "after_length": 153, "after_sha256": "e8642d8d03fde9d1d95cc55fb6b36db9cc7de8e381c29df93ef2b4ca50f7dc5f", "annex": "I", "before": {"end": 153, "start": 0, "text": "An absolute benefit of 13 percentage points in favour of the trastuzumab arm was estimated in terms of 3 years event-free survival rate (65% versus 52%).", "truncated": false}, "before_length": 153, "before_sha256": "e8642d8d03fde9d1d95cc55fb6b36db9cc7de8e381c29df93ef2b4ca50f7dc5f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-011c102889093dde8b6b7c6b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004361", "medicine_name": "Kanjinti", "medicine_slug": "kanjinti", "observed_at": "2026-10-12T19:40:28Z", "pipeline_version": "2.0.0", "presentation_label": "KANJINTI 150 mg powder for concentrate for solution for infusion KANJINTI 420 mg powder for 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "9f4119e69f965285688c3402ad669f6dc3298fbbaf20f5909a83d03f0f927312", "source_snapshot_id": "source-4222dc61a5c401d9ea981d06", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/kanjinti-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1476}
{"after": {"end": 447, "start": 0, "text": "Des taux élevés d’échec virologique et l’apparition d’une résistance à un stade précoce ont été signalés lorsque le ténofovir disoproxil a été associé à la lamivudine et à l’abacavir ainsi qu’à la lamivudine et à la didanosine dans le cadre d’un traitement en prise quotidienne unique. Par conséquent, les mêmes problèmes peuvent être observés si Emtricitabine/Ténofovir alafénamide Viatris est administré avec un troisième analogue nucléosidique.", "truncated": false}, "after_length": 447, "after_sha256": "695dc252ac5e520bfd5e1058ffeabd2fb594d2aea026f18f9842f686d1e88d44", "annex": "I", "before": {"end": 447, "start": 0, "text": "Des taux élevés d’échec virologique et l’apparition d’une résistance à un stade précoce ont été signalés lorsque le ténofovir disoproxil a été associé à la lamivudine et à l’abacavir ainsi qu’à la lamivudine et à la didanosine dans le cadre d’un traitement en prise quotidienne unique. Par conséquent, les mêmes problèmes peuvent être observés si Emtricitabine/Ténofovir alafénamide Viatris est administré avec un troisième analogue nucléosidique.", "truncated": false}, "before_length": 447, "before_sha256": "695dc252ac5e520bfd5e1058ffeabd2fb594d2aea026f18f9842f686d1e88d44", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01341ed725e9f91c5456c74d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006469", "medicine_name": "Emtricitabine / Tenofovir alafenamide Viatris", "medicine_slug": "emtricitabine-tenofovir-alafenamide-viatris", "observed_at": "2026-10-12T13:40:17Z", "pipeline_version": "2.0.0", "presentation_label": "Emtricitabine/Ténofovir alafénamide Viatris 200 mg/10 mg, comprimés pelliculés Emtricitabine/Ténofovir alafénamide Viatris 200 mg/25 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": "f756470c4d010c80a3cc0e1d2d813c1c039c3ca68b113594de79e065fdc70412", "source_snapshot_id": "source-e58329b521b2e223a700355b", "source_updated_at": "2026-04-16", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/emtricitabine-tenofovir-alafenamide-viatris-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 155}
{"after": {"end": 343, "start": 0, "text": "In clinical studies, patients with severe renal impairment (creatinine clearance < 30 mL/min) or receiving dialysis were at greater risk of developing hypocalcaemia in the absence of calcium supplementation. Adequate intake of calcium and vitamin D is important in patients with severe renal impairment or receiving dialysis (see section 4.4).", "truncated": false}, "after_length": 343, "after_sha256": "60efaf8d1782d30b662a8e33bdf176695fc09139d04441b00efa71d2b21dda7a", "annex": "I", "before": {"end": 343, "start": 0, "text": "In clinical studies, patients with severe renal impairment (creatinine clearance < 30 mL/min) or receiving dialysis were at greater risk of developing hypocalcaemia in the absence of calcium supplementation. Adequate intake of calcium and vitamin D is important in patients with severe renal impairment or receiving dialysis (see section 4.4).", "truncated": false}, "before_length": 343, "before_sha256": "60efaf8d1782d30b662a8e33bdf176695fc09139d04441b00efa71d2b21dda7a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01479b367c9c13e55972f0a7", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001120", "medicine_name": "Prolia", "medicine_slug": "prolia", "observed_at": "2026-10-12T13:28:42Z", "pipeline_version": "2.0.0", "presentation_label": "Prolia 60 mg solution for injection in prefilled syringe", "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": "5984d05d5bd9987a8e6f5cf86ff2e5032af0bc8bf5fe7a137a9f36a8466c5b97", "source_snapshot_id": "source-312c11aae5d59cae975290d1", "source_updated_at": "2026-08-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/prolia-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 312}
{"after": {"end": 167, "start": 0, "text": "L’administration d’héparine est recommandée à moins qu’une contre-indication ne s’y oppose (telle qu’un antécédent de thrombocytopénie associée à l’emploi d’héparine).", "truncated": false}, "after_length": 167, "after_sha256": "cfb549291c1f4b4fa1bb81c9ebc5eda58c728814bcba21915643009305c2f61b", "annex": "I", "before": {"end": 167, "start": 0, "text": "L’administration d’héparine est recommandée à moins qu’une contre-indication ne s’y oppose (telle qu’un antécédent de thrombocytopénie associée à l’emploi d’héparine).", "truncated": false}, "before_length": 167, "before_sha256": "cfb549291c1f4b4fa1bb81c9ebc5eda58c728814bcba21915643009305c2f61b", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0155a8455665be5e18f79587", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004104", "medicine_name": "Eptifibatide Accord", "medicine_slug": "eptifibatide-accord", "observed_at": "2026-10-12T19:45:11Z", "pipeline_version": "2.0.0", "presentation_label": "Eptifibatide Accord 2 mg/ml, 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": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "c9be002148fa73331c72aadac205f927e043f3407cf695e63a1cbe715480600b", "source_snapshot_id": "source-9e33d5d566c95289f1a7e6a6", "source_updated_at": "2025-05-02", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/eptifibatide-accord-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 565}
{"after": {"end": 88, "start": 0, "text": "Arthralgia, muscle spasms, back pain, pain in extremity, musculoskeletal pain, bone pain", "truncated": false}, "after_length": 88, "after_sha256": "f8e3b804c1c37dcaf7b1b8c3485236388b946315c54be5c7ed5fe1640eb97450", "annex": "I", "before": {"end": 88, "start": 0, "text": "Arthralgia, muscle spasms, back pain, pain in extremity, musculoskeletal pain, bone pain", "truncated": false}, "before_length": 88, "before_sha256": "f8e3b804c1c37dcaf7b1b8c3485236388b946315c54be5c7ed5fe1640eb97450", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01580b719a9034cc20148057", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006459", "medicine_name": "Eltrombopag Accord", "medicine_slug": "eltrombopag-accord", "observed_at": "2026-10-12T19:38:22Z", "pipeline_version": "2.0.0", "presentation_label": "Eltrombopag Accord 12.5 mg film-coated tablets Eltrombopag Accord 25 mg film-coated tablets Eltrombopag Accord 50 mg film-coated tablets Eltrombopag Accord 75 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": "0485f44a0e25bf9e0f930e8ce8c053598ed2a48f78476ffafefb66d9fb3e8d89", "source_snapshot_id": "source-d7e0f3276633f5a4a1cef1a4", "source_updated_at": "2025-05-20", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/eltrombopag-accord-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 627}
{"after": {"end": 210, "start": 0, "text": "Nexium Control contient des sphères de sucre qui contiennent du saccharose, un type de sucre. Si votre médecin vous a informé(e) d’une intolérance à certains sucres, contactez-le avant de prendre ce médicament.", "truncated": false}, "after_length": 210, "after_sha256": "63462b42c7bfc83c593043b868e417b3e4edda23e18c4d312fafb2869729c2bb", "annex": "IIIB", "before": {"end": 210, "start": 0, "text": "Nexium Control contient des sphères de sucre qui contiennent du saccharose, un type de sucre. Si votre médecin vous a informé(e) d’une intolérance à certains sucres, contactez-le avant de prendre ce médicament.", "truncated": false}, "before_length": 210, "before_sha256": "63462b42c7bfc83c593043b868e417b3e4edda23e18c4d312fafb2869729c2bb", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0160b91a314e2f44df3d3672", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002618", "medicine_name": "Nexium Control", "medicine_slug": "nexium-control", "observed_at": "2026-10-12T13:36:18Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "dd192e79554a2cf904e3b717c765e723c89937d2250f85a0df30f9a56f6cb2e1", "source_snapshot_id": "source-614e91f5970645497b96d67b", "source_updated_at": "2026-06-03", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nexium-control-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1886}
{"after": {"end": 90, "start": 0, "text": "Therapy should be initiated by a physician experienced in the management of HIV infection.", "truncated": false}, "after_length": 90, "after_sha256": "69e22fb7a38f211cc677442cde6987206db5bb7ea7a47ea8376b0c3b41942ff3", "annex": "I", "before": {"end": 90, "start": 0, "text": "Therapy should be initiated by a physician experienced in the management of HIV infection.", "truncated": false}, "before_length": 90, "before_sha256": "69e22fb7a38f211cc677442cde6987206db5bb7ea7a47ea8376b0c3b41942ff3", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01615f96b7526001c39164b2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006469", "medicine_name": "Emtricitabine / Tenofovir alafenamide Viatris", "medicine_slug": "emtricitabine-tenofovir-alafenamide-viatris", "observed_at": "2026-10-12T13:40:14Z", "pipeline_version": "2.0.0", "presentation_label": "Emtricitabine/Tenofovir alafenamide Viatris 200 mg/10 mg filmcoated tablets Emtricitabine/Tenofovir alafenamide Viatris 200 mg/25 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": "247b89d7ca1efa91cffaeb0f00556dd381d81e804eb2f9c23631d01a49578ea7", "source_snapshot_id": "source-246d08888d5f52d006efa07f", "source_updated_at": "2026-04-16", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/emtricitabine-tenofovir-alafenamide-viatris-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 68}
{"after": {"end": 46, "start": 0, "text": "Injury, poisoning and procedural complications", "truncated": false}, "after_length": 46, "after_sha256": "b5557df72e7b845fa1deba96c8bc465838285a1616da6db54e5b9c65d001f8aa", "annex": "I", "before": {"end": 46, "start": 0, "text": "Injury, poisoning and procedural complications", "truncated": false}, "before_length": 46, "before_sha256": "b5557df72e7b845fa1deba96c8bc465838285a1616da6db54e5b9c65d001f8aa", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0170bc8444605f69292ef402", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004361", "medicine_name": "Kanjinti", "medicine_slug": "kanjinti", "observed_at": "2026-10-12T19:40:28Z", "pipeline_version": "2.0.0", "presentation_label": "KANJINTI 150 mg powder for concentrate for solution for infusion KANJINTI 420 mg powder for 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": "9f4119e69f965285688c3402ad669f6dc3298fbbaf20f5909a83d03f0f927312", "source_snapshot_id": "source-4222dc61a5c401d9ea981d06", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/kanjinti-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 730}
{"after": {"end": 342, "start": 0, "text": "Post-marketing cases of renal impairment, including acute renal failure and proximal renal tubulopathy have been reported with tenofovir alafenamide-containing products. A potential risk of nephrotoxicity resulting from chronic exposure to low levels of tenofovir due to dosing with tenofovir alafenamide cannot be excluded (see section 5.3).", "truncated": false}, "after_length": 342, "after_sha256": "955b5118e079fb5c86c442c10903360fd2cd61b23e8c75716152dbb5fabf0be3", "annex": "I", "before": {"end": 342, "start": 0, "text": "Post-marketing cases of renal impairment, including acute renal failure and proximal renal tubulopathy have been reported with tenofovir alafenamide-containing products. A potential risk of nephrotoxicity resulting from chronic exposure to low levels of tenofovir due to dosing with tenofovir alafenamide cannot be excluded (see section 5.3).", "truncated": false}, "before_length": 342, "before_sha256": "955b5118e079fb5c86c442c10903360fd2cd61b23e8c75716152dbb5fabf0be3", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-017feca7b432d11bd1d04740", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006469", "medicine_name": "Emtricitabine / Tenofovir alafenamide Viatris", "medicine_slug": "emtricitabine-tenofovir-alafenamide-viatris", "observed_at": "2026-10-12T13:40:14Z", "pipeline_version": "2.0.0", "presentation_label": "Emtricitabine/Tenofovir alafenamide Viatris 200 mg/10 mg filmcoated tablets Emtricitabine/Tenofovir alafenamide Viatris 200 mg/25 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": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "247b89d7ca1efa91cffaeb0f00556dd381d81e804eb2f9c23631d01a49578ea7", "source_snapshot_id": "source-246d08888d5f52d006efa07f", "source_updated_at": "2026-04-16", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/emtricitabine-tenofovir-alafenamide-viatris-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 169}
{"after": {"end": 50, "start": 0, "text": "Volume d’eau pour préparations injectables stérile", "truncated": false}, "after_length": 50, "after_sha256": "1b7fe55bf519a9aeadf521d6e2d2fa9bfbe64eca791028b11f167eb0e5708997", "annex": "I", "before": {"end": 50, "start": 0, "text": "Volume d’eau pour préparations injectables stérile", "truncated": false}, "before_length": 50, "before_sha256": "1b7fe55bf519a9aeadf521d6e2d2fa9bfbe64eca791028b11f167eb0e5708997", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-018b86f61886ab6d46ec6aad", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004361", "medicine_name": "Kanjinti", "medicine_slug": "kanjinti", "observed_at": "2026-10-12T19:40:38Z", "pipeline_version": "2.0.0", "presentation_label": "KANJINTI 150 mg poudre pour solution à diluer pour perfusion KANJINTI 420 mg poudre pour 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": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "ea9ea0ca90af9dcbc236774255b0290bf3e784884d88a33522b45c8050f829cf", "source_snapshot_id": "source-a4621a49bcc40ac3f94d4939", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/kanjinti-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1869}
{"after": {"end": 184, "start": 0, "text": "The dosage of mercaptopurine may need to be reduced when this agent is combined with other medicinal products whose primary or secondary toxicity is myelosuppression (see Section 4.5).", "truncated": false}, "after_length": 184, "after_sha256": "ef80de51e581f210d2f39cbea0df8ea3f6fec36a9d75b9057e46ec39d18fd401", "annex": "I", "before": {"end": 184, "start": 0, "text": "The dosage of mercaptopurine may need to be reduced when this agent is combined with other medicinal products whose primary or secondary toxicity is myelosuppression (see Section 4.5).", "truncated": false}, "before_length": 184, "before_sha256": "ef80de51e581f210d2f39cbea0df8ea3f6fec36a9d75b9057e46ec39d18fd401", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01bc233911e623ec281c7d11", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002022", "medicine_name": "Xaluprine (previously Mercaptopurine Nova Laboratories)", "medicine_slug": "xaluprine-previously-mercaptopurine-nova-laboratories", "observed_at": "2026-10-12T19:08:02Z", "pipeline_version": "2.0.0", "presentation_label": "Xaluprine 20 mg/ml oral suspension", "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": "a352706294cb9013c5ba158da50186f12673cdb6fb887d0033e1457d44698091", "source_snapshot_id": "source-80b0d9db881bf774bffb5d3c", "source_updated_at": "2025-09-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/xaluprine-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 391}
{"after": {"end": 297, "start": 0, "text": "Les médicaments qui affectent la synthèse de l’ADN, comme l’hydroxycarbamide, peuvent être des substances actives mutagènes puissantes. Cette possibilité doit être soigneusement considérée avant d’administrer ce médicament à des patients, hommes ou femmes, qui pourraient envisager la procréation.", "truncated": false}, "after_length": 297, "after_sha256": "81216f8c47d735733147f9183ad9cf1815e0e840e1c34ba2de19a779ac1aae4f", "annex": "I", "before": {"end": 297, "start": 0, "text": "Les médicaments qui affectent la synthèse de l’ADN, comme l’hydroxycarbamide, peuvent être des substances actives mutagènes puissantes. Cette possibilité doit être soigneusement considérée avant d’administrer ce médicament à des patients, hommes ou femmes, qui pourraient envisager la procréation.", "truncated": false}, "before_length": 297, "before_sha256": "81216f8c47d735733147f9183ad9cf1815e0e840e1c34ba2de19a779ac1aae4f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01c4db887ed0a0e458bbe265", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004837", "medicine_name": "Xromi", "medicine_slug": "xromi", "observed_at": "2026-10-12T19:32:45Z", "pipeline_version": "2.0.0", "presentation_label": "Xromi 100 mg/mL solution buvable", "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": "09fc95ca63cda4685a64f9a6f2786bf839a7e56efe05863cd60781314e5f87b5", "source_snapshot_id": "source-6048aed0c6a5fd892436dd1f", "source_updated_at": "2025-06-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xromi-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 179}
{"after": {"end": 282, "start": 0, "text": "En cas de suppression médullaire, une normalisation hématologique apparaît habituellement dans les deux semaines qui suivent l’arrêt de l’hydroxycarbamide. Un ajustement posologique progressif est recommandé pour éviter des suppressions médullaires plus sévères (voir rubrique 4.2).", "truncated": false}, "after_length": 282, "after_sha256": "61e7ee1129fa8cf3277ed2a9cb93ac1c4b87d490ee610613016819750481fdd7", "annex": "I", "before": {"end": 282, "start": 0, "text": "En cas de suppression médullaire, une normalisation hématologique apparaît habituellement dans les deux semaines qui suivent l’arrêt de l’hydroxycarbamide. Un ajustement posologique progressif est recommandé pour éviter des suppressions médullaires plus sévères (voir rubrique 4.2).", "truncated": false}, "before_length": 282, "before_sha256": "61e7ee1129fa8cf3277ed2a9cb93ac1c4b87d490ee610613016819750481fdd7", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01c9cb4c0b1e5600eab4f718", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004837", "medicine_name": "Xromi", "medicine_slug": "xromi", "observed_at": "2026-10-12T19:32:45Z", "pipeline_version": "2.0.0", "presentation_label": "Xromi 100 mg/mL solution buvable", "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": "09fc95ca63cda4685a64f9a6f2786bf839a7e56efe05863cd60781314e5f87b5", "source_snapshot_id": "source-6048aed0c6a5fd892436dd1f", "source_updated_at": "2025-06-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xromi-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 276}
{"after": {"end": 261, "start": 0, "text": "c Inclut les patients qui ont interrompu le traitement à cause d’un EI ou du décès à tout moment de l’étude, à partir du jour 1 et jusqu’à la fenêtre de la semaine 48, si cela a entraîné l’absence de données virologiques sur le traitement pendant cette période.", "truncated": false}, "after_length": 261, "after_sha256": "25498c3c4b155bbfec9beb7ad36bf14e0fb9b6222311650dafb70bfac66e87a5", "annex": "I", "before": {"end": 261, "start": 0, "text": "c Inclut les patients qui ont interrompu le traitement à cause d’un EI ou du décès à tout moment de l’étude, à partir du jour 1 et jusqu’à la fenêtre de la semaine 48, si cela a entraîné l’absence de données virologiques sur le traitement pendant cette période.", "truncated": false}, "before_length": 261, "before_sha256": "25498c3c4b155bbfec9beb7ad36bf14e0fb9b6222311650dafb70bfac66e87a5", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01ce37ff00780c510a017ad8", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006469", "medicine_name": "Emtricitabine / Tenofovir alafenamide Viatris", "medicine_slug": "emtricitabine-tenofovir-alafenamide-viatris", "observed_at": "2026-10-12T13:40:17Z", "pipeline_version": "2.0.0", "presentation_label": "Emtricitabine/Ténofovir alafénamide Viatris 200 mg/10 mg, comprimés pelliculés Emtricitabine/Ténofovir alafénamide Viatris 200 mg/25 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "f756470c4d010c80a3cc0e1d2d813c1c039c3ca68b113594de79e065fdc70412", "source_snapshot_id": "source-e58329b521b2e223a700355b", "source_updated_at": "2026-04-16", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/emtricitabine-tenofovir-alafenamide-viatris-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 907}
{"after": {"end": 419, "start": 0, "text": "Unchanged rivastigmine is not found in the urine; renal excretion of the metabolites is the major route of elimination. Following administration of 14C-rivastigmine, renal elimination was rapid and essentially complete (>90%) within 24 hours. Less than 1% of the administered dose is excreted in the faeces. There is no accumulation of rivastigmine or the decarbamylated metabolite in patients with Alzheimer’s disease.", "truncated": false}, "after_length": 419, "after_sha256": "f007e10a156816effb5299ff7363435553f2f173324d0d1c32f552a2487d9f2e", "annex": "I", "before": {"end": 419, "start": 0, "text": "Unchanged rivastigmine is not found in the urine; renal excretion of the metabolites is the major route of elimination. Following administration of 14C-rivastigmine, renal elimination was rapid and essentially complete (>90%) within 24 hours. Less than 1% of the administered dose is excreted in the faeces. There is no accumulation of rivastigmine or the decarbamylated metabolite in patients with Alzheimer’s disease.", "truncated": false}, "before_length": 419, "before_sha256": "f007e10a156816effb5299ff7363435553f2f173324d0d1c32f552a2487d9f2e", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01cf471e460eb92f4408397f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001029", "medicine_name": "Nimvastid", "medicine_slug": "nimvastid", "observed_at": "2026-10-12T19:24:00Z", "pipeline_version": "2.0.0", "presentation_label": "Nimvastid 1.5 mg orodispersible tablets Nimvastid 3 mg orodispersible tablets Nimvastid 4.5 mg orodispersible tablets Nimvastid 6 mg orodispersible tablets", "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": "fa4c6e344db60bf4064eb3cc2d76d72c0fc858894147724d88ab2d66b9f9a0dc", "source_snapshot_id": "source-775bf49790604674d3549dac", "source_updated_at": "2025-07-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nimvastid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1646}
{"after": {"end": 174, "start": 0, "text": "The reduction in the incidence of endpoint events in patients receiving eptifibatide appeared early during treatment. There was no increased benefit thereafter, up to 1 year.", "truncated": false}, "after_length": 174, "after_sha256": "d6a3f50b0472374e06c6f66ef329e547fafa3e710c4b339911196380b98a3bc5", "annex": "I", "before": {"end": 174, "start": 0, "text": "The reduction in the incidence of endpoint events in patients receiving eptifibatide appeared early during treatment. There was no increased benefit thereafter, up to 1 year.", "truncated": false}, "before_length": 174, "before_sha256": "d6a3f50b0472374e06c6f66ef329e547fafa3e710c4b339911196380b98a3bc5", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01d03c274ea06cc713a8dc00", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004104", "medicine_name": "Eptifibatide Accord", "medicine_slug": "eptifibatide-accord", "observed_at": "2026-10-12T19:45:01Z", "pipeline_version": "2.0.0", "presentation_label": "Eptifibatide Accord 0.75 mg/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": "a45982959a207e1611cd67a6103370f86a234e3c45dfb3ab49b532886fe928cb", "source_snapshot_id": "source-8dd88a3db45e564c959f66e5", "source_updated_at": "2025-05-02", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/eptifibatide-accord-epar-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": 159, "start": 0, "text": "* Pour les patients recevant 25 mg d’eltrombopag une fois par jour, la réinitialisation du traitement à une dose de 25 mg un jour sur deux doit être envisagée.", "truncated": false}, "after_length": 159, "after_sha256": "b5632d664f29c20c9f0fd605fa5e9d108546bfa75dd0d47877d8af8b48a22410", "annex": "I", "before": {"end": 159, "start": 0, "text": "* Pour les patients recevant 25 mg d’eltrombopag une fois par jour, la réinitialisation du traitement à une dose de 25 mg un jour sur deux doit être envisagée.", "truncated": false}, "before_length": 159, "before_sha256": "b5632d664f29c20c9f0fd605fa5e9d108546bfa75dd0d47877d8af8b48a22410", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01d0a3bfbbf5358644f9e98f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006459", "medicine_name": "Eltrombopag Accord", "medicine_slug": "eltrombopag-accord", "observed_at": "2026-10-12T19:38:33Z", "pipeline_version": "2.0.0", "presentation_label": "Eltrombopag Accord 12,5 mg, comprimés pelliculés Eltrombopag Accord 25 mg, comprimés pelliculés Eltrombopag Accord 50 mg, comprimés pelliculés Eltrombopag Accord 75 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": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "4dba9ba2d13e28b9b00b5cee0ebfe8b72ef357d185dbbf0def82cb05d9f63530", "source_snapshot_id": "source-acb656ad31eb3184c264b4cd", "source_updated_at": "2025-05-20", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/eltrombopag-accord-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 161}
{"after": {"end": 356, "start": 0, "text": "In the BCIRG 006 study for the primary endpoint, DFS, the hazard ratio translates into an absolute benefit, in terms of 3year disease-free survival rate estimates of 5.8 percentage points (86.7% versus 80.9%) in favour of the AC→DH (trastuzumab) arm and 4.6 percentage points (85.5% versus 80.9%) in favour of the DCarbH (trastuzumab) arm compared to AC→D.", "truncated": false}, "after_length": 356, "after_sha256": "745a09275bfca192b56254186a24fc088e96120d7cadbabb412227e19fba86ce", "annex": "I", "before": {"end": 356, "start": 0, "text": "In the BCIRG 006 study for the primary endpoint, DFS, the hazard ratio translates into an absolute benefit, in terms of 3year disease-free survival rate estimates of 5.8 percentage points (86.7% versus 80.9%) in favour of the AC→DH (trastuzumab) arm and 4.6 percentage points (85.5% versus 80.9%) in favour of the DCarbH (trastuzumab) arm compared to AC→D.", "truncated": false}, "before_length": 356, "before_sha256": "745a09275bfca192b56254186a24fc088e96120d7cadbabb412227e19fba86ce", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01d14555039b91b4dcad9dfd", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004361", "medicine_name": "Kanjinti", "medicine_slug": "kanjinti", "observed_at": "2026-10-12T19:40:28Z", "pipeline_version": "2.0.0", "presentation_label": "KANJINTI 150 mg powder for concentrate for solution for infusion KANJINTI 420 mg powder for 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "9f4119e69f965285688c3402ad669f6dc3298fbbaf20f5909a83d03f0f927312", "source_snapshot_id": "source-4222dc61a5c401d9ea981d06", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/kanjinti-epar-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": 138, "start": 0, "text": "Pour les instructions concernant la reconstitution de la formulation intraveineuse de KANJINTI avant administration, voir la rubrique 6.6.", "truncated": false}, "after_length": 138, "after_sha256": "89cf1ff2b0aa4c162fa54e2a28ff1e5e4b44ccd27267c09f422d4a4592e8e3c9", "annex": "I", "before": {"end": 138, "start": 0, "text": "Pour les instructions concernant la reconstitution de la formulation intraveineuse de KANJINTI avant administration, voir la rubrique 6.6.", "truncated": false}, "before_length": 138, "before_sha256": "89cf1ff2b0aa4c162fa54e2a28ff1e5e4b44ccd27267c09f422d4a4592e8e3c9", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01d95dbf8e954de4c63db52b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004361", "medicine_name": "Kanjinti", "medicine_slug": "kanjinti", "observed_at": "2026-10-12T19:40:38Z", "pipeline_version": "2.0.0", "presentation_label": "KANJINTI 150 mg poudre pour solution à diluer pour perfusion KANJINTI 420 mg poudre pour 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": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "ea9ea0ca90af9dcbc236774255b0290bf3e784884d88a33522b45c8050f829cf", "source_snapshot_id": "source-a4621a49bcc40ac3f94d4939", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/kanjinti-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 157}
{"after": {"end": 221, "start": 0, "text": "Of the patients who were HBeAg positive at baseline, 1/30 (3.3%) achieved seroconversion to antiHBe at Week 48. Of the patients who were HBsAg positive at baseline, 3/70 (4.3%) achieved seroconversion to anti-HBs Week 48.", "truncated": false}, "after_length": 221, "after_sha256": "ff04791d44fbdf9b76875218bd6de9d4b38c009a8ca745475f353a82d20b1515", "annex": "I", "before": {"end": 221, "start": 0, "text": "Of the patients who were HBeAg positive at baseline, 1/30 (3.3%) achieved seroconversion to antiHBe at Week 48. Of the patients who were HBsAg positive at baseline, 3/70 (4.3%) achieved seroconversion to anti-HBs Week 48.", "truncated": false}, "before_length": 221, "before_sha256": "ff04791d44fbdf9b76875218bd6de9d4b38c009a8ca745475f353a82d20b1515", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01ed4659ea5f72e9891a52b3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006469", "medicine_name": "Emtricitabine / Tenofovir alafenamide Viatris", "medicine_slug": "emtricitabine-tenofovir-alafenamide-viatris", "observed_at": "2026-10-12T13:40:14Z", "pipeline_version": "2.0.0", "presentation_label": "Emtricitabine/Tenofovir alafenamide Viatris 200 mg/10 mg filmcoated tablets Emtricitabine/Tenofovir alafenamide Viatris 200 mg/25 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": "247b89d7ca1efa91cffaeb0f00556dd381d81e804eb2f9c23631d01a49578ea7", "source_snapshot_id": "source-246d08888d5f52d006efa07f", "source_updated_at": "2026-04-16", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/emtricitabine-tenofovir-alafenamide-viatris-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1011}
{"after": {"end": 181, "start": 0, "text": "Les tableaux présentant les volumes à injecter basés sur la dose recommandée en fonction du poids corporel chez les adultes et les enfants et adolescents figurent à la rubrique 4.2.", "truncated": false}, "after_length": 181, "after_sha256": "ce717598078a52f87a3d6a110ac5d7955582fc428ffa4e755713da867db54ceb", "annex": "I", "before": {"end": 181, "start": 0, "text": "Les tableaux présentant les volumes à injecter basés sur la dose recommandée en fonction du poids corporel chez les adultes et les enfants et adolescents figurent à la rubrique 4.2.", "truncated": false}, "before_length": 181, "before_sha256": "ce717598078a52f87a3d6a110ac5d7955582fc428ffa4e755713da867db54ceb", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01f0c81d9cb1f5af7fa40d1d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002345", "medicine_name": "Revestive", "medicine_slug": "revestive", "observed_at": "2026-10-12T19:38:11Z", "pipeline_version": "2.0.0", "presentation_label": "Revestive 5 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": "a977434b47f1efb8356de57d0e4e212d0d42a4215af7d29769e6a19a6e5b7354", "source_snapshot_id": "source-34689da4d07d48b1dbd0d784", "source_updated_at": "2025-05-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/revestive-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1279}
{"after": {"end": 82, "start": 0, "text": "Prefilled syringe (glass) with plungers (bromobutyl) containing 0.5 ml of solvent.", "truncated": false}, "after_length": 82, "after_sha256": "520aeb9b7a7cc384db0286c5f625514bed6309570d21c200393b2b5b0bf926f1", "annex": "I", "before": {"end": 82, "start": 0, "text": "Prefilled syringe (glass) with plungers (bromobutyl) containing 0.5 ml of solvent.", "truncated": false}, "before_length": 82, "before_sha256": "520aeb9b7a7cc384db0286c5f625514bed6309570d21c200393b2b5b0bf926f1", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01fd515dbdd017191845eaf5", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002345", "medicine_name": "Revestive", "medicine_slug": "revestive", "observed_at": "2026-10-12T19:38:01Z", "pipeline_version": "2.0.0", "presentation_label": "Revestive 1.25 mg powder and solvent 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": "6.5", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "0125d033ce2f8805dc45ece9b8ffa34db6682b195448a3a560e6d2483a8982b4", "source_snapshot_id": "source-8d7c3200418c650a002546aa", "source_updated_at": "2025-05-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/revestive-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 592}
{"after": {"end": 632, "start": 0, "text": "Les interactions entre les composants de l’emtricitabine/ténofovir alafénamide et les autres médicaments pouvant potentiellement faire l’objet d’une administration concomitante sont listées dans le tableau 2 (« ↑ » représente une augmentation, « ↓ » une diminution, « ↔ » l’absence de changement). Les interactions décrites reposent sur des études menées avec l’emtricitabine/ténofovir alafénamide ou les composants de l’emtricitabine/ténofovir alafénamide administrés individuellement et/ou en association, ou constituent des interactions médicamenteuses potentielles pouvant se produire avec l’emtricitabine/ténofovir alafénamide.", "truncated": false}, "after_length": 632, "after_sha256": "3e3128444fca3daa89f74277d55c1c7bcfda019fa71b251f6552edec89478bc7", "annex": "I", "before": {"end": 632, "start": 0, "text": "Les interactions entre les composants de l’emtricitabine/ténofovir alafénamide et les autres médicaments pouvant potentiellement faire l’objet d’une administration concomitante sont listées dans le tableau 2 (« ↑ » représente une augmentation, « ↓ » une diminution, « ↔ » l’absence de changement). Les interactions décrites reposent sur des études menées avec l’emtricitabine/ténofovir alafénamide ou les composants de l’emtricitabine/ténofovir alafénamide administrés individuellement et/ou en association, ou constituent des interactions médicamenteuses potentielles pouvant se produire avec l’emtricitabine/ténofovir alafénamide.", "truncated": false}, "before_length": 632, "before_sha256": "3e3128444fca3daa89f74277d55c1c7bcfda019fa71b251f6552edec89478bc7", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-02083b15422aeced711cec39", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006469", "medicine_name": "Emtricitabine / Tenofovir alafenamide Viatris", "medicine_slug": "emtricitabine-tenofovir-alafenamide-viatris", "observed_at": "2026-10-12T13:40:17Z", "pipeline_version": "2.0.0", "presentation_label": "Emtricitabine/Ténofovir alafénamide Viatris 200 mg/10 mg, comprimés pelliculés Emtricitabine/Ténofovir alafénamide Viatris 200 mg/25 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": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "f756470c4d010c80a3cc0e1d2d813c1c039c3ca68b113594de79e065fdc70412", "source_snapshot_id": "source-e58329b521b2e223a700355b", "source_updated_at": "2026-04-16", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/emtricitabine-tenofovir-alafenamide-viatris-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 205}
{"after": {"end": 657, "start": 0, "text": "The primary efficacy analysis of the study results showed no statistically significant difference between the group on teduglutide 0.10 mg/kg/day and the placebo group, while the proportion of subjects receiving the recommended teduglutide dose of 0.05 mg/kg/day achieving at least a 20% reduction of parenteral nutrition at Week 20 and 24 was statistically significantly different versus placebo (46% versus 6.3%, p< 0.01). Treatment with teduglutide resulted in a 2.5 l/week reduction in parenteral nutrition requirements (from a pretreatment baseline of 9.6 litres) versus 0.9 l/week (from a pretreatment baseline of 10.7 litres) for placebo at 24 weeks.", "truncated": false}, "after_length": 657, "after_sha256": "e09682475f5f8dcc2c5305c6dc3db1c1fc4fefcb6a57b34da8c832f977d12414", "annex": "I", "before": {"end": 657, "start": 0, "text": "The primary efficacy analysis of the study results showed no statistically significant difference between the group on teduglutide 0.10 mg/kg/day and the placebo group, while the proportion of subjects receiving the recommended teduglutide dose of 0.05 mg/kg/day achieving at least a 20% reduction of parenteral nutrition at Week 20 and 24 was statistically significantly different versus placebo (46% versus 6.3%, p< 0.01). Treatment with teduglutide resulted in a 2.5 l/week reduction in parenteral nutrition requirements (from a pretreatment baseline of 9.6 litres) versus 0.9 l/week (from a pretreatment baseline of 10.7 litres) for placebo at 24 weeks.", "truncated": false}, "before_length": 657, "before_sha256": "e09682475f5f8dcc2c5305c6dc3db1c1fc4fefcb6a57b34da8c832f977d12414", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-020db34dac41b8df87ebe5b3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002345", "medicine_name": "Revestive", "medicine_slug": "revestive", "observed_at": "2026-10-12T19:38:01Z", "pipeline_version": "2.0.0", "presentation_label": "Revestive 1.25 mg powder and solvent 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "0125d033ce2f8805dc45ece9b8ffa34db6682b195448a3a560e6d2483a8982b4", "source_snapshot_id": "source-8d7c3200418c650a002546aa", "source_updated_at": "2025-05-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/revestive-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 468}
{"after": {"end": 248, "start": 0, "text": "A population pharmacokinetic analysis showed that nicotine use increases the oral clearance of rivastigmine by 23% in patients with Alzheimer’s disease (n=75 smokers and 549 non-smokers) following rivastigmine oral capsule doses of up to 12 mg/day.", "truncated": false}, "after_length": 248, "after_sha256": "4feba6eb55661499f428cc213d83446f11b4b48acca4985b46d08dfddac0f6b5", "annex": "I", "before": {"end": 248, "start": 0, "text": "A population pharmacokinetic analysis showed that nicotine use increases the oral clearance of rivastigmine by 23% in patients with Alzheimer’s disease (n=75 smokers and 549 non-smokers) following rivastigmine oral capsule doses of up to 12 mg/day.", "truncated": false}, "before_length": 248, "before_sha256": "4feba6eb55661499f428cc213d83446f11b4b48acca4985b46d08dfddac0f6b5", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-020ef36bb5bb4f32d281f56b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001029", "medicine_name": "Nimvastid", "medicine_slug": "nimvastid", "observed_at": "2026-10-12T19:24:00Z", "pipeline_version": "2.0.0", "presentation_label": "Nimvastid 1.5 mg hard capsules Nimvastid 3 mg hard capsules Nimvastid 4.5 mg hard capsules Nimvastid 6 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": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "fa4c6e344db60bf4064eb3cc2d76d72c0fc858894147724d88ab2d66b9f9a0dc", "source_snapshot_id": "source-775bf49790604674d3549dac", "source_updated_at": "2025-07-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nimvastid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 762}
{"after": {"end": 70, "start": 0, "text": "Adequate intake of calcium and vitamin D is important in all patients.", "truncated": false}, "after_length": 70, "after_sha256": "9e14aff28372002e9af66accd5145bd4e200475655b34f704ef150cce41e638d", "annex": "I", "before": {"end": 70, "start": 0, "text": "Adequate intake of calcium and vitamin D is important in all patients.", "truncated": false}, "before_length": 70, "before_sha256": "9e14aff28372002e9af66accd5145bd4e200475655b34f704ef150cce41e638d", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-022d437e5995734c321c1500", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001120", "medicine_name": "Prolia", "medicine_slug": "prolia", "observed_at": "2026-10-12T13:28:42Z", "pipeline_version": "2.0.0", "presentation_label": "Prolia 60 mg solution for injection in prefilled syringe", "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": "5984d05d5bd9987a8e6f5cf86ff2e5032af0bc8bf5fe7a137a9f36a8466c5b97", "source_snapshot_id": "source-312c11aae5d59cae975290d1", "source_updated_at": "2026-08-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/prolia-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 108}
{"after": {"end": 64, "start": 0, "text": "KANJINTI 150 mg powder for concentrate for solution for infusion", "truncated": false}, "after_length": 64, "after_sha256": "b6a50c82c7131dfeb0a2ab26079e686146d4b1e746607857e2b9cf3bfaf42ff5", "annex": "I", "before": {"end": 64, "start": 0, "text": "KANJINTI 150 mg powder for concentrate for solution for infusion", "truncated": false}, "before_length": 64, "before_sha256": "b6a50c82c7131dfeb0a2ab26079e686146d4b1e746607857e2b9cf3bfaf42ff5", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-022dd925eb955e56813596f1", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004361", "medicine_name": "Kanjinti", "medicine_slug": "kanjinti", "observed_at": "2026-10-12T19:40:28Z", "pipeline_version": "2.0.0", "presentation_label": "KANJINTI 150 mg powder for 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": "1", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "9f4119e69f965285688c3402ad669f6dc3298fbbaf20f5909a83d03f0f927312", "source_snapshot_id": "source-4222dc61a5c401d9ea981d06", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/kanjinti-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 29}
{"after": {"end": 183, "start": 0, "text": "Pack size of one prefilled syringe, presented in blistered (prefilled syringe with or without a needle guard) or unblistered packaging (prefilled syringe without a needle guard only).", "truncated": false}, "after_length": 183, "after_sha256": "8831d2ef6106f870d1a26d9ab8a84d1e7519ffd206928b748735865986e3801e", "annex": "I", "before": {"end": 183, "start": 0, "text": "Pack size of one prefilled syringe, presented in blistered (prefilled syringe with or without a needle guard) or unblistered packaging (prefilled syringe without a needle guard only).", "truncated": false}, "before_length": 183, "before_sha256": "8831d2ef6106f870d1a26d9ab8a84d1e7519ffd206928b748735865986e3801e", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0246d39aeaf56e62471d4e81", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001120", "medicine_name": "Prolia", "medicine_slug": "prolia", "observed_at": "2026-10-12T13:28:42Z", "pipeline_version": "2.0.0", "presentation_label": "Prolia 60 mg solution for injection in prefilled syringe", "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": "5984d05d5bd9987a8e6f5cf86ff2e5032af0bc8bf5fe7a137a9f36a8466c5b97", "source_snapshot_id": "source-312c11aae5d59cae975290d1", "source_updated_at": "2026-08-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/prolia-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 594}
{"after": {"end": 178, "start": 0, "text": "25 mg should be considered if platelet counts exceed the required target. It is recommended to wait for 2 weeks to assess the effects of this and any subsequent dose adjustments.", "truncated": false}, "after_length": 178, "after_sha256": "34578ef7a93fa687e76e67a5b0a5b01765c0a366dd170e86d89a48ed125765ff", "annex": "I", "before": {"end": 178, "start": 0, "text": "25 mg should be considered if platelet counts exceed the required target. It is recommended to wait for 2 weeks to assess the effects of this and any subsequent dose adjustments.", "truncated": false}, "before_length": 178, "before_sha256": "34578ef7a93fa687e76e67a5b0a5b01765c0a366dd170e86d89a48ed125765ff", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-024b5e0255ef1c9d126679e8", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006459", "medicine_name": "Eltrombopag Accord", "medicine_slug": "eltrombopag-accord", "observed_at": "2026-10-12T19:38:22Z", "pipeline_version": "2.0.0", "presentation_label": "Eltrombopag Accord 12.5 mg film-coated tablets Eltrombopag Accord 25 mg film-coated tablets Eltrombopag Accord 50 mg film-coated tablets Eltrombopag Accord 75 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": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "0485f44a0e25bf9e0f930e8ce8c053598ed2a48f78476ffafefb66d9fb3e8d89", "source_snapshot_id": "source-d7e0f3276633f5a4a1cef1a4", "source_updated_at": "2025-05-20", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/eltrombopag-accord-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 146}
{"after": {"end": 615, "start": 0, "text": "Clinical efficacy of Emtricitabine/Tenofovir alafenamide in treatment-naïve patients was also established from a study conducted with emtricitabine and tenofovir alafenamide (10 mg) when given with darunavir (800 mg) and cobicistat as a fixed-dose combination tablet (D/C/F/TAF). In Study GSUS2990102, patients were randomised in a 2:1 ratio to receive either fixed-dose combination D/C/F/TAF once daily (n = 103) or darunavir and cobicistat and emtricitabine/tenofovir disoproxil fumarate once daily (n = 50). The proportions of patients with plasma HIV1 RNA < 50 copies/mL and < 20 copies/mL are shown in Table 5.", "truncated": false}, "after_length": 615, "after_sha256": "1ca3024b7c085f897944260f1239c27e9463410cbfbc2998b7f7bc2fda0ae630", "annex": "I", "before": {"end": 615, "start": 0, "text": "Clinical efficacy of Emtricitabine/Tenofovir alafenamide in treatment-naïve patients was also established from a study conducted with emtricitabine and tenofovir alafenamide (10 mg) when given with darunavir (800 mg) and cobicistat as a fixed-dose combination tablet (D/C/F/TAF). In Study GSUS2990102, patients were randomised in a 2:1 ratio to receive either fixed-dose combination D/C/F/TAF once daily (n = 103) or darunavir and cobicistat and emtricitabine/tenofovir disoproxil fumarate once daily (n = 50). The proportions of patients with plasma HIV1 RNA < 50 copies/mL and < 20 copies/mL are shown in Table 5.", "truncated": false}, "before_length": 615, "before_sha256": "1ca3024b7c085f897944260f1239c27e9463410cbfbc2998b7f7bc2fda0ae630", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0258a61fbc6f1343cf1690bb", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006469", "medicine_name": "Emtricitabine / Tenofovir alafenamide Viatris", "medicine_slug": "emtricitabine-tenofovir-alafenamide-viatris", "observed_at": "2026-10-12T13:40:14Z", "pipeline_version": "2.0.0", "presentation_label": "Emtricitabine/Tenofovir alafenamide Viatris 200 mg/10 mg filmcoated tablets Emtricitabine/Tenofovir alafenamide Viatris 200 mg/25 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": "247b89d7ca1efa91cffaeb0f00556dd381d81e804eb2f9c23631d01a49578ea7", "source_snapshot_id": "source-246d08888d5f52d006efa07f", "source_updated_at": "2026-04-16", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/emtricitabine-tenofovir-alafenamide-viatris-epar-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": 379, "start": 0, "text": "Des douleurs musculo-squelettiques, y compris des cas graves, ont été rapportées chez des patients traités par Prolia après la commercialisation. Dans les essais cliniques, les douleurs musculosquelettiques étaient très fréquentes dans le groupe denosumab et dans le groupe placebo. Les douleurs musculo-squelettiques ayant conduit à l’arrêt du traitement étaient peu fréquentes.", "truncated": false}, "after_length": 379, "after_sha256": "80a865eb36b97c97272148cc51ca4af9ed56502db51c4b69d5131e25e710df78", "annex": "I", "before": {"end": 379, "start": 0, "text": "Des douleurs musculo-squelettiques, y compris des cas graves, ont été rapportées chez des patients traités par Prolia après la commercialisation. Dans les essais cliniques, les douleurs musculosquelettiques étaient très fréquentes dans le groupe denosumab et dans le groupe placebo. Les douleurs musculo-squelettiques ayant conduit à l’arrêt du traitement étaient peu fréquentes.", "truncated": false}, "before_length": 379, "before_sha256": "80a865eb36b97c97272148cc51ca4af9ed56502db51c4b69d5131e25e710df78", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-026978a931d8e0407b259b17", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/001120", "medicine_name": "Prolia", "medicine_slug": "prolia", "observed_at": "2026-10-12T13:28:45Z", "pipeline_version": "2.0.0", "presentation_label": "Prolia 60 mg solution injectable en seringue préremplie", "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": "30e296cc06d303605f266e9544e10515b7e5c2063a0473f5aa3595a42d18a3e1", "source_snapshot_id": "source-2924aac36bd07813fcc1891d", "source_updated_at": "2026-08-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/prolia-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 300}
{"after": {"end": 71, "start": 0, "text": "Tableau 9. Résumé des analyses d’efficacité BCIRG 006 AC→D versus AC→DH", "truncated": false}, "after_length": 71, "after_sha256": "7cf307c4b6bc99436f9316bbb39d7be8ab5938327f6d4f5a6af9963345e8bed8", "annex": "I", "before": {"end": 71, "start": 0, "text": "Tableau 9. Résumé des analyses d’efficacité BCIRG 006 AC→D versus AC→DH", "truncated": false}, "before_length": 71, "before_sha256": "7cf307c4b6bc99436f9316bbb39d7be8ab5938327f6d4f5a6af9963345e8bed8", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-02716030a3ae04d0a1f823eb", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004361", "medicine_name": "Kanjinti", "medicine_slug": "kanjinti", "observed_at": "2026-10-12T19:40:38Z", "pipeline_version": "2.0.0", "presentation_label": "KANJINTI 150 mg poudre pour solution à diluer pour perfusion KANJINTI 420 mg poudre pour 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": "ea9ea0ca90af9dcbc236774255b0290bf3e784884d88a33522b45c8050f829cf", "source_snapshot_id": "source-a4621a49bcc40ac3f94d4939", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/kanjinti-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1311}
{"after": {"end": 261, "start": 0, "text": "Rivastigmine is rapidly and extensively metabolised (half-life in plasma approximately 1 hour), primarily via cholinesterase-mediated hydrolysis to the decarbamylated metabolite. In vitro, this metabolite shows minimal inhibition of acetylcholinesterase (<10%).", "truncated": false}, "after_length": 261, "after_sha256": "498674527485865a4c238e1f734916033852867bb516aa86d34d02fefce20f0c", "annex": "I", "before": {"end": 261, "start": 0, "text": "Rivastigmine is rapidly and extensively metabolised (half-life in plasma approximately 1 hour), primarily via cholinesterase-mediated hydrolysis to the decarbamylated metabolite. In vitro, this metabolite shows minimal inhibition of acetylcholinesterase (<10%).", "truncated": false}, "before_length": 261, "before_sha256": "498674527485865a4c238e1f734916033852867bb516aa86d34d02fefce20f0c", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0277341b34c2cdcd19591704", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001029", "medicine_name": "Nimvastid", "medicine_slug": "nimvastid", "observed_at": "2026-10-12T19:24:00Z", "pipeline_version": "2.0.0", "presentation_label": "Nimvastid 1.5 mg orodispersible tablets Nimvastid 3 mg orodispersible tablets Nimvastid 4.5 mg orodispersible tablets Nimvastid 6 mg orodispersible tablets", "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": "fa4c6e344db60bf4064eb3cc2d76d72c0fc858894147724d88ab2d66b9f9a0dc", "source_snapshot_id": "source-775bf49790604674d3549dac", "source_updated_at": "2025-07-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nimvastid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1641}
{"after": {"end": 67, "start": 0, "text": "Dyspnoea, oropharyngeal pain, dyspnoea exertional, productive cough", "truncated": false}, "after_length": 67, "after_sha256": "684402bea285029778d84b619f752a33c8be2cda11801658d852e647a6efd88e", "annex": "I", "before": {"end": 67, "start": 0, "text": "Dyspnoea, oropharyngeal pain, dyspnoea exertional, productive cough", "truncated": false}, "before_length": 67, "before_sha256": "684402bea285029778d84b619f752a33c8be2cda11801658d852e647a6efd88e", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0282cdc5a4fef6807cf5fddc", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006459", "medicine_name": "Eltrombopag Accord", "medicine_slug": "eltrombopag-accord", "observed_at": "2026-10-12T19:38:22Z", "pipeline_version": "2.0.0", "presentation_label": "Eltrombopag Accord 12.5 mg film-coated tablets Eltrombopag Accord 25 mg film-coated tablets Eltrombopag Accord 50 mg film-coated tablets Eltrombopag Accord 75 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": "0485f44a0e25bf9e0f930e8ce8c053598ed2a48f78476ffafefb66d9fb3e8d89", "source_snapshot_id": "source-d7e0f3276633f5a4a1cef1a4", "source_updated_at": "2025-05-20", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/eltrombopag-accord-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 597}
{"after": {"end": 96, "start": 0, "text": "Les patients traités par Prolia devront recevoir la notice et la carte d’information au patient.", "truncated": false}, "after_length": 96, "after_sha256": "97608ee3a4e7b659dda1a6ee437092906f1d3ec5d9c8f98b1dfc51f877f3c6b6", "annex": "I", "before": {"end": 96, "start": 0, "text": "Les patients traités par Prolia devront recevoir la notice et la carte d’information au patient.", "truncated": false}, "before_length": 96, "before_sha256": "97608ee3a4e7b659dda1a6ee437092906f1d3ec5d9c8f98b1dfc51f877f3c6b6", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-02a3724ddc04492adaf09365", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/001120", "medicine_name": "Prolia", "medicine_slug": "prolia", "observed_at": "2026-10-12T13:28:45Z", "pipeline_version": "2.0.0", "presentation_label": "Prolia 60 mg solution injectable en seringue préremplie", "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": "30e296cc06d303605f266e9544e10515b7e5c2063a0473f5aa3595a42d18a3e1", "source_snapshot_id": "source-2924aac36bd07813fcc1891d", "source_updated_at": "2026-08-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/prolia-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 67}
{"after": {"end": 50, "start": 0, "text": "- fréquence cardiaque ou pression sanguine élevée,", "truncated": false}, "after_length": 50, "after_sha256": "0bf735b96151cfd352fe043c571856b8b43e353aeff0c670a9b8d67021a71496", "annex": "I", "before": {"end": 50, "start": 0, "text": "- fréquence cardiaque ou pression sanguine élevée,", "truncated": false}, "before_length": 50, "before_sha256": "0bf735b96151cfd352fe043c571856b8b43e353aeff0c670a9b8d67021a71496", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-02a7ffb9195b4f91244ae29c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004104", "medicine_name": "Eptifibatide Accord", "medicine_slug": "eptifibatide-accord", "observed_at": "2026-10-12T19:45:11Z", "pipeline_version": "2.0.0", "presentation_label": "Eptifibatide Accord 2 mg/ml, 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "c9be002148fa73331c72aadac205f927e043f3407cf695e63a1cbe715480600b", "source_snapshot_id": "source-9e33d5d566c95289f1a7e6a6", "source_updated_at": "2025-05-02", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/eptifibatide-accord-epar-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": 151, "start": 0, "text": "A ce jour, aucune donnée d’études cliniques n’est disponible concernant le re-traitement des patients déjà traités par KANJINTI en situation adjuvante.", "truncated": false}, "after_length": 151, "after_sha256": "6cb530bc093fac03ecdeced0d8c7834f531ecf2986a22c96b526b1bf5f128475", "annex": "I", "before": {"end": 151, "start": 0, "text": "A ce jour, aucune donnée d’études cliniques n’est disponible concernant le re-traitement des patients déjà traités par KANJINTI en situation adjuvante.", "truncated": false}, "before_length": 151, "before_sha256": "6cb530bc093fac03ecdeced0d8c7834f531ecf2986a22c96b526b1bf5f128475", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-02aa1cfa59d7d3d1a58f3461", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004361", "medicine_name": "Kanjinti", "medicine_slug": "kanjinti", "observed_at": "2026-10-12T19:40:38Z", "pipeline_version": "2.0.0", "presentation_label": "KANJINTI 150 mg poudre pour solution à diluer pour perfusion KANJINTI 420 mg poudre pour 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": "ea9ea0ca90af9dcbc236774255b0290bf3e784884d88a33522b45c8050f829cf", "source_snapshot_id": "source-a4621a49bcc40ac3f94d4939", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/kanjinti-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 172}
{"after": {"end": 357, "start": 0, "text": "En cas de surdosage, le patient devra être surveillé afin d’identifier d’éventuelles manifestations de toxicité (voir rubrique 4.8). Le traitement du surdosage d’Emtricitabine/Ténofovir alafénamide Viatris repose sur une prise en charge générale symptomatique incluant la surveillance des signes vitaux ainsi que l’observation de l’état clinique du patient.", "truncated": false}, "after_length": 357, "after_sha256": "99dd0325bc5814038bc226111d80716d24dbe968004dd19fc7807e4f61474c3d", "annex": "I", "before": {"end": 357, "start": 0, "text": "En cas de surdosage, le patient devra être surveillé afin d’identifier d’éventuelles manifestations de toxicité (voir rubrique 4.8). Le traitement du surdosage d’Emtricitabine/Ténofovir alafénamide Viatris repose sur une prise en charge générale symptomatique incluant la surveillance des signes vitaux ainsi que l’observation de l’état clinique du patient.", "truncated": false}, "before_length": 357, "before_sha256": "99dd0325bc5814038bc226111d80716d24dbe968004dd19fc7807e4f61474c3d", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-02afc3377eda7cd1f779e0c4", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006469", "medicine_name": "Emtricitabine / Tenofovir alafenamide Viatris", "medicine_slug": "emtricitabine-tenofovir-alafenamide-viatris", "observed_at": "2026-10-12T13:40:17Z", "pipeline_version": "2.0.0", "presentation_label": "Emtricitabine/Ténofovir alafénamide Viatris 200 mg/10 mg, comprimés pelliculés Emtricitabine/Ténofovir alafénamide Viatris 200 mg/25 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": "f756470c4d010c80a3cc0e1d2d813c1c039c3ca68b113594de79e065fdc70412", "source_snapshot_id": "source-e58329b521b2e223a700355b", "source_updated_at": "2026-04-16", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/emtricitabine-tenofovir-alafenamide-viatris-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 650}
{"after": {"end": 268, "start": 0, "text": "Aucun effet du maraviroc, de la névirapine ou du raltégravir sur l’exposition au ténofovir alafénamide n’est attendu, et aucun effet du ténofovir alafénamide n’est attendu sur les voies de métabolisation et d’excrétion du maraviroc, de la névirapine ou du raltégravir.", "truncated": false}, "after_length": 268, "after_sha256": "cb066cce028d625f492b3e23596a75c737637d4de9ddc2152376c19732fa58f9", "annex": "I", "before": {"end": 268, "start": 0, "text": "Aucun effet du maraviroc, de la névirapine ou du raltégravir sur l’exposition au ténofovir alafénamide n’est attendu, et aucun effet du ténofovir alafénamide n’est attendu sur les voies de métabolisation et d’excrétion du maraviroc, de la névirapine ou du raltégravir.", "truncated": false}, "before_length": 268, "before_sha256": "cb066cce028d625f492b3e23596a75c737637d4de9ddc2152376c19732fa58f9", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-02bc4ea29d10bd3b70dc45e5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006469", "medicine_name": "Emtricitabine / Tenofovir alafenamide Viatris", "medicine_slug": "emtricitabine-tenofovir-alafenamide-viatris", "observed_at": "2026-10-12T13:40:17Z", "pipeline_version": "2.0.0", "presentation_label": "Emtricitabine/Ténofovir alafénamide Viatris 200 mg/10 mg, comprimés pelliculés Emtricitabine/Ténofovir alafénamide Viatris 200 mg/25 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": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "f756470c4d010c80a3cc0e1d2d813c1c039c3ca68b113594de79e065fdc70412", "source_snapshot_id": "source-e58329b521b2e223a700355b", "source_updated_at": "2026-04-16", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/emtricitabine-tenofovir-alafenamide-viatris-epar-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": 40, "start": 0, "text": "Chirurgie en urgence ou urgence différée", "truncated": false}, "after_length": 40, "after_sha256": "11eb212da9c594a0fc71463f207751467bc47cde951cb083e5c427dceec4622d", "annex": "I", "before": {"end": 40, "start": 0, "text": "Chirurgie en urgence ou urgence différée", "truncated": false}, "before_length": 40, "before_sha256": "11eb212da9c594a0fc71463f207751467bc47cde951cb083e5c427dceec4622d", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-02bd7c8e13ad15179ba6d5e4", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004104", "medicine_name": "Eptifibatide Accord", "medicine_slug": "eptifibatide-accord", "observed_at": "2026-10-12T19:45:11Z", "pipeline_version": "2.0.0", "presentation_label": "Eptifibatide Accord 0,75 mg/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": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "c9be002148fa73331c72aadac205f927e043f3407cf695e63a1cbe715480600b", "source_snapshot_id": "source-9e33d5d566c95289f1a7e6a6", "source_updated_at": "2025-05-02", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/eptifibatide-accord-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 87}
{"after": {"end": 578, "start": 0, "text": "En cas de survenue d'effets indésirables (par exemple nausées, vomissements, douleurs abdominales, perte d’appétit), d’une perte de poids ou d’une aggravation des symptômes extrapyramidaux (par exemple tremblements) chez les patients atteints d’une démence associée à la maladie de Parkinson au cours du traitement, ceux-ci peuvent régresser si l’on supprime une ou plusieurs prises. En cas de persistance de ces effets indésirables, la posologie quotidienne devrait revenir temporairement à la posologie quotidienne antérieure bien tolérée ou, le traitement pourra être arrêté.", "truncated": false}, "after_length": 578, "after_sha256": "b6487695ffb59bfd937e90523e05189b35dd309b6620c1fc40d522e02f32954a", "annex": "I", "before": {"end": 578, "start": 0, "text": "En cas de survenue d'effets indésirables (par exemple nausées, vomissements, douleurs abdominales, perte d’appétit), d’une perte de poids ou d’une aggravation des symptômes extrapyramidaux (par exemple tremblements) chez les patients atteints d’une démence associée à la maladie de Parkinson au cours du traitement, ceux-ci peuvent régresser si l’on supprime une ou plusieurs prises. En cas de persistance de ces effets indésirables, la posologie quotidienne devrait revenir temporairement à la posologie quotidienne antérieure bien tolérée ou, le traitement pourra être arrêté.", "truncated": false}, "before_length": 578, "before_sha256": "b6487695ffb59bfd937e90523e05189b35dd309b6620c1fc40d522e02f32954a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-02befcdca726a89057133e74", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/001029", "medicine_name": "Nimvastid", "medicine_slug": "nimvastid", "observed_at": "2026-10-12T19:24:04Z", "pipeline_version": "2.0.0", "presentation_label": "Nimvastid 1,5 mg gélule Nimvastid 3 mg gélule Nimvastid 4,5 mg gélule Nimvastid 6 mg gélule", "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": "8e6eaa143ff5f69cfa4caba1806dbd754ee713f2f64ce6a1b369433c9e511b46", "source_snapshot_id": "source-655cd60c5475e58b35c5a1c3", "source_updated_at": "2025-07-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nimvastid-epar-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": 40, "start": 0, "text": "Reduction in parenteral nutrition volume", "truncated": false}, "after_length": 40, "after_sha256": "82b00d87bdcc35bf84a5d696fc8a40b327c2c496ef4a1aff9c18ef61be8e5dc1", "annex": "I", "before": {"end": 40, "start": 0, "text": "Reduction in parenteral nutrition volume", "truncated": false}, "before_length": 40, "before_sha256": "82b00d87bdcc35bf84a5d696fc8a40b327c2c496ef4a1aff9c18ef61be8e5dc1", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-02ce35f1b08d404579c98f22", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002345", "medicine_name": "Revestive", "medicine_slug": "revestive", "observed_at": "2026-10-12T19:38:01Z", "pipeline_version": "2.0.0", "presentation_label": "Revestive 5 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "0125d033ce2f8805dc45ece9b8ffa34db6682b195448a3a560e6d2483a8982b4", "source_snapshot_id": "source-8d7c3200418c650a002546aa", "source_updated_at": "2025-05-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/revestive-epar-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": 252, "start": 0, "text": "Revestive has minor influence on the ability to drive, ride a bicycle, and use machines. However, cases of syncope have been reported in clinical studies (see section 4.8). Such events might impact the ability to drive, ride a bicycle, or use machines.", "truncated": false}, "after_length": 252, "after_sha256": "9502fe268c1f525853e4b32cf95db6f74828069dd75ecb33f575f9aa23621665", "annex": "I", "before": {"end": 252, "start": 0, "text": "Revestive has minor influence on the ability to drive, ride a bicycle, and use machines. However, cases of syncope have been reported in clinical studies (see section 4.8). Such events might impact the ability to drive, ride a bicycle, or use machines.", "truncated": false}, "before_length": 252, "before_sha256": "9502fe268c1f525853e4b32cf95db6f74828069dd75ecb33f575f9aa23621665", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-02da71e35f49627148e28301", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002345", "medicine_name": "Revestive", "medicine_slug": "revestive", "observed_at": "2026-10-12T19:38:01Z", "pipeline_version": "2.0.0", "presentation_label": "Revestive 1.25 mg powder and solvent 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": "4.7", "section_type": "driving", "source_provider": "European Medicines Agency", "source_sha256": "0125d033ce2f8805dc45ece9b8ffa34db6682b195448a3a560e6d2483a8982b4", "source_snapshot_id": "source-8d7c3200418c650a002546aa", "source_updated_at": "2025-05-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/revestive-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 226}
{"after": {"end": 61, "start": 0, "text": "Eltrombopag Accord n'est pas recommandé pendant la grossesse.", "truncated": false}, "after_length": 61, "after_sha256": "b9ce6cb6ad031eb5c98350c18d8191d4216aad6c3a087f21b3da64d2efd18958", "annex": "I", "before": {"end": 61, "start": 0, "text": "Eltrombopag Accord n'est pas recommandé pendant la grossesse.", "truncated": false}, "before_length": 61, "before_sha256": "b9ce6cb6ad031eb5c98350c18d8191d4216aad6c3a087f21b3da64d2efd18958", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-02dc5195e388635236de88b9", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006459", "medicine_name": "Eltrombopag Accord", "medicine_slug": "eltrombopag-accord", "observed_at": "2026-10-12T19:38:33Z", "pipeline_version": "2.0.0", "presentation_label": "Eltrombopag Accord 12,5 mg, comprimés pelliculés Eltrombopag Accord 25 mg, comprimés pelliculés Eltrombopag Accord 50 mg, comprimés pelliculés Eltrombopag Accord 75 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": "4.6", "section_type": "pregnancy", "source_provider": "European Medicines Agency", "source_sha256": "4dba9ba2d13e28b9b00b5cee0ebfe8b72ef357d185dbbf0def82cb05d9f63530", "source_snapshot_id": "source-acb656ad31eb3184c264b4cd", "source_updated_at": "2025-05-20", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/eltrombopag-accord-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 364}
{"after": {"end": 44, "start": 0, "text": "Median duration of response (months) (range)", "truncated": false}, "after_length": 44, "after_sha256": "7c7af649d876796b54210654d8603bf23acba9383168fea7a325dd0559b57c9c", "annex": "I", "before": {"end": 44, "start": 0, "text": "Median duration of response (months) (range)", "truncated": false}, "before_length": 44, "before_sha256": "7c7af649d876796b54210654d8603bf23acba9383168fea7a325dd0559b57c9c", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-02ed68f7061726f1feb2ddd3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004361", "medicine_name": "Kanjinti", "medicine_slug": "kanjinti", "observed_at": "2026-10-12T19:40:28Z", "pipeline_version": "2.0.0", "presentation_label": "KANJINTI 150 mg powder for concentrate for solution for infusion KANJINTI 420 mg powder for 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "9f4119e69f965285688c3402ad669f6dc3298fbbaf20f5909a83d03f0f927312", "source_snapshot_id": "source-4222dc61a5c401d9ea981d06", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/kanjinti-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 982}
{"after": {"end": 405, "start": 0, "text": "Emtricitabine is primarily excreted by the kidneys with complete recovery of the dose achieved in urine (approximately 86%) and faeces (approximately 14%). Thirteen percent of the emtricitabine dose was recovered in urine as three metabolites. The systemic clearance of emtricitabine averaged 307 mL/min. Following oral administration, the elimination half-life of emtricitabine is approximately 10 hours.", "truncated": false}, "after_length": 405, "after_sha256": "c46a6803dcda3bb32cbc5e15bc2644e7bfde71be860ecec3e1c39b507215c7db", "annex": "I", "before": {"end": 405, "start": 0, "text": "Emtricitabine is primarily excreted by the kidneys with complete recovery of the dose achieved in urine (approximately 86%) and faeces (approximately 14%). Thirteen percent of the emtricitabine dose was recovered in urine as three metabolites. The systemic clearance of emtricitabine averaged 307 mL/min. Following oral administration, the elimination half-life of emtricitabine is approximately 10 hours.", "truncated": false}, "before_length": 405, "before_sha256": "c46a6803dcda3bb32cbc5e15bc2644e7bfde71be860ecec3e1c39b507215c7db", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0309660f19dbab42a8da8683", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006469", "medicine_name": "Emtricitabine / Tenofovir alafenamide Viatris", "medicine_slug": "emtricitabine-tenofovir-alafenamide-viatris", "observed_at": "2026-10-12T13:40:14Z", "pipeline_version": "2.0.0", "presentation_label": "Emtricitabine/Tenofovir alafenamide Viatris 200 mg/10 mg filmcoated tablets Emtricitabine/Tenofovir alafenamide Viatris 200 mg/25 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": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "247b89d7ca1efa91cffaeb0f00556dd381d81e804eb2f9c23631d01a49578ea7", "source_snapshot_id": "source-246d08888d5f52d006efa07f", "source_updated_at": "2026-04-16", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/emtricitabine-tenofovir-alafenamide-viatris-epar-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": 142, "start": 0, "text": "Table 2 shows the adverse reactions reported in patients with dementia associated with Parkinson’s disease treated with rivastigmine capsules.", "truncated": false}, "after_length": 142, "after_sha256": "5146feee39c5ddd8dcfed1dd7b947d59f70dec4427dfd764d976f55e9ea0e4c2", "annex": "I", "before": {"end": 142, "start": 0, "text": "Table 2 shows the adverse reactions reported in patients with dementia associated with Parkinson’s disease treated with rivastigmine capsules.", "truncated": false}, "before_length": 142, "before_sha256": "5146feee39c5ddd8dcfed1dd7b947d59f70dec4427dfd764d976f55e9ea0e4c2", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0309a65096e29179e2039f4c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001029", "medicine_name": "Nimvastid", "medicine_slug": "nimvastid", "observed_at": "2026-10-12T19:24:00Z", "pipeline_version": "2.0.0", "presentation_label": "Nimvastid 1.5 mg hard capsules Nimvastid 3 mg hard capsules Nimvastid 4.5 mg hard capsules Nimvastid 6 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": "fa4c6e344db60bf4064eb3cc2d76d72c0fc858894147724d88ab2d66b9f9a0dc", "source_snapshot_id": "source-775bf49790604674d3549dac", "source_updated_at": "2025-07-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nimvastid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 314}
{"after": {"end": 147, "start": 0, "text": "Tableau 7 : pharmacocinétique de l’emtricitabine et du ténofovir alafénamide chez les adolescents et les adultes naïfs de traitement antirétroviral", "truncated": false}, "after_length": 147, "after_sha256": "b32cead3bc5579de750c5a1934a6a9ebce6500b98097283dc1e2a0520a882437", "annex": "I", "before": {"end": 147, "start": 0, "text": "Tableau 7 : pharmacocinétique de l’emtricitabine et du ténofovir alafénamide chez les adolescents et les adultes naïfs de traitement antirétroviral", "truncated": false}, "before_length": 147, "before_sha256": "b32cead3bc5579de750c5a1934a6a9ebce6500b98097283dc1e2a0520a882437", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-030cabc87809a5a7cf179d15", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006469", "medicine_name": "Emtricitabine / Tenofovir alafenamide Viatris", "medicine_slug": "emtricitabine-tenofovir-alafenamide-viatris", "observed_at": "2026-10-12T13:40:17Z", "pipeline_version": "2.0.0", "presentation_label": "Emtricitabine/Ténofovir alafénamide Viatris 200 mg/10 mg, comprimés pelliculés Emtricitabine/Ténofovir alafénamide Viatris 200 mg/25 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": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "f756470c4d010c80a3cc0e1d2d813c1c039c3ca68b113594de79e065fdc70412", "source_snapshot_id": "source-e58329b521b2e223a700355b", "source_updated_at": "2026-04-16", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/emtricitabine-tenofovir-alafenamide-viatris-epar-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": 105, "start": 0, "text": "Cohorte B - 4 cycles de FEC suivis par 4 cycles de Perjeta en association au trastuzumab et au docétaxel.", "truncated": false}, "after_length": 105, "after_sha256": "b9703f3d58b0671da70637bcba3a4cac6ca57111b272d1354378d690170ff88c", "annex": "I", "before": {"end": 105, "start": 0, "text": "Cohorte B - 4 cycles de FEC suivis par 4 cycles de Perjeta en association au trastuzumab et au docétaxel.", "truncated": false}, "before_length": 105, "before_sha256": "b9703f3d58b0671da70637bcba3a4cac6ca57111b272d1354378d690170ff88c", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-030d312e3fb8113a333b3cbb", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002547", "medicine_name": "Perjeta", "medicine_slug": "perjeta", "observed_at": "2026-10-12T13:39:17Z", "pipeline_version": "2.0.0", "presentation_label": "Perjeta 420 mg 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": "dfc85998efa134fbc08630f7e0f1d1183bd4fb18ec62a15b680bda3fd94b49bd", "source_snapshot_id": "source-791eb96e62fdebcce4c81ec4", "source_updated_at": "2026-04-28", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/perjeta-epar-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": 521, "start": 0, "text": "L’administration d’eltrombopag sous forme de comprimé ou de poudre pour suspension buvable avec un repas riche en calcium (par exemple un repas comprenant des produits laitiers) a réduit de manière significative l'ASC0- et la Cmax plasmatiques d’eltrombopag. En revanche, l’administration d’eltrombopag 2 heures avant ou 4 heures après un repas riche en calcium ou pauvre en calcium [< 50 mg de calcium] n’a pas altéré, de manière cliniquement significative, l’exposition plasmatique en eltrombopag (voir rubriques 4.2).", "truncated": false}, "after_length": 521, "after_sha256": "a118237d5c459a389a787ba860ef0dd93f75d1e88a91c9729c109a8a9f5b87a3", "annex": "I", "before": {"end": 521, "start": 0, "text": "L’administration d’eltrombopag sous forme de comprimé ou de poudre pour suspension buvable avec un repas riche en calcium (par exemple un repas comprenant des produits laitiers) a réduit de manière significative l'ASC0- et la Cmax plasmatiques d’eltrombopag. En revanche, l’administration d’eltrombopag 2 heures avant ou 4 heures après un repas riche en calcium ou pauvre en calcium [< 50 mg de calcium] n’a pas altéré, de manière cliniquement significative, l’exposition plasmatique en eltrombopag (voir rubriques 4.2).", "truncated": false}, "before_length": 521, "before_sha256": "a118237d5c459a389a787ba860ef0dd93f75d1e88a91c9729c109a8a9f5b87a3", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-030fd5079486ef631bf3eba6", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006459", "medicine_name": "Eltrombopag Accord", "medicine_slug": "eltrombopag-accord", "observed_at": "2026-10-12T19:38:33Z", "pipeline_version": "2.0.0", "presentation_label": "Eltrombopag Accord 12,5 mg, comprimés pelliculés Eltrombopag Accord 25 mg, comprimés pelliculés Eltrombopag Accord 50 mg, comprimés pelliculés Eltrombopag Accord 75 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": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "4dba9ba2d13e28b9b00b5cee0ebfe8b72ef357d185dbbf0def82cb05d9f63530", "source_snapshot_id": "source-acb656ad31eb3184c264b4cd", "source_updated_at": "2025-05-20", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/eltrombopag-accord-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 350}
{"after": {"end": 284, "start": 0, "text": "A tablet form of mercaptopurine is also available. The mercaptopurine oral suspension and tablet are not bioequivalent with respect to peak plasma concentration, and therefore intensified haematological monitoring of the patient is advised on switching formulations (see section 5.2).", "truncated": false}, "after_length": 284, "after_sha256": "77bfac071ffee2919cff4cc8b7f340a5ffaa2c66ef6d8dafa7b88e2ebecd42e7", "annex": "I", "before": {"end": 284, "start": 0, "text": "A tablet form of mercaptopurine is also available. The mercaptopurine oral suspension and tablet are not bioequivalent with respect to peak plasma concentration, and therefore intensified haematological monitoring of the patient is advised on switching formulations (see section 5.2).", "truncated": false}, "before_length": 284, "before_sha256": "77bfac071ffee2919cff4cc8b7f340a5ffaa2c66ef6d8dafa7b88e2ebecd42e7", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03199639823b58f1c1c75682", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002022", "medicine_name": "Xaluprine (previously Mercaptopurine Nova Laboratories)", "medicine_slug": "xaluprine-previously-mercaptopurine-nova-laboratories", "observed_at": "2026-10-12T19:08:02Z", "pipeline_version": "2.0.0", "presentation_label": "Xaluprine 20 mg/ml oral suspension", "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": "a352706294cb9013c5ba158da50186f12673cdb6fb887d0033e1457d44698091", "source_snapshot_id": "source-80b0d9db881bf774bffb5d3c", "source_updated_at": "2025-09-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/xaluprine-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 345}
{"after": {"end": 267, "start": 0, "text": "Les paramètres sanguins en cas d’insuffisance rénale et hépatique doivent être étroitement surveillés et le traitement par hydroxycarbamide doit être interrompu si nécessaire. Le cas échéant, le traitement par hydroxycarbamide doit être repris à une dose plus faible.", "truncated": false}, "after_length": 267, "after_sha256": "f4b772b87adbe1f2343696a194c2c560601d530634226ca5aec27f0642dbadb2", "annex": "I", "before": {"end": 267, "start": 0, "text": "Les paramètres sanguins en cas d’insuffisance rénale et hépatique doivent être étroitement surveillés et le traitement par hydroxycarbamide doit être interrompu si nécessaire. Le cas échéant, le traitement par hydroxycarbamide doit être repris à une dose plus faible.", "truncated": false}, "before_length": 267, "before_sha256": "f4b772b87adbe1f2343696a194c2c560601d530634226ca5aec27f0642dbadb2", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-031d610a91cf445072f09c6c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004837", "medicine_name": "Xromi", "medicine_slug": "xromi", "observed_at": "2026-10-12T19:32:45Z", "pipeline_version": "2.0.0", "presentation_label": "Xromi 100 mg/mL solution buvable", "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": "09fc95ca63cda4685a64f9a6f2786bf839a7e56efe05863cd60781314e5f87b5", "source_snapshot_id": "source-6048aed0c6a5fd892436dd1f", "source_updated_at": "2025-06-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xromi-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 127}
{"after": {"end": 307, "start": 0, "text": "En cas de surdosage massif, l’atropine peut être utilisée. Il est recommandé d’administrer initialement 0,03 mg/kg de sulfate d’atropine par voie intraveineuse, puis d’ajuster les doses ultérieures en fonction de la réponse clinique. L’administration de scopolamine à titre d’antidote n’est pas recommandée.", "truncated": false}, "after_length": 307, "after_sha256": "031056e6f253a742a9a9d3c8dc41b12f70472d442389da65767587e8abdca5e1", "annex": "I", "before": {"end": 307, "start": 0, "text": "En cas de surdosage massif, l’atropine peut être utilisée. Il est recommandé d’administrer initialement 0,03 mg/kg de sulfate d’atropine par voie intraveineuse, puis d’ajuster les doses ultérieures en fonction de la réponse clinique. L’administration de scopolamine à titre d’antidote n’est pas recommandée.", "truncated": false}, "before_length": 307, "before_sha256": "031056e6f253a742a9a9d3c8dc41b12f70472d442389da65767587e8abdca5e1", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-033916f1ac2a0aa12a8cd8d6", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/001029", "medicine_name": "Nimvastid", "medicine_slug": "nimvastid", "observed_at": "2026-10-12T19:24:04Z", "pipeline_version": "2.0.0", "presentation_label": "Nimvastid 1,5 mg gélule Nimvastid 3 mg gélule Nimvastid 4,5 mg gélule Nimvastid 6 mg gélule", "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": "8e6eaa143ff5f69cfa4caba1806dbd754ee713f2f64ce6a1b369433c9e511b46", "source_snapshot_id": "source-655cd60c5475e58b35c5a1c3", "source_updated_at": "2025-07-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nimvastid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 480}
{"after": {"end": 662, "start": 0, "text": "The pharmacokinetics of eltrombopag have been evaluated in 168 paediatric ITP patients dosed once daily in two studies, TRA108062/PETIT and TRA115450/PETIT-2. Plasma eltrombopag apparent clearance following oral administration (CL/F) increased with increasing body weight. The effects of race and sex on plasma eltrombopag CL/F estimates were consistent between paediatric and adult patients. East-/Southeast-Asian paediatric ITP patients had approximately 43% higher plasma eltrombopag AUC(0-τ) values as compared to non-Asian patients. Female paediatric ITP patients had approximately 25% higher plasma eltrombopag AUC(0-τ) values as compared to male patients.", "truncated": false}, "after_length": 662, "after_sha256": "5df59c766709cefd71f9303e7364d7ac31c097cbcbb4395cc5776f87387942aa", "annex": "I", "before": {"end": 662, "start": 0, "text": "The pharmacokinetics of eltrombopag have been evaluated in 168 paediatric ITP patients dosed once daily in two studies, TRA108062/PETIT and TRA115450/PETIT-2. Plasma eltrombopag apparent clearance following oral administration (CL/F) increased with increasing body weight. The effects of race and sex on plasma eltrombopag CL/F estimates were consistent between paediatric and adult patients. East-/Southeast-Asian paediatric ITP patients had approximately 43% higher plasma eltrombopag AUC(0-τ) values as compared to non-Asian patients. Female paediatric ITP patients had approximately 25% higher plasma eltrombopag AUC(0-τ) values as compared to male patients.", "truncated": false}, "before_length": 662, "before_sha256": "5df59c766709cefd71f9303e7364d7ac31c097cbcbb4395cc5776f87387942aa", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-033fd51eb13dc0ccebf69e33", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006459", "medicine_name": "Eltrombopag Accord", "medicine_slug": "eltrombopag-accord", "observed_at": "2026-10-12T19:38:22Z", "pipeline_version": "2.0.0", "presentation_label": "Eltrombopag Accord 12.5 mg film-coated tablets Eltrombopag Accord 25 mg film-coated tablets Eltrombopag Accord 50 mg film-coated tablets Eltrombopag Accord 75 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": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "0485f44a0e25bf9e0f930e8ce8c053598ed2a48f78476ffafefb66d9fb3e8d89", "source_snapshot_id": "source-d7e0f3276633f5a4a1cef1a4", "source_updated_at": "2025-05-20", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/eltrombopag-accord-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1271}
{"after": {"end": 117, "start": 0, "text": "Ce médicament contient moins de 1 mmol (23 mg) de sodium par dose, c.-à-d. qu’il est essentiellement « sans sodium ».", "truncated": false}, "after_length": 117, "after_sha256": "5391ba7b9fd39e1a6681401c1c2add5013ae066553dd13c0a9a43f242be0e464", "annex": "I", "before": {"end": 117, "start": 0, "text": "Ce médicament contient moins de 1 mmol (23 mg) de sodium par dose, c.-à-d. qu’il est essentiellement « sans sodium ».", "truncated": false}, "before_length": 117, "before_sha256": "5391ba7b9fd39e1a6681401c1c2add5013ae066553dd13c0a9a43f242be0e464", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0347b1f85d3c6d1c8ad9bbad", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004361", "medicine_name": "Kanjinti", "medicine_slug": "kanjinti", "observed_at": "2026-10-12T19:40:38Z", "pipeline_version": "2.0.0", "presentation_label": "KANJINTI 150 mg poudre pour solution à diluer pour perfusion KANJINTI 420 mg poudre pour 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": "ea9ea0ca90af9dcbc236774255b0290bf3e784884d88a33522b45c8050f829cf", "source_snapshot_id": "source-a4621a49bcc40ac3f94d4939", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/kanjinti-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 238}
{"after": {"end": 574, "start": 0, "text": "À la semaine 12, il a été observé une variation moyenne de 35,11 % (± 53,04) par rapport à la valeur initiale de l’apport calorique de la nutrition parentérale dans la population ITT, sur la base des données de prescription du médecin. La variation correspondante dans la cohorte recevant le traitement conventionnel était de 4,31 % (± 5,36). À la semaine 16, l’apport calorique dans la nutrition parentérale a continué à diminuer, avec des variations moyennes en pourcentage de 39,15 % (± 39,08) versus -0,87 % (± 9,25) dans la cohorte recevant le traitement conventionnel.", "truncated": false}, "after_length": 574, "after_sha256": "12e6d2c0f88d5e732851c613a07ed1fe8dc2c4f444bf6b1a65e993e045475c6a", "annex": "I", "before": {"end": 574, "start": 0, "text": "À la semaine 12, il a été observé une variation moyenne de 35,11 % (± 53,04) par rapport à la valeur initiale de l’apport calorique de la nutrition parentérale dans la population ITT, sur la base des données de prescription du médecin. La variation correspondante dans la cohorte recevant le traitement conventionnel était de 4,31 % (± 5,36). À la semaine 16, l’apport calorique dans la nutrition parentérale a continué à diminuer, avec des variations moyennes en pourcentage de 39,15 % (± 39,08) versus -0,87 % (± 9,25) dans la cohorte recevant le traitement conventionnel.", "truncated": false}, "before_length": 574, "before_sha256": "12e6d2c0f88d5e732851c613a07ed1fe8dc2c4f444bf6b1a65e993e045475c6a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-036701694f415f89af520947", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002345", "medicine_name": "Revestive", "medicine_slug": "revestive", "observed_at": "2026-10-12T19:38:11Z", "pipeline_version": "2.0.0", "presentation_label": "Revestive 1,25 mg poudre et solvant 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a977434b47f1efb8356de57d0e4e212d0d42a4215af7d29769e6a19a6e5b7354", "source_snapshot_id": "source-34689da4d07d48b1dbd0d784", "source_updated_at": "2025-05-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/revestive-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 422}
{"after": {"end": 141, "start": 0, "text": "According to epidemiological findings, a higher incidence of cardiovascular events has been associated with certain indicators, for instance:", "truncated": false}, "after_length": 141, "after_sha256": "51ccb30d587e0f3f988f37eb75e12e3f167f8eb47d1bd4acb5712c3b19e66f7c", "annex": "I", "before": {"end": 141, "start": 0, "text": "According to epidemiological findings, a higher incidence of cardiovascular events has been associated with certain indicators, for instance:", "truncated": false}, "before_length": 141, "before_sha256": "51ccb30d587e0f3f988f37eb75e12e3f167f8eb47d1bd4acb5712c3b19e66f7c", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-036913694f9817ea3397c4ef", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004104", "medicine_name": "Eptifibatide Accord", "medicine_slug": "eptifibatide-accord", "observed_at": "2026-10-12T19:45:01Z", "pipeline_version": "2.0.0", "presentation_label": "Eptifibatide Accord 2 mg/ml 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a45982959a207e1611cd67a6103370f86a234e3c45dfb3ab49b532886fe928cb", "source_snapshot_id": "source-8dd88a3db45e564c959f66e5", "source_updated_at": "2025-05-02", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/eptifibatide-accord-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 737}
{"after": {"end": 103, "start": 0, "text": "The total body clearance of hydroxycarbamide in adult patients with Sickle Cell Disease is 0.17 L/h/kg.", "truncated": false}, "after_length": 103, "after_sha256": "5b399e9e615cb2de7bd396a96717ef4d6b4553c3eaa1036301130a610ed985b0", "annex": "I", "before": {"end": 103, "start": 0, "text": "The total body clearance of hydroxycarbamide in adult patients with Sickle Cell Disease is 0.17 L/h/kg.", "truncated": false}, "before_length": 103, "before_sha256": "5b399e9e615cb2de7bd396a96717ef4d6b4553c3eaa1036301130a610ed985b0", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-037b826b6620db79acc6d2f3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004837", "medicine_name": "Xromi", "medicine_slug": "xromi", "observed_at": "2026-10-12T19:31:37Z", "pipeline_version": "2.0.0", "presentation_label": "Xromi 100 mg/ml oral solution", "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": "5e9826d3dd1edc48d9eb87b57c4ee7e70574bc6ce1c841b5477a3de3b9950a1e", "source_snapshot_id": "source-d10ea7497b831a802d8ae623", "source_updated_at": "2025-06-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/xromi-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 486}
{"after": {"end": 64, "start": 0, "text": "Store in the original package in order to protect from moisture.", "truncated": false}, "after_length": 64, "after_sha256": "8c33a5956b22e3095644323d16cea2b11c831c38fb55d764a65369b97c80e87d", "annex": "I", "before": {"end": 64, "start": 0, "text": "Store in the original package in order to protect from moisture.", "truncated": false}, "before_length": 64, "before_sha256": "8c33a5956b22e3095644323d16cea2b11c831c38fb55d764a65369b97c80e87d", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-037d88882762dd989a61cc59", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002618", "medicine_name": "Nexium Control", "medicine_slug": "nexium-control", "observed_at": "2026-10-12T13:36:16Z", "pipeline_version": "2.0.0", "presentation_label": "Nexium Control 20 mg gastroresistant hard capsules", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.4", "section_type": "storage", "source_provider": "European Medicines Agency", "source_sha256": "266d567343c3811aa2034b1a0d89c81f2a39f87634c27e040eddf35f3f1f5cac", "source_snapshot_id": "source-dfdf6861216bffe1c095176b", "source_updated_at": "2026-06-03", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nexium-control-epar-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": 44, "start": 0, "text": "Eligible pour une analyse de l’efficacité, n", "truncated": false}, "after_length": 44, "after_sha256": "09c9124cb15449dc179acc5423da749fdd2b240558f4eb0addbcadbb92b551ed", "annex": "I", "before": {"end": 44, "start": 0, "text": "Eligible pour une analyse de l’efficacité, n", "truncated": false}, "before_length": 44, "before_sha256": "09c9124cb15449dc179acc5423da749fdd2b240558f4eb0addbcadbb92b551ed", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-037e2d69cb34e376621f169b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006459", "medicine_name": "Eltrombopag Accord", "medicine_slug": "eltrombopag-accord", "observed_at": "2026-10-12T19:38:33Z", "pipeline_version": "2.0.0", "presentation_label": "Eltrombopag Accord 12,5 mg, comprimés pelliculés Eltrombopag Accord 25 mg, comprimés pelliculés Eltrombopag Accord 50 mg, comprimés pelliculés Eltrombopag Accord 75 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "4dba9ba2d13e28b9b00b5cee0ebfe8b72ef357d185dbbf0def82cb05d9f63530", "source_snapshot_id": "source-acb656ad31eb3184c264b4cd", "source_updated_at": "2025-05-20", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/eltrombopag-accord-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 862}
{"after": {"end": 77, "start": 0, "text": "Table 4 Efficacy results from the monotherapy and combination therapy studies", "truncated": false}, "after_length": 77, "after_sha256": "8a676ff4590853b10947cc8224593b4e2b317a6f0782a560abf133f2954cd267", "annex": "I", "before": {"end": 77, "start": 0, "text": "Table 4 Efficacy results from the monotherapy and combination therapy studies", "truncated": false}, "before_length": 77, "before_sha256": "8a676ff4590853b10947cc8224593b4e2b317a6f0782a560abf133f2954cd267", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0380b67ea7386c70dc3ddf28", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004361", "medicine_name": "Kanjinti", "medicine_slug": "kanjinti", "observed_at": "2026-10-12T19:40:28Z", "pipeline_version": "2.0.0", "presentation_label": "KANJINTI 150 mg powder for concentrate for solution for infusion KANJINTI 420 mg powder for 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "9f4119e69f965285688c3402ad669f6dc3298fbbaf20f5909a83d03f0f927312", "source_snapshot_id": "source-4222dc61a5c401d9ea981d06", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/kanjinti-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 886}
{"after": {"end": 45, "start": 0, "text": "Déclaration des effets indésirables suspectés", "truncated": false}, "after_length": 45, "after_sha256": "5b3933970e55d76dcd2d60a20b54ba5bd8e8c717323c29a9afa054a9156e9a85", "annex": "I", "before": {"end": 45, "start": 0, "text": "Déclaration des effets indésirables suspectés", "truncated": false}, "before_length": 45, "before_sha256": "5b3933970e55d76dcd2d60a20b54ba5bd8e8c717323c29a9afa054a9156e9a85", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-038117a1e471b99e9aadb264", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004104", "medicine_name": "Eptifibatide Accord", "medicine_slug": "eptifibatide-accord", "observed_at": "2026-10-12T19:45:11Z", "pipeline_version": "2.0.0", "presentation_label": "Eptifibatide Accord 2 mg/ml, 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": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "c9be002148fa73331c72aadac205f927e043f3407cf695e63a1cbe715480600b", "source_snapshot_id": "source-9e33d5d566c95289f1a7e6a6", "source_updated_at": "2025-05-02", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/eptifibatide-accord-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 665}
{"after": {"end": 207, "start": 0, "text": "The safety and efficacy of Avamys in children under the age of 6 years has not been established. Currently available data are described in section 5.1 and 5.2 but no recommendation on a posology can be made.", "truncated": false}, "after_length": 207, "after_sha256": "1be8376f042de5e247c0a39b66745e8a20bd99d25435b749cbcf8147e0e8d416", "annex": "I", "before": {"end": 207, "start": 0, "text": "The safety and efficacy of Avamys in children under the age of 6 years has not been established. Currently available data are described in section 5.1 and 5.2 but no recommendation on a posology can be made.", "truncated": false}, "before_length": 207, "before_sha256": "1be8376f042de5e247c0a39b66745e8a20bd99d25435b749cbcf8147e0e8d416", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03831617efc3862f78ace94d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000770", "medicine_name": "Avamys", "medicine_slug": "avamys", "observed_at": "2026-10-12T19:30:29Z", "pipeline_version": "2.0.0", "presentation_label": "AVAMYS 27.5 micrograms/spray, nasal spray suspension", "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": "30f949bc5059758fc7a5c6971f20b61b1a1216476650dc650963a3ac481e29e3", "source_snapshot_id": "source-74cb508bb20024b25ca75f56", "source_updated_at": "2025-06-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/avamys-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 79}
{"after": {"end": 385, "start": 0, "text": "Il convient donc d’être prudent lors de l’utilisation d’un schéma thérapeutique associant plusieurs immunosuppresseurs (y compris les thiopurines), car celui-ci pourrait entraîner des syndromes lymphoprolifératifs, certains d’issue fatale. La prise concomitante de plusieurs immunosuppresseurs augmente le risque de syndromes lymphoprolifératifs associés au virus d’Epstein-Barr (EBV).", "truncated": false}, "after_length": 385, "after_sha256": "4aed289570cd8800377f9ffd877baa7a20b24391c2a8898e3a384c7831470ddc", "annex": "I", "before": {"end": 385, "start": 0, "text": "Il convient donc d’être prudent lors de l’utilisation d’un schéma thérapeutique associant plusieurs immunosuppresseurs (y compris les thiopurines), car celui-ci pourrait entraîner des syndromes lymphoprolifératifs, certains d’issue fatale. La prise concomitante de plusieurs immunosuppresseurs augmente le risque de syndromes lymphoprolifératifs associés au virus d’Epstein-Barr (EBV).", "truncated": false}, "before_length": 385, "before_sha256": "4aed289570cd8800377f9ffd877baa7a20b24391c2a8898e3a384c7831470ddc", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0386fc83ec49928956c72d0c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002022", "medicine_name": "Xaluprine (previously Mercaptopurine Nova Laboratories)", "medicine_slug": "xaluprine-previously-mercaptopurine-nova-laboratories", "observed_at": "2026-10-12T19:08:05Z", "pipeline_version": "2.0.0", "presentation_label": "Xaluprine 20 mg/ml suspension orale", "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": "24d3b15ae521f391e697a4d72930da59f53e4eeefc26a100461fbfa83e960527", "source_snapshot_id": "source-22ca1025dfc29c23d7b323de", "source_updated_at": "2025-09-25", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xaluprine-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 404}
{"after": {"end": 279, "start": 0, "text": "No dose adjustment is necessary for paediatric patients with mild renal impairment. In paediatric patients with moderate and severe renal impairment (creatinine clearance less than 50 ml/min), and endstage renal disease, the daily dose should be reduced by 50% (see section 5.2).", "truncated": false}, "after_length": 279, "after_sha256": "cecf13e026b3ccdb926b983f3827ac5a9c4b616b08b5b9b9c2dd4ac2c83c7877", "annex": "I", "before": {"end": 279, "start": 0, "text": "No dose adjustment is necessary for paediatric patients with mild renal impairment. In paediatric patients with moderate and severe renal impairment (creatinine clearance less than 50 ml/min), and endstage renal disease, the daily dose should be reduced by 50% (see section 5.2).", "truncated": false}, "before_length": 279, "before_sha256": "cecf13e026b3ccdb926b983f3827ac5a9c4b616b08b5b9b9c2dd4ac2c83c7877", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0394a55999fb949280000923", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002345", "medicine_name": "Revestive", "medicine_slug": "revestive", "observed_at": "2026-10-12T19:38:01Z", "pipeline_version": "2.0.0", "presentation_label": "Revestive 1.25 mg powder and solvent 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": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "0125d033ce2f8805dc45ece9b8ffa34db6682b195448a3a560e6d2483a8982b4", "source_snapshot_id": "source-8d7c3200418c650a002546aa", "source_updated_at": "2025-05-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/revestive-epar-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": 42, "start": 0, "text": "Troubles du métabolisme et de la nutrition", "truncated": false}, "after_length": 42, "after_sha256": "1bb1a58898fc6bd79dda62677343c27961ff2d9eaad2e243f608d104ca548912", "annex": "I", "before": {"end": 42, "start": 0, "text": "Troubles du métabolisme et de la nutrition", "truncated": false}, "before_length": 42, "before_sha256": "1bb1a58898fc6bd79dda62677343c27961ff2d9eaad2e243f608d104ca548912", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03a3982f09d33063ef377296", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006459", "medicine_name": "Eltrombopag Accord", "medicine_slug": "eltrombopag-accord", "observed_at": "2026-10-12T19:38:33Z", "pipeline_version": "2.0.0", "presentation_label": "Eltrombopag Accord 12,5 mg, comprimés pelliculés Eltrombopag Accord 25 mg, comprimés pelliculés Eltrombopag Accord 50 mg, comprimés pelliculés Eltrombopag Accord 75 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": "4dba9ba2d13e28b9b00b5cee0ebfe8b72ef357d185dbbf0def82cb05d9f63530", "source_snapshot_id": "source-acb656ad31eb3184c264b4cd", "source_updated_at": "2025-05-20", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/eltrombopag-accord-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 430}
{"after": {"end": 201, "start": 0, "text": "L’administration concomitante du vaccin contre la fièvre jaune est contre-indiquée, en raison d’un risque de maladie vaccinale généralisée mortelle chez les patients immunodéprimés (voir rubrique 4.3).", "truncated": false}, "after_length": 201, "after_sha256": "caef57a69ecb7db69fa928ca499a4c341859c844b5dd113905b933b9709b77da", "annex": "I", "before": {"end": 201, "start": 0, "text": "L’administration concomitante du vaccin contre la fièvre jaune est contre-indiquée, en raison d’un risque de maladie vaccinale généralisée mortelle chez les patients immunodéprimés (voir rubrique 4.3).", "truncated": false}, "before_length": 201, "before_sha256": "caef57a69ecb7db69fa928ca499a4c341859c844b5dd113905b933b9709b77da", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03bdc9d43656bbac9220dd6f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002022", "medicine_name": "Xaluprine (previously Mercaptopurine Nova Laboratories)", "medicine_slug": "xaluprine-previously-mercaptopurine-nova-laboratories", "observed_at": "2026-10-12T19:08:05Z", "pipeline_version": "2.0.0", "presentation_label": "Xaluprine 20 mg/ml suspension orale", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "24d3b15ae521f391e697a4d72930da59f53e4eeefc26a100461fbfa83e960527", "source_snapshot_id": "source-22ca1025dfc29c23d7b323de", "source_updated_at": "2025-09-25", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xaluprine-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 450}
{"after": {"end": 42, "start": 0, "text": "Troubles du métabolisme et de la nutrition", "truncated": false}, "after_length": 42, "after_sha256": "1bb1a58898fc6bd79dda62677343c27961ff2d9eaad2e243f608d104ca548912", "annex": "I", "before": {"end": 42, "start": 0, "text": "Troubles du métabolisme et de la nutrition", "truncated": false}, "before_length": 42, "before_sha256": "1bb1a58898fc6bd79dda62677343c27961ff2d9eaad2e243f608d104ca548912", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03cb5a3475636ed041761771", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002618", "medicine_name": "Nexium Control", "medicine_slug": "nexium-control", "observed_at": "2026-10-12T13:36:18Z", "pipeline_version": "2.0.0", "presentation_label": "Nexium Control 20 mg, gélules gastrorésistantes", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "dd192e79554a2cf904e3b717c765e723c89937d2250f85a0df30f9a56f6cb2e1", "source_snapshot_id": "source-614e91f5970645497b96d67b", "source_updated_at": "2026-06-03", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nexium-control-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 719}
{"after": {"end": 77, "start": 0, "text": "Ces observations n’ont pas de conséquence sur la posologie de l’ésoméprazole.", "truncated": false}, "after_length": 77, "after_sha256": "300bd4df8fed420b314b85a96254130ff763d1c64f0e08feadb32bcc79a12c5c", "annex": "I", "before": {"end": 77, "start": 0, "text": "Ces observations n’ont pas de conséquence sur la posologie de l’ésoméprazole.", "truncated": false}, "before_length": 77, "before_sha256": "300bd4df8fed420b314b85a96254130ff763d1c64f0e08feadb32bcc79a12c5c", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03d7e97b0759efca43027f43", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002618", "medicine_name": "Nexium Control", "medicine_slug": "nexium-control", "observed_at": "2026-10-12T13:36:18Z", "pipeline_version": "2.0.0", "presentation_label": "Nexium Control 20 mg, gélules gastrorésistantes", "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": "dd192e79554a2cf904e3b717c765e723c89937d2250f85a0df30f9a56f6cb2e1", "source_snapshot_id": "source-614e91f5970645497b96d67b", "source_updated_at": "2026-06-03", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nexium-control-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 866}
{"after": {"end": 119, "start": 0, "text": "Hypersensitivity to the active substance, substituted benzimidazoles or to any of the excipients listed in section 6.1.", "truncated": false}, "after_length": 119, "after_sha256": "50314d8ebd87ab10b33c97ece5341d9e8686f2f6058f059414d8575e67709a03", "annex": "I", "before": {"end": 119, "start": 0, "text": "Hypersensitivity to the active substance, substituted benzimidazoles or to any of the excipients listed in section 6.1.", "truncated": false}, "before_length": 119, "before_sha256": "50314d8ebd87ab10b33c97ece5341d9e8686f2f6058f059414d8575e67709a03", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03e4d43661752d76f1b6c771", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002618", "medicine_name": "Nexium Control", "medicine_slug": "nexium-control", "observed_at": "2026-10-12T13:36:16Z", "pipeline_version": "2.0.0", "presentation_label": "Nexium Control 20 mg gastroresistant 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": "4.3", "section_type": "contraindication", "source_provider": "European Medicines Agency", "source_sha256": "266d567343c3811aa2034b1a0d89c81f2a39f87634c27e040eddf35f3f1f5cac", "source_snapshot_id": "source-dfdf6861216bffe1c095176b", "source_updated_at": "2026-06-03", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nexium-control-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 86}
{"after": {"end": 440, "start": 0, "text": "L’emtricitabine est principalement excrétée par les reins, avec récupération complète de la dose dans les urines (environ 86 %) et les fèces (environ 14 %). Treize pour cent de la dose d’emtricitabine ont été retrouvés dans les urines sous forme de trois métabolites. La clairance systémique de l’emtricitabine a été en moyenne de 307 mL/min. Après administration orale, la demi-vie d’élimination de l’emtricitabine est d’environ 10 heures.", "truncated": false}, "after_length": 440, "after_sha256": "d2957b2861edcdf1b2e75bb650fa488211ee3f1d2959fa745168f73179115179", "annex": "I", "before": {"end": 440, "start": 0, "text": "L’emtricitabine est principalement excrétée par les reins, avec récupération complète de la dose dans les urines (environ 86 %) et les fèces (environ 14 %). Treize pour cent de la dose d’emtricitabine ont été retrouvés dans les urines sous forme de trois métabolites. La clairance systémique de l’emtricitabine a été en moyenne de 307 mL/min. Après administration orale, la demi-vie d’élimination de l’emtricitabine est d’environ 10 heures.", "truncated": false}, "before_length": 440, "before_sha256": "d2957b2861edcdf1b2e75bb650fa488211ee3f1d2959fa745168f73179115179", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03ec292543e2cc5bb5989cb6", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006469", "medicine_name": "Emtricitabine / Tenofovir alafenamide Viatris", "medicine_slug": "emtricitabine-tenofovir-alafenamide-viatris", "observed_at": "2026-10-12T13:40:17Z", "pipeline_version": "2.0.0", "presentation_label": "Emtricitabine/Ténofovir alafénamide Viatris 200 mg/10 mg, comprimés pelliculés Emtricitabine/Ténofovir alafénamide Viatris 200 mg/25 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": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "f756470c4d010c80a3cc0e1d2d813c1c039c3ca68b113594de79e065fdc70412", "source_snapshot_id": "source-e58329b521b2e223a700355b", "source_updated_at": "2026-04-16", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/emtricitabine-tenofovir-alafenamide-viatris-epar-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": 949, "start": 0, "text": "Le trastuzumab est un anticorps monoclonal humanisé recombinant de classe IgG1 dirigé contre le récepteur 2 du facteur de croissance épidermique humain (HER2). Une surexpression de HER2 s’observe dans 20 à 30 % des cancers primitifs du sein. Les études de détermination du statut HER2 dans le cancer gastrique ont utilisé l’immunohistochimie (IHC) et une hybridation in situ en fluorescence (FISH) ou une hybridation in situ chromogénique (CISH) et ont montré qu’il existe une large variation de la positivité de HER2 allant de 6,8 % à 34,0 % pour l'IHC et de 7,1 % à 42,6 % pour la FISH. Des études montrent que la survie sans maladie est plus courte chez les patients atteints d’un cancer du sein dont les tumeurs surexpriment HER2 que chez les patients dont les tumeurs ne présentent pas cette surexpression. Le domaine extracellulaire du récepteur (ECD, p105) peut passer dans la circulation sanguine et être dosé dans les échantillons sériques.", "truncated": false}, "after_length": 949, "after_sha256": "629e1d7a97aa84c4151a79d8b62d78fc322980acd97b481bd72e29eb3fbdf6ae", "annex": "I", "before": {"end": 949, "start": 0, "text": "Le trastuzumab est un anticorps monoclonal humanisé recombinant de classe IgG1 dirigé contre le récepteur 2 du facteur de croissance épidermique humain (HER2). Une surexpression de HER2 s’observe dans 20 à 30 % des cancers primitifs du sein. Les études de détermination du statut HER2 dans le cancer gastrique ont utilisé l’immunohistochimie (IHC) et une hybridation in situ en fluorescence (FISH) ou une hybridation in situ chromogénique (CISH) et ont montré qu’il existe une large variation de la positivité de HER2 allant de 6,8 % à 34,0 % pour l'IHC et de 7,1 % à 42,6 % pour la FISH. Des études montrent que la survie sans maladie est plus courte chez les patients atteints d’un cancer du sein dont les tumeurs surexpriment HER2 que chez les patients dont les tumeurs ne présentent pas cette surexpression. Le domaine extracellulaire du récepteur (ECD, p105) peut passer dans la circulation sanguine et être dosé dans les échantillons sériques.", "truncated": false}, "before_length": 949, "before_sha256": "629e1d7a97aa84c4151a79d8b62d78fc322980acd97b481bd72e29eb3fbdf6ae", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03f24beaf66e7b2ea1c46f1c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004361", "medicine_name": "Kanjinti", "medicine_slug": "kanjinti", "observed_at": "2026-10-12T19:40:38Z", "pipeline_version": "2.0.0", "presentation_label": "KANJINTI 150 mg poudre pour solution à diluer pour perfusion KANJINTI 420 mg poudre pour 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": "ea9ea0ca90af9dcbc236774255b0290bf3e784884d88a33522b45c8050f829cf", "source_snapshot_id": "source-a4621a49bcc40ac3f94d4939", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/kanjinti-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 790}
{"after": {"end": 53, "start": 0, "text": "Perennial Allergic Rhinitis in adults and adolescents", "truncated": false}, "after_length": 53, "after_sha256": "563a47e56574b105501f09feaa3fd538b52567d85cf07d9219a7a0235ccee98c", "annex": "I", "before": {"end": 53, "start": 0, "text": "Perennial Allergic Rhinitis in adults and adolescents", "truncated": false}, "before_length": 53, "before_sha256": "563a47e56574b105501f09feaa3fd538b52567d85cf07d9219a7a0235ccee98c", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03f2d926d6d31de50643ef06", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000770", "medicine_name": "Avamys", "medicine_slug": "avamys", "observed_at": "2026-10-12T19:30:29Z", "pipeline_version": "2.0.0", "presentation_label": "AVAMYS 27.5 micrograms/spray, nasal spray suspension", "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": "30f949bc5059758fc7a5c6971f20b61b1a1216476650dc650963a3ac481e29e3", "source_snapshot_id": "source-74cb508bb20024b25ca75f56", "source_updated_at": "2025-06-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/avamys-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 246}
{"after": {"end": 47, "start": 0, "text": "Affections musculo-squelettiques et systémiques", "truncated": false}, "after_length": 47, "after_sha256": "a0bf97b282154729b104ceb052c458e29a5557b8c8ee234d6e12fd8993ef2ce4", "annex": "I", "before": {"end": 47, "start": 0, "text": "Affections musculo-squelettiques et systémiques", "truncated": false}, "before_length": 47, "before_sha256": "a0bf97b282154729b104ceb052c458e29a5557b8c8ee234d6e12fd8993ef2ce4", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03f51db4e68f6cbb4bcaf67d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002618", "medicine_name": "Nexium Control", "medicine_slug": "nexium-control", "observed_at": "2026-10-12T13:36:18Z", "pipeline_version": "2.0.0", "presentation_label": "Nexium Control 20 mg, gélules gastrorésistantes", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "dd192e79554a2cf904e3b717c765e723c89937d2250f85a0df30f9a56f6cb2e1", "source_snapshot_id": "source-614e91f5970645497b96d67b", "source_updated_at": "2026-06-03", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nexium-control-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 776}
{"after": {"end": 87, "start": 0, "text": "Darunavir/cobicistat (800/150 mg once daily), tenofovir alafenamide (25 mg once daily)5", "truncated": false}, "after_length": 87, "after_sha256": "9af159a15e2a6e7cf2c815e929bfe8f7d9221bd78310c488fd69a86016cf858f", "annex": "I", "before": {"end": 87, "start": 0, "text": "Darunavir/cobicistat (800/150 mg once daily), tenofovir alafenamide (25 mg once daily)5", "truncated": false}, "before_length": 87, "before_sha256": "9af159a15e2a6e7cf2c815e929bfe8f7d9221bd78310c488fd69a86016cf858f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03f92157840b4fd679a9d371", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006469", "medicine_name": "Emtricitabine / Tenofovir alafenamide Viatris", "medicine_slug": "emtricitabine-tenofovir-alafenamide-viatris", "observed_at": "2026-10-12T13:40:14Z", "pipeline_version": "2.0.0", "presentation_label": "Emtricitabine/Tenofovir alafenamide Viatris 200 mg/10 mg filmcoated tablets Emtricitabine/Tenofovir alafenamide Viatris 200 mg/25 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": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "247b89d7ca1efa91cffaeb0f00556dd381d81e804eb2f9c23631d01a49578ea7", "source_snapshot_id": "source-246d08888d5f52d006efa07f", "source_updated_at": "2026-04-16", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/emtricitabine-tenofovir-alafenamide-viatris-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 396}
{"after": {"end": 69, "start": 0, "text": "Each spray actuation delivers 27.5 micrograms of fluticasone furoate.", "truncated": false}, "after_length": 69, "after_sha256": "81bb38847b0c31bd965d27e9a5268d69e44e7f9d135e83bdd8859c9b803cad50", "annex": "I", "before": {"end": 69, "start": 0, "text": "Each spray actuation delivers 27.5 micrograms of fluticasone furoate.", "truncated": false}, "before_length": 69, "before_sha256": "81bb38847b0c31bd965d27e9a5268d69e44e7f9d135e83bdd8859c9b803cad50", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-040ad1a48cc9a987c5e56a36", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000770", "medicine_name": "Avamys", "medicine_slug": "avamys", "observed_at": "2026-10-12T19:30:29Z", "pipeline_version": "2.0.0", "presentation_label": "AVAMYS 27.5 micrograms/spray, nasal spray suspension", "presentation_occurrence": 1, "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": "30f949bc5059758fc7a5c6971f20b61b1a1216476650dc650963a3ac481e29e3", "source_snapshot_id": "source-74cb508bb20024b25ca75f56", "source_updated_at": "2025-06-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/avamys-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 36}
{"after": {"end": 41, "start": 0, "text": "Description of selected adverse reactions", "truncated": false}, "after_length": 41, "after_sha256": "f66db2a8100a521c1dea72ff90e696fa3846f9d5fcd6cf8e5e03ce5d71bde4a7", "annex": "I", "before": {"end": 41, "start": 0, "text": "Description of selected adverse reactions", "truncated": false}, "before_length": 41, "before_sha256": "f66db2a8100a521c1dea72ff90e696fa3846f9d5fcd6cf8e5e03ce5d71bde4a7", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0423b3bf2b01b6d7c9878a55", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004361", "medicine_name": "Kanjinti", "medicine_slug": "kanjinti", "observed_at": "2026-10-12T19:40:28Z", "pipeline_version": "2.0.0", "presentation_label": "KANJINTI 150 mg powder for concentrate for solution for infusion KANJINTI 420 mg powder for 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": "9f4119e69f965285688c3402ad669f6dc3298fbbaf20f5909a83d03f0f927312", "source_snapshot_id": "source-4222dc61a5c401d9ea981d06", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/kanjinti-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 737}
{"after": {"end": 112, "start": 0, "text": "L’hydroxycarbamide doit être utilisée avec prudence chez les patients présentant une dysfonction rénale marquée.", "truncated": false}, "after_length": 112, "after_sha256": "f2385415828a0cb7826259d596aff327278ce50b05696894c7432e6ec1f70901", "annex": "I", "before": {"end": 112, "start": 0, "text": "L’hydroxycarbamide doit être utilisée avec prudence chez les patients présentant une dysfonction rénale marquée.", "truncated": false}, "before_length": 112, "before_sha256": "f2385415828a0cb7826259d596aff327278ce50b05696894c7432e6ec1f70901", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-04280840c212cad014fcf2b9", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004837", "medicine_name": "Xromi", "medicine_slug": "xromi", "observed_at": "2026-10-12T19:32:45Z", "pipeline_version": "2.0.0", "presentation_label": "Xromi 100 mg/mL solution buvable", "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": "09fc95ca63cda4685a64f9a6f2786bf839a7e56efe05863cd60781314e5f87b5", "source_snapshot_id": "source-6048aed0c6a5fd892436dd1f", "source_updated_at": "2025-06-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xromi-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 125}
{"after": {"end": 74, "start": 0, "text": "Given its genotoxic potential, mercaptopurine is potentially carcinogenic.", "truncated": false}, "after_length": 74, "after_sha256": "4e43c75c988578280fa94fcf8689d4b1e45d2cdea0ecb7c64385f277a1ba0032", "annex": "I", "before": {"end": 74, "start": 0, "text": "Given its genotoxic potential, mercaptopurine is potentially carcinogenic.", "truncated": false}, "before_length": 74, "before_sha256": "4e43c75c988578280fa94fcf8689d4b1e45d2cdea0ecb7c64385f277a1ba0032", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0431edca6b3a2de093a3ef3c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002022", "medicine_name": "Xaluprine (previously Mercaptopurine Nova Laboratories)", "medicine_slug": "xaluprine-previously-mercaptopurine-nova-laboratories", "observed_at": "2026-10-12T19:08:02Z", "pipeline_version": "2.0.0", "presentation_label": "Xaluprine 20 mg/ml oral suspension", "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": "a352706294cb9013c5ba158da50186f12673cdb6fb887d0033e1457d44698091", "source_snapshot_id": "source-80b0d9db881bf774bffb5d3c", "source_updated_at": "2025-09-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/xaluprine-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 646}
{"after": {"end": 492, "start": 0, "text": "La demi-vie plasmatique de la rivastigmine est de 1 heure environ et la durée de l’inhibition de l’acétylcholinestérase est d’environ 9 heures : en cas de surdosage asymptomatique, il est donc recommandé de suspendre l’administration de rivastigmine pendant les 24 heures suivantes. En cas de surdosage s’accompagnant de nausées et de vomissements importants, des antiémétiques pourront être utilisés. Les autres effets indésirables feront l’objet d’un traitement symptomatique si nécessaire.", "truncated": false}, "after_length": 492, "after_sha256": "5736f437c0511684e929d21e9d4bc6b7c7330ba1904d52826d95ab449a93c647", "annex": "I", "before": {"end": 492, "start": 0, "text": "La demi-vie plasmatique de la rivastigmine est de 1 heure environ et la durée de l’inhibition de l’acétylcholinestérase est d’environ 9 heures : en cas de surdosage asymptomatique, il est donc recommandé de suspendre l’administration de rivastigmine pendant les 24 heures suivantes. En cas de surdosage s’accompagnant de nausées et de vomissements importants, des antiémétiques pourront être utilisés. Les autres effets indésirables feront l’objet d’un traitement symptomatique si nécessaire.", "truncated": false}, "before_length": 492, "before_sha256": "5736f437c0511684e929d21e9d4bc6b7c7330ba1904d52826d95ab449a93c647", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0439d40dad29fdb345874f76", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/001029", "medicine_name": "Nimvastid", "medicine_slug": "nimvastid", "observed_at": "2026-10-12T19:24:04Z", "pipeline_version": "2.0.0", "presentation_label": "Nimvastid 1,5 mg gélule Nimvastid 3 mg gélule Nimvastid 4,5 mg gélule Nimvastid 6 mg gélule", "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": "8e6eaa143ff5f69cfa4caba1806dbd754ee713f2f64ce6a1b369433c9e511b46", "source_snapshot_id": "source-655cd60c5475e58b35c5a1c3", "source_updated_at": "2025-07-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nimvastid-epar-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": 207, "start": 0, "text": "The 95% CI for the frequency distribution was computed using Clopper-Pearson exact method. ClopperPearson test was used for testing whether the proportion of responders was >15%. CI and pvalues are reported.", "truncated": false}, "after_length": 207, "after_sha256": "951ab0f16d87fb2a1626775bbef96ae3e5f3184544605650c19a71e604e42ae7", "annex": "I", "before": {"end": 207, "start": 0, "text": "The 95% CI for the frequency distribution was computed using Clopper-Pearson exact method. ClopperPearson test was used for testing whether the proportion of responders was >15%. CI and pvalues are reported.", "truncated": false}, "before_length": 207, "before_sha256": "951ab0f16d87fb2a1626775bbef96ae3e5f3184544605650c19a71e604e42ae7", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0444edc20fa6fe44f47b54cc", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006459", "medicine_name": "Eltrombopag Accord", "medicine_slug": "eltrombopag-accord", "observed_at": "2026-10-12T19:38:22Z", "pipeline_version": "2.0.0", "presentation_label": "Eltrombopag Accord 12.5 mg film-coated tablets Eltrombopag Accord 25 mg film-coated tablets Eltrombopag Accord 50 mg film-coated tablets Eltrombopag Accord 75 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "0485f44a0e25bf9e0f930e8ce8c053598ed2a48f78476ffafefb66d9fb3e8d89", "source_snapshot_id": "source-d7e0f3276633f5a4a1cef1a4", "source_updated_at": "2025-05-20", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/eltrombopag-accord-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 979}
{"after": {"end": 141, "start": 0, "text": "Le traitement doit être instauré sous la surveillance d’un médecin expérimenté dans la prise en charge du SGC chez les patients pédiatriques.", "truncated": false}, "after_length": 141, "after_sha256": "a464eafa586c33c038d0599336220b8807959680b73dcaf0b88547ec3f59badb", "annex": "I", "before": {"end": 141, "start": 0, "text": "Le traitement doit être instauré sous la surveillance d’un médecin expérimenté dans la prise en charge du SGC chez les patients pédiatriques.", "truncated": false}, "before_length": 141, "before_sha256": "a464eafa586c33c038d0599336220b8807959680b73dcaf0b88547ec3f59badb", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-04468a0cfc9fc86bb311c25f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002345", "medicine_name": "Revestive", "medicine_slug": "revestive", "observed_at": "2026-10-12T19:38:11Z", "pipeline_version": "2.0.0", "presentation_label": "Revestive 5 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": "a977434b47f1efb8356de57d0e4e212d0d42a4215af7d29769e6a19a6e5b7354", "source_snapshot_id": "source-34689da4d07d48b1dbd0d784", "source_updated_at": "2025-05-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/revestive-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 732}
{"after": {"end": 44, "start": 0, "text": "No infant subjects reached complete weaning.", "truncated": false}, "after_length": 44, "after_sha256": "3c487accf8bb918db4c9c3b4911a2b07edc9a6078789a4cfee790e7b7b59dbe9", "annex": "I", "before": {"end": 44, "start": 0, "text": "No infant subjects reached complete weaning.", "truncated": false}, "before_length": 44, "before_sha256": "3c487accf8bb918db4c9c3b4911a2b07edc9a6078789a4cfee790e7b7b59dbe9", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-04469e7a16fb684ba787c119", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002345", "medicine_name": "Revestive", "medicine_slug": "revestive", "observed_at": "2026-10-12T19:38:01Z", "pipeline_version": "2.0.0", "presentation_label": "Revestive 1.25 mg powder and solvent 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "0125d033ce2f8805dc45ece9b8ffa34db6682b195448a3a560e6d2483a8982b4", "source_snapshot_id": "source-8d7c3200418c650a002546aa", "source_updated_at": "2025-05-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/revestive-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 399}
{"after": {"end": 83, "start": 0, "text": "Méthotrexate (utilisé dans le traitement du cancer et des troubles rhumatologiques)", "truncated": false}, "after_length": 83, "after_sha256": "72ce432cf9b408aa715082c17c4f369c175f5c404a85624926efacfde6fe693c", "annex": "IIIB", "before": {"end": 83, "start": 0, "text": "Méthotrexate (utilisé dans le traitement du cancer et des troubles rhumatologiques)", "truncated": false}, "before_length": 83, "before_sha256": "72ce432cf9b408aa715082c17c4f369c175f5c404a85624926efacfde6fe693c", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-04580d68955d3fc700a1e26f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002618", "medicine_name": "Nexium Control", "medicine_slug": "nexium-control", "observed_at": "2026-10-12T13:36:18Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "dd192e79554a2cf904e3b717c765e723c89937d2250f85a0df30f9a56f6cb2e1", "source_snapshot_id": "source-614e91f5970645497b96d67b", "source_updated_at": "2026-06-03", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nexium-control-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1567}
{"after": {"end": 89, "start": 0, "text": "Classe pharmacothérapeutique : Agents antinéoplasiques, anticorps monoclonaux, Code ATC :", "truncated": false}, "after_length": 89, "after_sha256": "b65f4e6c7d23586b5e0467d64891c0a43fc83226ea1d61cd872e646750b30d7f", "annex": "I", "before": {"end": 89, "start": 0, "text": "Classe pharmacothérapeutique : Agents antinéoplasiques, anticorps monoclonaux, Code ATC :", "truncated": false}, "before_length": 89, "before_sha256": "b65f4e6c7d23586b5e0467d64891c0a43fc83226ea1d61cd872e646750b30d7f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-04735e857d513e112b3bfdbc", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002547", "medicine_name": "Perjeta", "medicine_slug": "perjeta", "observed_at": "2026-10-12T13:39:17Z", "pipeline_version": "2.0.0", "presentation_label": "Perjeta 420 mg 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": "dfc85998efa134fbc08630f7e0f1d1183bd4fb18ec62a15b680bda3fd94b49bd", "source_snapshot_id": "source-791eb96e62fdebcce4c81ec4", "source_updated_at": "2026-04-28", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/perjeta-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 482}
{"after": {"end": 126, "start": 0, "text": "Les résultats d’efficacité de l’étude BO16348 après un suivi médian de 12 mois* et de 8 ans** sont résumés dans le tableau 6 :", "truncated": false}, "after_length": 126, "after_sha256": "d3be6ab1787608dbcb118d1d6c4e5f409612f65d0e9000ac3a0e96aaa2d7be23", "annex": "I", "before": {"end": 126, "start": 0, "text": "Les résultats d’efficacité de l’étude BO16348 après un suivi médian de 12 mois* et de 8 ans** sont résumés dans le tableau 6 :", "truncated": false}, "before_length": 126, "before_sha256": "d3be6ab1787608dbcb118d1d6c4e5f409612f65d0e9000ac3a0e96aaa2d7be23", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0485512331f1df83e3835cac", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004361", "medicine_name": "Kanjinti", "medicine_slug": "kanjinti", "observed_at": "2026-10-12T19:40:38Z", "pipeline_version": "2.0.0", "presentation_label": "KANJINTI 150 mg poudre pour solution à diluer pour perfusion KANJINTI 420 mg poudre pour 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": "ea9ea0ca90af9dcbc236774255b0290bf3e784884d88a33522b45c8050f829cf", "source_snapshot_id": "source-a4621a49bcc40ac3f94d4939", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/kanjinti-epar-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": 211, "start": 0, "text": "In clinical studies with a TPO-R agonist in patients with MDS, cases of transient increases in blast cell counts were observed and cases of MDS disease progression to acute myeloid leukaemia (AML) were reported.", "truncated": false}, "after_length": 211, "after_sha256": "b4cdd015b64075383b76b94d05c843f78a65d455d20a49d4b1ae39f95c0afc5e", "annex": "I", "before": {"end": 211, "start": 0, "text": "In clinical studies with a TPO-R agonist in patients with MDS, cases of transient increases in blast cell counts were observed and cases of MDS disease progression to acute myeloid leukaemia (AML) were reported.", "truncated": false}, "before_length": 211, "before_sha256": "b4cdd015b64075383b76b94d05c843f78a65d455d20a49d4b1ae39f95c0afc5e", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-048b578280ad3062ad21ab91", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006459", "medicine_name": "Eltrombopag Accord", "medicine_slug": "eltrombopag-accord", "observed_at": "2026-10-12T19:38:22Z", "pipeline_version": "2.0.0", "presentation_label": "Eltrombopag Accord 12.5 mg film-coated tablets Eltrombopag Accord 25 mg film-coated tablets Eltrombopag Accord 50 mg film-coated tablets Eltrombopag Accord 75 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": "0485f44a0e25bf9e0f930e8ce8c053598ed2a48f78476ffafefb66d9fb3e8d89", "source_snapshot_id": "source-d7e0f3276633f5a4a1cef1a4", "source_updated_at": "2025-05-20", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/eltrombopag-accord-epar-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": 89, "start": 0, "text": "Il est à noter que la causalité n’a pas été déterminée pour tous les effets indésirables.", "truncated": false}, "after_length": 89, "after_sha256": "b5d414d19e537853939a818225ea20023868ee221726b6a4686cbc60f3d2177b", "annex": "I", "before": {"end": 89, "start": 0, "text": "Il est à noter que la causalité n’a pas été déterminée pour tous les effets indésirables.", "truncated": false}, "before_length": 89, "before_sha256": "b5d414d19e537853939a818225ea20023868ee221726b6a4686cbc60f3d2177b", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-048e5086aac8c7e11ad221d3", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004104", "medicine_name": "Eptifibatide Accord", "medicine_slug": "eptifibatide-accord", "observed_at": "2026-10-12T19:45:11Z", "pipeline_version": "2.0.0", "presentation_label": "Eptifibatide Accord 2 mg/ml, 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": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "c9be002148fa73331c72aadac205f927e043f3407cf695e63a1cbe715480600b", "source_snapshot_id": "source-9e33d5d566c95289f1a7e6a6", "source_updated_at": "2025-05-02", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/eptifibatide-accord-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 624}
{"after": {"end": 47, "start": 0, "text": "Paresthésie, hypoesthésie, somnolence, migraine", "truncated": false}, "after_length": 47, "after_sha256": "4fa90dd6897f1b86942b06622082061da7a830a6220e04d8dd53bd25d7eebab1", "annex": "I", "before": {"end": 47, "start": 0, "text": "Paresthésie, hypoesthésie, somnolence, migraine", "truncated": false}, "before_length": 47, "before_sha256": "4fa90dd6897f1b86942b06622082061da7a830a6220e04d8dd53bd25d7eebab1", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-04b1ed8750d6538b0b303b4a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006459", "medicine_name": "Eltrombopag Accord", "medicine_slug": "eltrombopag-accord", "observed_at": "2026-10-12T19:38:33Z", "pipeline_version": "2.0.0", "presentation_label": "Eltrombopag Accord 12,5 mg, comprimés pelliculés Eltrombopag Accord 25 mg, comprimés pelliculés Eltrombopag Accord 50 mg, comprimés pelliculés Eltrombopag Accord 75 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": "4dba9ba2d13e28b9b00b5cee0ebfe8b72ef357d185dbbf0def82cb05d9f63530", "source_snapshot_id": "source-acb656ad31eb3184c264b4cd", "source_updated_at": "2025-05-20", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/eltrombopag-accord-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 445}
{"after": {"end": 152, "start": 0, "text": "7 Étude menée avec du voxilaprévir 100 mg supplémentaire pour atteindre les expositions au voxilaprévir attendues chez les patients infectés par le VHC.", "truncated": false}, "after_length": 152, "after_sha256": "be8d0bfb3092f0c073669e640a9722fadbe646a8f3ae1d8015318927ff28da4f", "annex": "I", "before": {"end": 152, "start": 0, "text": "7 Étude menée avec du voxilaprévir 100 mg supplémentaire pour atteindre les expositions au voxilaprévir attendues chez les patients infectés par le VHC.", "truncated": false}, "before_length": 152, "before_sha256": "be8d0bfb3092f0c073669e640a9722fadbe646a8f3ae1d8015318927ff28da4f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-04b5299383a8184d9f3ead31", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006469", "medicine_name": "Emtricitabine / Tenofovir alafenamide Viatris", "medicine_slug": "emtricitabine-tenofovir-alafenamide-viatris", "observed_at": "2026-10-12T13:40:17Z", "pipeline_version": "2.0.0", "presentation_label": "Emtricitabine/Ténofovir alafénamide Viatris 200 mg/10 mg, comprimés pelliculés Emtricitabine/Ténofovir alafénamide Viatris 200 mg/25 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": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "f756470c4d010c80a3cc0e1d2d813c1c039c3ca68b113594de79e065fdc70412", "source_snapshot_id": "source-e58329b521b2e223a700355b", "source_updated_at": "2026-04-16", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/emtricitabine-tenofovir-alafenamide-viatris-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 538}
{"after": {"end": 43, "start": 0, "text": "Date du dernier renouvellement: 16 mai 2024", "truncated": false}, "after_length": 43, "after_sha256": "fdc9b9ad1e1df66e1b6b4fda8adf8ba733933b1845de82e79cc678c194bb4dd6", "annex": "I", "before": {"end": 43, "start": 0, "text": "Date du dernier renouvellement: 16 mai 2024", "truncated": false}, "before_length": 43, "before_sha256": "fdc9b9ad1e1df66e1b6b4fda8adf8ba733933b1845de82e79cc678c194bb4dd6", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-04b86c0dab43aed3ba25087c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004837", "medicine_name": "Xromi", "medicine_slug": "xromi", "observed_at": "2026-10-12T19:32:45Z", "pipeline_version": "2.0.0", "presentation_label": "Xromi 100 mg/mL solution buvable", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "9", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "09fc95ca63cda4685a64f9a6f2786bf839a7e56efe05863cd60781314e5f87b5", "source_snapshot_id": "source-6048aed0c6a5fd892436dd1f", "source_updated_at": "2025-06-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xromi-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 581}
{"after": {"end": 598, "start": 0, "text": "Aucune étude spécifique de l’insuffisance rénale n’a été menée avec Perjeta. Sur la base des résultats de l’analyse pharmacocinétique de population, l’exposition au pertuzumab chez les patients présentant une insuffisance rénale légère (clairance de la créatinine [CLcr] de 60 à 90 mL/min, N = 200) et une insuffisance rénale modérée (CLcr de 30 à 60 mL/min, N = 71) était similaire à celle des patients avec une fonction rénale normale (CLcr supérieure à 90 mL/min, N = 200). Aucune relation entre la CLcr et l’exposition au pertuzumab n’a été observée dans l’intervalle de CLcr (27 à 244 mL/min).", "truncated": false}, "after_length": 598, "after_sha256": "53b5f9497547ac856b7bd7d710ee599727a9a72a5776a222cf004de87ff79ead", "annex": "I", "before": {"end": 598, "start": 0, "text": "Aucune étude spécifique de l’insuffisance rénale n’a été menée avec Perjeta. Sur la base des résultats de l’analyse pharmacocinétique de population, l’exposition au pertuzumab chez les patients présentant une insuffisance rénale légère (clairance de la créatinine [CLcr] de 60 à 90 mL/min, N = 200) et une insuffisance rénale modérée (CLcr de 30 à 60 mL/min, N = 71) était similaire à celle des patients avec une fonction rénale normale (CLcr supérieure à 90 mL/min, N = 200). Aucune relation entre la CLcr et l’exposition au pertuzumab n’a été observée dans l’intervalle de CLcr (27 à 244 mL/min).", "truncated": false}, "before_length": 598, "before_sha256": "53b5f9497547ac856b7bd7d710ee599727a9a72a5776a222cf004de87ff79ead", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-04bceefcd6adf66b5b5ed8ec", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002547", "medicine_name": "Perjeta", "medicine_slug": "perjeta", "observed_at": "2026-10-12T13:39:17Z", "pipeline_version": "2.0.0", "presentation_label": "Perjeta 420 mg 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": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "dfc85998efa134fbc08630f7e0f1d1183bd4fb18ec62a15b680bda3fd94b49bd", "source_snapshot_id": "source-791eb96e62fdebcce4c81ec4", "source_updated_at": "2026-04-28", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/perjeta-epar-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": 120, "start": 0, "text": "Rivastigmine should be administered twice a day, with morning and evening meals. The capsules should be swallowed whole.", "truncated": false}, "after_length": 120, "after_sha256": "d4b87ad79f13ddd69b7d567395b03762dc5eb978888202e5e944ee11fd062e10", "annex": "I", "before": {"end": 120, "start": 0, "text": "Rivastigmine should be administered twice a day, with morning and evening meals. The capsules should be swallowed whole.", "truncated": false}, "before_length": 120, "before_sha256": "d4b87ad79f13ddd69b7d567395b03762dc5eb978888202e5e944ee11fd062e10", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-04ccf378150cc0e9608fcbe3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001029", "medicine_name": "Nimvastid", "medicine_slug": "nimvastid", "observed_at": "2026-10-12T19:24:00Z", "pipeline_version": "2.0.0", "presentation_label": "Nimvastid 1.5 mg hard capsules Nimvastid 3 mg hard capsules Nimvastid 4.5 mg hard capsules Nimvastid 6 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": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "fa4c6e344db60bf4064eb3cc2d76d72c0fc858894147724d88ab2d66b9f9a0dc", "source_snapshot_id": "source-775bf49790604674d3549dac", "source_updated_at": "2025-07-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nimvastid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 85}
{"after": {"end": 49, "start": 0, "text": "sensations vertigineuses, paresthésie, somnolence", "truncated": false}, "after_length": 49, "after_sha256": "480e57da4692390092cb93751a65a0b53f8f6359352254ed8869a772f6dfb66a", "annex": "I", "before": {"end": 49, "start": 0, "text": "sensations vertigineuses, paresthésie, somnolence", "truncated": false}, "before_length": 49, "before_sha256": "480e57da4692390092cb93751a65a0b53f8f6359352254ed8869a772f6dfb66a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-04d6b232ea60d921e8ca6f1c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002618", "medicine_name": "Nexium Control", "medicine_slug": "nexium-control", "observed_at": "2026-10-12T13:36:18Z", "pipeline_version": "2.0.0", "presentation_label": "Nexium Control 20 mg, comprimés gastrorésistants", "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": "dd192e79554a2cf904e3b717c765e723c89937d2250f85a0df30f9a56f6cb2e1", "source_snapshot_id": "source-614e91f5970645497b96d67b", "source_updated_at": "2026-06-03", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nexium-control-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 267}
{"after": {"end": 182, "start": 0, "text": "Le traitement par hydroxycarbamide doit être supervisé par un médecin ou d’autres professionnels de santé expérimentés dans la prise en charge des patients atteints de drépanocytose.", "truncated": false}, "after_length": 182, "after_sha256": "6f412f3a0cecab04ccfc3a8ab2e62fd8c720238e4efd272c872a0ed2a07e2b9a", "annex": "I", "before": {"end": 182, "start": 0, "text": "Le traitement par hydroxycarbamide doit être supervisé par un médecin ou d’autres professionnels de santé expérimentés dans la prise en charge des patients atteints de drépanocytose.", "truncated": false}, "before_length": 182, "before_sha256": "6f412f3a0cecab04ccfc3a8ab2e62fd8c720238e4efd272c872a0ed2a07e2b9a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-04da54cd881f5bb5d2a8a99f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004837", "medicine_name": "Xromi", "medicine_slug": "xromi", "observed_at": "2026-10-12T19:32:45Z", "pipeline_version": "2.0.0", "presentation_label": "Xromi 100 mg/mL solution buvable", "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": "09fc95ca63cda4685a64f9a6f2786bf839a7e56efe05863cd60781314e5f87b5", "source_snapshot_id": "source-6048aed0c6a5fd892436dd1f", "source_updated_at": "2025-06-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xromi-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 51}
{"after": {"end": 410, "start": 0, "text": "L’instauration du traitement ou d’un nouveau cycle de traitement doit être retardée chez les patients présentant des lésions des tissus mous non cicatrisées dans la bouche. Un examen bucco-dentaire comprenant des soins préventifs et une évaluation individuelle du bénéfice/risque sont recommandés avant d’initier un traitement par le denosumab chez les patients présentant des facteurs de risques concomitants.", "truncated": false}, "after_length": 410, "after_sha256": "afe11a48fafe81a82891e264d3fe92ca813ab28c58ed0499c32f65c90a73819e", "annex": "I", "before": {"end": 410, "start": 0, "text": "L’instauration du traitement ou d’un nouveau cycle de traitement doit être retardée chez les patients présentant des lésions des tissus mous non cicatrisées dans la bouche. Un examen bucco-dentaire comprenant des soins préventifs et une évaluation individuelle du bénéfice/risque sont recommandés avant d’initier un traitement par le denosumab chez les patients présentant des facteurs de risques concomitants.", "truncated": false}, "before_length": 410, "before_sha256": "afe11a48fafe81a82891e264d3fe92ca813ab28c58ed0499c32f65c90a73819e", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-04dbb1c597a85977279c2d15", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/001120", "medicine_name": "Prolia", "medicine_slug": "prolia", "observed_at": "2026-10-12T13:28:45Z", "pipeline_version": "2.0.0", "presentation_label": "Prolia 60 mg solution injectable en seringue préremplie", "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": "30e296cc06d303605f266e9544e10515b7e5c2063a0473f5aa3595a42d18a3e1", "source_snapshot_id": "source-2924aac36bd07813fcc1891d", "source_updated_at": "2026-08-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/prolia-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 127}
{"after": {"end": 123, "start": 0, "text": "---------------------------------------------------------------------------------------------------------------------------", "truncated": false}, "after_length": 123, "after_sha256": "cda4fbd930f1c9cc9904dd16e4018e62be448081cc78fac8cb9eb3bd31ce7fd9", "annex": "IIIB", "before": {"end": 123, "start": 0, "text": "---------------------------------------------------------------------------------------------------------------------------", "truncated": false}, "before_length": 123, "before_sha256": "cda4fbd930f1c9cc9904dd16e4018e62be448081cc78fac8cb9eb3bd31ce7fd9", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-04f068e04493f82607498972", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002618", "medicine_name": "Nexium Control", "medicine_slug": "nexium-control", "observed_at": "2026-10-12T13:36:18Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "dd192e79554a2cf904e3b717c765e723c89937d2250f85a0df30f9a56f6cb2e1", "source_snapshot_id": "source-614e91f5970645497b96d67b", "source_updated_at": "2026-06-03", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nexium-control-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1744}
{"after": {"end": 452, "start": 0, "text": "L’eltrombopag est très coloré et est donc susceptible d’interférer avec certains examens de laboratoire. Une décoloration du sérum et des interférences avec le test de la bilirubine totale et de la créatinine ont été rapportées chez les patients prenant de l’eltrombopag. Si les résultats de laboratoire et les observations cliniques ne sont pas cohérents, un nouvel examen utilisant une autre méthode pourra aider à déterminer la validité du résultat.", "truncated": false}, "after_length": 452, "after_sha256": "3ea7a10f080895c8e2264a6d2998d73e05128c755c48cac8ccd299580f689bcc", "annex": "I", "before": {"end": 452, "start": 0, "text": "L’eltrombopag est très coloré et est donc susceptible d’interférer avec certains examens de laboratoire. Une décoloration du sérum et des interférences avec le test de la bilirubine totale et de la créatinine ont été rapportées chez les patients prenant de l’eltrombopag. Si les résultats de laboratoire et les observations cliniques ne sont pas cohérents, un nouvel examen utilisant une autre méthode pourra aider à déterminer la validité du résultat.", "truncated": false}, "before_length": 452, "before_sha256": "3ea7a10f080895c8e2264a6d2998d73e05128c755c48cac8ccd299580f689bcc", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-04f29e402e7769bd1e69cecd", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006459", "medicine_name": "Eltrombopag Accord", "medicine_slug": "eltrombopag-accord", "observed_at": "2026-10-12T19:38:33Z", "pipeline_version": "2.0.0", "presentation_label": "Eltrombopag Accord 12,5 mg, comprimés pelliculés Eltrombopag Accord 25 mg, comprimés pelliculés Eltrombopag Accord 50 mg, comprimés pelliculés Eltrombopag Accord 75 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": "4dba9ba2d13e28b9b00b5cee0ebfe8b72ef357d185dbbf0def82cb05d9f63530", "source_snapshot_id": "source-acb656ad31eb3184c264b4cd", "source_updated_at": "2025-05-20", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/eltrombopag-accord-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 294}
{"after": {"end": 195, "start": 0, "text": "La sécurité et l’efficacité d’Emtricitabine/Ténofovir alafénamide Viatris chez les enfants âgés de moins de 12 ans ou pesant < 35 kg n’ont pas encore été établies. Aucune donnée n’est disponible.", "truncated": false}, "after_length": 195, "after_sha256": "36ce646635603847238ebcfae3c06c97283a8d22a059cb70942f562fa9d955af", "annex": "I", "before": {"end": 195, "start": 0, "text": "La sécurité et l’efficacité d’Emtricitabine/Ténofovir alafénamide Viatris chez les enfants âgés de moins de 12 ans ou pesant < 35 kg n’ont pas encore été établies. Aucune donnée n’est disponible.", "truncated": false}, "before_length": 195, "before_sha256": "36ce646635603847238ebcfae3c06c97283a8d22a059cb70942f562fa9d955af", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-04fb97e64f67517fe4da79e5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006469", "medicine_name": "Emtricitabine / Tenofovir alafenamide Viatris", "medicine_slug": "emtricitabine-tenofovir-alafenamide-viatris", "observed_at": "2026-10-12T13:40:17Z", "pipeline_version": "2.0.0", "presentation_label": "Emtricitabine/Ténofovir alafénamide Viatris 200 mg/10 mg, comprimés pelliculés Emtricitabine/Ténofovir alafénamide Viatris 200 mg/25 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": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "f756470c4d010c80a3cc0e1d2d813c1c039c3ca68b113594de79e065fdc70412", "source_snapshot_id": "source-e58329b521b2e223a700355b", "source_updated_at": "2026-04-16", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/emtricitabine-tenofovir-alafenamide-viatris-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 105}
{"after": {"end": 56, "start": 0, "text": "associés à une augmentation de la bilirubine directe, ou", "truncated": false}, "after_length": 56, "after_sha256": "b4d881239eb7a92e49e781aac84c48ff7e744e5c9f631d972d07c355332fdc7f", "annex": "I", "before": {"end": 56, "start": 0, "text": "associés à une augmentation de la bilirubine directe, ou", "truncated": false}, "before_length": 56, "before_sha256": "b4d881239eb7a92e49e781aac84c48ff7e744e5c9f631d972d07c355332fdc7f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-050711ab7de3c87e8507f009", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006459", "medicine_name": "Eltrombopag Accord", "medicine_slug": "eltrombopag-accord", "observed_at": "2026-10-12T19:38:33Z", "pipeline_version": "2.0.0", "presentation_label": "Eltrombopag Accord 12,5 mg, comprimés pelliculés Eltrombopag Accord 25 mg, comprimés pelliculés Eltrombopag Accord 50 mg, comprimés pelliculés Eltrombopag Accord 75 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": "4dba9ba2d13e28b9b00b5cee0ebfe8b72ef357d185dbbf0def82cb05d9f63530", "source_snapshot_id": "source-acb656ad31eb3184c264b4cd", "source_updated_at": "2025-05-20", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/eltrombopag-accord-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 221}
{"after": {"end": 145, "start": 0, "text": "- evidence of gastrointestinal bleeding, gross genitourinary bleeding or other active abnormal bleeding within the previous 30 days of treatment;", "truncated": false}, "after_length": 145, "after_sha256": "ec2cecd07c138cd3108e53dafa574d7ea8ae09decd7d56aa64063057633f9967", "annex": "I", "before": {"end": 145, "start": 0, "text": "- evidence of gastrointestinal bleeding, gross genitourinary bleeding or other active abnormal bleeding within the previous 30 days of treatment;", "truncated": false}, "before_length": 145, "before_sha256": "ec2cecd07c138cd3108e53dafa574d7ea8ae09decd7d56aa64063057633f9967", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-051113337969f52abac06c32", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004104", "medicine_name": "Eptifibatide Accord", "medicine_slug": "eptifibatide-accord", "observed_at": "2026-10-12T19:45:01Z", "pipeline_version": "2.0.0", "presentation_label": "Eptifibatide Accord 0.75 mg/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": "4.3", "section_type": "contraindication", "source_provider": "European Medicines Agency", "source_sha256": "a45982959a207e1611cd67a6103370f86a234e3c45dfb3ab49b532886fe928cb", "source_snapshot_id": "source-8dd88a3db45e564c959f66e5", "source_updated_at": "2025-05-02", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/eptifibatide-accord-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 110}
{"after": {"end": 53, "start": 0, "text": "Thrombocytopenia with HCV infection in adult patients", "truncated": false}, "after_length": 53, "after_sha256": "5c0f31161825e72bdf4c61c657774996cdf11d1fc1cc39cee3116b36abc73b6a", "annex": "I", "before": {"end": 53, "start": 0, "text": "Thrombocytopenia with HCV infection in adult patients", "truncated": false}, "before_length": 53, "before_sha256": "5c0f31161825e72bdf4c61c657774996cdf11d1fc1cc39cee3116b36abc73b6a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-05149e3a0787fee480148ecd", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006459", "medicine_name": "Eltrombopag Accord", "medicine_slug": "eltrombopag-accord", "observed_at": "2026-10-12T19:38:22Z", "pipeline_version": "2.0.0", "presentation_label": "Eltrombopag Accord 12.5 mg film-coated tablets Eltrombopag Accord 25 mg film-coated tablets Eltrombopag Accord 50 mg film-coated tablets Eltrombopag Accord 75 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": "0485f44a0e25bf9e0f930e8ce8c053598ed2a48f78476ffafefb66d9fb3e8d89", "source_snapshot_id": "source-d7e0f3276633f5a4a1cef1a4", "source_updated_at": "2025-05-20", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/eltrombopag-accord-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 395}
{"after": {"end": 657, "start": 0, "text": "Co-administration of eltrombopag with lopinavir/ritonavir may cause a decrease in the concentration of eltrombopag. A study in 40 healthy volunteers showed that the co-administration of a single 100 mg dose of eltrombopag with repeat dose lopinavir/ritonavir 400/100 mg twice daily resulted in a reduction in eltrombopag plasma AUC0-∞ by 17% (90% CI: 6.6%, 26.6%). Therefore, caution should be used when co-administration of eltrombopag with lopinavir/ritonavir takes place. Platelet count should be closely monitored in order to ensure appropriate medical management of the dose of eltrombopag when lopinavir/ritonavir therapy is initiated or discontinued.", "truncated": false}, "after_length": 657, "after_sha256": "1250bf7c938941142309959035fbb32b6d796d6ad8da7f8d8f23bc6940396357", "annex": "I", "before": {"end": 657, "start": 0, "text": "Co-administration of eltrombopag with lopinavir/ritonavir may cause a decrease in the concentration of eltrombopag. A study in 40 healthy volunteers showed that the co-administration of a single 100 mg dose of eltrombopag with repeat dose lopinavir/ritonavir 400/100 mg twice daily resulted in a reduction in eltrombopag plasma AUC0-∞ by 17% (90% CI: 6.6%, 26.6%). Therefore, caution should be used when co-administration of eltrombopag with lopinavir/ritonavir takes place. Platelet count should be closely monitored in order to ensure appropriate medical management of the dose of eltrombopag when lopinavir/ritonavir therapy is initiated or discontinued.", "truncated": false}, "before_length": 657, "before_sha256": "1250bf7c938941142309959035fbb32b6d796d6ad8da7f8d8f23bc6940396357", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-051b5aee017d6e949caea1e6", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006459", "medicine_name": "Eltrombopag Accord", "medicine_slug": "eltrombopag-accord", "observed_at": "2026-10-12T19:38:22Z", "pipeline_version": "2.0.0", "presentation_label": "Eltrombopag Accord 12.5 mg film-coated tablets Eltrombopag Accord 25 mg film-coated tablets Eltrombopag Accord 50 mg film-coated tablets Eltrombopag Accord 75 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": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "0485f44a0e25bf9e0f930e8ce8c053598ed2a48f78476ffafefb66d9fb3e8d89", "source_snapshot_id": "source-d7e0f3276633f5a4a1cef1a4", "source_updated_at": "2025-05-20", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/eltrombopag-accord-epar-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": 55, "start": 0, "text": "Emtricitabine/ Tenofovir alafenamide containing regimen", "truncated": false}, "after_length": 55, "after_sha256": "9002e972f34e174ed4eb0ca974e2b1e239b5481bb1b8f7f4d7f13d638bcf2954", "annex": "I", "before": {"end": 55, "start": 0, "text": "Emtricitabine/ Tenofovir alafenamide containing regimen", "truncated": false}, "before_length": 55, "before_sha256": "9002e972f34e174ed4eb0ca974e2b1e239b5481bb1b8f7f4d7f13d638bcf2954", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-051e2ec9ee31166661fe6c43", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006469", "medicine_name": "Emtricitabine / Tenofovir alafenamide Viatris", "medicine_slug": "emtricitabine-tenofovir-alafenamide-viatris", "observed_at": "2026-10-12T13:40:14Z", "pipeline_version": "2.0.0", "presentation_label": "Emtricitabine/Tenofovir alafenamide Viatris 200 mg/10 mg filmcoated tablets Emtricitabine/Tenofovir alafenamide Viatris 200 mg/25 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": "247b89d7ca1efa91cffaeb0f00556dd381d81e804eb2f9c23631d01a49578ea7", "source_snapshot_id": "source-246d08888d5f52d006efa07f", "source_updated_at": "2026-04-16", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/emtricitabine-tenofovir-alafenamide-viatris-epar-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": 510, "start": 0, "text": "Patients were randomised (1:1) to receive Alecensa or platinumbased chemotherapy following tumour resection. Randomisation was stratified by race (Asian and nonAsian) and stage of disease (IB, II and IIIA). Alecensa was administered at the recommended oral dose of 600 mg twice daily for a total of 2 years, or until disease recurrence or unacceptable toxicity. Platinumbased chemotherapy was administered intravenously for 4 cycles, with each cycle lasting 21 days, according to one of the following regimens:", "truncated": false}, "after_length": 510, "after_sha256": "b141b90d7abcce2d19d51b1d91bc0783101a243440942720c4524e4559c2d4f3", "annex": "I", "before": {"end": 510, "start": 0, "text": "Patients were randomised (1:1) to receive Alecensa or platinumbased chemotherapy following tumour resection. Randomisation was stratified by race (Asian and nonAsian) and stage of disease (IB, II and IIIA). Alecensa was administered at the recommended oral dose of 600 mg twice daily for a total of 2 years, or until disease recurrence or unacceptable toxicity. Platinumbased chemotherapy was administered intravenously for 4 cycles, with each cycle lasting 21 days, according to one of the following regimens:", "truncated": false}, "before_length": 510, "before_sha256": "b141b90d7abcce2d19d51b1d91bc0783101a243440942720c4524e4559c2d4f3", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-051e89b5b9ea1137501d703d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004164", "medicine_name": "Alecensa", "medicine_slug": "alecensa", "observed_at": "2026-10-12T19:00:33Z", "pipeline_version": "2.0.0", "presentation_label": "Alecensa 150 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "815d015f485abccb366cc8b59bef3ff2b7589fb9206cca47f8f889f776e1f3af", "source_snapshot_id": "source-c8b17db176ebb33561bb1413", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/alecensa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 436}
{"after": {"end": 85, "start": 0, "text": "Patients infectés par le VIH-1 et présentant une insuffisance rénale légère à modérée", "truncated": false}, "after_length": 85, "after_sha256": "20a9d02bb4942613da3889e58ccca25eb8ac39f6a9ffb5477997c8f9da2c2d90", "annex": "I", "before": {"end": 85, "start": 0, "text": "Patients infectés par le VIH-1 et présentant une insuffisance rénale légère à modérée", "truncated": false}, "before_length": 85, "before_sha256": "20a9d02bb4942613da3889e58ccca25eb8ac39f6a9ffb5477997c8f9da2c2d90", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-05288dde8b6ef564e556bdb7", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006469", "medicine_name": "Emtricitabine / Tenofovir alafenamide Viatris", "medicine_slug": "emtricitabine-tenofovir-alafenamide-viatris", "observed_at": "2026-10-12T13:40:17Z", "pipeline_version": "2.0.0", "presentation_label": "Emtricitabine/Ténofovir alafénamide Viatris 200 mg/10 mg, comprimés pelliculés Emtricitabine/Ténofovir alafénamide Viatris 200 mg/25 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "f756470c4d010c80a3cc0e1d2d813c1c039c3ca68b113594de79e065fdc70412", "source_snapshot_id": "source-e58329b521b2e223a700355b", "source_updated_at": "2026-04-16", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/emtricitabine-tenofovir-alafenamide-viatris-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 984}
{"after": {"end": 69, "start": 0, "text": "Results of response on treatment analysis by time since ITP diagnosis", "truncated": false}, "after_length": 69, "after_sha256": "9dee4d03351db3106b678009530f6872e371e4d988ba4defe66eca7ad299fff3", "annex": "I", "before": {"end": 69, "start": 0, "text": "Results of response on treatment analysis by time since ITP diagnosis", "truncated": false}, "before_length": 69, "before_sha256": "9dee4d03351db3106b678009530f6872e371e4d988ba4defe66eca7ad299fff3", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-054a89d2e872461477ab8adf", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006459", "medicine_name": "Eltrombopag Accord", "medicine_slug": "eltrombopag-accord", "observed_at": "2026-10-12T19:38:22Z", "pipeline_version": "2.0.0", "presentation_label": "Eltrombopag Accord 12.5 mg film-coated tablets Eltrombopag Accord 25 mg film-coated tablets Eltrombopag Accord 50 mg film-coated tablets Eltrombopag Accord 75 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "0485f44a0e25bf9e0f930e8ce8c053598ed2a48f78476ffafefb66d9fb3e8d89", "source_snapshot_id": "source-d7e0f3276633f5a4a1cef1a4", "source_updated_at": "2025-05-20", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/eltrombopag-accord-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 982}
{"after": {"end": 227, "start": 0, "text": "La dose initiale recommandée d'eltrombopag est de 50 mg une fois par jour. Pour les patients originaires d’Asie de l’Est/Sud-Est, l’eltrombopag doit être initié à une dose réduite de 25 mg une fois par jour (voir rubrique 5.2).", "truncated": false}, "after_length": 227, "after_sha256": "3ab262772356d0b39e90934e735e07fff8a42dabfb9dc1046f1fcb921ae542d1", "annex": "I", "before": {"end": 227, "start": 0, "text": "La dose initiale recommandée d'eltrombopag est de 50 mg une fois par jour. Pour les patients originaires d’Asie de l’Est/Sud-Est, l’eltrombopag doit être initié à une dose réduite de 25 mg une fois par jour (voir rubrique 5.2).", "truncated": false}, "before_length": 227, "before_sha256": "3ab262772356d0b39e90934e735e07fff8a42dabfb9dc1046f1fcb921ae542d1", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-054b1a04e7786084f2a1c259", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006459", "medicine_name": "Eltrombopag Accord", "medicine_slug": "eltrombopag-accord", "observed_at": "2026-10-12T19:38:33Z", "pipeline_version": "2.0.0", "presentation_label": "Eltrombopag Accord 12,5 mg, comprimés pelliculés Eltrombopag Accord 25 mg, comprimés pelliculés Eltrombopag Accord 50 mg, comprimés pelliculés Eltrombopag Accord 75 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": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "4dba9ba2d13e28b9b00b5cee0ebfe8b72ef357d185dbbf0def82cb05d9f63530", "source_snapshot_id": "source-acb656ad31eb3184c264b4cd", "source_updated_at": "2025-05-20", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/eltrombopag-accord-epar-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": 422, "start": 0, "text": "Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/or long-term exposure to CART. Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.", "truncated": false}, "after_length": 422, "after_sha256": "1c3a7c53c2e418420e02693d618de7013e6d84b51e2f491b70afbc46588ff2c9", "annex": "I", "before": {"end": 422, "start": 0, "text": "Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/or long-term exposure to CART. Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.", "truncated": false}, "before_length": 422, "before_sha256": "1c3a7c53c2e418420e02693d618de7013e6d84b51e2f491b70afbc46588ff2c9", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-054b92029c6acab2ea70acb8", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006469", "medicine_name": "Emtricitabine / Tenofovir alafenamide Viatris", "medicine_slug": "emtricitabine-tenofovir-alafenamide-viatris", "observed_at": "2026-10-12T13:40:14Z", "pipeline_version": "2.0.0", "presentation_label": "Emtricitabine/Tenofovir alafenamide Viatris 200 mg/10 mg filmcoated tablets Emtricitabine/Tenofovir alafenamide Viatris 200 mg/25 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": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "247b89d7ca1efa91cffaeb0f00556dd381d81e804eb2f9c23631d01a49578ea7", "source_snapshot_id": "source-246d08888d5f52d006efa07f", "source_updated_at": "2026-04-16", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/emtricitabine-tenofovir-alafenamide-viatris-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 165}
{"after": {"end": 64, "start": 0, "text": "Infusion reactions, allergic-like reactions and hypersensitivity", "truncated": false}, "after_length": 64, "after_sha256": "440b11089212cd61bbf6a0969af02756d79fb5ea6b185c5192c28459eb99ff51", "annex": "I", "before": {"end": 64, "start": 0, "text": "Infusion reactions, allergic-like reactions and hypersensitivity", "truncated": false}, "before_length": 64, "before_sha256": "440b11089212cd61bbf6a0969af02756d79fb5ea6b185c5192c28459eb99ff51", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-054ee8738da3ff40de71e8f8", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004361", "medicine_name": "Kanjinti", "medicine_slug": "kanjinti", "observed_at": "2026-10-12T19:40:28Z", "pipeline_version": "2.0.0", "presentation_label": "KANJINTI 150 mg powder for concentrate for solution for infusion KANJINTI 420 mg powder for 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": "9f4119e69f965285688c3402ad669f6dc3298fbbaf20f5909a83d03f0f927312", "source_snapshot_id": "source-4222dc61a5c401d9ea981d06", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/kanjinti-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 751}
{"after": {"end": 55, "start": 0, "text": "Troubles généraux et anomalies au site d’administration", "truncated": false}, "after_length": 55, "after_sha256": "e3f83e4cc859b8934fee6b7e7b4aad54d495f591eba36a9dd96935a56770867e", "annex": "I", "before": {"end": 55, "start": 0, "text": "Troubles généraux et anomalies au site d’administration", "truncated": false}, "before_length": 55, "before_sha256": "e3f83e4cc859b8934fee6b7e7b4aad54d495f591eba36a9dd96935a56770867e", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-055871a4e8fabeb625c69762", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006469", "medicine_name": "Emtricitabine / Tenofovir alafenamide Viatris", "medicine_slug": "emtricitabine-tenofovir-alafenamide-viatris", "observed_at": "2026-10-12T13:40:17Z", "pipeline_version": "2.0.0", "presentation_label": "Emtricitabine/Ténofovir alafénamide Viatris 200 mg/10 mg, comprimés pelliculés Emtricitabine/Ténofovir alafénamide Viatris 200 mg/25 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": "f756470c4d010c80a3cc0e1d2d813c1c039c3ca68b113594de79e065fdc70412", "source_snapshot_id": "source-e58329b521b2e223a700355b", "source_updated_at": "2026-04-16", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/emtricitabine-tenofovir-alafenamide-viatris-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 604}
{"after": {"end": 493, "start": 0, "text": "Les inhibiteurs de la pompe à protons sont associés à des cas très peu fréquents de LECS. Si des lésions se développent, notamment sur les zones cutanées exposées au soleil, et si elles s'accompagnent d'arthralgie, le patient doit consulter un médecin rapidement et le professionnel de santé doit envisager d'arrêter Nexium Control. La survenue d’un LECS après traitement par un inhibiteur de la pompe à protons peut augmenter le risque de LECS avec d'autres inhibiteurs de la pompe à protons.", "truncated": false}, "after_length": 493, "after_sha256": "aa0f50146c285d6284d27ebdb1f79a8c5a7da5aa6fa401faa12e46d644ba3764", "annex": "I", "before": {"end": 493, "start": 0, "text": "Les inhibiteurs de la pompe à protons sont associés à des cas très peu fréquents de LECS. Si des lésions se développent, notamment sur les zones cutanées exposées au soleil, et si elles s'accompagnent d'arthralgie, le patient doit consulter un médecin rapidement et le professionnel de santé doit envisager d'arrêter Nexium Control. La survenue d’un LECS après traitement par un inhibiteur de la pompe à protons peut augmenter le risque de LECS avec d'autres inhibiteurs de la pompe à protons.", "truncated": false}, "before_length": 493, "before_sha256": "aa0f50146c285d6284d27ebdb1f79a8c5a7da5aa6fa401faa12e46d644ba3764", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-056c05473e152d1484fa6606", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002618", "medicine_name": "Nexium Control", "medicine_slug": "nexium-control", "observed_at": "2026-10-12T13:36:18Z", "pipeline_version": "2.0.0", "presentation_label": "Nexium Control 20 mg, gélules gastrorésistantes", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "dd192e79554a2cf904e3b717c765e723c89937d2250f85a0df30f9a56f6cb2e1", "source_snapshot_id": "source-614e91f5970645497b96d67b", "source_updated_at": "2026-06-03", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nexium-control-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 591}
{"after": {"end": 114, "start": 0, "text": "Temporarily withhold until recovery to baseline or to ≤ 2.5 times ULN, then resume at reduced dose as per Table 1.", "truncated": false}, "after_length": 114, "after_sha256": "183fcf0eca45c7813372cad69faa92bd6010d35f99ad467c4f00a30f23cbad52", "annex": "I", "before": {"end": 114, "start": 0, "text": "Temporarily withhold until recovery to baseline or to ≤ 2.5 times ULN, then resume at reduced dose as per Table 1.", "truncated": false}, "before_length": 114, "before_sha256": "183fcf0eca45c7813372cad69faa92bd6010d35f99ad467c4f00a30f23cbad52", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-05738a6217d56dcfaa9e9e1a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004164", "medicine_name": "Alecensa", "medicine_slug": "alecensa", "observed_at": "2026-10-12T19:00:33Z", "pipeline_version": "2.0.0", "presentation_label": "Alecensa 150 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": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "815d015f485abccb366cc8b59bef3ff2b7589fb9206cca47f8f889f776e1f3af", "source_snapshot_id": "source-c8b17db176ebb33561bb1413", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/alecensa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 117}
{"after": {"end": 783, "start": 0, "text": "EARLY ACS (Early Glycoprotein IIb/IIIa Inhibition in Non-ST-segment Elevation Acute Coronary Syndrome) was a study of early routine eptifibatide versus placebo (with delayed provisional use of eptifibatide in the catheterization laboratory) used in combination with antithrombotic therapies (ASA, UFH, bivalirudin, fondaparinux or low molecular weight heparin), in subjects with high-risk NSTE ACS. Patients were to undergo an invasive strategy for further management after receiving study drug for 12 to 96 hours. Patients could be medically managed, proceed to coronary artery bypass graft (CABG), or undergo percutaneous coronary intervention (PCI). Unlike the approved posology in the EU, the study used a double bolus of study drug (separated by 10 minutes) before the infusion.", "truncated": false}, "after_length": 783, "after_sha256": "86e57addf8d80fdf8e174686f797d970fee268797dae60e9ab799f4182ad1eec", "annex": "I", "before": {"end": 783, "start": 0, "text": "EARLY ACS (Early Glycoprotein IIb/IIIa Inhibition in Non-ST-segment Elevation Acute Coronary Syndrome) was a study of early routine eptifibatide versus placebo (with delayed provisional use of eptifibatide in the catheterization laboratory) used in combination with antithrombotic therapies (ASA, UFH, bivalirudin, fondaparinux or low molecular weight heparin), in subjects with high-risk NSTE ACS. Patients were to undergo an invasive strategy for further management after receiving study drug for 12 to 96 hours. Patients could be medically managed, proceed to coronary artery bypass graft (CABG), or undergo percutaneous coronary intervention (PCI). Unlike the approved posology in the EU, the study used a double bolus of study drug (separated by 10 minutes) before the infusion.", "truncated": false}, "before_length": 783, "before_sha256": "86e57addf8d80fdf8e174686f797d970fee268797dae60e9ab799f4182ad1eec", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-059383fdf9a8839c54402495", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004104", "medicine_name": "Eptifibatide Accord", "medicine_slug": "eptifibatide-accord", "observed_at": "2026-10-12T19:45:01Z", "pipeline_version": "2.0.0", "presentation_label": "Eptifibatide Accord 0.75 mg/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": "a45982959a207e1611cd67a6103370f86a234e3c45dfb3ab49b532886fe928cb", "source_snapshot_id": "source-8dd88a3db45e564c959f66e5", "source_updated_at": "2025-05-02", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/eptifibatide-accord-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 356}
{"after": {"end": 278, "start": 0, "text": "As a cholinesterase inhibitor, rivastigmine may exaggerate the effects of succinylcholine-type muscle relaxants during anaesthesia. Caution is recommended when selecting anaesthetic agents. Possible dose adjustments or temporarily stopping treatment can be considered if needed.", "truncated": false}, "after_length": 278, "after_sha256": "229130c962bd4df352d4f0614a79cb7ee2df47c056e50f6c6f97efbf9928eb65", "annex": "I", "before": {"end": 278, "start": 0, "text": "As a cholinesterase inhibitor, rivastigmine may exaggerate the effects of succinylcholine-type muscle relaxants during anaesthesia. Caution is recommended when selecting anaesthetic agents. Possible dose adjustments or temporarily stopping treatment can be considered if needed.", "truncated": false}, "before_length": 278, "before_sha256": "229130c962bd4df352d4f0614a79cb7ee2df47c056e50f6c6f97efbf9928eb65", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-059f99045f3598b60b4119bd", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001029", "medicine_name": "Nimvastid", "medicine_slug": "nimvastid", "observed_at": "2026-10-12T19:24:00Z", "pipeline_version": "2.0.0", "presentation_label": "Nimvastid 1.5 mg hard capsules Nimvastid 3 mg hard capsules Nimvastid 4.5 mg hard capsules Nimvastid 6 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": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "fa4c6e344db60bf4064eb3cc2d76d72c0fc858894147724d88ab2d66b9f9a0dc", "source_snapshot_id": "source-775bf49790604674d3549dac", "source_updated_at": "2025-07-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nimvastid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 165}
{"after": {"end": 133, "start": 0, "text": "Le traitement par Alecensa doit être poursuivi jusqu’à récidive de la maladie, survenue d’une toxicité inacceptable ou pendant 2 ans.", "truncated": false}, "after_length": 133, "after_sha256": "a3602f81d5ea868ae50e1ebb0dcfe3a66024be6dab91e78bec0e9637f03e50da", "annex": "I", "before": {"end": 133, "start": 0, "text": "Le traitement par Alecensa doit être poursuivi jusqu’à récidive de la maladie, survenue d’une toxicité inacceptable ou pendant 2 ans.", "truncated": false}, "before_length": 133, "before_sha256": "a3602f81d5ea868ae50e1ebb0dcfe3a66024be6dab91e78bec0e9637f03e50da", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-05c90191b4fa9960d0184dfb", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004164", "medicine_name": "Alecensa", "medicine_slug": "alecensa", "observed_at": "2026-10-12T19:00:36Z", "pipeline_version": "2.0.0", "presentation_label": "Alecensa 150 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": "83ee6e171c0e05bd6ab2daf5408dcacb676175e21156c6f5251ff1b3290852d9", "source_snapshot_id": "source-b1925a54bfeff5c1398e0f30", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/alecensa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 72}
{"after": {"end": 55, "start": 0, "text": "Cross-over comparison with placebo (Ferster et al 1996)", "truncated": false}, "after_length": 55, "after_sha256": "5eb9e4e057183417c11b550aa37763ce1f04548795e646c285d0d0a662069520", "annex": "I", "before": {"end": 55, "start": 0, "text": "Cross-over comparison with placebo (Ferster et al 1996)", "truncated": false}, "before_length": 55, "before_sha256": "5eb9e4e057183417c11b550aa37763ce1f04548795e646c285d0d0a662069520", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-05cbf6903e9639cc12d6bca9", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004837", "medicine_name": "Xromi", "medicine_slug": "xromi", "observed_at": "2026-10-12T19:31:37Z", "pipeline_version": "2.0.0", "presentation_label": "Xromi 100 mg/ml oral solution", "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": "5e9826d3dd1edc48d9eb87b57c4ee7e70574bc6ce1c841b5477a3de3b9950a1e", "source_snapshot_id": "source-d10ea7497b831a802d8ae623", "source_updated_at": "2025-06-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/xromi-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 332}
{"after": {"end": 637, "start": 0, "text": "Patients treated with KANJINTI are at increased risk for developing CHF (New York Heart Association [NYHA] class IIIV) or asymptomatic cardiac dysfunction. These events have been observed in patients receiving trastuzumab therapy alone or in combination with paclitaxel or docetaxel, particularly following anthracycline (doxorubicin or epirubicin) containing chemotherapy. These may be moderate to severe and have been associated with death (see section 4.8). In addition, caution should be exercised in treating patients with increased cardiac risk, e.g. hypertension, documented coronary artery disease, CHF, LVEF of < 55%, older age.", "truncated": false}, "after_length": 637, "after_sha256": "9e9a6b682e6eec04721a2db9ef7a041faf0780c346e2e66e91456d26df33ed67", "annex": "I", "before": {"end": 637, "start": 0, "text": "Patients treated with KANJINTI are at increased risk for developing CHF (New York Heart Association [NYHA] class IIIV) or asymptomatic cardiac dysfunction. These events have been observed in patients receiving trastuzumab therapy alone or in combination with paclitaxel or docetaxel, particularly following anthracycline (doxorubicin or epirubicin) containing chemotherapy. These may be moderate to severe and have been associated with death (see section 4.8). In addition, caution should be exercised in treating patients with increased cardiac risk, e.g. hypertension, documented coronary artery disease, CHF, LVEF of < 55%, older age.", "truncated": false}, "before_length": 637, "before_sha256": "9e9a6b682e6eec04721a2db9ef7a041faf0780c346e2e66e91456d26df33ed67", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-05cd6452706c19987a78d15a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004361", "medicine_name": "Kanjinti", "medicine_slug": "kanjinti", "observed_at": "2026-10-12T19:40:28Z", "pipeline_version": "2.0.0", "presentation_label": "KANJINTI 150 mg powder for concentrate for solution for infusion KANJINTI 420 mg powder for 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": "9f4119e69f965285688c3402ad669f6dc3298fbbaf20f5909a83d03f0f927312", "source_snapshot_id": "source-4222dc61a5c401d9ea981d06", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/kanjinti-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 180}
{"after": {"end": 45, "start": 0, "text": "Amélioration à l’ADAS-Cog d’au moins 4 points", "truncated": false}, "after_length": 45, "after_sha256": "3ee7d29b3f53bd945150542ffa536f410c29408c0fbd8bdcd4091f748beda428", "annex": "I", "before": {"end": 45, "start": 0, "text": "Amélioration à l’ADAS-Cog d’au moins 4 points", "truncated": false}, "before_length": 45, "before_sha256": "3ee7d29b3f53bd945150542ffa536f410c29408c0fbd8bdcd4091f748beda428", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-05ced817f3a39d450c5d1a84", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/001029", "medicine_name": "Nimvastid", "medicine_slug": "nimvastid", "observed_at": "2026-10-12T19:24:04Z", "pipeline_version": "2.0.0", "presentation_label": "Nimvastid 1,5 mg gélule Nimvastid 3 mg gélule Nimvastid 4,5 mg gélule Nimvastid 6 mg gélule", "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": "8e6eaa143ff5f69cfa4caba1806dbd754ee713f2f64ce6a1b369433c9e511b46", "source_snapshot_id": "source-655cd60c5475e58b35c5a1c3", "source_updated_at": "2025-07-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nimvastid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1380}
{"after": {"end": 177, "start": 0, "text": "The data sources used to determine adverse reaction frequency descriptors included two phase III clinical studies (PURSUIT and ESPRIT). These trials are briefly described below.", "truncated": false}, "after_length": 177, "after_sha256": "ce7aefc233f1272174fc78c665c837e44ff610118fd9ad006ecadec43db03d57", "annex": "I", "before": {"end": 177, "start": 0, "text": "The data sources used to determine adverse reaction frequency descriptors included two phase III clinical studies (PURSUIT and ESPRIT). These trials are briefly described below.", "truncated": false}, "before_length": 177, "before_sha256": "ce7aefc233f1272174fc78c665c837e44ff610118fd9ad006ecadec43db03d57", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-05e02a98bdb288eb0414c42c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004104", "medicine_name": "Eptifibatide Accord", "medicine_slug": "eptifibatide-accord", "observed_at": "2026-10-12T19:45:01Z", "pipeline_version": "2.0.0", "presentation_label": "Eptifibatide Accord 0.75 mg/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": "a45982959a207e1611cd67a6103370f86a234e3c45dfb3ab49b532886fe928cb", "source_snapshot_id": "source-8dd88a3db45e564c959f66e5", "source_updated_at": "2025-05-02", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/eptifibatide-accord-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 201}
{"after": {"end": 228, "start": 0, "text": "La réduction de l’incidence de ces évènements du critère principal chez les patients recevant de l’eptifibatide est apparue tôt au cours du traitement. Il n’y a pas eu d’augmentation ultérieure de ce bénéfice et ce jusqu’à 1 an.", "truncated": false}, "after_length": 228, "after_sha256": "1ccb0c7af476608ee7504af57c5c4e483b2566a4fe971d637cf39342ef12ed12", "annex": "I", "before": {"end": 228, "start": 0, "text": "La réduction de l’incidence de ces évènements du critère principal chez les patients recevant de l’eptifibatide est apparue tôt au cours du traitement. Il n’y a pas eu d’augmentation ultérieure de ce bénéfice et ce jusqu’à 1 an.", "truncated": false}, "before_length": 228, "before_sha256": "1ccb0c7af476608ee7504af57c5c4e483b2566a4fe971d637cf39342ef12ed12", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0601d5d74918dac5f04f5771", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004104", "medicine_name": "Eptifibatide Accord", "medicine_slug": "eptifibatide-accord", "observed_at": "2026-10-12T19:45:11Z", "pipeline_version": "2.0.0", "presentation_label": "Eptifibatide Accord 0,75 mg/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": "c9be002148fa73331c72aadac205f927e043f3407cf695e63a1cbe715480600b", "source_snapshot_id": "source-9e33d5d566c95289f1a7e6a6", "source_updated_at": "2025-05-02", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/eptifibatide-accord-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 350}
{"after": {"end": 331, "start": 0, "text": "In an exploratory subgroup analysis performed in the TOGA (BO18255) study there was no apparent benefit on overall survival with the addition of trastuzumab in patients with ECOG PS 2 at baseline [HR 0.96 (95% CI: 0.51-1.79)], non measurable [HR 1.78 (95% CI: 0.87-3.66)] and locally advanced disease [HR 1.20 (95% CI: 0.29-4.97)].", "truncated": false}, "after_length": 331, "after_sha256": "97bdf44aac5125a77f6b10e907e2aedc820151bea8c51796486169fbca1f614f", "annex": "I", "before": {"end": 331, "start": 0, "text": "In an exploratory subgroup analysis performed in the TOGA (BO18255) study there was no apparent benefit on overall survival with the addition of trastuzumab in patients with ECOG PS 2 at baseline [HR 0.96 (95% CI: 0.51-1.79)], non measurable [HR 1.78 (95% CI: 0.87-3.66)] and locally advanced disease [HR 1.20 (95% CI: 0.29-4.97)].", "truncated": false}, "before_length": 331, "before_sha256": "97bdf44aac5125a77f6b10e907e2aedc820151bea8c51796486169fbca1f614f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-060a6dbdbdf9f04a3debaec3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004361", "medicine_name": "Kanjinti", "medicine_slug": "kanjinti", "observed_at": "2026-10-12T19:40:28Z", "pipeline_version": "2.0.0", "presentation_label": "KANJINTI 150 mg powder for concentrate for solution for infusion KANJINTI 420 mg powder for 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "9f4119e69f965285688c3402ad669f6dc3298fbbaf20f5909a83d03f0f927312", "source_snapshot_id": "source-4222dc61a5c401d9ea981d06", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/kanjinti-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1536}
{"after": {"end": 41, "start": 0, "text": "Description of selected adverse reactions", "truncated": false}, "after_length": 41, "after_sha256": "f66db2a8100a521c1dea72ff90e696fa3846f9d5fcd6cf8e5e03ce5d71bde4a7", "annex": "I", "before": {"end": 41, "start": 0, "text": "Description of selected adverse reactions", "truncated": false}, "before_length": 41, "before_sha256": "f66db2a8100a521c1dea72ff90e696fa3846f9d5fcd6cf8e5e03ce5d71bde4a7", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0614b7e5b9e2de6d36c12309", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002345", "medicine_name": "Revestive", "medicine_slug": "revestive", "observed_at": "2026-10-12T19:38:01Z", "pipeline_version": "2.0.0", "presentation_label": "Revestive 5 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": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "0125d033ce2f8805dc45ece9b8ffa34db6682b195448a3a560e6d2483a8982b4", "source_snapshot_id": "source-8d7c3200418c650a002546aa", "source_updated_at": "2025-05-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/revestive-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1002}
{"after": {"end": 43, "start": 0, "text": "8 mg/kg + 6 mg/kg toutes les trois semaines", "truncated": false}, "after_length": 43, "after_sha256": "cea162c5d70e753f6ac20b3af58668760fde50d6f24ae0a4a0b3062e4b2f33f8", "annex": "I", "before": {"end": 43, "start": 0, "text": "8 mg/kg + 6 mg/kg toutes les trois semaines", "truncated": false}, "before_length": 43, "before_sha256": "cea162c5d70e753f6ac20b3af58668760fde50d6f24ae0a4a0b3062e4b2f33f8", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0618e29859e14cc17b70c56f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004361", "medicine_name": "Kanjinti", "medicine_slug": "kanjinti", "observed_at": "2026-10-12T19:40:38Z", "pipeline_version": "2.0.0", "presentation_label": "KANJINTI 150 mg poudre pour solution à diluer pour perfusion KANJINTI 420 mg poudre pour 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": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "ea9ea0ca90af9dcbc236774255b0290bf3e784884d88a33522b45c8050f829cf", "source_snapshot_id": "source-a4621a49bcc40ac3f94d4939", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/kanjinti-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1627}
{"after": {"end": 46, "start": 0, "text": "Eltrombopag Accord 50 mg, comprimés pelliculés", "truncated": false}, "after_length": 46, "after_sha256": "86166e8e9bab096c20e54b26aa10a97c99072fa36fb6d237abd8f97d7c60dc84", "annex": "I", "before": {"end": 46, "start": 0, "text": "Eltrombopag Accord 50 mg, comprimés pelliculés", "truncated": false}, "before_length": 46, "before_sha256": "86166e8e9bab096c20e54b26aa10a97c99072fa36fb6d237abd8f97d7c60dc84", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-063a771c086d066b6d4164ed", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006459", "medicine_name": "Eltrombopag Accord", "medicine_slug": "eltrombopag-accord", "observed_at": "2026-10-12T19:38:33Z", "pipeline_version": "2.0.0", "presentation_label": "Eltrombopag Accord 12,5 mg, comprimés pelliculés Eltrombopag Accord 25 mg, comprimés pelliculés Eltrombopag Accord 50 mg, comprimés pelliculés Eltrombopag Accord 75 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": "8", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "4dba9ba2d13e28b9b00b5cee0ebfe8b72ef357d185dbbf0def82cb05d9f63530", "source_snapshot_id": "source-acb656ad31eb3184c264b4cd", "source_updated_at": "2025-05-20", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/eltrombopag-accord-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1403}
{"after": {"end": 132, "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}, "after_length": 132, "after_sha256": "fba34ac1edb209ef8124b4946314ce314afe37296fd79bd3bc12621669c97835", "annex": "I", "before": {"end": 132, "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": 132, "before_sha256": "fba34ac1edb209ef8124b4946314ce314afe37296fd79bd3bc12621669c97835", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-063d5249739dd890cf9fa5b0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004104", "medicine_name": "Eptifibatide Accord", "medicine_slug": "eptifibatide-accord", "observed_at": "2026-10-12T19:45:01Z", "pipeline_version": "2.0.0", "presentation_label": "Eptifibatide Accord 0.75 mg/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": "10", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "a45982959a207e1611cd67a6103370f86a234e3c45dfb3ab49b532886fe928cb", "source_snapshot_id": "source-8dd88a3db45e564c959f66e5", "source_updated_at": "2025-05-02", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/eptifibatide-accord-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 452}
{"after": {"end": 590, "start": 0, "text": "La grande majorité des patients a reçu de l’acide acétylsalicylique (75-325 mg une fois par jour). L’héparine non fractionnée était administrée par voie intraveineuse ou sous-cutanée selon le choix du médecin, le plus souvent sous forme d’un bolus intraveineux de 5.000 U suivi par une perfusion continue de 1.000 U/h. Un TCA de 50-70 secondes était recommandé. Un total de 1.250 patients a subi une ICP dans les 72 heures suivant la randomisation, avec une administration intraveineuse d’héparine non fractionnée afin de maintenir un temps de coagulation activée (ACT) de 300-350 secondes.", "truncated": false}, "after_length": 590, "after_sha256": "c5d1c4ff5d7f15bfacb8bb235bdbf951ca544064f64a71200ccdf40862bdcc19", "annex": "I", "before": {"end": 590, "start": 0, "text": "La grande majorité des patients a reçu de l’acide acétylsalicylique (75-325 mg une fois par jour). L’héparine non fractionnée était administrée par voie intraveineuse ou sous-cutanée selon le choix du médecin, le plus souvent sous forme d’un bolus intraveineux de 5.000 U suivi par une perfusion continue de 1.000 U/h. Un TCA de 50-70 secondes était recommandé. Un total de 1.250 patients a subi une ICP dans les 72 heures suivant la randomisation, avec une administration intraveineuse d’héparine non fractionnée afin de maintenir un temps de coagulation activée (ACT) de 300-350 secondes.", "truncated": false}, "before_length": 590, "before_sha256": "c5d1c4ff5d7f15bfacb8bb235bdbf951ca544064f64a71200ccdf40862bdcc19", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0645ecedd85fc0afae5059df", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004104", "medicine_name": "Eptifibatide Accord", "medicine_slug": "eptifibatide-accord", "observed_at": "2026-10-12T19:45:11Z", "pipeline_version": "2.0.0", "presentation_label": "Eptifibatide Accord 0,75 mg/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": "c9be002148fa73331c72aadac205f927e043f3407cf695e63a1cbe715480600b", "source_snapshot_id": "source-9e33d5d566c95289f1a7e6a6", "source_updated_at": "2025-05-02", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/eptifibatide-accord-epar-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": 208, "start": 0, "text": "En règle générale, la SISH ou la FISH est considérée comme positive si le rapport entre le nombre de copies du gène HER2 par cellule tumorale et le nombre de copies du chromosome 17 est supérieur ou égal à 2.", "truncated": false}, "after_length": 208, "after_sha256": "2eeac9006cbf20fa2b58464d44fbaeb29b612d491c74822165d6ffc322690ac1", "annex": "I", "before": {"end": 208, "start": 0, "text": "En règle générale, la SISH ou la FISH est considérée comme positive si le rapport entre le nombre de copies du gène HER2 par cellule tumorale et le nombre de copies du chromosome 17 est supérieur ou égal à 2.", "truncated": false}, "before_length": 208, "before_sha256": "2eeac9006cbf20fa2b58464d44fbaeb29b612d491c74822165d6ffc322690ac1", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-064ca936fae9daf1a993d993", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004361", "medicine_name": "Kanjinti", "medicine_slug": "kanjinti", "observed_at": "2026-10-12T19:40:38Z", "pipeline_version": "2.0.0", "presentation_label": "KANJINTI 150 mg poudre pour solution à diluer pour perfusion KANJINTI 420 mg poudre pour 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": "ea9ea0ca90af9dcbc236774255b0290bf3e784884d88a33522b45c8050f829cf", "source_snapshot_id": "source-a4621a49bcc40ac3f94d4939", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/kanjinti-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 865}
{"after": {"end": 154, "start": 0, "text": "Additionally there have been post-marketing cases of dizziness, tremor, headache, somnolence, confusional state, hypertension, hallucinations and malaise.", "truncated": false}, "after_length": 154, "after_sha256": "ccac79ea05f552d468252f2c87ac905cc21cdddc71cb6de1aff3711f3eb1119c", "annex": "I", "before": {"end": 154, "start": 0, "text": "Additionally there have been post-marketing cases of dizziness, tremor, headache, somnolence, confusional state, hypertension, hallucinations and malaise.", "truncated": false}, "before_length": 154, "before_sha256": "ccac79ea05f552d468252f2c87ac905cc21cdddc71cb6de1aff3711f3eb1119c", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0650618d6c4fa038b747b72f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001029", "medicine_name": "Nimvastid", "medicine_slug": "nimvastid", "observed_at": "2026-10-12T19:24:00Z", "pipeline_version": "2.0.0", "presentation_label": "Nimvastid 1.5 mg hard capsules Nimvastid 3 mg hard capsules Nimvastid 4.5 mg hard capsules Nimvastid 6 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": "4.9", "section_type": "overdose", "source_provider": "European Medicines Agency", "source_sha256": "fa4c6e344db60bf4064eb3cc2d76d72c0fc858894147724d88ab2d66b9f9a0dc", "source_snapshot_id": "source-775bf49790604674d3549dac", "source_updated_at": "2025-07-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nimvastid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 487}
{"after": {"end": 86, "start": 0, "text": "Citalopram, imipramine ou clomipramine (utilisés dans le traitement de la dépression).", "truncated": false}, "after_length": 86, "after_sha256": "3c4c8aeac2436c307af8a4575c419b97f53a06c26678d0af05b6a79eb2ae93db", "annex": "IIIB", "before": {"end": 86, "start": 0, "text": "Citalopram, imipramine ou clomipramine (utilisés dans le traitement de la dépression).", "truncated": false}, "before_length": 86, "before_sha256": "3c4c8aeac2436c307af8a4575c419b97f53a06c26678d0af05b6a79eb2ae93db", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-06550b46875560517926667a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002618", "medicine_name": "Nexium Control", "medicine_slug": "nexium-control", "observed_at": "2026-10-12T13:36:18Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 2, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "dd192e79554a2cf904e3b717c765e723c89937d2250f85a0df30f9a56f6cb2e1", "source_snapshot_id": "source-614e91f5970645497b96d67b", "source_updated_at": "2026-06-03", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nexium-control-epar-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": 131, "start": 0, "text": "CI confidence interval; DOR duration of response; IRC independent review committee; ORR objective response rate; NE = not estimable", "truncated": false}, "after_length": 131, "after_sha256": "787bc54a786f6ce82ac1706f81d46d819e90a98e083364c46892b0134f998aaf", "annex": "I", "before": {"end": 131, "start": 0, "text": "CI confidence interval; DOR duration of response; IRC independent review committee; ORR objective response rate; NE = not estimable", "truncated": false}, "before_length": 131, "before_sha256": "787bc54a786f6ce82ac1706f81d46d819e90a98e083364c46892b0134f998aaf", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-065d7ec1477a984a79035e39", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004164", "medicine_name": "Alecensa", "medicine_slug": "alecensa", "observed_at": "2026-10-12T19:00:33Z", "pipeline_version": "2.0.0", "presentation_label": "Alecensa 150 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "815d015f485abccb366cc8b59bef3ff2b7589fb9206cca47f8f889f776e1f3af", "source_snapshot_id": "source-c8b17db176ebb33561bb1413", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/alecensa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 813}
{"after": {"end": 50, "start": 0, "text": "Médicaments dont l’absorption est dépendante du pH", "truncated": false}, "after_length": 50, "after_sha256": "11a1f2938299e6682307e963250331ca66f5e08b2c830a0ac5f5e4c1d82a8df2", "annex": "I", "before": {"end": 50, "start": 0, "text": "Médicaments dont l’absorption est dépendante du pH", "truncated": false}, "before_length": 50, "before_sha256": "11a1f2938299e6682307e963250331ca66f5e08b2c830a0ac5f5e4c1d82a8df2", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0680b92a0ade89e0c1c2f040", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002618", "medicine_name": "Nexium Control", "medicine_slug": "nexium-control", "observed_at": "2026-10-12T13:36:18Z", "pipeline_version": "2.0.0", "presentation_label": "Nexium Control 20 mg, gélules gastrorésistantes", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "dd192e79554a2cf904e3b717c765e723c89937d2250f85a0df30f9a56f6cb2e1", "source_snapshot_id": "source-614e91f5970645497b96d67b", "source_updated_at": "2026-06-03", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nexium-control-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 629}
{"after": {"end": 46, "start": 0, "text": "8. NUMÉRO D'AUTORISATION DE MISE SUR LE MARCHÉ", "truncated": false}, "after_length": 46, "after_sha256": "740bfe31e37d4a1613dca7886083259c9ba4b10deb77179587b47da37eada340", "annex": "I", "before": {"end": 46, "start": 0, "text": "8. NUMÉRO D'AUTORISATION DE MISE SUR LE MARCHÉ", "truncated": false}, "before_length": 46, "before_sha256": "740bfe31e37d4a1613dca7886083259c9ba4b10deb77179587b47da37eada340", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-068ae3a69c3d1ed692360fbc", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004104", "medicine_name": "Eptifibatide Accord", "medicine_slug": "eptifibatide-accord", "observed_at": "2026-10-12T19:45:11Z", "pipeline_version": "2.0.0", "presentation_label": "Eptifibatide Accord 2 mg/ml, 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": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "c9be002148fa73331c72aadac205f927e043f3407cf695e63a1cbe715480600b", "source_snapshot_id": "source-9e33d5d566c95289f1a7e6a6", "source_updated_at": "2025-05-02", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/eptifibatide-accord-epar-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": 765, "start": 0, "text": "As renal excretion is a pathway of elimination, consideration should be given to decreasing the dose of hydroxycarbamide in patients with renal impairment. In an open single-dose study in adult patients with Sickle Cell Disease the influence of renal function on pharmacokinetics of hydroxycarbamide was assessed. Patients with normal (CrCl > 90 ml/min), mild (CrCl 6089 ml/min), moderate (CrCl 30 59 ml/min), severe (CrCl 1529 ml/min) renal impairment, and End Stage Renal Disease (CrCL < 15 ml/min) received hydroxycarbamide as a single dose of 15 mg/kg body weight. In patients, whose CrCl was below 60 ml/min or patients with End Stage Renal Disease the mean exposure to hydroxycarbamide was approximately 64% higher than in patients with normal renal function.", "truncated": false}, "after_length": 765, "after_sha256": "06ce369eb2c77f8e980a7a7ead44cc3e4ee46d16975eed1f7b7c3cbfd764376e", "annex": "I", "before": {"end": 765, "start": 0, "text": "As renal excretion is a pathway of elimination, consideration should be given to decreasing the dose of hydroxycarbamide in patients with renal impairment. In an open single-dose study in adult patients with Sickle Cell Disease the influence of renal function on pharmacokinetics of hydroxycarbamide was assessed. Patients with normal (CrCl > 90 ml/min), mild (CrCl 6089 ml/min), moderate (CrCl 30 59 ml/min), severe (CrCl 1529 ml/min) renal impairment, and End Stage Renal Disease (CrCL < 15 ml/min) received hydroxycarbamide as a single dose of 15 mg/kg body weight. In patients, whose CrCl was below 60 ml/min or patients with End Stage Renal Disease the mean exposure to hydroxycarbamide was approximately 64% higher than in patients with normal renal function.", "truncated": false}, "before_length": 765, "before_sha256": "06ce369eb2c77f8e980a7a7ead44cc3e4ee46d16975eed1f7b7c3cbfd764376e", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-068b579d1c1eaa59f22e372f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004837", "medicine_name": "Xromi", "medicine_slug": "xromi", "observed_at": "2026-10-12T19:31:37Z", "pipeline_version": "2.0.0", "presentation_label": "Xromi 100 mg/ml oral solution", "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": "5e9826d3dd1edc48d9eb87b57c4ee7e70574bc6ce1c841b5477a3de3b9950a1e", "source_snapshot_id": "source-d10ea7497b831a802d8ae623", "source_updated_at": "2025-06-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/xromi-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 495}
{"after": {"end": 236, "start": 0, "text": "PURSUIT: This was a randomized, double-blind evaluation of the efficacy and safety of eptifibatide versus placebo for reducing mortality and myocardial (re)infarction in patients with unstable angina or non-Q-wave myocardial infarction.", "truncated": false}, "after_length": 236, "after_sha256": "dc38b99d4db43c16ebfc329e5ac3d5b48a60db293e6ae0458a9b9bc3bd09a6fa", "annex": "I", "before": {"end": 236, "start": 0, "text": "PURSUIT: This was a randomized, double-blind evaluation of the efficacy and safety of eptifibatide versus placebo for reducing mortality and myocardial (re)infarction in patients with unstable angina or non-Q-wave myocardial infarction.", "truncated": false}, "before_length": 236, "before_sha256": "dc38b99d4db43c16ebfc329e5ac3d5b48a60db293e6ae0458a9b9bc3bd09a6fa", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-069535e82456c8626fec4370", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004104", "medicine_name": "Eptifibatide Accord", "medicine_slug": "eptifibatide-accord", "observed_at": "2026-10-12T19:45:01Z", "pipeline_version": "2.0.0", "presentation_label": "Eptifibatide Accord 0.75 mg/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": "a45982959a207e1611cd67a6103370f86a234e3c45dfb3ab49b532886fe928cb", "source_snapshot_id": "source-8dd88a3db45e564c959f66e5", "source_updated_at": "2025-05-02", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/eptifibatide-accord-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 203}
{"after": {"end": 81, "start": 0, "text": "Etude d’extension en ouvert dans le traitement de l’ostéoporose post-ménopausique", "truncated": false}, "after_length": 81, "after_sha256": "86c9c385b5b933108658ad9bd9cec4e71977983c0d004c02dd1088ee2847b0ca", "annex": "I", "before": {"end": 81, "start": 0, "text": "Etude d’extension en ouvert dans le traitement de l’ostéoporose post-ménopausique", "truncated": false}, "before_length": 81, "before_sha256": "86c9c385b5b933108658ad9bd9cec4e71977983c0d004c02dd1088ee2847b0ca", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0695a95c43557f6f7d4e74f3", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/001120", "medicine_name": "Prolia", "medicine_slug": "prolia", "observed_at": "2026-10-12T13:28:45Z", "pipeline_version": "2.0.0", "presentation_label": "Prolia 60 mg solution injectable en seringue préremplie", "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": "30e296cc06d303605f266e9544e10515b7e5c2063a0473f5aa3595a42d18a3e1", "source_snapshot_id": "source-2924aac36bd07813fcc1891d", "source_updated_at": "2026-08-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/prolia-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 443}
{"after": {"end": 126, "start": 0, "text": "Il n’y a pas d’utilisation justifiée de Nimvastid dans la population pédiatrique dans le traitement de la maladie d’Alzheimer.", "truncated": false}, "after_length": 126, "after_sha256": "a214fa628534cc11185567935d030f08ac9734d1c3db9fc403b9c942a8b331bf", "annex": "I", "before": {"end": 126, "start": 0, "text": "Il n’y a pas d’utilisation justifiée de Nimvastid dans la population pédiatrique dans le traitement de la maladie d’Alzheimer.", "truncated": false}, "before_length": 126, "before_sha256": "a214fa628534cc11185567935d030f08ac9734d1c3db9fc403b9c942a8b331bf", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-06ae7863c8a210dd945f1955", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/001029", "medicine_name": "Nimvastid", "medicine_slug": "nimvastid", "observed_at": "2026-10-12T19:24:04Z", "pipeline_version": "2.0.0", "presentation_label": "Nimvastid 1,5 mg gélule Nimvastid 3 mg gélule Nimvastid 4,5 mg gélule Nimvastid 6 mg gélule", "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": "8e6eaa143ff5f69cfa4caba1806dbd754ee713f2f64ce6a1b369433c9e511b46", "source_snapshot_id": "source-655cd60c5475e58b35c5a1c3", "source_updated_at": "2025-07-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nimvastid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 108}
{"after": {"end": 489, "start": 0, "text": "Teratology studies have been performed by continuous intravenous infusion of eptifibatide in pregnant rats at total daily doses of up to 72 mg/kg/day (about 4 times the recommended maximum daily human dose on a body surface area basis) and in pregnant rabbits at total daily doses of up to 36 mg/kg/day (about 4 times the recommended maximum daily human dose on a body surface area basis). These studies revealed no evidence of impaired fertility or harm to the foetus due to eptifibatide.", "truncated": false}, "after_length": 489, "after_sha256": "650f795148b0ec80505d6284906ed15aad2e2f68f7700418d47c14e1ca90be3a", "annex": "I", "before": {"end": 489, "start": 0, "text": "Teratology studies have been performed by continuous intravenous infusion of eptifibatide in pregnant rats at total daily doses of up to 72 mg/kg/day (about 4 times the recommended maximum daily human dose on a body surface area basis) and in pregnant rabbits at total daily doses of up to 36 mg/kg/day (about 4 times the recommended maximum daily human dose on a body surface area basis). These studies revealed no evidence of impaired fertility or harm to the foetus due to eptifibatide.", "truncated": false}, "before_length": 489, "before_sha256": "650f795148b0ec80505d6284906ed15aad2e2f68f7700418d47c14e1ca90be3a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-06b789e5372ee44e04a644af", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004104", "medicine_name": "Eptifibatide Accord", "medicine_slug": "eptifibatide-accord", "observed_at": "2026-10-12T19:45:01Z", "pipeline_version": "2.0.0", "presentation_label": "Eptifibatide Accord 0.75 mg/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": "5.3", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a45982959a207e1611cd67a6103370f86a234e3c45dfb3ab49b532886fe928cb", "source_snapshot_id": "source-8dd88a3db45e564c959f66e5", "source_updated_at": "2025-05-02", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/eptifibatide-accord-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 384}
{"after": {"end": 55, "start": 0, "text": "Troubles généraux et anomalies au site d’administration", "truncated": false}, "after_length": 55, "after_sha256": "e3f83e4cc859b8934fee6b7e7b4aad54d495f591eba36a9dd96935a56770867e", "annex": "I", "before": {"end": 55, "start": 0, "text": "Troubles généraux et anomalies au site d’administration", "truncated": false}, "before_length": 55, "before_sha256": "e3f83e4cc859b8934fee6b7e7b4aad54d495f591eba36a9dd96935a56770867e", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-06e2b52fe5a6a20940e4bd55", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002345", "medicine_name": "Revestive", "medicine_slug": "revestive", "observed_at": "2026-10-12T19:38:11Z", "pipeline_version": "2.0.0", "presentation_label": "Revestive 5 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": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "a977434b47f1efb8356de57d0e4e212d0d42a4215af7d29769e6a19a6e5b7354", "source_snapshot_id": "source-34689da4d07d48b1dbd0d784", "source_updated_at": "2025-05-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/revestive-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 984}
{"after": {"end": 495, "start": 0, "text": "ALINA a démontré une amélioration statistiquement significative de la DFS chez les patients traités par Alecensa par rapport aux patients traités par chimiothérapie dans les populations de patients de stade II – IIIA et de stade IB (≥ 4 cm) – IIIA (ITT). Les données d’OS n’étaient pas matures au moment de l’analyse de la DFS avec 2,3 % de décès rapportés dans l’ensemble. La durée médiane du suivi de survie était de 27,8 mois dans le bras Alecensa et de 28,4 mois dans le bras chimiothérapie.", "truncated": false}, "after_length": 495, "after_sha256": "3b69509871d54f3fa17d65e4ab31417e9236e3d3413512498ead3d6649201aee", "annex": "I", "before": {"end": 495, "start": 0, "text": "ALINA a démontré une amélioration statistiquement significative de la DFS chez les patients traités par Alecensa par rapport aux patients traités par chimiothérapie dans les populations de patients de stade II – IIIA et de stade IB (≥ 4 cm) – IIIA (ITT). Les données d’OS n’étaient pas matures au moment de l’analyse de la DFS avec 2,3 % de décès rapportés dans l’ensemble. La durée médiane du suivi de survie était de 27,8 mois dans le bras Alecensa et de 28,4 mois dans le bras chimiothérapie.", "truncated": false}, "before_length": 495, "before_sha256": "3b69509871d54f3fa17d65e4ab31417e9236e3d3413512498ead3d6649201aee", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-06e88df6e49ce8c5071d8cfd", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004164", "medicine_name": "Alecensa", "medicine_slug": "alecensa", "observed_at": "2026-10-12T19:00:36Z", "pipeline_version": "2.0.0", "presentation_label": "Alecensa 150 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "83ee6e171c0e05bd6ab2daf5408dcacb676175e21156c6f5251ff1b3290852d9", "source_snapshot_id": "source-b1925a54bfeff5c1398e0f30", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/alecensa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 476}
{"after": {"end": 301, "start": 0, "text": "If the patient requires emergency or urgent cardiac surgery during the course of eptifibatide therapy, terminate the infusion immediately. If the patient requires semi-elective surgery, stop the eptifibatide infusion at an appropriate time to allow time for platelet function to return towards normal.", "truncated": false}, "after_length": 301, "after_sha256": "2d59fb613444acc4fce37e0174249301c4d106cc55dc6dd64a54b826f48dc4f9", "annex": "I", "before": {"end": 301, "start": 0, "text": "If the patient requires emergency or urgent cardiac surgery during the course of eptifibatide therapy, terminate the infusion immediately. If the patient requires semi-elective surgery, stop the eptifibatide infusion at an appropriate time to allow time for platelet function to return towards normal.", "truncated": false}, "before_length": 301, "before_sha256": "2d59fb613444acc4fce37e0174249301c4d106cc55dc6dd64a54b826f48dc4f9", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-07125c20c5d0df96fd797cbd", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004104", "medicine_name": "Eptifibatide Accord", "medicine_slug": "eptifibatide-accord", "observed_at": "2026-10-12T19:45:01Z", "pipeline_version": "2.0.0", "presentation_label": "Eptifibatide Accord 2 mg/ml 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": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "a45982959a207e1611cd67a6103370f86a234e3c45dfb3ab49b532886fe928cb", "source_snapshot_id": "source-8dd88a3db45e564c959f66e5", "source_updated_at": "2025-05-02", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/eptifibatide-accord-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 502}
{"after": {"end": 462, "start": 0, "text": "Dans l’étude de phase II dans l’AMS réfractaire avec l’eltrombopag avec une dose de départ de 50 mg/jour (augmentation toutes les 2 semaines jusqu’à un maximum de 150 mg/jour) (ELT112523), l’incidence de nouvelles anomalies cytogénétiques a été observée chez 17,1 % des patients adultes [7/41 (parmi lesquels 4 d’entre eux présentaient des modifications du chromosome 7)]. Le délai médian d’apparition d’une anomalie cytogénétique dans l’étude était de 2,9 mois.", "truncated": false}, "after_length": 462, "after_sha256": "8a212e27853733adac35940e3a2eda8a2b7888cc365bb628d27f01aa8619da93", "annex": "I", "before": {"end": 462, "start": 0, "text": "Dans l’étude de phase II dans l’AMS réfractaire avec l’eltrombopag avec une dose de départ de 50 mg/jour (augmentation toutes les 2 semaines jusqu’à un maximum de 150 mg/jour) (ELT112523), l’incidence de nouvelles anomalies cytogénétiques a été observée chez 17,1 % des patients adultes [7/41 (parmi lesquels 4 d’entre eux présentaient des modifications du chromosome 7)]. Le délai médian d’apparition d’une anomalie cytogénétique dans l’étude était de 2,9 mois.", "truncated": false}, "before_length": 462, "before_sha256": "8a212e27853733adac35940e3a2eda8a2b7888cc365bb628d27f01aa8619da93", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-07207ac711f99af0e33c414a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006459", "medicine_name": "Eltrombopag Accord", "medicine_slug": "eltrombopag-accord", "observed_at": "2026-10-12T19:38:33Z", "pipeline_version": "2.0.0", "presentation_label": "Eltrombopag Accord 12,5 mg, comprimés pelliculés Eltrombopag Accord 25 mg, comprimés pelliculés Eltrombopag Accord 50 mg, comprimés pelliculés Eltrombopag Accord 75 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": "4dba9ba2d13e28b9b00b5cee0ebfe8b72ef357d185dbbf0def82cb05d9f63530", "source_snapshot_id": "source-acb656ad31eb3184c264b4cd", "source_updated_at": "2025-05-20", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/eltrombopag-accord-epar-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": 64, "start": 0, "text": "Eptifibatide Accord est contre-indiqué chez les patients ayant :", "truncated": false}, "after_length": 64, "after_sha256": "4a7e427e18ab7c07716d123de963ffc7c44d58c8c836d9b810634e2fa48f7c97", "annex": "I", "before": {"end": 64, "start": 0, "text": "Eptifibatide Accord est contre-indiqué chez les patients ayant :", "truncated": false}, "before_length": 64, "before_sha256": "4a7e427e18ab7c07716d123de963ffc7c44d58c8c836d9b810634e2fa48f7c97", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0722a57a332347bee8d897ba", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004104", "medicine_name": "Eptifibatide Accord", "medicine_slug": "eptifibatide-accord", "observed_at": "2026-10-12T19:45:11Z", "pipeline_version": "2.0.0", "presentation_label": "Eptifibatide Accord 2 mg/ml, 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": "4.3", "section_type": "contraindication", "source_provider": "European Medicines Agency", "source_sha256": "c9be002148fa73331c72aadac205f927e043f3407cf695e63a1cbe715480600b", "source_snapshot_id": "source-9e33d5d566c95289f1a7e6a6", "source_updated_at": "2025-05-02", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/eptifibatide-accord-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 517}
{"after": {"end": 134, "start": 0, "text": "Les données d’efficacité recueillies à partir des études cliniques en monothérapie et en association sont résumées dans le tableau 4 :", "truncated": false}, "after_length": 134, "after_sha256": "352a3de6ef7ac7404868da807bced73419d82235dd71e83542e76f8d37f4d457", "annex": "I", "before": {"end": 134, "start": 0, "text": "Les données d’efficacité recueillies à partir des études cliniques en monothérapie et en association sont résumées dans le tableau 4 :", "truncated": false}, "before_length": 134, "before_sha256": "352a3de6ef7ac7404868da807bced73419d82235dd71e83542e76f8d37f4d457", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-07392bfdfb2eb655548f5636", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004361", "medicine_name": "Kanjinti", "medicine_slug": "kanjinti", "observed_at": "2026-10-12T19:40:38Z", "pipeline_version": "2.0.0", "presentation_label": "KANJINTI 150 mg poudre pour solution à diluer pour perfusion KANJINTI 420 mg poudre pour 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": "ea9ea0ca90af9dcbc236774255b0290bf3e784884d88a33522b45c8050f829cf", "source_snapshot_id": "source-a4621a49bcc40ac3f94d4939", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/kanjinti-epar-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": 397, "start": 0, "text": "Bien que l’effet du traitement ait été démontré dans la totalité de la population de l’étude, les données suggèrent qu’un effet supérieur du traitement par rapport au placebo a été observé chez les patients atteints d’une démence modérée associée à la maladie de Parkinson. De façon similaire, un effet plus important a été observé chez les patients avec hallucinations visuelles (voir Tableau 6).", "truncated": false}, "after_length": 397, "after_sha256": "61ca5a3f6c70cb110371d5da06ec6701fdfdcff5c2fda95a9e6afac66ef9a083", "annex": "I", "before": {"end": 397, "start": 0, "text": "Bien que l’effet du traitement ait été démontré dans la totalité de la population de l’étude, les données suggèrent qu’un effet supérieur du traitement par rapport au placebo a été observé chez les patients atteints d’une démence modérée associée à la maladie de Parkinson. De façon similaire, un effet plus important a été observé chez les patients avec hallucinations visuelles (voir Tableau 6).", "truncated": false}, "before_length": 397, "before_sha256": "61ca5a3f6c70cb110371d5da06ec6701fdfdcff5c2fda95a9e6afac66ef9a083", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-073b7035b67ef316b86ec586", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/001029", "medicine_name": "Nimvastid", "medicine_slug": "nimvastid", "observed_at": "2026-10-12T19:24:04Z", "pipeline_version": "2.0.0", "presentation_label": "Nimvastid 1,5 mg gélule Nimvastid 3 mg gélule Nimvastid 4,5 mg gélule Nimvastid 6 mg gélule", "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": "8e6eaa143ff5f69cfa4caba1806dbd754ee713f2f64ce6a1b369433c9e511b46", "source_snapshot_id": "source-655cd60c5475e58b35c5a1c3", "source_updated_at": "2025-07-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nimvastid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 631}
{"after": {"end": 405, "start": 0, "text": "Une analyse pharmacocinétique de population a été réalisée sur les données issues de 481 patients inclus dans différentes études cliniques (phase I, II et III) avec différents types de tumeurs malignes avancées et qui avaient reçu Perjeta en monothérapie ou en association, à des doses de pertuzumab allant de 2 à 25 mg/kg, administrées toutes les 3 semaines en perfusion intraveineuse de 30 à 60 minutes.", "truncated": false}, "after_length": 405, "after_sha256": "6a3f4d547ec2b1059a04e3d3c82feddb67bed5a524fee47a18d8b3a8242d5460", "annex": "I", "before": {"end": 405, "start": 0, "text": "Une analyse pharmacocinétique de population a été réalisée sur les données issues de 481 patients inclus dans différentes études cliniques (phase I, II et III) avec différents types de tumeurs malignes avancées et qui avaient reçu Perjeta en monothérapie ou en association, à des doses de pertuzumab allant de 2 à 25 mg/kg, administrées toutes les 3 semaines en perfusion intraveineuse de 30 à 60 minutes.", "truncated": false}, "before_length": 405, "before_sha256": "6a3f4d547ec2b1059a04e3d3c82feddb67bed5a524fee47a18d8b3a8242d5460", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0741bcfb7b8898437b616fdc", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002547", "medicine_name": "Perjeta", "medicine_slug": "perjeta", "observed_at": "2026-10-12T13:39:17Z", "pipeline_version": "2.0.0", "presentation_label": "Perjeta 420 mg 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": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "dfc85998efa134fbc08630f7e0f1d1183bd4fb18ec62a15b680bda3fd94b49bd", "source_snapshot_id": "source-791eb96e62fdebcce4c81ec4", "source_updated_at": "2026-04-28", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/perjeta-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1009}
{"after": {"end": 279, "start": 0, "text": "En raison de ses propriétés pharmacodynamiques et de ses possibles effets additifs, la rivastigmine ne doit pas être administrée simultanément à d'autres cholinomimétiques. La rivastigmine pourrait interférer avec l'activité des anticholinergiques (ex. oxybutynine, toltérodine).", "truncated": false}, "after_length": 279, "after_sha256": "aa6ebe52c6165e5931163db434c34f13c09cf3f50530fa4686fe9c5bed0cc40f", "annex": "I", "before": {"end": 279, "start": 0, "text": "En raison de ses propriétés pharmacodynamiques et de ses possibles effets additifs, la rivastigmine ne doit pas être administrée simultanément à d'autres cholinomimétiques. La rivastigmine pourrait interférer avec l'activité des anticholinergiques (ex. oxybutynine, toltérodine).", "truncated": false}, "before_length": 279, "before_sha256": "aa6ebe52c6165e5931163db434c34f13c09cf3f50530fa4686fe9c5bed0cc40f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-074c532437ffa601571faa75", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/001029", "medicine_name": "Nimvastid", "medicine_slug": "nimvastid", "observed_at": "2026-10-12T19:24:04Z", "pipeline_version": "2.0.0", "presentation_label": "Nimvastid 1,5 mg gélule Nimvastid 3 mg gélule Nimvastid 4,5 mg gélule Nimvastid 6 mg gélule", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "8e6eaa143ff5f69cfa4caba1806dbd754ee713f2f64ce6a1b369433c9e511b46", "source_snapshot_id": "source-655cd60c5475e58b35c5a1c3", "source_updated_at": "2025-07-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nimvastid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1020}
{"after": {"end": 44, "start": 0, "text": "Pruritus, allergic dermatitis (disseminated)", "truncated": false}, "after_length": 44, "after_sha256": "a6a26b29451a8b9c1c54093efc24e06ec6a1f71ce64927c498ecb1d06b661f72", "annex": "I", "before": {"end": 44, "start": 0, "text": "Pruritus, allergic dermatitis (disseminated)", "truncated": false}, "before_length": 44, "before_sha256": "a6a26b29451a8b9c1c54093efc24e06ec6a1f71ce64927c498ecb1d06b661f72", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0754d156536ecec8bb1252ba", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001029", "medicine_name": "Nimvastid", "medicine_slug": "nimvastid", "observed_at": "2026-10-12T19:24:00Z", "pipeline_version": "2.0.0", "presentation_label": "Nimvastid 1.5 mg hard capsules Nimvastid 3 mg hard capsules Nimvastid 4.5 mg hard capsules Nimvastid 6 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": "fa4c6e344db60bf4064eb3cc2d76d72c0fc858894147724d88ab2d66b9f9a0dc", "source_snapshot_id": "source-775bf49790604674d3549dac", "source_updated_at": "2025-07-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nimvastid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 298}
{"after": {"end": 286, "start": 0, "text": "4 weeks. Primary study endpoints were splenic function (qualitative uptake on 99mTc spleen scan) and renal function (glomerular filtration rate by 99mTc-DTPA clearance). Additional evaluations included blood counts, HbF, chemistry profiles, spleen function biomarkers, urine osmolality,", "truncated": false}, "after_length": 286, "after_sha256": "809cffca9047abe51b9d33cf3c51bc9d95dcfa32d78e3f7163ee48fd7ad19d7a", "annex": "I", "before": {"end": 286, "start": 0, "text": "4 weeks. Primary study endpoints were splenic function (qualitative uptake on 99mTc spleen scan) and renal function (glomerular filtration rate by 99mTc-DTPA clearance). Additional evaluations included blood counts, HbF, chemistry profiles, spleen function biomarkers, urine osmolality,", "truncated": false}, "before_length": 286, "before_sha256": "809cffca9047abe51b9d33cf3c51bc9d95dcfa32d78e3f7163ee48fd7ad19d7a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0756b08347d712ca02c3e97b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004837", "medicine_name": "Xromi", "medicine_slug": "xromi", "observed_at": "2026-10-12T19:31:37Z", "pipeline_version": "2.0.0", "presentation_label": "Xromi 100 mg/ml oral solution", "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": "5e9826d3dd1edc48d9eb87b57c4ee7e70574bc6ce1c841b5477a3de3b9950a1e", "source_snapshot_id": "source-d10ea7497b831a802d8ae623", "source_updated_at": "2025-06-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/xromi-epar-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": 246, "start": 0, "text": "Au moment de l’analyse primaire, les bénéfices de Perjeta étaient plus manifestes dans les sous-groupes de patients avec un risque élevé de récidive : patients avec une atteinte ganglionnaire ou des récepteurs hormonaux négatifs (voir tableau 6).", "truncated": false}, "after_length": 246, "after_sha256": "f404dc5e1613d2782d42bd1a6612032fbb1afce81ac8a129b6bea600f30909e4", "annex": "I", "before": {"end": 246, "start": 0, "text": "Au moment de l’analyse primaire, les bénéfices de Perjeta étaient plus manifestes dans les sous-groupes de patients avec un risque élevé de récidive : patients avec une atteinte ganglionnaire ou des récepteurs hormonaux négatifs (voir tableau 6).", "truncated": false}, "before_length": 246, "before_sha256": "f404dc5e1613d2782d42bd1a6612032fbb1afce81ac8a129b6bea600f30909e4", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-078234876545b47b8ebd08d0", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002547", "medicine_name": "Perjeta", "medicine_slug": "perjeta", "observed_at": "2026-10-12T13:39:17Z", "pipeline_version": "2.0.0", "presentation_label": "Perjeta 420 mg 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": "dfc85998efa134fbc08630f7e0f1d1183bd4fb18ec62a15b680bda3fd94b49bd", "source_snapshot_id": "source-791eb96e62fdebcce4c81ec4", "source_updated_at": "2026-04-28", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/perjeta-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 941}
{"after": {"end": 293, "start": 0, "text": "Following a single dose of 40 mg esomeprazole the mean are under the plasma concentrationtime curve is approximately 30% higher in females than in males. No gender difference is seen after repeated oncedaily administration. These findings have no implications for the posology of esomeprazole.", "truncated": false}, "after_length": 293, "after_sha256": "5bbca03be2d9151f8c003bc2ae07dbda91fe43c73807c52146da6b979803e273", "annex": "I", "before": {"end": 293, "start": 0, "text": "Following a single dose of 40 mg esomeprazole the mean are under the plasma concentrationtime curve is approximately 30% higher in females than in males. No gender difference is seen after repeated oncedaily administration. These findings have no implications for the posology of esomeprazole.", "truncated": false}, "before_length": 293, "before_sha256": "5bbca03be2d9151f8c003bc2ae07dbda91fe43c73807c52146da6b979803e273", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-078e74b2fab3e3dd4edd3690", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002618", "medicine_name": "Nexium Control", "medicine_slug": "nexium-control", "observed_at": "2026-10-12T13:36:16Z", "pipeline_version": "2.0.0", "presentation_label": "Nexium Control 20 mg gastroresistant hard capsules", "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": "266d567343c3811aa2034b1a0d89c81f2a39f87634c27e040eddf35f3f1f5cac", "source_snapshot_id": "source-dfdf6861216bffe1c095176b", "source_updated_at": "2026-06-03", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nexium-control-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 867}
{"after": {"end": 254, "start": 0, "text": "A 6-week study that assessed the effect of fluticasone furoate nasal spray 110 micrograms once daily on adrenal function in children aged 2 to 11 years showed that there was no significant effect on 24-hour serum cortisol profiles, compared with placebo.", "truncated": false}, "after_length": 254, "after_sha256": "983fa95c05aa58c7557e8c71f768b86893de8b12b84aec2f0fe21b821af34abf", "annex": "I", "before": {"end": 254, "start": 0, "text": "A 6-week study that assessed the effect of fluticasone furoate nasal spray 110 micrograms once daily on adrenal function in children aged 2 to 11 years showed that there was no significant effect on 24-hour serum cortisol profiles, compared with placebo.", "truncated": false}, "before_length": 254, "before_sha256": "983fa95c05aa58c7557e8c71f768b86893de8b12b84aec2f0fe21b821af34abf", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0798d206fb0335733c9794f5", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000770", "medicine_name": "Avamys", "medicine_slug": "avamys", "observed_at": "2026-10-12T19:30:29Z", "pipeline_version": "2.0.0", "presentation_label": "AVAMYS 27.5 micrograms/spray, nasal spray suspension", "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": "30f949bc5059758fc7a5c6971f20b61b1a1216476650dc650963a3ac481e29e3", "source_snapshot_id": "source-74cb508bb20024b25ca75f56", "source_updated_at": "2025-06-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/avamys-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 259}
{"after": {"end": 54, "start": 0, "text": "Affections respiratoires, thoraciques et médiastinales", "truncated": false}, "after_length": 54, "after_sha256": "70f6454ab7aee01858f48672bf215cf17bf2d980603e92ee989866df8df3e2b9", "annex": "I", "before": {"end": 54, "start": 0, "text": "Affections respiratoires, thoraciques et médiastinales", "truncated": false}, "before_length": 54, "before_sha256": "70f6454ab7aee01858f48672bf215cf17bf2d980603e92ee989866df8df3e2b9", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-07b50fdf8d6c4277318da5ac", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006459", "medicine_name": "Eltrombopag Accord", "medicine_slug": "eltrombopag-accord", "observed_at": "2026-10-12T19:38:33Z", "pipeline_version": "2.0.0", "presentation_label": "Eltrombopag Accord 12,5 mg, comprimés pelliculés Eltrombopag Accord 25 mg, comprimés pelliculés Eltrombopag Accord 50 mg, comprimés pelliculés Eltrombopag Accord 75 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": "4dba9ba2d13e28b9b00b5cee0ebfe8b72ef357d185dbbf0def82cb05d9f63530", "source_snapshot_id": "source-acb656ad31eb3184c264b4cd", "source_updated_at": "2025-05-20", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/eltrombopag-accord-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 594}
{"after": {"end": 47, "start": 0, "text": "Respiratory, thoracic and mediastinal disorders", "truncated": false}, "after_length": 47, "after_sha256": "0be568c6bb895bba2a30d02ffe7ab02ab7f88ff648e8b2533b8ee1583a07e624", "annex": "I", "before": {"end": 47, "start": 0, "text": "Respiratory, thoracic and mediastinal disorders", "truncated": false}, "before_length": 47, "before_sha256": "0be568c6bb895bba2a30d02ffe7ab02ab7f88ff648e8b2533b8ee1583a07e624", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-07cfc313f9af4767eb9bb2be", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002618", "medicine_name": "Nexium Control", "medicine_slug": "nexium-control", "observed_at": "2026-10-12T13:36:16Z", "pipeline_version": "2.0.0", "presentation_label": "Nexium Control 20 mg gastroresistant 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": "266d567343c3811aa2034b1a0d89c81f2a39f87634c27e040eddf35f3f1f5cac", "source_snapshot_id": "source-dfdf6861216bffe1c095176b", "source_updated_at": "2026-06-03", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nexium-control-epar-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": 209, "start": 0, "text": "The most common ADRs (≥30%) from this pooled data were diarrhoea, alopecia, nausea, fatigue, neutropenia, and vomiting. The most common NCI-CTCAE Grade 3-4 ADRs (≥10%) were neutropenia and febrile neutropenia.", "truncated": false}, "after_length": 209, "after_sha256": "2c51a1ee44b41583ef4ec6b71372af14021e7f11107a45e70e730b02f67f9178", "annex": "I", "before": {"end": 209, "start": 0, "text": "The most common ADRs (≥30%) from this pooled data were diarrhoea, alopecia, nausea, fatigue, neutropenia, and vomiting. The most common NCI-CTCAE Grade 3-4 ADRs (≥10%) were neutropenia and febrile neutropenia.", "truncated": false}, "before_length": 209, "before_sha256": "2c51a1ee44b41583ef4ec6b71372af14021e7f11107a45e70e730b02f67f9178", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-07e9b3714e76a12f636b79a2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002547", "medicine_name": "Perjeta", "medicine_slug": "perjeta", "observed_at": "2026-10-12T13:39:17Z", "pipeline_version": "2.0.0", "presentation_label": "Perjeta 420 mg 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": "cb28465c58604d0b3ae410ab4b7f20b7947f60bdf7475f845ec18185037e8ea6", "source_snapshot_id": "source-f34b78f381a5e027cfbe1fe6", "source_updated_at": "2026-04-28", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/perjeta-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 277}
{"after": {"end": 55, "start": 0, "text": "Interaction studies have only been performed in adults.", "truncated": false}, "after_length": 55, "after_sha256": "27d91298937e9be3835721f0bf7f967649f1c06c5a485887df615f044da18d70", "annex": "I", "before": {"end": 55, "start": 0, "text": "Interaction studies have only been performed in adults.", "truncated": false}, "before_length": 55, "before_sha256": "27d91298937e9be3835721f0bf7f967649f1c06c5a485887df615f044da18d70", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0822a0df8662c8f00fb21b33", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002618", "medicine_name": "Nexium Control", "medicine_slug": "nexium-control", "observed_at": "2026-10-12T13:36:16Z", "pipeline_version": "2.0.0", "presentation_label": "Nexium Control 20 mg gastroresistant 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": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "266d567343c3811aa2034b1a0d89c81f2a39f87634c27e040eddf35f3f1f5cac", "source_snapshot_id": "source-dfdf6861216bffe1c095176b", "source_updated_at": "2026-06-03", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nexium-control-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 140}
{"after": {"end": 40, "start": 0, "text": "Reporting of suspected adverse reactions", "truncated": false}, "after_length": 40, "after_sha256": "822da43363cee11e87abeb55cf82453415269315377df150bb5de7dde8dd938f", "annex": "I", "before": {"end": 40, "start": 0, "text": "Reporting of suspected adverse reactions", "truncated": false}, "before_length": 40, "before_sha256": "822da43363cee11e87abeb55cf82453415269315377df150bb5de7dde8dd938f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0834b509db3831b49a5463e9", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000770", "medicine_name": "Avamys", "medicine_slug": "avamys", "observed_at": "2026-10-12T19:30:29Z", "pipeline_version": "2.0.0", "presentation_label": "AVAMYS 27.5 micrograms/spray, nasal spray suspension", "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": "30f949bc5059758fc7a5c6971f20b61b1a1216476650dc650963a3ac481e29e3", "source_snapshot_id": "source-74cb508bb20024b25ca75f56", "source_updated_at": "2025-06-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/avamys-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 215}
{"after": {"end": 116, "start": 0, "text": "Ce médicament contient moins de 1 mmol de sodium (23 mg) par 60 mg, c.àd. qu’il est essentiellement « sans sodium ».", "truncated": false}, "after_length": 116, "after_sha256": "0769cb44be7b7c50038548702b41cbb3ece2ea485f67e4a2bdf82ca7c5148533", "annex": "I", "before": {"end": 116, "start": 0, "text": "Ce médicament contient moins de 1 mmol de sodium (23 mg) par 60 mg, c.àd. qu’il est essentiellement « sans sodium ».", "truncated": false}, "before_length": 116, "before_sha256": "0769cb44be7b7c50038548702b41cbb3ece2ea485f67e4a2bdf82ca7c5148533", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0884169a04e1c53c98424fdd", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/001120", "medicine_name": "Prolia", "medicine_slug": "prolia", "observed_at": "2026-10-12T13:28:45Z", "pipeline_version": "2.0.0", "presentation_label": "Prolia 60 mg solution injectable en seringue préremplie", "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": "30e296cc06d303605f266e9544e10515b7e5c2063a0473f5aa3595a42d18a3e1", "source_snapshot_id": "source-2924aac36bd07813fcc1891d", "source_updated_at": "2026-08-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/prolia-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 160}
{"after": {"end": 44, "start": 0, "text": "Complication d’une stomie gastro-intestinale", "truncated": false}, "after_length": 44, "after_sha256": "f67f6063ff679f9242425bd73d4e6fe6000006424d97c47946b004c95e0db26d", "annex": "I", "before": {"end": 44, "start": 0, "text": "Complication d’une stomie gastro-intestinale", "truncated": false}, "before_length": 44, "before_sha256": "f67f6063ff679f9242425bd73d4e6fe6000006424d97c47946b004c95e0db26d", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-089d5046531dc3a26dc85c39", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002345", "medicine_name": "Revestive", "medicine_slug": "revestive", "observed_at": "2026-10-12T19:38:11Z", "pipeline_version": "2.0.0", "presentation_label": "Revestive 5 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": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "a977434b47f1efb8356de57d0e4e212d0d42a4215af7d29769e6a19a6e5b7354", "source_snapshot_id": "source-34689da4d07d48b1dbd0d784", "source_updated_at": "2025-05-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/revestive-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 990}
{"after": {"end": 165, "start": 0, "text": "Le risque de surdosage est également augmenté lorsque des inhibiteurs de la xanthine oxydase et la mercaptopurine sont administrés simultanément (voir rubrique 4.5).", "truncated": false}, "after_length": 165, "after_sha256": "e677713214372d3609b6cf8650857fb1ca37898d44bee1ac1714ca3a32e9fdcd", "annex": "I", "before": {"end": 165, "start": 0, "text": "Le risque de surdosage est également augmenté lorsque des inhibiteurs de la xanthine oxydase et la mercaptopurine sont administrés simultanément (voir rubrique 4.5).", "truncated": false}, "before_length": 165, "before_sha256": "e677713214372d3609b6cf8650857fb1ca37898d44bee1ac1714ca3a32e9fdcd", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-08a29752991b944968e56652", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002022", "medicine_name": "Xaluprine (previously Mercaptopurine Nova Laboratories)", "medicine_slug": "xaluprine-previously-mercaptopurine-nova-laboratories", "observed_at": "2026-10-12T19:08:05Z", "pipeline_version": "2.0.0", "presentation_label": "Xaluprine 20 mg/ml suspension orale", "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": "24d3b15ae521f391e697a4d72930da59f53e4eeefc26a100461fbfa83e960527", "source_snapshot_id": "source-22ca1025dfc29c23d7b323de", "source_updated_at": "2025-09-25", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xaluprine-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 607}
{"after": {"end": 185, "start": 0, "text": "Globalement, l’exposition à l’hydroxycarbamide produit des anomalies chez plusieurs espèces animales expérimentales et affecte la capacité de reproduction des animaux mâles et femelles.", "truncated": false}, "after_length": 185, "after_sha256": "64afc8ab8e394b2353bee2034d2119f6fa697986fa0a4a0e754225d468d9fea4", "annex": "I", "before": {"end": 185, "start": 0, "text": "Globalement, l’exposition à l’hydroxycarbamide produit des anomalies chez plusieurs espèces animales expérimentales et affecte la capacité de reproduction des animaux mâles et femelles.", "truncated": false}, "before_length": 185, "before_sha256": "64afc8ab8e394b2353bee2034d2119f6fa697986fa0a4a0e754225d468d9fea4", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-08ee2c2b0293b7669cf3f650", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004837", "medicine_name": "Xromi", "medicine_slug": "xromi", "observed_at": "2026-10-12T19:32:45Z", "pipeline_version": "2.0.0", "presentation_label": "Xromi 100 mg/mL solution buvable", "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": "09fc95ca63cda4685a64f9a6f2786bf839a7e56efe05863cd60781314e5f87b5", "source_snapshot_id": "source-6048aed0c6a5fd892436dd1f", "source_updated_at": "2025-06-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xromi-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 507}
{"after": {"end": 101, "start": 0, "text": "L’effet du traitement n’a pas été étudié au delà de 6 mois dans des études contrôlées versus placebo.", "truncated": false}, "after_length": 101, "after_sha256": "ba90f8006ef4a82411bfea1a34fa6abd1eff24a7bbb9a25dd99171a936a87ded", "annex": "I", "before": {"end": 101, "start": 0, "text": "L’effet du traitement n’a pas été étudié au delà de 6 mois dans des études contrôlées versus placebo.", "truncated": false}, "before_length": 101, "before_sha256": "ba90f8006ef4a82411bfea1a34fa6abd1eff24a7bbb9a25dd99171a936a87ded", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-08f77faf47fb41e7ae13f2e1", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/001029", "medicine_name": "Nimvastid", "medicine_slug": "nimvastid", "observed_at": "2026-10-12T19:24:04Z", "pipeline_version": "2.0.0", "presentation_label": "Nimvastid 1,5 mg gélule Nimvastid 3 mg gélule Nimvastid 4,5 mg gélule Nimvastid 6 mg gélule", "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": "8e6eaa143ff5f69cfa4caba1806dbd754ee713f2f64ce6a1b369433c9e511b46", "source_snapshot_id": "source-655cd60c5475e58b35c5a1c3", "source_updated_at": "2025-07-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nimvastid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 99}
{"after": {"end": 325, "start": 0, "text": "The European Medicines Agency has waived the obligation to submit the results of studies with rivastigmine in all subsets of the paediatric population in the treatment of Alzheimer’s dementia and in the treatment of dementia in patients with idiopathic Parkinson’s disease (see section 4.2 for information on paediatric use).", "truncated": false}, "after_length": 325, "after_sha256": "1c017e9be528695e779983f46d8f46ef0407bf2d2aef0bde65a7d1fa1eecc5f0", "annex": "I", "before": {"end": 325, "start": 0, "text": "The European Medicines Agency has waived the obligation to submit the results of studies with rivastigmine in all subsets of the paediatric population in the treatment of Alzheimer’s dementia and in the treatment of dementia in patients with idiopathic Parkinson’s disease (see section 4.2 for information on paediatric use).", "truncated": false}, "before_length": 325, "before_sha256": "1c017e9be528695e779983f46d8f46ef0407bf2d2aef0bde65a7d1fa1eecc5f0", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-090ec3d38f1680bd0d1f9591", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001029", "medicine_name": "Nimvastid", "medicine_slug": "nimvastid", "observed_at": "2026-10-12T19:24:00Z", "pipeline_version": "2.0.0", "presentation_label": "Nimvastid 1.5 mg orodispersible tablets Nimvastid 3 mg orodispersible tablets Nimvastid 4.5 mg orodispersible tablets Nimvastid 6 mg orodispersible tablets", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "fa4c6e344db60bf4064eb3cc2d76d72c0fc858894147724d88ab2d66b9f9a0dc", "source_snapshot_id": "source-775bf49790604674d3549dac", "source_updated_at": "2025-07-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nimvastid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1628}
{"after": {"end": 95, "start": 0, "text": "c n = 539 (TAF) or 841 (TFV) adults (GS-US-292-0111 and GS-US-292-0104, population PK analysis)", "truncated": false}, "after_length": 95, "after_sha256": "2495557aab28f51f628b2548297c7240f10e5b68e3d7b363e999a1bf53da9c5b", "annex": "I", "before": {"end": 95, "start": 0, "text": "c n = 539 (TAF) or 841 (TFV) adults (GS-US-292-0111 and GS-US-292-0104, population PK analysis)", "truncated": false}, "before_length": 95, "before_sha256": "2495557aab28f51f628b2548297c7240f10e5b68e3d7b363e999a1bf53da9c5b", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0922b5c738e7c107b2bac295", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006469", "medicine_name": "Emtricitabine / Tenofovir alafenamide Viatris", "medicine_slug": "emtricitabine-tenofovir-alafenamide-viatris", "observed_at": "2026-10-12T13:40:14Z", "pipeline_version": "2.0.0", "presentation_label": "Emtricitabine/Tenofovir alafenamide Viatris 200 mg/10 mg filmcoated tablets Emtricitabine/Tenofovir alafenamide Viatris 200 mg/25 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": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "247b89d7ca1efa91cffaeb0f00556dd381d81e804eb2f9c23631d01a49578ea7", "source_snapshot_id": "source-246d08888d5f52d006efa07f", "source_updated_at": "2026-04-16", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/emtricitabine-tenofovir-alafenamide-viatris-epar-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": 263, "start": 0, "text": "La macrocytose provoquée par l’hydroxycarbamide ne dépend pas de la vitamine B12 ou de l’acide folique. L’anémie couramment observée est principalement due à une infection par le parvovirus, à une séquestration splénique ou hépatique ou à une insuffisance rénale.", "truncated": false}, "after_length": 263, "after_sha256": "ae0ae3fc3888b6c5afd002ea0e245c2a76a3082f64133e894f1b7daa85ae694c", "annex": "I", "before": {"end": 263, "start": 0, "text": "La macrocytose provoquée par l’hydroxycarbamide ne dépend pas de la vitamine B12 ou de l’acide folique. L’anémie couramment observée est principalement due à une infection par le parvovirus, à une séquestration splénique ou hépatique ou à une insuffisance rénale.", "truncated": false}, "before_length": 263, "before_sha256": "ae0ae3fc3888b6c5afd002ea0e245c2a76a3082f64133e894f1b7daa85ae694c", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0936675ebfdc952fa5f0f00c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004837", "medicine_name": "Xromi", "medicine_slug": "xromi", "observed_at": "2026-10-12T19:32:45Z", "pipeline_version": "2.0.0", "presentation_label": "Xromi 100 mg/mL solution buvable", "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": "09fc95ca63cda4685a64f9a6f2786bf839a7e56efe05863cd60781314e5f87b5", "source_snapshot_id": "source-6048aed0c6a5fd892436dd1f", "source_updated_at": "2025-06-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xromi-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 277}
{"after": {"end": 422, "start": 0, "text": "Le flacon ne doit pas être agité, mais peut être roulé entre les paumes et délicatement retourné tête en bas une seule fois. Quand une solution limpide et incolore s’est formée dans le flacon, la solution doit être aspirée dans une seringue de 1 ml pour injection (ou dans une seringue de 0,5 ml ou d’un volume inférieur pour l’usage pédiatrique) munie de graduations de 0,02 ml ou inférieures (non incluse dans la boîte).", "truncated": false}, "after_length": 422, "after_sha256": "51bf82bfd00cab2471dda8c7247b07e47a1be42912f89172ac98a1022945b1ff", "annex": "I", "before": {"end": 422, "start": 0, "text": "Le flacon ne doit pas être agité, mais peut être roulé entre les paumes et délicatement retourné tête en bas une seule fois. Quand une solution limpide et incolore s’est formée dans le flacon, la solution doit être aspirée dans une seringue de 1 ml pour injection (ou dans une seringue de 0,5 ml ou d’un volume inférieur pour l’usage pédiatrique) munie de graduations de 0,02 ml ou inférieures (non incluse dans la boîte).", "truncated": false}, "before_length": 422, "before_sha256": "51bf82bfd00cab2471dda8c7247b07e47a1be42912f89172ac98a1022945b1ff", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0962401de73a31b2b0eb19d5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002345", "medicine_name": "Revestive", "medicine_slug": "revestive", "observed_at": "2026-10-12T19:38:11Z", "pipeline_version": "2.0.0", "presentation_label": "Revestive 1,25 mg poudre et solvant 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": "a977434b47f1efb8356de57d0e4e212d0d42a4215af7d29769e6a19a6e5b7354", "source_snapshot_id": "source-34689da4d07d48b1dbd0d784", "source_updated_at": "2025-05-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/revestive-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 605}
{"after": {"end": 77, "start": 0, "text": "* maladie inflammatoire de l’intestin (IBD) est une indication non autorisée.", "truncated": false}, "after_length": 77, "after_sha256": "8c527dbcb0bca1e5ffaf21f3ac2542b3d046fe4249ba360893f62ad55e7e031a", "annex": "I", "before": {"end": 77, "start": 0, "text": "* maladie inflammatoire de l’intestin (IBD) est une indication non autorisée.", "truncated": false}, "before_length": 77, "before_sha256": "8c527dbcb0bca1e5ffaf21f3ac2542b3d046fe4249ba360893f62ad55e7e031a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-09688c1afc8e7e4e851ba6ca", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002022", "medicine_name": "Xaluprine (previously Mercaptopurine Nova Laboratories)", "medicine_slug": "xaluprine-previously-mercaptopurine-nova-laboratories", "observed_at": "2026-10-12T19:08:05Z", "pipeline_version": "2.0.0", "presentation_label": "Xaluprine 20 mg/ml suspension orale", "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": "24d3b15ae521f391e697a4d72930da59f53e4eeefc26a100461fbfa83e960527", "source_snapshot_id": "source-22ca1025dfc29c23d7b323de", "source_updated_at": "2025-09-25", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xaluprine-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 411}
{"after": {"end": 168, "start": 0, "text": "§Includes the following preferred terms: Injection site haematoma, Injection site erythema, Injection site pain, Injection site swelling and Injection site haemorrhage.", "truncated": false}, "after_length": 168, "after_sha256": "c2eb6a5d5bfac20986f31bdbf8b62ff236a6ba9c1d4aaf87ab9b628a684eafff", "annex": "I", "before": {"end": 168, "start": 0, "text": "§Includes the following preferred terms: Injection site haematoma, Injection site erythema, Injection site pain, Injection site swelling and Injection site haemorrhage.", "truncated": false}, "before_length": 168, "before_sha256": "c2eb6a5d5bfac20986f31bdbf8b62ff236a6ba9c1d4aaf87ab9b628a684eafff", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0975232565449b0e90e0645a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002345", "medicine_name": "Revestive", "medicine_slug": "revestive", "observed_at": "2026-10-12T19:38:01Z", "pipeline_version": "2.0.0", "presentation_label": "Revestive 5 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": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "0125d033ce2f8805dc45ece9b8ffa34db6682b195448a3a560e6d2483a8982b4", "source_snapshot_id": "source-8d7c3200418c650a002546aa", "source_updated_at": "2025-05-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/revestive-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1000}
{"after": {"end": 283, "start": 0, "text": "Emtricitabine/Tenofovir alafenamide Viatris should be avoided in patients with estimated CrCl ≥ 15 mL/min and < 30 mL/min, or < 15 mL/min who are not on chronic haemodialysis, as the safety of Emtricitabine/Tenofovir alafenamide Viatris has not been established in these populations.", "truncated": false}, "after_length": 283, "after_sha256": "ad6de73d1c120626ce723e6f3e0cf5ca2a6aa57f8d80d545a6ec4f9e8274527e", "annex": "I", "before": {"end": 283, "start": 0, "text": "Emtricitabine/Tenofovir alafenamide Viatris should be avoided in patients with estimated CrCl ≥ 15 mL/min and < 30 mL/min, or < 15 mL/min who are not on chronic haemodialysis, as the safety of Emtricitabine/Tenofovir alafenamide Viatris has not been established in these populations.", "truncated": false}, "before_length": 283, "before_sha256": "ad6de73d1c120626ce723e6f3e0cf5ca2a6aa57f8d80d545a6ec4f9e8274527e", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-098366b895f22aea962c31b7", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006469", "medicine_name": "Emtricitabine / Tenofovir alafenamide Viatris", "medicine_slug": "emtricitabine-tenofovir-alafenamide-viatris", "observed_at": "2026-10-12T13:40:14Z", "pipeline_version": "2.0.0", "presentation_label": "Emtricitabine/Tenofovir alafenamide Viatris 200 mg/10 mg filmcoated tablets Emtricitabine/Tenofovir alafenamide Viatris 200 mg/25 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": "247b89d7ca1efa91cffaeb0f00556dd381d81e804eb2f9c23631d01a49578ea7", "source_snapshot_id": "source-246d08888d5f52d006efa07f", "source_updated_at": "2026-04-16", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/emtricitabine-tenofovir-alafenamide-viatris-epar-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": 80, "start": 0, "text": "Taux de réponse objective (CRI) chez les patients pré-traités par chimiothérapie", "truncated": false}, "after_length": 80, "after_sha256": "a869d7037107bc3a1fb3e7ed83c53f5fed0aaaa8f620e0af8b5e99c9fc68ca2f", "annex": "I", "before": {"end": 80, "start": 0, "text": "Taux de réponse objective (CRI) chez les patients pré-traités par chimiothérapie", "truncated": false}, "before_length": 80, "before_sha256": "a869d7037107bc3a1fb3e7ed83c53f5fed0aaaa8f620e0af8b5e99c9fc68ca2f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0992aa96a21beb06e5a2d34e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004164", "medicine_name": "Alecensa", "medicine_slug": "alecensa", "observed_at": "2026-10-12T19:00:36Z", "pipeline_version": "2.0.0", "presentation_label": "Alecensa 150 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "83ee6e171c0e05bd6ab2daf5408dcacb676175e21156c6f5251ff1b3290852d9", "source_snapshot_id": "source-b1925a54bfeff5c1398e0f30", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/alecensa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 819}
{"after": {"end": 100, "start": 0, "text": "Tout médicament non utilisé ou déchet doit être éliminé conformément à la réglementation en vigueur.", "truncated": false}, "after_length": 100, "after_sha256": "f9673871856e0b65a0aab1e2787b76a78aafb072fd8e972a82ee109179a0a58c", "annex": "I", "before": {"end": 100, "start": 0, "text": "Tout médicament non utilisé ou déchet doit être éliminé conformément à la réglementation en vigueur.", "truncated": false}, "before_length": 100, "before_sha256": "f9673871856e0b65a0aab1e2787b76a78aafb072fd8e972a82ee109179a0a58c", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0995b85404232ff9e8e1d463", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002345", "medicine_name": "Revestive", "medicine_slug": "revestive", "observed_at": "2026-10-12T19:38:11Z", "pipeline_version": "2.0.0", "presentation_label": "Revestive 5 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": "a977434b47f1efb8356de57d0e4e212d0d42a4215af7d29769e6a19a6e5b7354", "source_snapshot_id": "source-34689da4d07d48b1dbd0d784", "source_updated_at": "2025-05-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/revestive-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1297}
{"after": {"end": 226, "start": 0, "text": "This medicinal product contains sugar spheres (sucrose). Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucraseisomaltase insufficiency should not take this medicinal product.", "truncated": false}, "after_length": 226, "after_sha256": "bd1979096d160fb1b07e74cf669cbd1e83773125101d28208c9c5e84e07d5b86", "annex": "I", "before": {"end": 226, "start": 0, "text": "This medicinal product contains sugar spheres (sucrose). Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucraseisomaltase insufficiency should not take this medicinal product.", "truncated": false}, "before_length": 226, "before_sha256": "bd1979096d160fb1b07e74cf669cbd1e83773125101d28208c9c5e84e07d5b86", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0998e16295b6b1906fb730aa", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002618", "medicine_name": "Nexium Control", "medicine_slug": "nexium-control", "observed_at": "2026-10-12T13:36:16Z", "pipeline_version": "2.0.0", "presentation_label": "Nexium Control 20 mg gastroresistant 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": "266d567343c3811aa2034b1a0d89c81f2a39f87634c27e040eddf35f3f1f5cac", "source_snapshot_id": "source-dfdf6861216bffe1c095176b", "source_updated_at": "2026-06-03", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nexium-control-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 133}
{"after": {"end": 140, "start": 0, "text": "Denosumab is a human monoclonal IgG2 antibody produced in a mammalian cell line (Chinese hamster ovary cells) by recombinant DNA technology.", "truncated": false}, "after_length": 140, "after_sha256": "a32d8e6f1d75086ceb6bad58c598fe9f5c3848919e900c27e62539a03d350c37", "annex": "I", "before": {"end": 140, "start": 0, "text": "Denosumab is a human monoclonal IgG2 antibody produced in a mammalian cell line (Chinese hamster ovary cells) by recombinant DNA technology.", "truncated": false}, "before_length": 140, "before_sha256": "a32d8e6f1d75086ceb6bad58c598fe9f5c3848919e900c27e62539a03d350c37", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-09bc3a02bed4723418da4ac1", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001120", "medicine_name": "Prolia", "medicine_slug": "prolia", "observed_at": "2026-10-12T13:28:42Z", "pipeline_version": "2.0.0", "presentation_label": "Prolia 60 mg solution for injection in prefilled syringe", "presentation_occurrence": 1, "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": "5984d05d5bd9987a8e6f5cf86ff2e5032af0bc8bf5fe7a137a9f36a8466c5b97", "source_snapshot_id": "source-312c11aae5d59cae975290d1", "source_updated_at": "2026-08-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/prolia-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 34}
{"after": {"end": 96, "start": 0, "text": "de gestation (période d’organogénèse) était embryotoxique, avec une augmentation dose-dépendante", "truncated": false}, "after_length": 96, "after_sha256": "9c12e6585f1506f77d167765b07de751563499da1b29f7ace470169f15602a21", "annex": "I", "before": {"end": 96, "start": 0, "text": "de gestation (période d’organogénèse) était embryotoxique, avec une augmentation dose-dépendante", "truncated": false}, "before_length": 96, "before_sha256": "9c12e6585f1506f77d167765b07de751563499da1b29f7ace470169f15602a21", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-09c43901be2e759c8fd0b5bc", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002547", "medicine_name": "Perjeta", "medicine_slug": "perjeta", "observed_at": "2026-10-12T13:39:17Z", "pipeline_version": "2.0.0", "presentation_label": "Perjeta 420 mg 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": "5.3", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "dfc85998efa134fbc08630f7e0f1d1183bd4fb18ec62a15b680bda3fd94b49bd", "source_snapshot_id": "source-791eb96e62fdebcce4c81ec4", "source_updated_at": "2026-04-28", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/perjeta-epar-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": 490, "start": 0, "text": "Les propriétés pharmacocinétiques de la mercaptopurine n’ayant pas fait l’objet d’une étude formelle en cas d’insuffisance hépatique, aucune recommandation particulière ne peut être donnée. L’élimination de la mercaptopurine pouvant être réduite chez les insuffisants hépatiques, il convient d’envisager de réduire les doses de départ chez ces patients. Les patients doivent être étroitement surveillés pour détecter d’éventuelles réactions indésirables liées à la dose (voir rubrique 4.4).", "truncated": false}, "after_length": 490, "after_sha256": "fa07930f299c5be46fac0d7ffc5a9f0fa8277fec67fbb086d4958c5166ef5a10", "annex": "I", "before": {"end": 490, "start": 0, "text": "Les propriétés pharmacocinétiques de la mercaptopurine n’ayant pas fait l’objet d’une étude formelle en cas d’insuffisance hépatique, aucune recommandation particulière ne peut être donnée. L’élimination de la mercaptopurine pouvant être réduite chez les insuffisants hépatiques, il convient d’envisager de réduire les doses de départ chez ces patients. Les patients doivent être étroitement surveillés pour détecter d’éventuelles réactions indésirables liées à la dose (voir rubrique 4.4).", "truncated": false}, "before_length": 490, "before_sha256": "fa07930f299c5be46fac0d7ffc5a9f0fa8277fec67fbb086d4958c5166ef5a10", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-09ca363a2c4fbd116692a1cd", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002022", "medicine_name": "Xaluprine (previously Mercaptopurine Nova Laboratories)", "medicine_slug": "xaluprine-previously-mercaptopurine-nova-laboratories", "observed_at": "2026-10-12T19:08:05Z", "pipeline_version": "2.0.0", "presentation_label": "Xaluprine 20 mg/ml suspension orale", "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": "24d3b15ae521f391e697a4d72930da59f53e4eeefc26a100461fbfa83e960527", "source_snapshot_id": "source-22ca1025dfc29c23d7b323de", "source_updated_at": "2025-09-25", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xaluprine-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 341}
{"after": {"end": 139, "start": 0, "text": "The risk of overdose is also increased when xanthine oxidase inhibitors is being given concomitantly with mercaptopurine (see section 4.5).", "truncated": false}, "after_length": 139, "after_sha256": "191c5c124248e4a21fb7247902f03b13a9cf38deb27ce062c795c6d7e4ee858f", "annex": "I", "before": {"end": 139, "start": 0, "text": "The risk of overdose is also increased when xanthine oxidase inhibitors is being given concomitantly with mercaptopurine (see section 4.5).", "truncated": false}, "before_length": 139, "before_sha256": "191c5c124248e4a21fb7247902f03b13a9cf38deb27ce062c795c6d7e4ee858f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-09d885fd4f956e4f952dba0d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002022", "medicine_name": "Xaluprine (previously Mercaptopurine Nova Laboratories)", "medicine_slug": "xaluprine-previously-mercaptopurine-nova-laboratories", "observed_at": "2026-10-12T19:08:02Z", "pipeline_version": "2.0.0", "presentation_label": "Xaluprine 20 mg/ml oral suspension", "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": "a352706294cb9013c5ba158da50186f12673cdb6fb887d0033e1457d44698091", "source_snapshot_id": "source-80b0d9db881bf774bffb5d3c", "source_updated_at": "2025-09-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/xaluprine-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 608}
{"after": {"end": 93, "start": 0, "text": "ONJ has been reported rarely in patients receiving Prolia for osteoporosis (see section 4.8).", "truncated": false}, "after_length": 93, "after_sha256": "3cf69d15097bba4b42399e2edd8bc454894c62db65adf40cbc9f5db5d6bda44c", "annex": "I", "before": {"end": 93, "start": 0, "text": "ONJ has been reported rarely in patients receiving Prolia for osteoporosis (see section 4.8).", "truncated": false}, "before_length": 93, "before_sha256": "3cf69d15097bba4b42399e2edd8bc454894c62db65adf40cbc9f5db5d6bda44c", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-09fa0c5403b343389d4b9716", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001120", "medicine_name": "Prolia", "medicine_slug": "prolia", "observed_at": "2026-10-12T13:28:42Z", "pipeline_version": "2.0.0", "presentation_label": "Prolia 60 mg solution for injection in prefilled syringe", "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": "5984d05d5bd9987a8e6f5cf86ff2e5032af0bc8bf5fe7a137a9f36a8466c5b97", "source_snapshot_id": "source-312c11aae5d59cae975290d1", "source_updated_at": "2026-08-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/prolia-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 126}
{"after": {"end": 43, "start": 0, "text": "Lésion hépatique d’origine médicamenteuse8)", "truncated": false}, "after_length": 43, "after_sha256": "1e7562cd62b871b3f0cc6c303bd150fcd6f10e42b3889e1347ec02fe43141c26", "annex": "I", "before": {"end": 43, "start": 0, "text": "Lésion hépatique d’origine médicamenteuse8)", "truncated": false}, "before_length": 43, "before_sha256": "1e7562cd62b871b3f0cc6c303bd150fcd6f10e42b3889e1347ec02fe43141c26", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0a2fcf095c72c2221e1069cd", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004164", "medicine_name": "Alecensa", "medicine_slug": "alecensa", "observed_at": "2026-10-12T19:00:36Z", "pipeline_version": "2.0.0", "presentation_label": "Alecensa 150 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": "83ee6e171c0e05bd6ab2daf5408dcacb676175e21156c6f5251ff1b3290852d9", "source_snapshot_id": "source-b1925a54bfeff5c1398e0f30", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/alecensa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 339}
{"after": {"end": 144, "start": 0, "text": "7) includes cases of blood bilirubin increased, hyperbilirubinaemia, bilirubin conjugated increased, and blood bilirubin unconjugated increased.", "truncated": false}, "after_length": 144, "after_sha256": "195c3c92e28fc7a97f6cd853a312384e9b9e5980701bc8cd8107b733c0f60616", "annex": "I", "before": {"end": 144, "start": 0, "text": "7) includes cases of blood bilirubin increased, hyperbilirubinaemia, bilirubin conjugated increased, and blood bilirubin unconjugated increased.", "truncated": false}, "before_length": 144, "before_sha256": "195c3c92e28fc7a97f6cd853a312384e9b9e5980701bc8cd8107b733c0f60616", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0a4762e73bf8662dbe529667", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004164", "medicine_name": "Alecensa", "medicine_slug": "alecensa", "observed_at": "2026-10-12T19:00:33Z", "pipeline_version": "2.0.0", "presentation_label": "Alecensa 150 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": "815d015f485abccb366cc8b59bef3ff2b7589fb9206cca47f8f889f776e1f3af", "source_snapshot_id": "source-c8b17db176ebb33561bb1413", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/alecensa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 370}
{"after": {"end": 47, "start": 0, "text": "Perjeta 420 mg solution à diluer pour perfusion", "truncated": false}, "after_length": 47, "after_sha256": "c762b0529751ba50d85e2bda205c4b4d830ce52bb40716a059de9041d5ad40b7", "annex": "I", "before": {"end": 47, "start": 0, "text": "Perjeta 420 mg solution à diluer pour perfusion", "truncated": false}, "before_length": 47, "before_sha256": "c762b0529751ba50d85e2bda205c4b4d830ce52bb40716a059de9041d5ad40b7", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0a48942e4a04e67f29e381c4", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002547", "medicine_name": "Perjeta", "medicine_slug": "perjeta", "observed_at": "2026-10-12T13:39:17Z", "pipeline_version": "2.0.0", "presentation_label": "Perjeta 420 mg 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": "1", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "dfc85998efa134fbc08630f7e0f1d1183bd4fb18ec62a15b680bda3fd94b49bd", "source_snapshot_id": "source-791eb96e62fdebcce4c81ec4", "source_updated_at": "2026-04-28", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/perjeta-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 35}
{"after": {"end": 68, "start": 0, "text": "Patients should not take another PPI or H2 antagonist concomitantly.", "truncated": false}, "after_length": 68, "after_sha256": "59e58c933cfcf0a19743813d10344840c46d66e0d195c33f62321de46d9345b9", "annex": "I", "before": {"end": 68, "start": 0, "text": "Patients should not take another PPI or H2 antagonist concomitantly.", "truncated": false}, "before_length": 68, "before_sha256": "59e58c933cfcf0a19743813d10344840c46d66e0d195c33f62321de46d9345b9", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0a48c660df3d5a20b2749ff0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002618", "medicine_name": "Nexium Control", "medicine_slug": "nexium-control", "observed_at": "2026-10-12T13:36:16Z", "pipeline_version": "2.0.0", "presentation_label": "Nexium Control 20 mg gastroresistant hard capsules", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "266d567343c3811aa2034b1a0d89c81f2a39f87634c27e040eddf35f3f1f5cac", "source_snapshot_id": "source-dfdf6861216bffe1c095176b", "source_updated_at": "2026-06-03", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nexium-control-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 583}
{"after": {"end": 111, "start": 0, "text": "There is also a serious risk of leukaemia and in the elderly, skin cancer, although the frequency is not known.", "truncated": false}, "after_length": 111, "after_sha256": "a38785b60fb25f0c4b54715750393c528f6f63d0b1fea075a21055acc7464d27", "annex": "I", "before": {"end": 111, "start": 0, "text": "There is also a serious risk of leukaemia and in the elderly, skin cancer, although the frequency is not known.", "truncated": false}, "before_length": 111, "before_sha256": "a38785b60fb25f0c4b54715750393c528f6f63d0b1fea075a21055acc7464d27", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0a5633f0e27798c96a23e005", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004837", "medicine_name": "Xromi", "medicine_slug": "xromi", "observed_at": "2026-10-12T19:31:37Z", "pipeline_version": "2.0.0", "presentation_label": "Xromi 100 mg/ml oral solution", "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": "5e9826d3dd1edc48d9eb87b57c4ee7e70574bc6ce1c841b5477a3de3b9950a1e", "source_snapshot_id": "source-d10ea7497b831a802d8ae623", "source_updated_at": "2025-06-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/xromi-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 213}
{"after": {"end": 44, "start": 0, "text": "Réactions d'hypersensibilité/anaphylactiques", "truncated": false}, "after_length": 44, "after_sha256": "4c7feb57f88e64ac52493b5dc8dc817dda695549d4fdbda03bec1dfe2b65542f", "annex": "I", "before": {"end": 44, "start": 0, "text": "Réactions d'hypersensibilité/anaphylactiques", "truncated": false}, "before_length": 44, "before_sha256": "4c7feb57f88e64ac52493b5dc8dc817dda695549d4fdbda03bec1dfe2b65542f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0a5a4ea758a3f3779b0b073a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002547", "medicine_name": "Perjeta", "medicine_slug": "perjeta", "observed_at": "2026-10-12T13:39:17Z", "pipeline_version": "2.0.0", "presentation_label": "Perjeta 420 mg 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": "dfc85998efa134fbc08630f7e0f1d1183bd4fb18ec62a15b680bda3fd94b49bd", "source_snapshot_id": "source-791eb96e62fdebcce4c81ec4", "source_updated_at": "2026-04-28", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/perjeta-epar-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": 83, "start": 0, "text": "hepatic failure, hepatic encephalopathy in patients with pre-existing liver disease", "truncated": false}, "after_length": 83, "after_sha256": "2cb4386ba79d3fdd25e692290a385812558046140ea8571f72360dafead4799e", "annex": "I", "before": {"end": 83, "start": 0, "text": "hepatic failure, hepatic encephalopathy in patients with pre-existing liver disease", "truncated": false}, "before_length": 83, "before_sha256": "2cb4386ba79d3fdd25e692290a385812558046140ea8571f72360dafead4799e", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0a5febed74e80ca184c9dded", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002618", "medicine_name": "Nexium Control", "medicine_slug": "nexium-control", "observed_at": "2026-10-12T13:36:16Z", "pipeline_version": "2.0.0", "presentation_label": "Nexium Control 20 mg gastroresistant hard capsules", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "266d567343c3811aa2034b1a0d89c81f2a39f87634c27e040eddf35f3f1f5cac", "source_snapshot_id": "source-dfdf6861216bffe1c095176b", "source_updated_at": "2026-06-03", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nexium-control-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 766}
{"after": {"end": 101, "start": 0, "text": "Interaction not studied with either of the components of Emtricitabine/Tenofovir alafenamide Viatris.", "truncated": false}, "after_length": 101, "after_sha256": "797d8af3bc243164b9fcbbcddb26e1adaa51b00e6235e1be0a7194c7ead3682a", "annex": "I", "before": {"end": 101, "start": 0, "text": "Interaction not studied with either of the components of Emtricitabine/Tenofovir alafenamide Viatris.", "truncated": false}, "before_length": 101, "before_sha256": "797d8af3bc243164b9fcbbcddb26e1adaa51b00e6235e1be0a7194c7ead3682a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0a7d34adca0be172a782c9c2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006469", "medicine_name": "Emtricitabine / Tenofovir alafenamide Viatris", "medicine_slug": "emtricitabine-tenofovir-alafenamide-viatris", "observed_at": "2026-10-12T13:40:14Z", "pipeline_version": "2.0.0", "presentation_label": "Emtricitabine/Tenofovir alafenamide Viatris 200 mg/10 mg filmcoated tablets Emtricitabine/Tenofovir alafenamide Viatris 200 mg/25 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": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "247b89d7ca1efa91cffaeb0f00556dd381d81e804eb2f9c23631d01a49578ea7", "source_snapshot_id": "source-246d08888d5f52d006efa07f", "source_updated_at": "2026-04-16", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/emtricitabine-tenofovir-alafenamide-viatris-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 219}
{"after": {"end": 416, "start": 0, "text": "Results from studies in healthy subjects have shown a pharmacokinetic (PK)/pharmacodynamic (PD) interaction between clopidogrel (300 mg loading dose/75 mg daily maintenance dose) and esomeprazole (40 mg orally daily) resulting in decreased exposure to the active metabolite of clopidogrel by an average of 40%, and resulting in decreased maximum inhibition of (ADP induced) platelet aggregation by an average of 14%.", "truncated": false}, "after_length": 416, "after_sha256": "8de8b611ee59fffb5a58a6d2291bef5fbbf051027cf64df35a9686c60de8db69", "annex": "I", "before": {"end": 416, "start": 0, "text": "Results from studies in healthy subjects have shown a pharmacokinetic (PK)/pharmacodynamic (PD) interaction between clopidogrel (300 mg loading dose/75 mg daily maintenance dose) and esomeprazole (40 mg orally daily) resulting in decreased exposure to the active metabolite of clopidogrel by an average of 40%, and resulting in decreased maximum inhibition of (ADP induced) platelet aggregation by an average of 14%.", "truncated": false}, "before_length": 416, "before_sha256": "8de8b611ee59fffb5a58a6d2291bef5fbbf051027cf64df35a9686c60de8db69", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0a7ec8a393e30cf104ea62c2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002618", "medicine_name": "Nexium Control", "medicine_slug": "nexium-control", "observed_at": "2026-10-12T13:36:16Z", "pipeline_version": "2.0.0", "presentation_label": "Nexium Control 20 mg gastroresistant hard capsules", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "266d567343c3811aa2034b1a0d89c81f2a39f87634c27e040eddf35f3f1f5cac", "source_snapshot_id": "source-dfdf6861216bffe1c095176b", "source_updated_at": "2026-06-03", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nexium-control-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 639}
{"after": {"end": 361, "start": 0, "text": "Since renal excretion is a pathway of elimination, consideration should be given to decreasing the dosage of hydroxycarbamide in renally impaired patients. In patients with a creatinine clearance (CrCl) ≤ 60 ml/min the initial hydroxycarbamide dose should be decreased by 50%. Close monitoring of blood parameters is advised in these patients (see section 4.4).", "truncated": false}, "after_length": 361, "after_sha256": "ee251215218f97b75295202470ffbe4ebcfed7e37d3b7990957e4f9486b74b97", "annex": "I", "before": {"end": 361, "start": 0, "text": "Since renal excretion is a pathway of elimination, consideration should be given to decreasing the dosage of hydroxycarbamide in renally impaired patients. In patients with a creatinine clearance (CrCl) ≤ 60 ml/min the initial hydroxycarbamide dose should be decreased by 50%. Close monitoring of blood parameters is advised in these patients (see section 4.4).", "truncated": false}, "before_length": 361, "before_sha256": "ee251215218f97b75295202470ffbe4ebcfed7e37d3b7990957e4f9486b74b97", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0a8efed45aaa387ddf73c3c9", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004837", "medicine_name": "Xromi", "medicine_slug": "xromi", "observed_at": "2026-10-12T19:31:37Z", "pipeline_version": "2.0.0", "presentation_label": "Xromi 100 mg/ml oral solution", "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": "5e9826d3dd1edc48d9eb87b57c4ee7e70574bc6ce1c841b5477a3de3b9950a1e", "source_snapshot_id": "source-d10ea7497b831a802d8ae623", "source_updated_at": "2025-06-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/xromi-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 82}
{"after": {"end": 387, "start": 0, "text": "Cases of ILD/pneumonitis have been reported in clinical trials with Alecensa (see section 4.8). Patients should be monitored for pulmonary symptoms indicative of pneumonitis. Alecensa should be immediately interrupted in patients diagnosed with ILD/pneumonitis and should be permanently discontinued if no other potential causes of ILD/pneumonitis have been identified (see section 4.2).", "truncated": false}, "after_length": 387, "after_sha256": "e382beb76fcf03f7f6ede11d1ff86b6dcc3929a213e6105ff241e674b6360a9f", "annex": "I", "before": {"end": 387, "start": 0, "text": "Cases of ILD/pneumonitis have been reported in clinical trials with Alecensa (see section 4.8). Patients should be monitored for pulmonary symptoms indicative of pneumonitis. Alecensa should be immediately interrupted in patients diagnosed with ILD/pneumonitis and should be permanently discontinued if no other potential causes of ILD/pneumonitis have been identified (see section 4.2).", "truncated": false}, "before_length": 387, "before_sha256": "e382beb76fcf03f7f6ede11d1ff86b6dcc3929a213e6105ff241e674b6360a9f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0aba192eb4d546d0bd9ca8e8", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004164", "medicine_name": "Alecensa", "medicine_slug": "alecensa", "observed_at": "2026-10-12T19:00:33Z", "pipeline_version": "2.0.0", "presentation_label": "Alecensa 150 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": "815d015f485abccb366cc8b59bef3ff2b7589fb9206cca47f8f889f776e1f3af", "source_snapshot_id": "source-c8b17db176ebb33561bb1413", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/alecensa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 151}
{"after": {"end": 71, "start": 0, "text": "3) comprend des cas de dysgueusie, d’hypogueusie et de trouble du goût.", "truncated": false}, "after_length": 71, "after_sha256": "5d3ce05a839eaea8bfb5edae42cba92eebddc49421a59f4f721fabd8035d521c", "annex": "I", "before": {"end": 71, "start": 0, "text": "3) comprend des cas de dysgueusie, d’hypogueusie et de trouble du goût.", "truncated": false}, "before_length": 71, "before_sha256": "5d3ce05a839eaea8bfb5edae42cba92eebddc49421a59f4f721fabd8035d521c", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0abee31ef5fed70e04f2618c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004164", "medicine_name": "Alecensa", "medicine_slug": "alecensa", "observed_at": "2026-10-12T19:00:36Z", "pipeline_version": "2.0.0", "presentation_label": "Alecensa 150 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": "83ee6e171c0e05bd6ab2daf5408dcacb676175e21156c6f5251ff1b3290852d9", "source_snapshot_id": "source-b1925a54bfeff5c1398e0f30", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/alecensa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 394}
{"after": {"end": 510, "start": 0, "text": "Dans les essais cliniques étudiant les effets de l'arrêt de Prolia, la DMO est approximativement revenue aux niveaux préthérapeutiques et est restée supérieure à la DMO sous placebo au cours des 18 mois suivant l'administration de la dernière dose. Ces données indiquent qu’il est nécessaire de poursuivre le traitement par Prolia pour maintenir l'effet du médicament. La réintroduction de Prolia a entraîné des gains de DMO comparables à ceux obtenus lorsque Prolia avait été administré pour la première fois.", "truncated": false}, "after_length": 510, "after_sha256": "c2064c9771db573514943bf6d8985c4b2c65d87f76098897253820ef340fc48a", "annex": "I", "before": {"end": 510, "start": 0, "text": "Dans les essais cliniques étudiant les effets de l'arrêt de Prolia, la DMO est approximativement revenue aux niveaux préthérapeutiques et est restée supérieure à la DMO sous placebo au cours des 18 mois suivant l'administration de la dernière dose. Ces données indiquent qu’il est nécessaire de poursuivre le traitement par Prolia pour maintenir l'effet du médicament. La réintroduction de Prolia a entraîné des gains de DMO comparables à ceux obtenus lorsque Prolia avait été administré pour la première fois.", "truncated": false}, "before_length": 510, "before_sha256": "c2064c9771db573514943bf6d8985c4b2c65d87f76098897253820ef340fc48a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0abf091b93a0b508ea4f335c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/001120", "medicine_name": "Prolia", "medicine_slug": "prolia", "observed_at": "2026-10-12T13:28:45Z", "pipeline_version": "2.0.0", "presentation_label": "Prolia 60 mg solution injectable en seringue préremplie", "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": "30e296cc06d303605f266e9544e10515b7e5c2063a0473f5aa3595a42d18a3e1", "source_snapshot_id": "source-2924aac36bd07813fcc1891d", "source_updated_at": "2026-08-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/prolia-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 441}
{"after": {"end": 48, "start": 0, "text": "Effects of other medicinal products on alectinib", "truncated": false}, "after_length": 48, "after_sha256": "490b6de0551d6e9cf18dee4a1d45099ac44f391bd7637992ddcbcf4158f9b9ed", "annex": "I", "before": {"end": 48, "start": 0, "text": "Effects of other medicinal products on alectinib", "truncated": false}, "before_length": 48, "before_sha256": "490b6de0551d6e9cf18dee4a1d45099ac44f391bd7637992ddcbcf4158f9b9ed", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0acc0c6352742a958600d953", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004164", "medicine_name": "Alecensa", "medicine_slug": "alecensa", "observed_at": "2026-10-12T19:00:33Z", "pipeline_version": "2.0.0", "presentation_label": "Alecensa 150 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": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "815d015f485abccb366cc8b59bef3ff2b7589fb9206cca47f8f889f776e1f3af", "source_snapshot_id": "source-c8b17db176ebb33561bb1413", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/alecensa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 188}
{"after": {"end": 806, "start": 0, "text": "Lors d’une étude de cancérogenèse chez le rat, les néoplasies bénignes liées au traitement consistaient en tumeurs de l’épithélium des voies biliaires chez les mâles exposés à des concentrations plasmatiques de teduglutide environ 32 et 155 fois plus élevées que celles obtenues chez les patients recevant la dose recommandée (incidence de 1 sur 44 et 4 sur 48 respectivement). Des adénomes de la muqueuse du jéjunum ont été observés chez 1 mâle sur 50 et chez 5 mâles sur 50 exposés à des concentrations plasmatiques de teduglutide environ 10 et 155 fois plus élevées que celles obtenues chez les patients recevant la dose recommandée. Un adénocarcinome jéjunal a été également observé chez un rat mâle ayant reçu la plus faible dose testée (marge d’exposition plasmatique animal/homme d’environ 10 fois).", "truncated": false}, "after_length": 806, "after_sha256": "e88b2e58e0417738291e24d33352e03800a1f9c01fb4d9dace340410f0eb532a", "annex": "I", "before": {"end": 806, "start": 0, "text": "Lors d’une étude de cancérogenèse chez le rat, les néoplasies bénignes liées au traitement consistaient en tumeurs de l’épithélium des voies biliaires chez les mâles exposés à des concentrations plasmatiques de teduglutide environ 32 et 155 fois plus élevées que celles obtenues chez les patients recevant la dose recommandée (incidence de 1 sur 44 et 4 sur 48 respectivement). Des adénomes de la muqueuse du jéjunum ont été observés chez 1 mâle sur 50 et chez 5 mâles sur 50 exposés à des concentrations plasmatiques de teduglutide environ 10 et 155 fois plus élevées que celles obtenues chez les patients recevant la dose recommandée. Un adénocarcinome jéjunal a été également observé chez un rat mâle ayant reçu la plus faible dose testée (marge d’exposition plasmatique animal/homme d’environ 10 fois).", "truncated": false}, "before_length": 806, "before_sha256": "e88b2e58e0417738291e24d33352e03800a1f9c01fb4d9dace340410f0eb532a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0af529aa2cd852dd66242ecd", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002345", "medicine_name": "Revestive", "medicine_slug": "revestive", "observed_at": "2026-10-12T19:38:11Z", "pipeline_version": "2.0.0", "presentation_label": "Revestive 1,25 mg poudre et solvant 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": "5.3", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a977434b47f1efb8356de57d0e4e212d0d42a4215af7d29769e6a19a6e5b7354", "source_snapshot_id": "source-34689da4d07d48b1dbd0d784", "source_updated_at": "2025-05-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/revestive-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 537}
{"after": {"end": 356, "start": 0, "text": "There were over 2700 patients treated with fluticasone furoate in safety and efficacy studies for seasonal and perennial allergic rhinitis. Paediatric exposure to fluticasone furoate in safety and efficacy studies in seasonal and perennial allergic rhinitis included 243 patients 12 to <18 years, 790 patients 6 to <12 years and 241 patients 2 to <6 years.", "truncated": false}, "after_length": 356, "after_sha256": "81cf41892982a2471bacb00502dce8aa1cee2e511a1f4b00d82a57cc7b8ebde5", "annex": "I", "before": {"end": 356, "start": 0, "text": "There were over 2700 patients treated with fluticasone furoate in safety and efficacy studies for seasonal and perennial allergic rhinitis. Paediatric exposure to fluticasone furoate in safety and efficacy studies in seasonal and perennial allergic rhinitis included 243 patients 12 to <18 years, 790 patients 6 to <12 years and 241 patients 2 to <6 years.", "truncated": false}, "before_length": 356, "before_sha256": "81cf41892982a2471bacb00502dce8aa1cee2e511a1f4b00d82a57cc7b8ebde5", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0b1d421ea84a4c76d88ce9e2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000770", "medicine_name": "Avamys", "medicine_slug": "avamys", "observed_at": "2026-10-12T19:30:29Z", "pipeline_version": "2.0.0", "presentation_label": "AVAMYS 27.5 micrograms/spray, nasal spray suspension", "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": "30f949bc5059758fc7a5c6971f20b61b1a1216476650dc650963a3ac481e29e3", "source_snapshot_id": "source-74cb508bb20024b25ca75f56", "source_updated_at": "2025-06-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/avamys-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 164}
{"after": {"end": 175, "start": 0, "text": "The recommended starting dose is one spray actuation (27.5 micrograms of fluticasone furoate per spray actuation) in each nostril once daily (total daily dose, 55 micrograms).", "truncated": false}, "after_length": 175, "after_sha256": "fed68dee4187d32c2995f8fc173b58821d2c4350a83719872cca72ed3548aa8b", "annex": "I", "before": {"end": 175, "start": 0, "text": "The recommended starting dose is one spray actuation (27.5 micrograms of fluticasone furoate per spray actuation) in each nostril once daily (total daily dose, 55 micrograms).", "truncated": false}, "before_length": 175, "before_sha256": "fed68dee4187d32c2995f8fc173b58821d2c4350a83719872cca72ed3548aa8b", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0b258858770484a0567b3735", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000770", "medicine_name": "Avamys", "medicine_slug": "avamys", "observed_at": "2026-10-12T19:30:29Z", "pipeline_version": "2.0.0", "presentation_label": "AVAMYS 27.5 micrograms/spray, nasal spray suspension", "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": "30f949bc5059758fc7a5c6971f20b61b1a1216476650dc650963a3ac481e29e3", "source_snapshot_id": "source-74cb508bb20024b25ca75f56", "source_updated_at": "2025-06-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/avamys-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 71}
{"after": {"end": 71, "start": 0, "text": "Tableau 5 Efficacité globale : population en intention de traiter (ITT)", "truncated": false}, "after_length": 71, "after_sha256": "c3e52d5ea7c2024e1f46804f4556e0fc46896a56c1d4fa9dce60235c57912166", "annex": "I", "before": {"end": 71, "start": 0, "text": "Tableau 5 Efficacité globale : population en intention de traiter (ITT)", "truncated": false}, "before_length": 71, "before_sha256": "c3e52d5ea7c2024e1f46804f4556e0fc46896a56c1d4fa9dce60235c57912166", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0b2a9a87dc3a1248222f227e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002547", "medicine_name": "Perjeta", "medicine_slug": "perjeta", "observed_at": "2026-10-12T13:39:17Z", "pipeline_version": "2.0.0", "presentation_label": "Perjeta 420 mg 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": "dfc85998efa134fbc08630f7e0f1d1183bd4fb18ec62a15b680bda3fd94b49bd", "source_snapshot_id": "source-791eb96e62fdebcce4c81ec4", "source_updated_at": "2026-04-28", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/perjeta-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 863}
{"after": {"end": 53, "start": 0, "text": "Effects of other medicinal products on mercaptopurine", "truncated": false}, "after_length": 53, "after_sha256": "f8e0b2e6fdb9715058549d190f9f068c09df365ec2a433b0f84d595ee3fbd909", "annex": "I", "before": {"end": 53, "start": 0, "text": "Effects of other medicinal products on mercaptopurine", "truncated": false}, "before_length": 53, "before_sha256": "f8e0b2e6fdb9715058549d190f9f068c09df365ec2a433b0f84d595ee3fbd909", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0b342dc4e825392d88b7c470", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002022", "medicine_name": "Xaluprine (previously Mercaptopurine Nova Laboratories)", "medicine_slug": "xaluprine-previously-mercaptopurine-nova-laboratories", "observed_at": "2026-10-12T19:08:02Z", "pipeline_version": "2.0.0", "presentation_label": "Xaluprine 20 mg/ml oral suspension", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "a352706294cb9013c5ba158da50186f12673cdb6fb887d0033e1457d44698091", "source_snapshot_id": "source-80b0d9db881bf774bffb5d3c", "source_updated_at": "2025-09-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/xaluprine-epar-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": 84, "start": 0, "text": "Patients should not take Nexium Control as a long term preventive medicinal product.", "truncated": false}, "after_length": 84, "after_sha256": "b11fa16af77c8c3fdf71fbfd9b9b13ea21524c172448da20d6c4c767dae9794c", "annex": "I", "before": {"end": 84, "start": 0, "text": "Patients should not take Nexium Control as a long term preventive medicinal product.", "truncated": false}, "before_length": 84, "before_sha256": "b11fa16af77c8c3fdf71fbfd9b9b13ea21524c172448da20d6c4c767dae9794c", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0b3895cc1054c28c52cad616", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002618", "medicine_name": "Nexium Control", "medicine_slug": "nexium-control", "observed_at": "2026-10-12T13:36:16Z", "pipeline_version": "2.0.0", "presentation_label": "Nexium Control 20 mg gastroresistant hard capsules", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "266d567343c3811aa2034b1a0d89c81f2a39f87634c27e040eddf35f3f1f5cac", "source_snapshot_id": "source-dfdf6861216bffe1c095176b", "source_updated_at": "2026-06-03", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nexium-control-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 572}
{"after": {"end": 108, "start": 0, "text": "Pour les instructions concernant la reconstitution du médicament avant administration, voir la rubrique 6.6.", "truncated": false}, "after_length": 108, "after_sha256": "ff32365137e5b4fdc1c890c6dc6de1c9e39ec257a47af90f4577766a9e8f465d", "annex": "I", "before": {"end": 108, "start": 0, "text": "Pour les instructions concernant la reconstitution du médicament avant administration, voir la rubrique 6.6.", "truncated": false}, "before_length": 108, "before_sha256": "ff32365137e5b4fdc1c890c6dc6de1c9e39ec257a47af90f4577766a9e8f465d", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0b456850440d6b9666b029c1", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002345", "medicine_name": "Revestive", "medicine_slug": "revestive", "observed_at": "2026-10-12T19:38:11Z", "pipeline_version": "2.0.0", "presentation_label": "Revestive 1,25 mg poudre et solvant 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": "a977434b47f1efb8356de57d0e4e212d0d42a4215af7d29769e6a19a6e5b7354", "source_snapshot_id": "source-34689da4d07d48b1dbd0d784", "source_updated_at": "2025-05-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/revestive-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 117}
{"after": {"end": 76, "start": 0, "text": "Troubles gastro-intestinaux, ulcère gastro-intestinal, hypomagnésémie sévère", "truncated": false}, "after_length": 76, "after_sha256": "199f4cf2216cf8ceb1929d13e389466da785df09a820a255fc36fc2dc947cc02", "annex": "I", "before": {"end": 76, "start": 0, "text": "Troubles gastro-intestinaux, ulcère gastro-intestinal, hypomagnésémie sévère", "truncated": false}, "before_length": 76, "before_sha256": "199f4cf2216cf8ceb1929d13e389466da785df09a820a255fc36fc2dc947cc02", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0b471dac9e79bcab42e8b893", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004837", "medicine_name": "Xromi", "medicine_slug": "xromi", "observed_at": "2026-10-12T19:32:45Z", "pipeline_version": "2.0.0", "presentation_label": "Xromi 100 mg/mL solution buvable", "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": "09fc95ca63cda4685a64f9a6f2786bf839a7e56efe05863cd60781314e5f87b5", "source_snapshot_id": "source-6048aed0c6a5fd892436dd1f", "source_updated_at": "2025-06-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xromi-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 249}
{"after": {"end": 64, "start": 0, "text": "Safety and efficacy in this group has not been well established.", "truncated": false}, "after_length": 64, "after_sha256": "f1ab63dfda12c2ff609c387041eea9c16d752906fc0f7c59517bfbd26fd8f178", "annex": "I", "before": {"end": 64, "start": 0, "text": "Safety and efficacy in this group has not been well established.", "truncated": false}, "before_length": 64, "before_sha256": "f1ab63dfda12c2ff609c387041eea9c16d752906fc0f7c59517bfbd26fd8f178", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0b49f607fc70cea5bdeafb3b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000770", "medicine_name": "Avamys", "medicine_slug": "avamys", "observed_at": "2026-10-12T19:30:29Z", "pipeline_version": "2.0.0", "presentation_label": "AVAMYS 27.5 micrograms/spray, nasal spray suspension", "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": "30f949bc5059758fc7a5c6971f20b61b1a1216476650dc650963a3ac481e29e3", "source_snapshot_id": "source-74cb508bb20024b25ca75f56", "source_updated_at": "2025-06-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/avamys-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 265}
{"after": {"end": 235, "start": 0, "text": "This medicinal product contains aspartame (E951), a source of phenylalanine. May be harmful for people with phenylketonuria. Neither non-clinical nor clinical data are available to assess aspartame use in infants below 12 weeks of age.", "truncated": false}, "after_length": 235, "after_sha256": "04c389b8b15a6af08e3ea57aa1ec050fd80e7aff46d5256bd5dfc55376624d67", "annex": "I", "before": {"end": 235, "start": 0, "text": "This medicinal product contains aspartame (E951), a source of phenylalanine. May be harmful for people with phenylketonuria. Neither non-clinical nor clinical data are available to assess aspartame use in infants below 12 weeks of age.", "truncated": false}, "before_length": 235, "before_sha256": "04c389b8b15a6af08e3ea57aa1ec050fd80e7aff46d5256bd5dfc55376624d67", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0b6fb37df0c6bce9beec2d31", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002022", "medicine_name": "Xaluprine (previously Mercaptopurine Nova Laboratories)", "medicine_slug": "xaluprine-previously-mercaptopurine-nova-laboratories", "observed_at": "2026-10-12T19:08:02Z", "pipeline_version": "2.0.0", "presentation_label": "Xaluprine 20 mg/ml oral suspension", "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": "a352706294cb9013c5ba158da50186f12673cdb6fb887d0033e1457d44698091", "source_snapshot_id": "source-80b0d9db881bf774bffb5d3c", "source_updated_at": "2025-09-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/xaluprine-epar-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": 247, "start": 0, "text": "Saignement (majeur et mineur, incluant point de ponction artériel fémoral, lié au PAC, gastro-intestinal, génito-urinaire, rétro-péritonéal, intracrânien, hématémèse, hématurie, oral/oropharyngé, diminution de l’hémoglobine/hématocrite et autres).", "truncated": false}, "after_length": 247, "after_sha256": "de26a896278763e0778783f9608f1bb9bedbc9142c319d1ec124851346074087", "annex": "I", "before": {"end": 247, "start": 0, "text": "Saignement (majeur et mineur, incluant point de ponction artériel fémoral, lié au PAC, gastro-intestinal, génito-urinaire, rétro-péritonéal, intracrânien, hématémèse, hématurie, oral/oropharyngé, diminution de l’hémoglobine/hématocrite et autres).", "truncated": false}, "before_length": 247, "before_sha256": "de26a896278763e0778783f9608f1bb9bedbc9142c319d1ec124851346074087", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0b761836b5dfe92c22578234", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004104", "medicine_name": "Eptifibatide Accord", "medicine_slug": "eptifibatide-accord", "observed_at": "2026-10-12T19:45:11Z", "pipeline_version": "2.0.0", "presentation_label": "Eptifibatide Accord 2 mg/ml, 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": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "c9be002148fa73331c72aadac205f927e043f3407cf695e63a1cbe715480600b", "source_snapshot_id": "source-9e33d5d566c95289f1a7e6a6", "source_updated_at": "2025-05-02", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/eptifibatide-accord-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 628}
{"after": {"end": 309, "start": 0, "text": "L’hydroxycarbamide administrée à des rats mâles à raison de 60 mg/kg de poids corporel par jour (environ le double de la dose maximale habituelle recommandée chez l’homme) a entraîné une atrophie testiculaire, une diminution de la spermatogenèse et une réduction significative de leur capacité de fécondation.", "truncated": false}, "after_length": 309, "after_sha256": "8df62d2013af9dc3369e95f16f0cd079d8ce119adc9de66828cfad02ed04b800", "annex": "I", "before": {"end": 309, "start": 0, "text": "L’hydroxycarbamide administrée à des rats mâles à raison de 60 mg/kg de poids corporel par jour (environ le double de la dose maximale habituelle recommandée chez l’homme) a entraîné une atrophie testiculaire, une diminution de la spermatogenèse et une réduction significative de leur capacité de fécondation.", "truncated": false}, "before_length": 309, "before_sha256": "8df62d2013af9dc3369e95f16f0cd079d8ce119adc9de66828cfad02ed04b800", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0ba60be63ad6ce8c4c934351", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004837", "medicine_name": "Xromi", "medicine_slug": "xromi", "observed_at": "2026-10-12T19:32:45Z", "pipeline_version": "2.0.0", "presentation_label": "Xromi 100 mg/mL solution buvable", "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": "09fc95ca63cda4685a64f9a6f2786bf839a7e56efe05863cd60781314e5f87b5", "source_snapshot_id": "source-6048aed0c6a5fd892436dd1f", "source_updated_at": "2025-06-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xromi-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 505}
{"after": {"end": 199, "start": 0, "text": "§ Inclut les termes préférentiels suivants : hématome au site d’injection, érythème au site d’injection, douleur au site d’injection, gonflement au site d’injection et hémorragie au site d’injection.", "truncated": false}, "after_length": 199, "after_sha256": "1e4a198c889868a3d6c093f7b9ead1ef2b4f8f0b3627156c98ec099d747a8a7a", "annex": "I", "before": {"end": 199, "start": 0, "text": "§ Inclut les termes préférentiels suivants : hématome au site d’injection, érythème au site d’injection, douleur au site d’injection, gonflement au site d’injection et hémorragie au site d’injection.", "truncated": false}, "before_length": 199, "before_sha256": "1e4a198c889868a3d6c093f7b9ead1ef2b4f8f0b3627156c98ec099d747a8a7a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0be97381ffe336c217fc0916", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002345", "medicine_name": "Revestive", "medicine_slug": "revestive", "observed_at": "2026-10-12T19:38:11Z", "pipeline_version": "2.0.0", "presentation_label": "Revestive 1,25 mg poudre et solvant 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": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "a977434b47f1efb8356de57d0e4e212d0d42a4215af7d29769e6a19a6e5b7354", "source_snapshot_id": "source-34689da4d07d48b1dbd0d784", "source_updated_at": "2025-05-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/revestive-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 323}
{"after": {"end": 132, "start": 0, "text": "La biodisponibilité absolue des gélules alectinib était de 36,9 % (IC à 90 % : 33,9 % ; 40,3 %) avec un repas chez des sujets sains.", "truncated": false}, "after_length": 132, "after_sha256": "a12942a7a392998c64e66fef05b74864d5e7e1eb9cd2ac8d0184c0f9768ee742", "annex": "I", "before": {"end": 132, "start": 0, "text": "La biodisponibilité absolue des gélules alectinib était de 36,9 % (IC à 90 % : 33,9 % ; 40,3 %) avec un repas chez des sujets sains.", "truncated": false}, "before_length": 132, "before_sha256": "a12942a7a392998c64e66fef05b74864d5e7e1eb9cd2ac8d0184c0f9768ee742", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0c628da45a7a602b0248a081", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004164", "medicine_name": "Alecensa", "medicine_slug": "alecensa", "observed_at": "2026-10-12T19:00:36Z", "pipeline_version": "2.0.0", "presentation_label": "Alecensa 150 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": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "83ee6e171c0e05bd6ab2daf5408dcacb676175e21156c6f5251ff1b3290852d9", "source_snapshot_id": "source-b1925a54bfeff5c1398e0f30", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/alecensa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 913}
{"after": {"end": 455, "start": 0, "text": "Fracture incidence was evaluated as a safety endpoint but efficacy in fracture prevention cannot be estimated due to high number of discontinuations and openlabel design. The cumulative incidence of new vertebral and nonvertebral fractures were approximately 6.8% and 13.1% respectively, in patients who remained on denosumab treatment for 10 years (n = 1 278). Patients who did not complete the study for any reason had higher ontreatment fracture rates.", "truncated": false}, "after_length": 455, "after_sha256": "330f78d96f7c32dd38f34d31111ea5a914eda8a81e0ea2de75a8ea6beb86b81b", "annex": "I", "before": {"end": 455, "start": 0, "text": "Fracture incidence was evaluated as a safety endpoint but efficacy in fracture prevention cannot be estimated due to high number of discontinuations and openlabel design. The cumulative incidence of new vertebral and nonvertebral fractures were approximately 6.8% and 13.1% respectively, in patients who remained on denosumab treatment for 10 years (n = 1 278). Patients who did not complete the study for any reason had higher ontreatment fracture rates.", "truncated": false}, "before_length": 455, "before_sha256": "330f78d96f7c32dd38f34d31111ea5a914eda8a81e0ea2de75a8ea6beb86b81b", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0c78003373346a19c19c03d3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001120", "medicine_name": "Prolia", "medicine_slug": "prolia", "observed_at": "2026-10-12T13:28:42Z", "pipeline_version": "2.0.0", "presentation_label": "Prolia 60 mg solution for injection in prefilled syringe", "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": "5984d05d5bd9987a8e6f5cf86ff2e5032af0bc8bf5fe7a137a9f36a8466c5b97", "source_snapshot_id": "source-312c11aae5d59cae975290d1", "source_updated_at": "2026-08-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/prolia-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 449}
{"after": {"end": 101, "start": 0, "text": "† Inclut les termes préférentiels suivants : pancréatite, pancréatite aiguë et pancréatite chronique.", "truncated": false}, "after_length": 101, "after_sha256": "efcf34cc676ae89a20bf0bc68aa16397edeebb0a0152553f09390432dd84162f", "annex": "I", "before": {"end": 101, "start": 0, "text": "† Inclut les termes préférentiels suivants : pancréatite, pancréatite aiguë et pancréatite chronique.", "truncated": false}, "before_length": 101, "before_sha256": "efcf34cc676ae89a20bf0bc68aa16397edeebb0a0152553f09390432dd84162f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0ca0bb9b96bdca2eaf1bad09", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002345", "medicine_name": "Revestive", "medicine_slug": "revestive", "observed_at": "2026-10-12T19:38:11Z", "pipeline_version": "2.0.0", "presentation_label": "Revestive 5 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": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "a977434b47f1efb8356de57d0e4e212d0d42a4215af7d29769e6a19a6e5b7354", "source_snapshot_id": "source-34689da4d07d48b1dbd0d784", "source_updated_at": "2025-05-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/revestive-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 995}
{"after": {"end": 140, "start": 0, "text": "Ledipasvir (90 mg once daily)/ sofosbuvir (400 mg once daily), emtricitabine (200 mg once daily)/ tenofovir alafenamide (25 mg once daily) 4", "truncated": false}, "after_length": 140, "after_sha256": "3b28f46ceec5ebdb418b648848ba88977f1acd435c6b9a9b01e4e6549ac039b4", "annex": "I", "before": {"end": 140, "start": 0, "text": "Ledipasvir (90 mg once daily)/ sofosbuvir (400 mg once daily), emtricitabine (200 mg once daily)/ tenofovir alafenamide (25 mg once daily) 4", "truncated": false}, "before_length": 140, "before_sha256": "3b28f46ceec5ebdb418b648848ba88977f1acd435c6b9a9b01e4e6549ac039b4", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0cacb30a6392d1df056f282a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006469", "medicine_name": "Emtricitabine / Tenofovir alafenamide Viatris", "medicine_slug": "emtricitabine-tenofovir-alafenamide-viatris", "observed_at": "2026-10-12T13:40:14Z", "pipeline_version": "2.0.0", "presentation_label": "Emtricitabine/Tenofovir alafenamide Viatris 200 mg/10 mg filmcoated tablets Emtricitabine/Tenofovir alafenamide Viatris 200 mg/25 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": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "247b89d7ca1efa91cffaeb0f00556dd381d81e804eb2f9c23631d01a49578ea7", "source_snapshot_id": "source-246d08888d5f52d006efa07f", "source_updated_at": "2026-04-16", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/emtricitabine-tenofovir-alafenamide-viatris-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 264}
{"after": {"end": 183, "start": 0, "text": "Il contient également du parahydroxybenzoate de méthyle sodique et du parahydroxybenzoate d’éthyle sodique, qui peuvent provoquer des réactions allergiques (éventuellement retardées).", "truncated": false}, "after_length": 183, "after_sha256": "39f548b06fcc5636911762b72b4f7e1c851c7e84b9701624e02420f4f75c560b", "annex": "I", "before": {"end": 183, "start": 0, "text": "Il contient également du parahydroxybenzoate de méthyle sodique et du parahydroxybenzoate d’éthyle sodique, qui peuvent provoquer des réactions allergiques (éventuellement retardées).", "truncated": false}, "before_length": 183, "before_sha256": "39f548b06fcc5636911762b72b4f7e1c851c7e84b9701624e02420f4f75c560b", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0cc2469fc940b2a005abf9e1", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002022", "medicine_name": "Xaluprine (previously Mercaptopurine Nova Laboratories)", "medicine_slug": "xaluprine-previously-mercaptopurine-nova-laboratories", "observed_at": "2026-10-12T19:08:05Z", "pipeline_version": "2.0.0", "presentation_label": "Xaluprine 20 mg/ml suspension orale", "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": "24d3b15ae521f391e697a4d72930da59f53e4eeefc26a100461fbfa83e960527", "source_snapshot_id": "source-22ca1025dfc29c23d7b323de", "source_updated_at": "2025-09-25", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xaluprine-epar-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": 49, "start": 0, "text": "For the full list of excipients, see section 6.1.", "truncated": false}, "after_length": 49, "after_sha256": "ba6b711ddc24074f0157a995f2479f1c19a9397f8b69091972a8e12be0abc28d", "annex": "I", "before": {"end": 49, "start": 0, "text": "For the full list of excipients, see section 6.1.", "truncated": false}, "before_length": 49, "before_sha256": "ba6b711ddc24074f0157a995f2479f1c19a9397f8b69091972a8e12be0abc28d", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0cdf7de9e2de0cd319d5ae5c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002022", "medicine_name": "Xaluprine (previously Mercaptopurine Nova Laboratories)", "medicine_slug": "xaluprine-previously-mercaptopurine-nova-laboratories", "observed_at": "2026-10-12T19:08:02Z", "pipeline_version": "2.0.0", "presentation_label": "Xaluprine 20 mg/ml oral suspension", "presentation_occurrence": 1, "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": "a352706294cb9013c5ba158da50186f12673cdb6fb887d0033e1457d44698091", "source_snapshot_id": "source-80b0d9db881bf774bffb5d3c", "source_updated_at": "2025-09-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/xaluprine-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 36}
{"after": {"end": 167, "start": 0, "text": "Le traitement par le teduglutide a induit un accroissement de l’absorption épithéliale en augmentant significativement la hauteur des villosités dans l’intestin grêle.", "truncated": false}, "after_length": 167, "after_sha256": "5f39ac4302cbdd2437aa7a451174a9abed783da855fa2391c8dde64fe5c2b1ef", "annex": "I", "before": {"end": 167, "start": 0, "text": "Le traitement par le teduglutide a induit un accroissement de l’absorption épithéliale en augmentant significativement la hauteur des villosités dans l’intestin grêle.", "truncated": false}, "before_length": 167, "before_sha256": "5f39ac4302cbdd2437aa7a451174a9abed783da855fa2391c8dde64fe5c2b1ef", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0d2807727e2e833d097ff957", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002345", "medicine_name": "Revestive", "medicine_slug": "revestive", "observed_at": "2026-10-12T19:38:11Z", "pipeline_version": "2.0.0", "presentation_label": "Revestive 1,25 mg poudre et solvant 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a977434b47f1efb8356de57d0e4e212d0d42a4215af7d29769e6a19a6e5b7354", "source_snapshot_id": "source-34689da4d07d48b1dbd0d784", "source_updated_at": "2025-05-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/revestive-epar-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": 1500, "start": 0, "text": "Other secondary endpoints were supportive of the primary endpoint, including relief of heartburn at week 1 and week 2, percentage of 24 hour days without heartburn at week 1 and week 2, mean heartburn severity at week 1 and week 2, and time to initial and sustained resolution of heartburn over a 24 hour period and during the night compared to placebo. Approximately 78% of the subjects on 20 mg esomeprazole reported first resolution of heartburn within the first week of treatment compared to 52 – 58% for placebo. Time to sustained resolution of heartburn, defined as when 7 consecutive days of no heartburn was first recorded, was significantly shorter in the esomeprazole 20 mg group (39.7% - 48.7% by day 14 vs placebo 11.0% - 20.2%). The median time to first resolution of nighttime heartburn was 1 day, statistically significant compared to placebo in one study (p=0.048) and approaching significance in the other (p=0.069). About 80% of nights were heartburn free during all time periods and 90% of nights were heartburn free by week 2 of each clinical study, compared to 72.4 – 78.3% for placebo. The investigators’ assessments of heartburn resolution were consistent with the subjects’ assessments, showing statistically significant differences between esomeprazole (34.7% - 41.8%) compared to placebo (8.0% - 11.4%). The investigators also found esomeprazole to be significantly more effective than placebo in resolving acid regurgitation (58.5% 63.6% vs placebo 28.3% - 37.4%) during th", "truncated": true}, "after_length": 1520, "after_sha256": "3f5bdbc1e991564d0542cac33b14872f357e1cbebc328536a245c741947aaa92", "annex": "I", "before": {"end": 1500, "start": 0, "text": "Other secondary endpoints were supportive of the primary endpoint, including relief of heartburn at week 1 and week 2, percentage of 24 hour days without heartburn at week 1 and week 2, mean heartburn severity at week 1 and week 2, and time to initial and sustained resolution of heartburn over a 24 hour period and during the night compared to placebo. Approximately 78% of the subjects on 20 mg esomeprazole reported first resolution of heartburn within the first week of treatment compared to 52 – 58% for placebo. Time to sustained resolution of heartburn, defined as when 7 consecutive days of no heartburn was first recorded, was significantly shorter in the esomeprazole 20 mg group (39.7% - 48.7% by day 14 vs placebo 11.0% - 20.2%). The median time to first resolution of nighttime heartburn was 1 day, statistically significant compared to placebo in one study (p=0.048) and approaching significance in the other (p=0.069). About 80% of nights were heartburn free during all time periods and 90% of nights were heartburn free by week 2 of each clinical study, compared to 72.4 – 78.3% for placebo. The investigators’ assessments of heartburn resolution were consistent with the subjects’ assessments, showing statistically significant differences between esomeprazole (34.7% - 41.8%) compared to placebo (8.0% - 11.4%). The investigators also found esomeprazole to be significantly more effective than placebo in resolving acid regurgitation (58.5% 63.6% vs placebo 28.3% - 37.4%) during th", "truncated": true}, "before_length": 1520, "before_sha256": "3f5bdbc1e991564d0542cac33b14872f357e1cbebc328536a245c741947aaa92", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0d4a24811ce0a6332fd6f1bc", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002618", "medicine_name": "Nexium Control", "medicine_slug": "nexium-control", "observed_at": "2026-10-12T13:36:16Z", "pipeline_version": "2.0.0", "presentation_label": "Nexium Control 20 mg gastroresistant 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": "266d567343c3811aa2034b1a0d89c81f2a39f87634c27e040eddf35f3f1f5cac", "source_snapshot_id": "source-dfdf6861216bffe1c095176b", "source_updated_at": "2026-06-03", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nexium-control-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 375}
{"after": {"end": 402, "start": 0, "text": "The recommended dose of Revestive is 0.05 mg/kg body weight once daily. The injection volume per body weight is provided below in Table 1. Due to the heterogeneity of the SBS population, a carefully monitored downtitration of the daily dose may be considered for some patients to optimise tolerability of the treatment. If a dose is missed, that dose should be injected as soon as possible on that day.", "truncated": false}, "after_length": 402, "after_sha256": "cf80439df5ff4b037ba376e63be7062da4f61f2bb36e4bdc843de5e3a708adc0", "annex": "I", "before": {"end": 402, "start": 0, "text": "The recommended dose of Revestive is 0.05 mg/kg body weight once daily. The injection volume per body weight is provided below in Table 1. Due to the heterogeneity of the SBS population, a carefully monitored downtitration of the daily dose may be considered for some patients to optimise tolerability of the treatment. If a dose is missed, that dose should be injected as soon as possible on that day.", "truncated": false}, "before_length": 402, "before_sha256": "cf80439df5ff4b037ba376e63be7062da4f61f2bb36e4bdc843de5e3a708adc0", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0d670be9182ffffaf9c8b9c0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002345", "medicine_name": "Revestive", "medicine_slug": "revestive", "observed_at": "2026-10-12T19:38:01Z", "pipeline_version": "2.0.0", "presentation_label": "Revestive 5 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": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "0125d033ce2f8805dc45ece9b8ffa34db6682b195448a3a560e6d2483a8982b4", "source_snapshot_id": "source-8d7c3200418c650a002546aa", "source_updated_at": "2025-05-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/revestive-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 693}
{"after": {"end": 266, "start": 0, "text": "The BERENICE study included two parallel groups of patients. Patients considered suitable for neoadjuvant treatment with trastuzumab plus anthracycline/taxane-based chemotherapy were allocated to receive one of the two following regimens prior to surgery as follows:", "truncated": false}, "after_length": 266, "after_sha256": "714d53626e960ad6780704f4b98228197a96aba75030384a4ed46dfed3a2becd", "annex": "I", "before": {"end": 266, "start": 0, "text": "The BERENICE study included two parallel groups of patients. Patients considered suitable for neoadjuvant treatment with trastuzumab plus anthracycline/taxane-based chemotherapy were allocated to receive one of the two following regimens prior to surgery as follows:", "truncated": false}, "before_length": 266, "before_sha256": "714d53626e960ad6780704f4b98228197a96aba75030384a4ed46dfed3a2becd", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0d6a415e95baafd5cdaa7b1e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002547", "medicine_name": "Perjeta", "medicine_slug": "perjeta", "observed_at": "2026-10-12T13:39:17Z", "pipeline_version": "2.0.0", "presentation_label": "Perjeta 420 mg 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "cb28465c58604d0b3ae410ab4b7f20b7947f60bdf7475f845ec18185037e8ea6", "source_snapshot_id": "source-f34b78f381a5e027cfbe1fe6", "source_updated_at": "2026-04-28", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/perjeta-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 824}
{"after": {"end": 297, "start": 0, "text": "There are no data that support specific dose adjustments in patients with hepatic impairment. Close monitoring of blood parameters is advised in these patients. Due to safety considerations, hydroxycarbamide is contraindicated in patients with severe hepatic impairment (see sections 4.3 and 4.4).", "truncated": false}, "after_length": 297, "after_sha256": "5187a9ccca5c43d38fa33122865b652c2a3634acfa86bbddaf8b898087840179", "annex": "I", "before": {"end": 297, "start": 0, "text": "There are no data that support specific dose adjustments in patients with hepatic impairment. Close monitoring of blood parameters is advised in these patients. Due to safety considerations, hydroxycarbamide is contraindicated in patients with severe hepatic impairment (see sections 4.3 and 4.4).", "truncated": false}, "before_length": 297, "before_sha256": "5187a9ccca5c43d38fa33122865b652c2a3634acfa86bbddaf8b898087840179", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0d7a47f2c14407b757debed7", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004837", "medicine_name": "Xromi", "medicine_slug": "xromi", "observed_at": "2026-10-12T19:31:37Z", "pipeline_version": "2.0.0", "presentation_label": "Xromi 100 mg/ml oral solution", "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": "5e9826d3dd1edc48d9eb87b57c4ee7e70574bc6ce1c841b5477a3de3b9950a1e", "source_snapshot_id": "source-d10ea7497b831a802d8ae623", "source_updated_at": "2025-06-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/xromi-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 86}
{"after": {"end": 328, "start": 0, "text": "Traitement de la perte osseuse associée à un traitement hormono-ablatif chez les hommes atteints de cancer de la prostate à risque élevé de fractures (voir rubrique 5.1). Chez les hommes atteints de cancer de la prostate recevant un traitement hormono-ablatif, Prolia réduit significativement le risque de fractures vertébrales.", "truncated": false}, "after_length": 328, "after_sha256": "237bc0130c9108ee066535e912209d9ea9d24ecee82a1c8af656d7289ebf9eb8", "annex": "I", "before": {"end": 328, "start": 0, "text": "Traitement de la perte osseuse associée à un traitement hormono-ablatif chez les hommes atteints de cancer de la prostate à risque élevé de fractures (voir rubrique 5.1). Chez les hommes atteints de cancer de la prostate recevant un traitement hormono-ablatif, Prolia réduit significativement le risque de fractures vertébrales.", "truncated": false}, "before_length": 328, "before_sha256": "237bc0130c9108ee066535e912209d9ea9d24ecee82a1c8af656d7289ebf9eb8", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0dad0f0e9919d8476d14ff56", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/001120", "medicine_name": "Prolia", "medicine_slug": "prolia", "observed_at": "2026-10-12T13:28:45Z", "pipeline_version": "2.0.0", "presentation_label": "Prolia 60 mg solution injectable en seringue préremplie", "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": "30e296cc06d303605f266e9544e10515b7e5c2063a0473f5aa3595a42d18a3e1", "source_snapshot_id": "source-2924aac36bd07813fcc1891d", "source_updated_at": "2026-08-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/prolia-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 55}
{"after": {"end": 102, "start": 0, "text": "Each hard capsule contains 33.7 mg lactose (as monohydrate) and 6 mg sodium (as sodium laurilsulfate).", "truncated": false}, "after_length": 102, "after_sha256": "8e44266e233be0be3b254c43d3e7464db96ecc5ce27cae5205a6e9b2baf9947f", "annex": "I", "before": {"end": 102, "start": 0, "text": "Each hard capsule contains 33.7 mg lactose (as monohydrate) and 6 mg sodium (as sodium laurilsulfate).", "truncated": false}, "before_length": 102, "before_sha256": "8e44266e233be0be3b254c43d3e7464db96ecc5ce27cae5205a6e9b2baf9947f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0dde01954868258ae2427e70", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004164", "medicine_name": "Alecensa", "medicine_slug": "alecensa", "observed_at": "2026-10-12T19:00:33Z", "pipeline_version": "2.0.0", "presentation_label": "Alecensa 150 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": "2", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "815d015f485abccb366cc8b59bef3ff2b7589fb9206cca47f8f889f776e1f3af", "source_snapshot_id": "source-c8b17db176ebb33561bb1413", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/alecensa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 35}
{"after": {"end": 99, "start": 0, "text": "For instructions on reconstitution of the medicinal product before administration, see section 6.6.", "truncated": false}, "after_length": 99, "after_sha256": "6dc54f319cad37754949624ff7905f698e6d691bfd4eca621a9a7528eaabf15f", "annex": "I", "before": {"end": 99, "start": 0, "text": "For instructions on reconstitution of the medicinal product before administration, see section 6.6.", "truncated": false}, "before_length": 99, "before_sha256": "6dc54f319cad37754949624ff7905f698e6d691bfd4eca621a9a7528eaabf15f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0ddedeaf201a0b4f1e578635", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002345", "medicine_name": "Revestive", "medicine_slug": "revestive", "observed_at": "2026-10-12T19:38:01Z", "pipeline_version": "2.0.0", "presentation_label": "Revestive 1.25 mg powder and solvent 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": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "0125d033ce2f8805dc45ece9b8ffa34db6682b195448a3a560e6d2483a8982b4", "source_snapshot_id": "source-8d7c3200418c650a002546aa", "source_updated_at": "2025-05-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/revestive-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 119}
{"after": {"end": 50, "start": 0, "text": "Nexium Control 20 mg gastroresistant hard capsules", "truncated": false}, "after_length": 50, "after_sha256": "d78a47432ac403e6285cff8915c90099358101f583795601917324cef5c9480a", "annex": "I", "before": {"end": 50, "start": 0, "text": "Nexium Control 20 mg gastroresistant hard capsules", "truncated": false}, "before_length": 50, "before_sha256": "d78a47432ac403e6285cff8915c90099358101f583795601917324cef5c9480a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0dfc52c2af43095866387eea", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002618", "medicine_name": "Nexium Control", "medicine_slug": "nexium-control", "observed_at": "2026-10-12T13:36:16Z", "pipeline_version": "2.0.0", "presentation_label": "Nexium Control 20 mg gastroresistant hard capsules", "presentation_occurrence": 2, "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": "266d567343c3811aa2034b1a0d89c81f2a39f87634c27e040eddf35f3f1f5cac", "source_snapshot_id": "source-dfdf6861216bffe1c095176b", "source_updated_at": "2026-06-03", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nexium-control-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 494}
{"after": {"end": 52, "start": 0, "text": "Pharmacocinétique dans des populations particulières", "truncated": false}, "after_length": 52, "after_sha256": "8ec405a27f9c087b8e5ea41a4571036b747eddb3ed63228d20f90e5d4c105cb5", "annex": "I", "before": {"end": 52, "start": 0, "text": "Pharmacocinétique dans des populations particulières", "truncated": false}, "before_length": 52, "before_sha256": "8ec405a27f9c087b8e5ea41a4571036b747eddb3ed63228d20f90e5d4c105cb5", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0e3e148b3dbf9ca2cd5efffc", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004164", "medicine_name": "Alecensa", "medicine_slug": "alecensa", "observed_at": "2026-10-12T19:00:36Z", "pipeline_version": "2.0.0", "presentation_label": "Alecensa 150 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": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "83ee6e171c0e05bd6ab2daf5408dcacb676175e21156c6f5251ff1b3290852d9", "source_snapshot_id": "source-b1925a54bfeff5c1398e0f30", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/alecensa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 934}
{"after": {"end": 332, "start": 0, "text": "A significant fraction of hydroxycarbamide is eliminated by nonrenal (mainly hepatic) mechanisms. In adults, the urinary recovery of unchanged drug is reported to be approximately 37% of the oral dose when renal function is normal. In children, the fraction of hydroxycarbamide excreted unchanged into the urine comprised about 50%.", "truncated": false}, "after_length": 332, "after_sha256": "0d48f313c4912afc49260ce013b05e789e24507819866aa7401727bcdb300a6e", "annex": "I", "before": {"end": 332, "start": 0, "text": "A significant fraction of hydroxycarbamide is eliminated by nonrenal (mainly hepatic) mechanisms. In adults, the urinary recovery of unchanged drug is reported to be approximately 37% of the oral dose when renal function is normal. In children, the fraction of hydroxycarbamide excreted unchanged into the urine comprised about 50%.", "truncated": false}, "before_length": 332, "before_sha256": "0d48f313c4912afc49260ce013b05e789e24507819866aa7401727bcdb300a6e", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0e4de6da461f683af823ff0d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004837", "medicine_name": "Xromi", "medicine_slug": "xromi", "observed_at": "2026-10-12T19:31:37Z", "pipeline_version": "2.0.0", "presentation_label": "Xromi 100 mg/ml oral solution", "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": "5e9826d3dd1edc48d9eb87b57c4ee7e70574bc6ce1c841b5477a3de3b9950a1e", "source_snapshot_id": "source-d10ea7497b831a802d8ae623", "source_updated_at": "2025-06-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/xromi-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 488}
{"after": {"end": 201, "start": 0, "text": "In view of its action on cellular deoxyribonucleic acid (DNA) mercaptopurine is potentially carcinogenic and consideration should be given to the theoretical risk of carcinogenesis with this treatment.", "truncated": false}, "after_length": 201, "after_sha256": "3eeb9d78ed11b58ee86c75377c1b0c558bf6bd13fa34b05c51d1d12056693198", "annex": "I", "before": {"end": 201, "start": 0, "text": "In view of its action on cellular deoxyribonucleic acid (DNA) mercaptopurine is potentially carcinogenic and consideration should be given to the theoretical risk of carcinogenesis with this treatment.", "truncated": false}, "before_length": 201, "before_sha256": "3eeb9d78ed11b58ee86c75377c1b0c558bf6bd13fa34b05c51d1d12056693198", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0eb52594c8a8a500954afdae", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002022", "medicine_name": "Xaluprine (previously Mercaptopurine Nova Laboratories)", "medicine_slug": "xaluprine-previously-mercaptopurine-nova-laboratories", "observed_at": "2026-10-12T19:08:02Z", "pipeline_version": "2.0.0", "presentation_label": "Xaluprine 20 mg/ml oral suspension", "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": "a352706294cb9013c5ba158da50186f12673cdb6fb887d0033e1457d44698091", "source_snapshot_id": "source-80b0d9db881bf774bffb5d3c", "source_updated_at": "2025-09-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/xaluprine-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 409}
{"after": {"end": 55, "start": 0, "text": "Troubles généraux et anomalies au site d'administration", "truncated": false}, "after_length": 55, "after_sha256": "b878d3889cb73c86f79b55897dec8fee8bf4e54ae6b850d137e6ee9e1f294326", "annex": "I", "before": {"end": 55, "start": 0, "text": "Troubles généraux et anomalies au site d'administration", "truncated": false}, "before_length": 55, "before_sha256": "b878d3889cb73c86f79b55897dec8fee8bf4e54ae6b850d137e6ee9e1f294326", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0ed106cde5974f004d63b351", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004164", "medicine_name": "Alecensa", "medicine_slug": "alecensa", "observed_at": "2026-10-12T19:00:36Z", "pipeline_version": "2.0.0", "presentation_label": "Alecensa 150 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": "83ee6e171c0e05bd6ab2daf5408dcacb676175e21156c6f5251ff1b3290852d9", "source_snapshot_id": "source-b1925a54bfeff5c1398e0f30", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/alecensa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 372}
{"after": {"end": 102, "start": 0, "text": "Pharmacotherapeutic group: antineoplastic agents, antimetabolites, purine analogues, ATC code: L01BB02", "truncated": false}, "after_length": 102, "after_sha256": "3f40070d69b1d68d16759a4569f2db5feaea8b31c30fcd6984ba4b7cf95823d8", "annex": "I", "before": {"end": 102, "start": 0, "text": "Pharmacotherapeutic group: antineoplastic agents, antimetabolites, purine analogues, ATC code: L01BB02", "truncated": false}, "before_length": 102, "before_sha256": "3f40070d69b1d68d16759a4569f2db5feaea8b31c30fcd6984ba4b7cf95823d8", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0ee211ed83af36401c2c92ec", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002022", "medicine_name": "Xaluprine (previously Mercaptopurine Nova Laboratories)", "medicine_slug": "xaluprine-previously-mercaptopurine-nova-laboratories", "observed_at": "2026-10-12T19:08:02Z", "pipeline_version": "2.0.0", "presentation_label": "Xaluprine 20 mg/ml oral suspension", "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": "a352706294cb9013c5ba158da50186f12673cdb6fb887d0033e1457d44698091", "source_snapshot_id": "source-80b0d9db881bf774bffb5d3c", "source_updated_at": "2025-09-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/xaluprine-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 618}
{"after": {"end": 218, "start": 0, "text": "Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for prolonged periods (see section 4.4). Growth retardation has been reported in children receiving nasal corticosteroids.", "truncated": false}, "after_length": 218, "after_sha256": "010366372dc7567653b9fed708166746a9fccdfc9ad6c29aff4cd13b013c016e", "annex": "I", "before": {"end": 218, "start": 0, "text": "Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for prolonged periods (see section 4.4). Growth retardation has been reported in children receiving nasal corticosteroids.", "truncated": false}, "before_length": 218, "before_sha256": "010366372dc7567653b9fed708166746a9fccdfc9ad6c29aff4cd13b013c016e", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0ef1fcf4b065e3f068d1bfe8", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000770", "medicine_name": "Avamys", "medicine_slug": "avamys", "observed_at": "2026-10-12T19:30:29Z", "pipeline_version": "2.0.0", "presentation_label": "AVAMYS 27.5 micrograms/spray, nasal spray suspension", "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": "30f949bc5059758fc7a5c6971f20b61b1a1216476650dc650963a3ac481e29e3", "source_snapshot_id": "source-74cb508bb20024b25ca75f56", "source_updated_at": "2025-06-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/avamys-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 201}
{"after": {"end": 472, "start": 0, "text": "In the neoadjuvant and adjuvant trials, hypersensitivity/anaphylaxis events were consistent with those observed in CLEOPATRA. In NEOSPHERE, two patients in the Perjeta and docetaxel-treated group experienced anaphylaxis. In both the TRYPHAENA and APHINITY trials, the overall frequency of hypersensitivity/anaphylaxis was highest in the Perjeta and TCH treated group (13.2% and 7.6%, respectively), of which 2.6% and 1.3% of events, respectively, were NCI-CTCAE Grade 3-4.", "truncated": false}, "after_length": 472, "after_sha256": "a0e0e2bff36eedec5e0e26c52464a997af461363c0b07920666a969d6426e978", "annex": "I", "before": {"end": 472, "start": 0, "text": "In the neoadjuvant and adjuvant trials, hypersensitivity/anaphylaxis events were consistent with those observed in CLEOPATRA. In NEOSPHERE, two patients in the Perjeta and docetaxel-treated group experienced anaphylaxis. In both the TRYPHAENA and APHINITY trials, the overall frequency of hypersensitivity/anaphylaxis was highest in the Perjeta and TCH treated group (13.2% and 7.6%, respectively), of which 2.6% and 1.3% of events, respectively, were NCI-CTCAE Grade 3-4.", "truncated": false}, "before_length": 472, "before_sha256": "a0e0e2bff36eedec5e0e26c52464a997af461363c0b07920666a969d6426e978", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0f195c67a41b70ada5447aa8", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002547", "medicine_name": "Perjeta", "medicine_slug": "perjeta", "observed_at": "2026-10-12T13:39:17Z", "pipeline_version": "2.0.0", "presentation_label": "Perjeta 420 mg 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": "cb28465c58604d0b3ae410ab4b7f20b7947f60bdf7475f845ec18185037e8ea6", "source_snapshot_id": "source-f34b78f381a5e027cfbe1fe6", "source_updated_at": "2026-04-28", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/perjeta-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 422}
{"after": {"end": 185, "start": 0, "text": "Dans une analyse post hoc réalisée chez les femmes de plus de 75 ans, une réduction du risque relatif de 62 % a été observée avec Prolia (réduction du risque absolu de 1,4 %, p < 0,01).", "truncated": false}, "after_length": 185, "after_sha256": "7d6c10a8e0300d991bf9b11abbf18f38f8f6a98a3bcf4e4c7b34c846a8738964", "annex": "I", "before": {"end": 185, "start": 0, "text": "Dans une analyse post hoc réalisée chez les femmes de plus de 75 ans, une réduction du risque relatif de 62 % a été observée avec Prolia (réduction du risque absolu de 1,4 %, p < 0,01).", "truncated": false}, "before_length": 185, "before_sha256": "7d6c10a8e0300d991bf9b11abbf18f38f8f6a98a3bcf4e4c7b34c846a8738964", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0f5737bfefbeb7bf7e87962d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/001120", "medicine_name": "Prolia", "medicine_slug": "prolia", "observed_at": "2026-10-12T13:28:45Z", "pipeline_version": "2.0.0", "presentation_label": "Prolia 60 mg solution injectable en seringue préremplie", "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": "30e296cc06d303605f266e9544e10515b7e5c2063a0473f5aa3595a42d18a3e1", "source_snapshot_id": "source-2924aac36bd07813fcc1891d", "source_updated_at": "2026-08-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/prolia-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 382}
{"after": {"end": 212, "start": 0, "text": "If a contributing concomitant medicinal product is identified and discontinued, or its dose is adjusted, resume at previous dose upon recovery to Grade 1 (asymptomatic) bradycardia or to a heart rate of ≥ 60 bpm.", "truncated": false}, "after_length": 212, "after_sha256": "1a5bbe4376cc4e8a47fa865a28233c9f0359f7549fb571f03843869747836aec", "annex": "I", "before": {"end": 212, "start": 0, "text": "If a contributing concomitant medicinal product is identified and discontinued, or its dose is adjusted, resume at previous dose upon recovery to Grade 1 (asymptomatic) bradycardia or to a heart rate of ≥ 60 bpm.", "truncated": false}, "before_length": 212, "before_sha256": "1a5bbe4376cc4e8a47fa865a28233c9f0359f7549fb571f03843869747836aec", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0fab0ba6e59a791ce31ca352", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004164", "medicine_name": "Alecensa", "medicine_slug": "alecensa", "observed_at": "2026-10-12T19:00:33Z", "pipeline_version": "2.0.0", "presentation_label": "Alecensa 150 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": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "815d015f485abccb366cc8b59bef3ff2b7589fb9206cca47f8f889f776e1f3af", "source_snapshot_id": "source-c8b17db176ebb33561bb1413", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/alecensa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 108}
{"after": {"end": 431, "start": 0, "text": "The following events have been identified as adverse reactions. The adverse reactions are displayed by system organ class and frequency: very common (≥1/10), common (≥1/100 to < 1/10), uncommon (≥1/1000 to < 1/100), rare (≥1/10,000 to < 1/1000), very rare (< 1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.", "truncated": false}, "after_length": 431, "after_sha256": "31cfd2333d354262a64887eeedef0d283486a6bd0452860a5966add1c666015d", "annex": "I", "before": {"end": 431, "start": 0, "text": "The following events have been identified as adverse reactions. The adverse reactions are displayed by system organ class and frequency: very common (≥1/10), common (≥1/100 to < 1/10), uncommon (≥1/1000 to < 1/100), rare (≥1/10,000 to < 1/1000), very rare (< 1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.", "truncated": false}, "before_length": 431, "before_sha256": "31cfd2333d354262a64887eeedef0d283486a6bd0452860a5966add1c666015d", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0ff4238ae412a74b0f7fcf6c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002022", "medicine_name": "Xaluprine (previously Mercaptopurine Nova Laboratories)", "medicine_slug": "xaluprine-previously-mercaptopurine-nova-laboratories", "observed_at": "2026-10-12T19:08:02Z", "pipeline_version": "2.0.0", "presentation_label": "Xaluprine 20 mg/ml oral suspension", "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": "a352706294cb9013c5ba158da50186f12673cdb6fb887d0033e1457d44698091", "source_snapshot_id": "source-80b0d9db881bf774bffb5d3c", "source_updated_at": "2025-09-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/xaluprine-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 516}
{"after": {"end": 1500, "start": 0, "text": "In a two-year study designed to assess the ocular safety of fluticasone furoate (110 micrograms once daily intranasal spray), adults and adolescents with perennial allergic rhinitis received either fluticasone furoate (n=367) or placebo (n=181). The primary outcomes [time to increase in posterior subcapsular opacity (0.3 from baseline in Lens Opacities Classification System, Version III (LOCS III grade)) and time to increase in intraocular pressure (IOP; 7 mmHg from baseline)] were not statistically significant between the two groups. Increases in posterior subcapsular opacity (0.3 from baseline) were more frequent in subjects treated with fluticasone furoate 110 micrograms [14 (4%)] versus placebo [4 (2%)] and were transient in nature for ten subjects in the fluticasone furoate group and two subjects in the placebo group. Increases in IOP (7 mmHg from baseline) were more frequent in subjects treated with fluticasone furoate 110 micrograms: 7 (2%) for fluticasone furoate 110 micrograms once daily and 1 (<1%) for placebo. These events were transient in nature for six subjects in the fluticasone furoate group and one placebo subject. At weeks 52 and 104, 95% of subjects in both treatment groups had posterior subcapsular opacity values within ± 0.1 of baseline values for each eye and, at week 104, ≤1% of subjects in both treatment groups had 0.3 increase from baseline in posterior subcapsular opacity. At weeks 52 and 104, the majority of subjects (>95%) had IOP values of within ", "truncated": true}, "after_length": 1650, "after_sha256": "d675425aa7139b6cc8adccb2110e4a2c4dcbe987664e139b35024a0568c55a40", "annex": "I", "before": {"end": 1500, "start": 0, "text": "In a two-year study designed to assess the ocular safety of fluticasone furoate (110 micrograms once daily intranasal spray), adults and adolescents with perennial allergic rhinitis received either fluticasone furoate (n=367) or placebo (n=181). The primary outcomes [time to increase in posterior subcapsular opacity (0.3 from baseline in Lens Opacities Classification System, Version III (LOCS III grade)) and time to increase in intraocular pressure (IOP; 7 mmHg from baseline)] were not statistically significant between the two groups. Increases in posterior subcapsular opacity (0.3 from baseline) were more frequent in subjects treated with fluticasone furoate 110 micrograms [14 (4%)] versus placebo [4 (2%)] and were transient in nature for ten subjects in the fluticasone furoate group and two subjects in the placebo group. Increases in IOP (7 mmHg from baseline) were more frequent in subjects treated with fluticasone furoate 110 micrograms: 7 (2%) for fluticasone furoate 110 micrograms once daily and 1 (<1%) for placebo. These events were transient in nature for six subjects in the fluticasone furoate group and one placebo subject. At weeks 52 and 104, 95% of subjects in both treatment groups had posterior subcapsular opacity values within ± 0.1 of baseline values for each eye and, at week 104, ≤1% of subjects in both treatment groups had 0.3 increase from baseline in posterior subcapsular opacity. At weeks 52 and 104, the majority of subjects (>95%) had IOP values of within ", "truncated": true}, "before_length": 1650, "before_sha256": "d675425aa7139b6cc8adccb2110e4a2c4dcbe987664e139b35024a0568c55a40", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-1000fdcb29e05c9eb8aa9a06", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000770", "medicine_name": "Avamys", "medicine_slug": "avamys", "observed_at": "2026-10-12T19:30:29Z", "pipeline_version": "2.0.0", "presentation_label": "AVAMYS 27.5 micrograms/spray, nasal spray suspension", "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": "30f949bc5059758fc7a5c6971f20b61b1a1216476650dc650963a3ac481e29e3", "source_snapshot_id": "source-74cb508bb20024b25ca75f56", "source_updated_at": "2025-06-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/avamys-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 251}
{"after": {"end": 139, "start": 0, "text": "The safety and efficacy of Perjeta have not been studied in patients with hepatic impairment. No specific dose recommendations can be made.", "truncated": false}, "after_length": 139, "after_sha256": "dd34d3b99b710f80a0b726342b0a9c11defbe65b2d0acbb0950ab502f38c7edc", "annex": "I", "before": {"end": 139, "start": 0, "text": "The safety and efficacy of Perjeta have not been studied in patients with hepatic impairment. No specific dose recommendations can be made.", "truncated": false}, "before_length": 139, "before_sha256": "dd34d3b99b710f80a0b726342b0a9c11defbe65b2d0acbb0950ab502f38c7edc", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-101446b3a560a1f68a8fb285", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002547", "medicine_name": "Perjeta", "medicine_slug": "perjeta", "observed_at": "2026-10-12T13:39:17Z", "pipeline_version": "2.0.0", "presentation_label": "Perjeta 420 mg 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": "cb28465c58604d0b3ae410ab4b7f20b7947f60bdf7475f845ec18185037e8ea6", "source_snapshot_id": "source-f34b78f381a5e027cfbe1fe6", "source_updated_at": "2026-04-28", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/perjeta-epar-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": 704, "start": 0, "text": "Il apparaît que le nitroxyle, l’acide carboxylique correspondant et le monoxyde d’azote sont des métabolites. Il a également été démontré que l’urée est un métabolite de l’hydroxycarbamide. L’hydroxycarbamide à 30, 100 et 300 µM n’est pas métabolisée in vitro par les cytochromes P450 des microsomes hépatiques humains. Aux concentrations comprises entre 10 et 300 µM, l’hydroxycarbamide ne stimule pas l’activité ATPase in vitro de la glycoprotéine P recombinante humaine (Pgp), ce qui indique que l’hydroxycarbamide n’est pas un substrat de la Pgp. Aucune interaction n’est donc attendue en cas d’administration concomitante avec des substances qui sont des substrats des cytochromes P450 ou de la Pgp.", "truncated": false}, "after_length": 704, "after_sha256": "9e5521075397533c2a768b50ce53111b2a457e0545f27e669e483fe256a5d89a", "annex": "I", "before": {"end": 704, "start": 0, "text": "Il apparaît que le nitroxyle, l’acide carboxylique correspondant et le monoxyde d’azote sont des métabolites. Il a également été démontré que l’urée est un métabolite de l’hydroxycarbamide. L’hydroxycarbamide à 30, 100 et 300 µM n’est pas métabolisée in vitro par les cytochromes P450 des microsomes hépatiques humains. Aux concentrations comprises entre 10 et 300 µM, l’hydroxycarbamide ne stimule pas l’activité ATPase in vitro de la glycoprotéine P recombinante humaine (Pgp), ce qui indique que l’hydroxycarbamide n’est pas un substrat de la Pgp. Aucune interaction n’est donc attendue en cas d’administration concomitante avec des substances qui sont des substrats des cytochromes P450 ou de la Pgp.", "truncated": false}, "before_length": 704, "before_sha256": "9e5521075397533c2a768b50ce53111b2a457e0545f27e669e483fe256a5d89a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-10372df3e0db8c9e548c5f74", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004837", "medicine_name": "Xromi", "medicine_slug": "xromi", "observed_at": "2026-10-12T19:32:45Z", "pipeline_version": "2.0.0", "presentation_label": "Xromi 100 mg/mL solution buvable", "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": "09fc95ca63cda4685a64f9a6f2786bf839a7e56efe05863cd60781314e5f87b5", "source_snapshot_id": "source-6048aed0c6a5fd892436dd1f", "source_updated_at": "2025-06-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xromi-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 479}
{"after": {"end": 79, "start": 0, "text": "Prolia has no or negligible influence on the ability to drive and use machines.", "truncated": false}, "after_length": 79, "after_sha256": "d9b5903c33755bc68aae60476d57bcdbf41ba8c18ed607f4b3ec4a510fd98361", "annex": "I", "before": {"end": 79, "start": 0, "text": "Prolia has no or negligible influence on the ability to drive and use machines.", "truncated": false}, "before_length": 79, "before_sha256": "d9b5903c33755bc68aae60476d57bcdbf41ba8c18ed607f4b3ec4a510fd98361", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-104ed5ae07a81f9f44a29c2c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001120", "medicine_name": "Prolia", "medicine_slug": "prolia", "observed_at": "2026-10-12T13:28:42Z", "pipeline_version": "2.0.0", "presentation_label": "Prolia 60 mg solution for injection in prefilled syringe", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.7", "section_type": "driving", "source_provider": "European Medicines Agency", "source_sha256": "5984d05d5bd9987a8e6f5cf86ff2e5032af0bc8bf5fe7a137a9f36a8466c5b97", "source_snapshot_id": "source-312c11aae5d59cae975290d1", "source_updated_at": "2026-08-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/prolia-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 189}
{"after": {"end": 315, "start": 0, "text": "La demi-vie d’élimination de la mercaptopurine est de 90 ± 30 minutes, mais les métabolites actifs ont une demi-vie plus longue (environ 5 heures) que la prodrogue. La clairance corporelle apparente est de 4,832 ± 2,562 ml/min/m2. La mercaptopurine présente une faible pénétration dans le liquide céphalo-rachidien.", "truncated": false}, "after_length": 315, "after_sha256": "f9acc1465074bcfc1bd1e495ceaa9b25e59d5325b5ea90d99508987397510295", "annex": "I", "before": {"end": 315, "start": 0, "text": "La demi-vie d’élimination de la mercaptopurine est de 90 ± 30 minutes, mais les métabolites actifs ont une demi-vie plus longue (environ 5 heures) que la prodrogue. La clairance corporelle apparente est de 4,832 ± 2,562 ml/min/m2. La mercaptopurine présente une faible pénétration dans le liquide céphalo-rachidien.", "truncated": false}, "before_length": 315, "before_sha256": "f9acc1465074bcfc1bd1e495ceaa9b25e59d5325b5ea90d99508987397510295", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-10506f3e7dc1c9bd7fc22263", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002022", "medicine_name": "Xaluprine (previously Mercaptopurine Nova Laboratories)", "medicine_slug": "xaluprine-previously-mercaptopurine-nova-laboratories", "observed_at": "2026-10-12T19:08:05Z", "pipeline_version": "2.0.0", "presentation_label": "Xaluprine 20 mg/ml suspension orale", "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": "24d3b15ae521f391e697a4d72930da59f53e4eeefc26a100461fbfa83e960527", "source_snapshot_id": "source-22ca1025dfc29c23d7b323de", "source_updated_at": "2025-09-25", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xaluprine-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 635}
{"after": {"end": 45, "start": 0, "text": "Patients porteurs d’un variant du gène NUDT15", "truncated": false}, "after_length": 45, "after_sha256": "52a1f873631a1a96aacdebccdd30e1ed441e01996f708957303d6ee153f9f069", "annex": "I", "before": {"end": 45, "start": 0, "text": "Patients porteurs d’un variant du gène NUDT15", "truncated": false}, "before_length": 45, "before_sha256": "52a1f873631a1a96aacdebccdd30e1ed441e01996f708957303d6ee153f9f069", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-108c32415c0029b1fea63310", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002022", "medicine_name": "Xaluprine (previously Mercaptopurine Nova Laboratories)", "medicine_slug": "xaluprine-previously-mercaptopurine-nova-laboratories", "observed_at": "2026-10-12T19:08:05Z", "pipeline_version": "2.0.0", "presentation_label": "Xaluprine 20 mg/ml suspension orale", "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": "24d3b15ae521f391e697a4d72930da59f53e4eeefc26a100461fbfa83e960527", "source_snapshot_id": "source-22ca1025dfc29c23d7b323de", "source_updated_at": "2025-09-25", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xaluprine-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 382}
{"after": {"end": 205, "start": 0, "text": "The infusion should be discontinued immediately and permanently if the patient experiences a NCI-CTCAE Grade 4 reaction (anaphylaxis), bronchospasm or acute respiratory distress syndrome (see section 4.4).", "truncated": false}, "after_length": 205, "after_sha256": "14869e70ee1809e9afa05685e08ec11e98d50143d5182911f0d84571aa32a64b", "annex": "I", "before": {"end": 205, "start": 0, "text": "The infusion should be discontinued immediately and permanently if the patient experiences a NCI-CTCAE Grade 4 reaction (anaphylaxis), bronchospasm or acute respiratory distress syndrome (see section 4.4).", "truncated": false}, "before_length": 205, "before_sha256": "14869e70ee1809e9afa05685e08ec11e98d50143d5182911f0d84571aa32a64b", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-109f2e20bed474de98381820", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002547", "medicine_name": "Perjeta", "medicine_slug": "perjeta", "observed_at": "2026-10-12T13:39:17Z", "pipeline_version": "2.0.0", "presentation_label": "Perjeta 420 mg 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": "cb28465c58604d0b3ae410ab4b7f20b7947f60bdf7475f845ec18185037e8ea6", "source_snapshot_id": "source-f34b78f381a5e027cfbe1fe6", "source_updated_at": "2026-04-28", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/perjeta-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 176}
{"after": {"end": 285, "start": 0, "text": "Les données limitées sur la tolérance et l’efficacité d’Alecensa chez les patients âgés de 65 ans et plus ne suggèrent pas qu’une adaptation posologique soit nécessaire pour les patients âgés (voir rubrique 5.2). Aucune donnée n’est disponible pour les patients âgés de plus de 80 ans.", "truncated": false}, "after_length": 285, "after_sha256": "a1f27c16a79eea567d86187d4927b3404b1c1ade662b369d4541690dc2c1091b", "annex": "I", "before": {"end": 285, "start": 0, "text": "Les données limitées sur la tolérance et l’efficacité d’Alecensa chez les patients âgés de 65 ans et plus ne suggèrent pas qu’une adaptation posologique soit nécessaire pour les patients âgés (voir rubrique 5.2). Aucune donnée n’est disponible pour les patients âgés de plus de 80 ans.", "truncated": false}, "before_length": 285, "before_sha256": "a1f27c16a79eea567d86187d4927b3404b1c1ade662b369d4541690dc2c1091b", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-11096196140e4fd5ad3ca874", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004164", "medicine_name": "Alecensa", "medicine_slug": "alecensa", "observed_at": "2026-10-12T19:00:36Z", "pipeline_version": "2.0.0", "presentation_label": "Alecensa 150 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": "83ee6e171c0e05bd6ab2daf5408dcacb676175e21156c6f5251ff1b3290852d9", "source_snapshot_id": "source-b1925a54bfeff5c1398e0f30", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/alecensa-epar-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": 431, "start": 0, "text": "Alectinib was not mutagenic in vitro in the bacterial reverse mutation (Ames) assay but induced a slight increase in numerical aberrations in the in vitro cytogenetic assay using Chinese Hamster Lung (CHL) cells with metabolic activation, and micronuclei in a rat bone marrow micronucleus test. The mechanism of micronucleus induction was abnormal chromosome segregation (aneugenicity), and not a clastogenic effect on chromosomes.", "truncated": false}, "after_length": 431, "after_sha256": "abab001871ddd6dcf942bc7fa80008a7f125e2ff31f4b5e2ea0f0184e6ac8336", "annex": "I", "before": {"end": 431, "start": 0, "text": "Alectinib was not mutagenic in vitro in the bacterial reverse mutation (Ames) assay but induced a slight increase in numerical aberrations in the in vitro cytogenetic assay using Chinese Hamster Lung (CHL) cells with metabolic activation, and micronuclei in a rat bone marrow micronucleus test. The mechanism of micronucleus induction was abnormal chromosome segregation (aneugenicity), and not a clastogenic effect on chromosomes.", "truncated": false}, "before_length": 431, "before_sha256": "abab001871ddd6dcf942bc7fa80008a7f125e2ff31f4b5e2ea0f0184e6ac8336", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-110eb52171bd382c78d7b728", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004164", "medicine_name": "Alecensa", "medicine_slug": "alecensa", "observed_at": "2026-10-12T19:00:33Z", "pipeline_version": "2.0.0", "presentation_label": "Alecensa 150 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": "5.3", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "815d015f485abccb366cc8b59bef3ff2b7589fb9206cca47f8f889f776e1f3af", "source_snapshot_id": "source-c8b17db176ebb33561bb1413", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/alecensa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 870}
{"after": {"end": 48, "start": 0, "text": "Musculoskeletal and connective tissues disorders", "truncated": false}, "after_length": 48, "after_sha256": "855beeeac57de19c6416854e412174a2c3514ee2bc8e8f401933de25deb09560", "annex": "I", "before": {"end": 48, "start": 0, "text": "Musculoskeletal and connective tissues disorders", "truncated": false}, "before_length": 48, "before_sha256": "855beeeac57de19c6416854e412174a2c3514ee2bc8e8f401933de25deb09560", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-111a86a689db5f9db38eea93", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004164", "medicine_name": "Alecensa", "medicine_slug": "alecensa", "observed_at": "2026-10-12T19:00:33Z", "pipeline_version": "2.0.0", "presentation_label": "Alecensa 150 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": "815d015f485abccb366cc8b59bef3ff2b7589fb9206cca47f8f889f776e1f3af", "source_snapshot_id": "source-c8b17db176ebb33561bb1413", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/alecensa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 333}
{"after": {"end": 699, "start": 0, "text": "L’hydroxycarbamide se distribue rapidement dans l’organisme humain, passe dans le liquide céphalo rachidien, apparaît dans le liquide péritonéal et les ascites et se concentre dans les leucocytes et les hématies. Le volume de distribution estimé de l’hydroxycarbamide se rapproche du volume hydrique total de l’organisme. Le volume de distribution après administration orale d’hydroxycarbamide est approximativement égal au volume hydrique total: des valeurs chez les adultes de 0,48 à 0,90 L/kg ont été rapportées, tandis que chez les enfants, une estimation obtenue par analyse de population de 0,7 L/kg a été rapportée. L’importance de la liaison de l’hydroxycarbamide aux protéines est inconnue.", "truncated": false}, "after_length": 699, "after_sha256": "3b68a3c2f9713a24302e872348a300325077c53385f75f1057eff97c4dac6f58", "annex": "I", "before": {"end": 699, "start": 0, "text": "L’hydroxycarbamide se distribue rapidement dans l’organisme humain, passe dans le liquide céphalo rachidien, apparaît dans le liquide péritonéal et les ascites et se concentre dans les leucocytes et les hématies. Le volume de distribution estimé de l’hydroxycarbamide se rapproche du volume hydrique total de l’organisme. Le volume de distribution après administration orale d’hydroxycarbamide est approximativement égal au volume hydrique total: des valeurs chez les adultes de 0,48 à 0,90 L/kg ont été rapportées, tandis que chez les enfants, une estimation obtenue par analyse de population de 0,7 L/kg a été rapportée. L’importance de la liaison de l’hydroxycarbamide aux protéines est inconnue.", "truncated": false}, "before_length": 699, "before_sha256": "3b68a3c2f9713a24302e872348a300325077c53385f75f1057eff97c4dac6f58", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-1130f85bf8c1634c99cf5416", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004837", "medicine_name": "Xromi", "medicine_slug": "xromi", "observed_at": "2026-10-12T19:32:45Z", "pipeline_version": "2.0.0", "presentation_label": "Xromi 100 mg/mL solution buvable", "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": "09fc95ca63cda4685a64f9a6f2786bf839a7e56efe05863cd60781314e5f87b5", "source_snapshot_id": "source-6048aed0c6a5fd892436dd1f", "source_updated_at": "2025-06-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xromi-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 476}
{"after": {"end": 161, "start": 0, "text": "The study also showed a statistically significant increase in HbF and Hb levels and a decrease in haemolytic markers in the groups treated with hydroxycarbamide.", "truncated": false}, "after_length": 161, "after_sha256": "c14aee28504dbd7982771f7db51b4bb127f62654dc6476ba5fe26905232f6dbc", "annex": "I", "before": {"end": 161, "start": 0, "text": "The study also showed a statistically significant increase in HbF and Hb levels and a decrease in haemolytic markers in the groups treated with hydroxycarbamide.", "truncated": false}, "before_length": 161, "before_sha256": "c14aee28504dbd7982771f7db51b4bb127f62654dc6476ba5fe26905232f6dbc", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-11adfe1f7df22036277fb41c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004837", "medicine_name": "Xromi", "medicine_slug": "xromi", "observed_at": "2026-10-12T19:31:37Z", "pipeline_version": "2.0.0", "presentation_label": "Xromi 100 mg/ml oral solution", "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": "5e9826d3dd1edc48d9eb87b57c4ee7e70574bc6ce1c841b5477a3de3b9950a1e", "source_snapshot_id": "source-d10ea7497b831a802d8ae623", "source_updated_at": "2025-06-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/xromi-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 418}
{"after": {"end": 145, "start": 0, "text": "The recommended dose is 60 mg denosumab administered as a single subcutaneous injection once every 6 months into the thigh, abdomen or upper arm.", "truncated": false}, "after_length": 145, "after_sha256": "c7c741cf3ac7fca544bb30c8dea6c929e6cd2fbbf5e47c472516d3f08d152889", "annex": "I", "before": {"end": 145, "start": 0, "text": "The recommended dose is 60 mg denosumab administered as a single subcutaneous injection once every 6 months into the thigh, abdomen or upper arm.", "truncated": false}, "before_length": 145, "before_sha256": "c7c741cf3ac7fca544bb30c8dea6c929e6cd2fbbf5e47c472516d3f08d152889", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-11bc120f61331be85be1c693", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001120", "medicine_name": "Prolia", "medicine_slug": "prolia", "observed_at": "2026-10-12T13:28:42Z", "pipeline_version": "2.0.0", "presentation_label": "Prolia 60 mg solution for injection in prefilled syringe", "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": "5984d05d5bd9987a8e6f5cf86ff2e5032af0bc8bf5fe7a137a9f36a8466c5b97", "source_snapshot_id": "source-312c11aae5d59cae975290d1", "source_updated_at": "2026-08-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/prolia-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 64}
{"after": {"end": 314, "start": 0, "text": "Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.", "truncated": false}, "after_length": 314, "after_sha256": "592714388cd40eddf52b5c277fef6ba9407ec0ec0002d5395044954328cd9419", "annex": "I", "before": {"end": 314, "start": 0, "text": "Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.", "truncated": false}, "before_length": 314, "before_sha256": "592714388cd40eddf52b5c277fef6ba9407ec0ec0002d5395044954328cd9419", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-11d5a20469ec0e16f61ec5e6", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001120", "medicine_name": "Prolia", "medicine_slug": "prolia", "observed_at": "2026-10-12T13:28:42Z", "pipeline_version": "2.0.0", "presentation_label": "Prolia 60 mg solution for injection in prefilled syringe", "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": "5984d05d5bd9987a8e6f5cf86ff2e5032af0bc8bf5fe7a137a9f36a8466c5b97", "source_snapshot_id": "source-312c11aae5d59cae975290d1", "source_updated_at": "2026-08-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/prolia-epar-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": 366, "start": 0, "text": "The safety and efficacy of Alecensa were studied in a global randomised Phase III open label clinical trial (BO28984, ALEX) in ALKpositive NSCLC patients who were treatment naïve. Central testing for ALK protein expression positivity of tissue samples from all patients by Ventana antiALK (D5F3) immunohistochemistry was required before randomisation into the study.", "truncated": false}, "after_length": 366, "after_sha256": "cbc9ebb18bb88ad440ff02d5b6d97a7338ee59ffd373e0030e52d684265cf355", "annex": "I", "before": {"end": 366, "start": 0, "text": "The safety and efficacy of Alecensa were studied in a global randomised Phase III open label clinical trial (BO28984, ALEX) in ALKpositive NSCLC patients who were treatment naïve. Central testing for ALK protein expression positivity of tissue samples from all patients by Ventana antiALK (D5F3) immunohistochemistry was required before randomisation into the study.", "truncated": false}, "before_length": 366, "before_sha256": "cbc9ebb18bb88ad440ff02d5b6d97a7338ee59ffd373e0030e52d684265cf355", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-123ad84ba20942f67793bceb", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004164", "medicine_name": "Alecensa", "medicine_slug": "alecensa", "observed_at": "2026-10-12T19:00:33Z", "pipeline_version": "2.0.0", "presentation_label": "Alecensa 150 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "815d015f485abccb366cc8b59bef3ff2b7589fb9206cca47f8f889f776e1f3af", "source_snapshot_id": "source-c8b17db176ebb33561bb1413", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/alecensa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 486}
{"after": {"end": 126, "start": 0, "text": "ALT or AST elevation of > 3 times ULN with total bilirubin elevation > 2 times ULN in the absence of cholestasis or haemolysis", "truncated": false}, "after_length": 126, "after_sha256": "ca4b952bf0d8bc9a34666823c0079d8dce6b363eb723720a071ba2542bfd347d", "annex": "I", "before": {"end": 126, "start": 0, "text": "ALT or AST elevation of > 3 times ULN with total bilirubin elevation > 2 times ULN in the absence of cholestasis or haemolysis", "truncated": false}, "before_length": 126, "before_sha256": "ca4b952bf0d8bc9a34666823c0079d8dce6b363eb723720a071ba2542bfd347d", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-124f0b46ddb0c4e89468a940", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004164", "medicine_name": "Alecensa", "medicine_slug": "alecensa", "observed_at": "2026-10-12T19:00:33Z", "pipeline_version": "2.0.0", "presentation_label": "Alecensa 150 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": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "815d015f485abccb366cc8b59bef3ff2b7589fb9206cca47f8f889f776e1f3af", "source_snapshot_id": "source-c8b17db176ebb33561bb1413", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/alecensa-epar-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": 291, "start": 0, "text": "During remission induction when rapid cell lysis is occurring, uric acid levels in blood and urine should be monitored as hyperuricaemia and/or hyperuricosuria may develop, with the risk of uric acid nephropathy. Hydration and urine alkalinisation may minimize potential renal complications.", "truncated": false}, "after_length": 291, "after_sha256": "4f7502be5b2381c3ad5787455851f8759238f3aded360d805e1bba96bad3d663", "annex": "I", "before": {"end": 291, "start": 0, "text": "During remission induction when rapid cell lysis is occurring, uric acid levels in blood and urine should be monitored as hyperuricaemia and/or hyperuricosuria may develop, with the risk of uric acid nephropathy. Hydration and urine alkalinisation may minimize potential renal complications.", "truncated": false}, "before_length": 291, "before_sha256": "4f7502be5b2381c3ad5787455851f8759238f3aded360d805e1bba96bad3d663", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-127d7bdb3563dab73ec7b1ea", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002022", "medicine_name": "Xaluprine (previously Mercaptopurine Nova Laboratories)", "medicine_slug": "xaluprine-previously-mercaptopurine-nova-laboratories", "observed_at": "2026-10-12T19:08:02Z", "pipeline_version": "2.0.0", "presentation_label": "Xaluprine 20 mg/ml oral suspension", "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": "a352706294cb9013c5ba158da50186f12673cdb6fb887d0033e1457d44698091", "source_snapshot_id": "source-80b0d9db881bf774bffb5d3c", "source_updated_at": "2025-09-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/xaluprine-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 397}
{"after": {"end": 453, "start": 0, "text": "Les données présentées ci-dessous reflètent l’exposition à Alecensa chez 533 patients atteints d’un CBNPC réséqué ou avancé ALK-positif. Ces patients ont reçu Alecensa à la dose recommandée de 600 mg deux fois par jour dans les essais cliniques pivots pour le traitement adjuvant du CBNPC réséqué (BO40336, ALINA) ou du CBNPC avancé (BO28984, ALEX; NP28761; NP28673). Voir rubrique 5.1 pour plus d’informations sur les participants des essais cliniques.", "truncated": false}, "after_length": 453, "after_sha256": "5ce660631e23723e03fe788e9d46f4e9fbce084dd3e71dbb4b4065a58616340a", "annex": "I", "before": {"end": 453, "start": 0, "text": "Les données présentées ci-dessous reflètent l’exposition à Alecensa chez 533 patients atteints d’un CBNPC réséqué ou avancé ALK-positif. Ces patients ont reçu Alecensa à la dose recommandée de 600 mg deux fois par jour dans les essais cliniques pivots pour le traitement adjuvant du CBNPC réséqué (BO40336, ALINA) ou du CBNPC avancé (BO28984, ALEX; NP28761; NP28673). Voir rubrique 5.1 pour plus d’informations sur les participants des essais cliniques.", "truncated": false}, "before_length": 453, "before_sha256": "5ce660631e23723e03fe788e9d46f4e9fbce084dd3e71dbb4b4065a58616340a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-12cd94e1419f5c6e4b85aaf5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004164", "medicine_name": "Alecensa", "medicine_slug": "alecensa", "observed_at": "2026-10-12T19:00:36Z", "pipeline_version": "2.0.0", "presentation_label": "Alecensa 150 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": "83ee6e171c0e05bd6ab2daf5408dcacb676175e21156c6f5251ff1b3290852d9", "source_snapshot_id": "source-b1925a54bfeff5c1398e0f30", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/alecensa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 253}
{"after": {"end": 262, "start": 0, "text": "Les patients traités par denosumab ne doivent pas recevoir simultanément d'autres médicaments contenant du denosumab (utilisé dans la prévention des complications osseuses chez des patients adultes atteints de tumeurs solides présentant des métastases osseuses).", "truncated": false}, "after_length": 262, "after_sha256": "0ed68b264ff64e5445f9f3576a720e0d8beebf70b400c99235ab61f8a164c86b", "annex": "I", "before": {"end": 262, "start": 0, "text": "Les patients traités par denosumab ne doivent pas recevoir simultanément d'autres médicaments contenant du denosumab (utilisé dans la prévention des complications osseuses chez des patients adultes atteints de tumeurs solides présentant des métastases osseuses).", "truncated": false}, "before_length": 262, "before_sha256": "0ed68b264ff64e5445f9f3576a720e0d8beebf70b400c99235ab61f8a164c86b", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-12f37fb8e1d68842cf5cd938", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/001120", "medicine_name": "Prolia", "medicine_slug": "prolia", "observed_at": "2026-10-12T13:28:45Z", "pipeline_version": "2.0.0", "presentation_label": "Prolia 60 mg solution injectable en seringue préremplie", "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": "30e296cc06d303605f266e9544e10515b7e5c2063a0473f5aa3595a42d18a3e1", "source_snapshot_id": "source-2924aac36bd07813fcc1891d", "source_updated_at": "2026-08-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/prolia-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 152}
{"after": {"end": 146, "start": 0, "text": "Xaluprine ne doit pas être administré aux patientes enceintes ou susceptibles de l’être sans une évaluation minutieuse du rapport bénéfice/risque.", "truncated": false}, "after_length": 146, "after_sha256": "d9ea903b968b6ef3a83d0612539bc9210f52b7241ae18e597acdb0d35df420c5", "annex": "I", "before": {"end": 146, "start": 0, "text": "Xaluprine ne doit pas être administré aux patientes enceintes ou susceptibles de l’être sans une évaluation minutieuse du rapport bénéfice/risque.", "truncated": false}, "before_length": 146, "before_sha256": "d9ea903b968b6ef3a83d0612539bc9210f52b7241ae18e597acdb0d35df420c5", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-1307ef9188e980b7eb8944c2", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002022", "medicine_name": "Xaluprine (previously Mercaptopurine Nova Laboratories)", "medicine_slug": "xaluprine-previously-mercaptopurine-nova-laboratories", "observed_at": "2026-10-12T19:08:05Z", "pipeline_version": "2.0.0", "presentation_label": "Xaluprine 20 mg/ml suspension orale", "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": "24d3b15ae521f391e697a4d72930da59f53e4eeefc26a100461fbfa83e960527", "source_snapshot_id": "source-22ca1025dfc29c23d7b323de", "source_updated_at": "2025-09-25", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xaluprine-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 485}
{"after": {"end": 192, "start": 0, "text": "The primary endpoint of this study was cardiac safety during the neoadjuvant treatment period of the study. Secondary efficacy endpoints were pCR rate in the breast (ypT0/is), DFS, PFS and OS.", "truncated": false}, "after_length": 192, "after_sha256": "e2ea0e937c2319d8f5f696401f9b03ca512347fbf72d396f2d8a580139d7cfa7", "annex": "I", "before": {"end": 192, "start": 0, "text": "The primary endpoint of this study was cardiac safety during the neoadjuvant treatment period of the study. Secondary efficacy endpoints were pCR rate in the breast (ypT0/is), DFS, PFS and OS.", "truncated": false}, "before_length": 192, "before_sha256": "e2ea0e937c2319d8f5f696401f9b03ca512347fbf72d396f2d8a580139d7cfa7", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-1309ffc10f679f240a3b2f27", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002547", "medicine_name": "Perjeta", "medicine_slug": "perjeta", "observed_at": "2026-10-12T13:39:17Z", "pipeline_version": "2.0.0", "presentation_label": "Perjeta 420 mg 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "cb28465c58604d0b3ae410ab4b7f20b7947f60bdf7475f845ec18185037e8ea6", "source_snapshot_id": "source-f34b78f381a5e027cfbe1fe6", "source_updated_at": "2026-04-28", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/perjeta-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 689}
{"after": {"end": 889, "start": 0, "text": "In the pivotal trial CLEOPATRA, the majority of patients in both treatment groups experienced at least one leucopenic event (63.0% of patients in the Perjeta-treated group and 58.3% of patients in the placebo-treated group), of which the majority were neutropenic events (see section 4.4). Febrile neutropenia occurred in 13.7% of Perjeta-treated patients and 7.6% of placebo-treated patients. In both treatment groups, the proportion of patients experiencing febrile neutropenia was highest in the first cycle of therapy and declined steadily thereafter. An increased incidence of febrile neutropenia was observed among Asian patients in both treatment groups compared with patients of other races and from other geographic regions. Among Asian patients, the incidence of febrile neutropenia was higher in the Perjeta-treated group (25.8%) compared with the placebo-treated group (11.3%).", "truncated": false}, "after_length": 889, "after_sha256": "5eeb46e813907de4f7f2429b5ecf3d2e1983792ee0ed0548a0510b0cc76cc293", "annex": "I", "before": {"end": 889, "start": 0, "text": "In the pivotal trial CLEOPATRA, the majority of patients in both treatment groups experienced at least one leucopenic event (63.0% of patients in the Perjeta-treated group and 58.3% of patients in the placebo-treated group), of which the majority were neutropenic events (see section 4.4). Febrile neutropenia occurred in 13.7% of Perjeta-treated patients and 7.6% of placebo-treated patients. In both treatment groups, the proportion of patients experiencing febrile neutropenia was highest in the first cycle of therapy and declined steadily thereafter. An increased incidence of febrile neutropenia was observed among Asian patients in both treatment groups compared with patients of other races and from other geographic regions. Among Asian patients, the incidence of febrile neutropenia was higher in the Perjeta-treated group (25.8%) compared with the placebo-treated group (11.3%).", "truncated": false}, "before_length": 889, "before_sha256": "5eeb46e813907de4f7f2429b5ecf3d2e1983792ee0ed0548a0510b0cc76cc293", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-130e74a6b938e1b590bbf8c6", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002547", "medicine_name": "Perjeta", "medicine_slug": "perjeta", "observed_at": "2026-10-12T13:39:17Z", "pipeline_version": "2.0.0", "presentation_label": "Perjeta 420 mg 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": "cb28465c58604d0b3ae410ab4b7f20b7947f60bdf7475f845ec18185037e8ea6", "source_snapshot_id": "source-f34b78f381a5e027cfbe1fe6", "source_updated_at": "2026-04-28", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/perjeta-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 425}
{"after": {"end": 720, "start": 0, "text": "Le syndrome d’activation macrophagique (SAM) est une affection connue, engageant le pronostic vital, pouvant se développer chez des patients atteints d’affections auto-immunes, en particulier les maladies inflammatoires chroniques de l’intestin (MICI) (indication non autorisée). Il pourrait exister une susceptibilité accrue de le développer en cas d’utilisation de la mercaptopurine. En cas de SAM avéré ou suspecté, une prise en charge et un traitement doivent être initiés aussi rapidement que possible, et le traitement par mercaptopurine doit être arrêté. Les médecins doivent être attentifs aux symptômes d’infections par l’EBV ou le cytomégalovirus (CMV), ces virus étant des éléments déclencheurs connus du SAM.", "truncated": false}, "after_length": 720, "after_sha256": "4d28f7f019b5d427acd2b9fb8c468368d13f358b2c3a3c2180f8cd9c090eac6b", "annex": "I", "before": {"end": 720, "start": 0, "text": "Le syndrome d’activation macrophagique (SAM) est une affection connue, engageant le pronostic vital, pouvant se développer chez des patients atteints d’affections auto-immunes, en particulier les maladies inflammatoires chroniques de l’intestin (MICI) (indication non autorisée). Il pourrait exister une susceptibilité accrue de le développer en cas d’utilisation de la mercaptopurine. En cas de SAM avéré ou suspecté, une prise en charge et un traitement doivent être initiés aussi rapidement que possible, et le traitement par mercaptopurine doit être arrêté. Les médecins doivent être attentifs aux symptômes d’infections par l’EBV ou le cytomégalovirus (CMV), ces virus étant des éléments déclencheurs connus du SAM.", "truncated": false}, "before_length": 720, "before_sha256": "4d28f7f019b5d427acd2b9fb8c468368d13f358b2c3a3c2180f8cd9c090eac6b", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-13ea9f45bfdf146b5bf14254", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002022", "medicine_name": "Xaluprine (previously Mercaptopurine Nova Laboratories)", "medicine_slug": "xaluprine-previously-mercaptopurine-nova-laboratories", "observed_at": "2026-10-12T19:08:05Z", "pipeline_version": "2.0.0", "presentation_label": "Xaluprine 20 mg/ml suspension orale", "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": "24d3b15ae521f391e697a4d72930da59f53e4eeefc26a100461fbfa83e960527", "source_snapshot_id": "source-22ca1025dfc29c23d7b323de", "source_updated_at": "2025-09-25", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xaluprine-epar-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": 74, "start": 0, "text": "Avamys is indicated in adults, adolescents and children (6 years and over)", "truncated": false}, "after_length": 74, "after_sha256": "dad387484848cc09784a7b6e9e09cc31ced9e11a363543305eaa0a5141fb3f75", "annex": "I", "before": {"end": 74, "start": 0, "text": "Avamys is indicated in adults, adolescents and children (6 years and over)", "truncated": false}, "before_length": 74, "before_sha256": "dad387484848cc09784a7b6e9e09cc31ced9e11a363543305eaa0a5141fb3f75", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-13ee779a06e5e430c6e50367", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000770", "medicine_name": "Avamys", "medicine_slug": "avamys", "observed_at": "2026-10-12T19:30:29Z", "pipeline_version": "2.0.0", "presentation_label": "AVAMYS 27.5 micrograms/spray, nasal spray suspension", "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": "30f949bc5059758fc7a5c6971f20b61b1a1216476650dc650963a3ac481e29e3", "source_snapshot_id": "source-74cb508bb20024b25ca75f56", "source_updated_at": "2025-06-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/avamys-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 56}
{"after": {"end": 425, "start": 0, "text": "In a study of children with Sickle Cell Disease, liquid and capsule formulations resulted in similar area under the curve, peak concentrations, and half-life. The largest difference in the pharmacokinetic profile was a trend towards a shorter time to peak concentration following ingestion of the liquid compared with the capsule, but that difference did not reach statistical significance (0.74 versus 0.97 hours, p = 0.14).", "truncated": false}, "after_length": 425, "after_sha256": "f569f754d6d1d18a03fc6c821223f1dd70e69002bc233b62a2ffbcf5c651479a", "annex": "I", "before": {"end": 425, "start": 0, "text": "In a study of children with Sickle Cell Disease, liquid and capsule formulations resulted in similar area under the curve, peak concentrations, and half-life. The largest difference in the pharmacokinetic profile was a trend towards a shorter time to peak concentration following ingestion of the liquid compared with the capsule, but that difference did not reach statistical significance (0.74 versus 0.97 hours, p = 0.14).", "truncated": false}, "before_length": 425, "before_sha256": "f569f754d6d1d18a03fc6c821223f1dd70e69002bc233b62a2ffbcf5c651479a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-142b3224427ea913ab49b5f1", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004837", "medicine_name": "Xromi", "medicine_slug": "xromi", "observed_at": "2026-10-12T19:31:37Z", "pipeline_version": "2.0.0", "presentation_label": "Xromi 100 mg/ml oral solution", "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": "5e9826d3dd1edc48d9eb87b57c4ee7e70574bc6ce1c841b5477a3de3b9950a1e", "source_snapshot_id": "source-d10ea7497b831a802d8ae623", "source_updated_at": "2025-06-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/xromi-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 477}
{"after": {"end": 243, "start": 0, "text": "No specific study in patients with hepatic impairment was performed. In general, monoclonal antibodies are not eliminated via hepatic metabolic mechanisms. The pharmacokinetics of denosumab is not expected to be affected by hepatic impairment.", "truncated": false}, "after_length": 243, "after_sha256": "e509f6827558f4f6ba090a1b3f8f276242f1e1b9bd0c9fc6e251ac0ec0eb1eda", "annex": "I", "before": {"end": 243, "start": 0, "text": "No specific study in patients with hepatic impairment was performed. In general, monoclonal antibodies are not eliminated via hepatic metabolic mechanisms. The pharmacokinetics of denosumab is not expected to be affected by hepatic impairment.", "truncated": false}, "before_length": 243, "before_sha256": "e509f6827558f4f6ba090a1b3f8f276242f1e1b9bd0c9fc6e251ac0ec0eb1eda", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-14443ab2bbc9e942a9aa069a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001120", "medicine_name": "Prolia", "medicine_slug": "prolia", "observed_at": "2026-10-12T13:28:42Z", "pipeline_version": "2.0.0", "presentation_label": "Prolia 60 mg solution for injection in prefilled syringe", "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": "5984d05d5bd9987a8e6f5cf86ff2e5032af0bc8bf5fe7a137a9f36a8466c5b97", "source_snapshot_id": "source-312c11aae5d59cae975290d1", "source_updated_at": "2026-08-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/prolia-epar-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": 195, "start": 0, "text": "1 mL de solution dans une seringue préremplie à usage unique en verre de type I avec une aiguille en acier inoxydable de calibre 27G, avec ou sans dispositif sécurisé de protection de l’aiguille.", "truncated": false}, "after_length": 195, "after_sha256": "fbc7d4964bb06593b0232737a746f48db6d6aea5d0dad4a89500ab80763937b7", "annex": "I", "before": {"end": 195, "start": 0, "text": "1 mL de solution dans une seringue préremplie à usage unique en verre de type I avec une aiguille en acier inoxydable de calibre 27G, avec ou sans dispositif sécurisé de protection de l’aiguille.", "truncated": false}, "before_length": 195, "before_sha256": "fbc7d4964bb06593b0232737a746f48db6d6aea5d0dad4a89500ab80763937b7", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-14894ac68a45e7507abf3046", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/001120", "medicine_name": "Prolia", "medicine_slug": "prolia", "observed_at": "2026-10-12T13:28:45Z", "pipeline_version": "2.0.0", "presentation_label": "Prolia 60 mg solution injectable en seringue préremplie", "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": "30e296cc06d303605f266e9544e10515b7e5c2063a0473f5aa3595a42d18a3e1", "source_snapshot_id": "source-2924aac36bd07813fcc1891d", "source_updated_at": "2026-08-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/prolia-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 591}
{"after": {"end": 45, "start": 0, "text": "Leukaemia, skin cancers (in elderly patients)", "truncated": false}, "after_length": 45, "after_sha256": "d666cfb4781546aef07a91eb79ac8c9177c5da437d65f7c84c174915e7f092e9", "annex": "I", "before": {"end": 45, "start": 0, "text": "Leukaemia, skin cancers (in elderly patients)", "truncated": false}, "before_length": 45, "before_sha256": "d666cfb4781546aef07a91eb79ac8c9177c5da437d65f7c84c174915e7f092e9", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-1490742b72a07505c7a414ae", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004837", "medicine_name": "Xromi", "medicine_slug": "xromi", "observed_at": "2026-10-12T19:31:37Z", "pipeline_version": "2.0.0", "presentation_label": "Xromi 100 mg/ml oral solution", "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": "5e9826d3dd1edc48d9eb87b57c4ee7e70574bc6ce1c841b5477a3de3b9950a1e", "source_snapshot_id": "source-d10ea7497b831a802d8ae623", "source_updated_at": "2025-06-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/xromi-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 226}
{"after": {"end": 101, "start": 0, "text": "2 Excludes those of the vertebrae, skull, facial, mandible, metacarpus, and finger and toe phalanges.", "truncated": false}, "after_length": 101, "after_sha256": "034dd9f4c4ff2974a798861dccbe53a49c465a7386b3b9535ca7d5007d05cbe6", "annex": "I", "before": {"end": 101, "start": 0, "text": "2 Excludes those of the vertebrae, skull, facial, mandible, metacarpus, and finger and toe phalanges.", "truncated": false}, "before_length": 101, "before_sha256": "034dd9f4c4ff2974a798861dccbe53a49c465a7386b3b9535ca7d5007d05cbe6", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-1494464c4ce85a16b8837d64", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001120", "medicine_name": "Prolia", "medicine_slug": "prolia", "observed_at": "2026-10-12T13:28:42Z", "pipeline_version": "2.0.0", "presentation_label": "Prolia 60 mg solution for injection in prefilled syringe", "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": "5984d05d5bd9987a8e6f5cf86ff2e5032af0bc8bf5fe7a137a9f36a8466c5b97", "source_snapshot_id": "source-312c11aae5d59cae975290d1", "source_updated_at": "2026-08-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/prolia-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 431}
{"after": {"end": 444, "start": 0, "text": "^ Table 2 shows pooled data from the overall treatment period in CLEOPATRA (data cutoff 11 February 2014; median number of cycles of Perjeta was 24); and from the neoadjuvant treatment period in NEOSPHERE (median number of cycles of Perjeta was 4, across all treatment arms) and TRYPHAENA (median number of cycles of Perjeta was 3 – 6 across treatment arms) and from the treatment period of APHINITY (median number of cycles of Perjeta was 18).", "truncated": false}, "after_length": 444, "after_sha256": "2ae1fa4970635c0746fed29eeaf3254b02b347f33ed79cca24ead0ee32e0a453", "annex": "I", "before": {"end": 444, "start": 0, "text": "^ Table 2 shows pooled data from the overall treatment period in CLEOPATRA (data cutoff 11 February 2014; median number of cycles of Perjeta was 24); and from the neoadjuvant treatment period in NEOSPHERE (median number of cycles of Perjeta was 4, across all treatment arms) and TRYPHAENA (median number of cycles of Perjeta was 3 – 6 across treatment arms) and from the treatment period of APHINITY (median number of cycles of Perjeta was 18).", "truncated": false}, "before_length": 444, "before_sha256": "2ae1fa4970635c0746fed29eeaf3254b02b347f33ed79cca24ead0ee32e0a453", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-14d7c22ccc61c49e20d5f8e7", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002547", "medicine_name": "Perjeta", "medicine_slug": "perjeta", "observed_at": "2026-10-12T13:39:17Z", "pipeline_version": "2.0.0", "presentation_label": "Perjeta 420 mg 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": "cb28465c58604d0b3ae410ab4b7f20b7947f60bdf7475f845ec18185037e8ea6", "source_snapshot_id": "source-f34b78f381a5e027cfbe1fe6", "source_updated_at": "2026-04-28", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/perjeta-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 390}
{"after": {"end": 205, "start": 0, "text": "** For the overall treatment period across the 4 studies. The incidence of left ventricular dysfunction and cardiac failure congestive reflect the MedDRA Preferred Terms reported in the individual studies.", "truncated": false}, "after_length": 205, "after_sha256": "9e302fcc03816d0671e0a645b0ab5cc3d1f73d35ced8eb3e7338da5ec8aa0f79", "annex": "I", "before": {"end": 205, "start": 0, "text": "** For the overall treatment period across the 4 studies. The incidence of left ventricular dysfunction and cardiac failure congestive reflect the MedDRA Preferred Terms reported in the individual studies.", "truncated": false}, "before_length": 205, "before_sha256": "9e302fcc03816d0671e0a645b0ab5cc3d1f73d35ced8eb3e7338da5ec8aa0f79", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-14ef43694adefe0ce6401179", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002547", "medicine_name": "Perjeta", "medicine_slug": "perjeta", "observed_at": "2026-10-12T13:39:17Z", "pipeline_version": "2.0.0", "presentation_label": "Perjeta 420 mg 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": "cb28465c58604d0b3ae410ab4b7f20b7947f60bdf7475f845ec18185037e8ea6", "source_snapshot_id": "source-f34b78f381a5e027cfbe1fe6", "source_updated_at": "2026-04-28", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/perjeta-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 393}
{"after": {"end": 404, "start": 0, "text": "In perennial allergic rhinitis, fluticasone furoate nasal spray 55 micrograms once daily exhibited a more consistent efficacy profile than fluticasone furoate nasal spray 110 micrograms once daily over 4 weeks’ treatment. Post-hoc analysis over 6 and 12 weeks in the same study, as well as 6-week HPA axis safety study, supported the efficacy of fluticasone furoate nasal spray 110 micrograms once daily.", "truncated": false}, "after_length": 404, "after_sha256": "9333a849dbc3ea2ba16ed2ecd9e9acda3f3678de778ff824fa1eaa6aead21604", "annex": "I", "before": {"end": 404, "start": 0, "text": "In perennial allergic rhinitis, fluticasone furoate nasal spray 55 micrograms once daily exhibited a more consistent efficacy profile than fluticasone furoate nasal spray 110 micrograms once daily over 4 weeks’ treatment. Post-hoc analysis over 6 and 12 weeks in the same study, as well as 6-week HPA axis safety study, supported the efficacy of fluticasone furoate nasal spray 110 micrograms once daily.", "truncated": false}, "before_length": 404, "before_sha256": "9333a849dbc3ea2ba16ed2ecd9e9acda3f3678de778ff824fa1eaa6aead21604", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-14fd989dd2a778819422fd5f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000770", "medicine_name": "Avamys", "medicine_slug": "avamys", "observed_at": "2026-10-12T19:30:29Z", "pipeline_version": "2.0.0", "presentation_label": "AVAMYS 27.5 micrograms/spray, nasal spray suspension", "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": "30f949bc5059758fc7a5c6971f20b61b1a1216476650dc650963a3ac481e29e3", "source_snapshot_id": "source-74cb508bb20024b25ca75f56", "source_updated_at": "2025-06-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/avamys-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 258}
{"after": {"end": 283, "start": 0, "text": "The elimination halflife of mercaptopurine is 90 ± 30 minutes, but the active metabolites have a longer halflife (approximately 5 hours) than the parent compound. The apparent body clearance is 4832 ± 2562 ml/min/m2. There is low entry of mercaptopurine into the cerebrospinal fluid.", "truncated": false}, "after_length": 283, "after_sha256": "45a014facafa951654f9ff83c2c900c5779bc632a6a849919759fa354acb66ab", "annex": "I", "before": {"end": 283, "start": 0, "text": "The elimination halflife of mercaptopurine is 90 ± 30 minutes, but the active metabolites have a longer halflife (approximately 5 hours) than the parent compound. The apparent body clearance is 4832 ± 2562 ml/min/m2. There is low entry of mercaptopurine into the cerebrospinal fluid.", "truncated": false}, "before_length": 283, "before_sha256": "45a014facafa951654f9ff83c2c900c5779bc632a6a849919759fa354acb66ab", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-15489d697f6ae59e7cc11f01", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002022", "medicine_name": "Xaluprine (previously Mercaptopurine Nova Laboratories)", "medicine_slug": "xaluprine-previously-mercaptopurine-nova-laboratories", "observed_at": "2026-10-12T19:08:02Z", "pipeline_version": "2.0.0", "presentation_label": "Xaluprine 20 mg/ml oral suspension", "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": "a352706294cb9013c5ba158da50186f12673cdb6fb887d0033e1457d44698091", "source_snapshot_id": "source-80b0d9db881bf774bffb5d3c", "source_updated_at": "2025-09-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/xaluprine-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 636}
{"after": {"end": 66, "start": 0, "text": "Chaque mL de solution de ce médicament contient 47 mg de sorbitol.", "truncated": false}, "after_length": 66, "after_sha256": "331a08b195b7b7ed07dea1a20699672736c1d7b9115178fec4c0e7d8a8a6cc6d", "annex": "I", "before": {"end": 66, "start": 0, "text": "Chaque mL de solution de ce médicament contient 47 mg de sorbitol.", "truncated": false}, "before_length": 66, "before_sha256": "331a08b195b7b7ed07dea1a20699672736c1d7b9115178fec4c0e7d8a8a6cc6d", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-15edbcf2aea73b2f5623cc54", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/001120", "medicine_name": "Prolia", "medicine_slug": "prolia", "observed_at": "2026-10-12T13:28:45Z", "pipeline_version": "2.0.0", "presentation_label": "Prolia 60 mg solution injectable en seringue préremplie", "presentation_occurrence": 1, "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": "30e296cc06d303605f266e9544e10515b7e5c2063a0473f5aa3595a42d18a3e1", "source_snapshot_id": "source-2924aac36bd07813fcc1891d", "source_updated_at": "2026-08-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/prolia-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 37}
{"after": {"end": 150, "start": 0, "text": "La sécurité et l’efficacité d’Alecensa chez les enfants et adolescents âgés de moins de 18 ans n’ont pas été établies. Aucune donnée n’est disponible.", "truncated": false}, "after_length": 150, "after_sha256": "71c7b1def9716669db41e594ef2dac39ecb99169ecc572f424b8ddce20724c70", "annex": "I", "before": {"end": 150, "start": 0, "text": "La sécurité et l’efficacité d’Alecensa chez les enfants et adolescents âgés de moins de 18 ans n’ont pas été établies. Aucune donnée n’est disponible.", "truncated": false}, "before_length": 150, "before_sha256": "71c7b1def9716669db41e594ef2dac39ecb99169ecc572f424b8ddce20724c70", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-1691797f645b977b3cefe1ca", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004164", "medicine_name": "Alecensa", "medicine_slug": "alecensa", "observed_at": "2026-10-12T19:00:36Z", "pipeline_version": "2.0.0", "presentation_label": "Alecensa 150 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": "83ee6e171c0e05bd6ab2daf5408dcacb676175e21156c6f5251ff1b3290852d9", "source_snapshot_id": "source-b1925a54bfeff5c1398e0f30", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/alecensa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 140}
{"after": {"end": 109, "start": 0, "text": "The metabolism of pertuzumab has not been directly studied. Antibodies are cleared principally by catabolism.", "truncated": false}, "after_length": 109, "after_sha256": "55e65ebf9f422c0c5f215aeb34b1595f42e4e2c9013295c37837a78043d26bcd", "annex": "I", "before": {"end": 109, "start": 0, "text": "The metabolism of pertuzumab has not been directly studied. Antibodies are cleared principally by catabolism.", "truncated": false}, "before_length": 109, "before_sha256": "55e65ebf9f422c0c5f215aeb34b1595f42e4e2c9013295c37837a78043d26bcd", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-16dda457867b77b1ef18699b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002547", "medicine_name": "Perjeta", "medicine_slug": "perjeta", "observed_at": "2026-10-12T13:39:17Z", "pipeline_version": "2.0.0", "presentation_label": "Perjeta 420 mg 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": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "cb28465c58604d0b3ae410ab4b7f20b7947f60bdf7475f845ec18185037e8ea6", "source_snapshot_id": "source-f34b78f381a5e027cfbe1fe6", "source_updated_at": "2026-04-28", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/perjeta-epar-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": 328, "start": 0, "text": "D’après les données obtenues in vitro, le CYP3A4 est la principale enzyme servant de médiateur sur le métabolisme à la fois d’alectinib et de son principal métabolite actif (M4) et le CYP3A contribue à 40-50 % du métabolisme hépatique total. Le métabolite M4 a montré une puissance et une activité similaire in vitro contre ALK.", "truncated": false}, "after_length": 328, "after_sha256": "4a0d7152db8adf36fc78856e7b21a7ef98ce671dda0cedfbab56b2ecc2d00750", "annex": "I", "before": {"end": 328, "start": 0, "text": "D’après les données obtenues in vitro, le CYP3A4 est la principale enzyme servant de médiateur sur le métabolisme à la fois d’alectinib et de son principal métabolite actif (M4) et le CYP3A contribue à 40-50 % du métabolisme hépatique total. Le métabolite M4 a montré une puissance et une activité similaire in vitro contre ALK.", "truncated": false}, "before_length": 328, "before_sha256": "4a0d7152db8adf36fc78856e7b21a7ef98ce671dda0cedfbab56b2ecc2d00750", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-1752a8efafe509c31298dc0d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004164", "medicine_name": "Alecensa", "medicine_slug": "alecensa", "observed_at": "2026-10-12T19:00:36Z", "pipeline_version": "2.0.0", "presentation_label": "Alecensa 150 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": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "83ee6e171c0e05bd6ab2daf5408dcacb676175e21156c6f5251ff1b3290852d9", "source_snapshot_id": "source-b1925a54bfeff5c1398e0f30", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/alecensa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 193}
{"after": {"end": 252, "start": 0, "text": "Il convient de recommander aux parents, aux personnes soignantes et aux patients de conserver Xaluprine hors de la portée et de la vue des enfants, de préférence dans un placard fermé à clé. Une ingestion accidentelle peut être fatale pour les enfants.", "truncated": false}, "after_length": 252, "after_sha256": "7017cc927c303e5c7c2fb8db0bde2aac6c9c584bab2f9dcd72dbe1fd262ee657", "annex": "I", "before": {"end": 252, "start": 0, "text": "Il convient de recommander aux parents, aux personnes soignantes et aux patients de conserver Xaluprine hors de la portée et de la vue des enfants, de préférence dans un placard fermé à clé. Une ingestion accidentelle peut être fatale pour les enfants.", "truncated": false}, "before_length": 252, "before_sha256": "7017cc927c303e5c7c2fb8db0bde2aac6c9c584bab2f9dcd72dbe1fd262ee657", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-183d19f2fd53e87c52c1daaf", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002022", "medicine_name": "Xaluprine (previously Mercaptopurine Nova Laboratories)", "medicine_slug": "xaluprine-previously-mercaptopurine-nova-laboratories", "observed_at": "2026-10-12T19:08:05Z", "pipeline_version": "2.0.0", "presentation_label": "Xaluprine 20 mg/ml suspension orale", "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": "24d3b15ae521f391e697a4d72930da59f53e4eeefc26a100461fbfa83e960527", "source_snapshot_id": "source-22ca1025dfc29c23d7b323de", "source_updated_at": "2025-09-25", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xaluprine-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 695}
{"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": 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}, "before_length": 134, "before_sha256": "9f2a855337f11701b0cd4191c51820fa5a70b201b2e0721ba6acd34544486f89", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-188f54900404e3eff54b3710", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001120", "medicine_name": "Prolia", "medicine_slug": "prolia", "observed_at": "2026-10-12T13:28:42Z", "pipeline_version": "2.0.0", "presentation_label": "Prolia 60 mg solution for injection in prefilled syringe", "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": "5984d05d5bd9987a8e6f5cf86ff2e5032af0bc8bf5fe7a137a9f36a8466c5b97", "source_snapshot_id": "source-312c11aae5d59cae975290d1", "source_updated_at": "2026-08-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/prolia-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 633}
{"after": {"end": 167, "start": 0, "text": "The 420 mg dose of pertuzumab should be administered as soon as possible. Do not wait until the next planned dose. Thereafter, revert to the original planned schedule.", "truncated": false}, "after_length": 167, "after_sha256": "8958f05a948ba0c718e42c4194cd3f71ac3ee765927b723f5d370d6a5000c755", "annex": "I", "before": {"end": 167, "start": 0, "text": "The 420 mg dose of pertuzumab should be administered as soon as possible. Do not wait until the next planned dose. Thereafter, revert to the original planned schedule.", "truncated": false}, "before_length": 167, "before_sha256": "8958f05a948ba0c718e42c4194cd3f71ac3ee765927b723f5d370d6a5000c755", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-192846a3c78e53d1134fdcd3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002547", "medicine_name": "Perjeta", "medicine_slug": "perjeta", "observed_at": "2026-10-12T13:39:17Z", "pipeline_version": "2.0.0", "presentation_label": "Perjeta 420 mg 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": "cb28465c58604d0b3ae410ab4b7f20b7947f60bdf7475f845ec18185037e8ea6", "source_snapshot_id": "source-f34b78f381a5e027cfbe1fe6", "source_updated_at": "2026-04-28", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/perjeta-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 113}