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{"after": {"end": 158, "start": 0, "text": "As in adults, there is no evidence of clinically significant medicinal product interactions in paediatric patients receiving up to 60 mg/kg/day levetiracetam.", "truncated": false}, "after_length": 158, "after_sha256": "2f1aab92fc0d2e1f31b686dc7cf9144583d5584e6c286de4a23abb9f478df7c6", "annex": "I", "before": {"end": 158, "start": 0, "text": "As in adults, there is no evidence of clinically significant medicinal product interactions in paediatric patients receiving up to 60 mg/kg/day levetiracetam.", "truncated": false}, "before_length": 158, "before_sha256": "2f1aab92fc0d2e1f31b686dc7cf9144583d5584e6c286de4a23abb9f478df7c6", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-000f91b04a87dd9d6d8e6c73", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000277", "medicine_name": "Keppra", "medicine_slug": "keppra", "observed_at": "2026-10-12T13:40:48Z", "pipeline_version": "2.0.0", "presentation_label": "Keppra 500 mg film-coated 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": "74ef623005d36ee5c55466c546571211e70d55ed0682dc86570d24204be5a004", "source_snapshot_id": "source-5cc7e60b7ce7491db0871744", "source_updated_at": "2026-04-01", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/keppra-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 884}
{"after": {"end": 557, "start": 0, "text": "The demographic and baseline characteristics were similar between the atazanavir with cobicistat and atazanavir with ritonavir groups. The median age of subjects was 36 years (range: 1970). The median baseline plasma HIV1 RNA was 4.81 log10 copies/mL (range: 3.216.44). The median baseline CD4+ cell count was 352 cells/mm3 (range: 11455) and 16.9% had CD4+ cell counts ≤ 200 cells/mm3. The percentage of subjects with baseline viral loads > 100,000 copies/mL was 39.7%. Treatment outcomes at Weeks 48 and 144 for study GSUS2160114 are presented in Table 3.", "truncated": false}, "after_length": 557, "after_sha256": "aff86f3f05271ba7e272ae04762bbec94d582b4a44369fc51dba49ae6d457cbe", "annex": "I", "before": {"end": 557, "start": 0, "text": "The demographic and baseline characteristics were similar between the atazanavir with cobicistat and atazanavir with ritonavir groups. The median age of subjects was 36 years (range: 1970). The median baseline plasma HIV1 RNA was 4.81 log10 copies/mL (range: 3.216.44). The median baseline CD4+ cell count was 352 cells/mm3 (range: 11455) and 16.9% had CD4+ cell counts ≤ 200 cells/mm3. The percentage of subjects with baseline viral loads > 100,000 copies/mL was 39.7%. Treatment outcomes at Weeks 48 and 144 for study GSUS2160114 are presented in Table 3.", "truncated": false}, "before_length": 557, "before_sha256": "aff86f3f05271ba7e272ae04762bbec94d582b4a44369fc51dba49ae6d457cbe", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0012e52d69b3277640860c66", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003904", "medicine_name": "Evotaz", "medicine_slug": "evotaz", "observed_at": "2026-10-12T19:30:00Z", "pipeline_version": "2.0.0", "presentation_label": "EVOTAZ 300 mg/150 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": "c1c81e29fc6ac333270e0137ac89849b3158977371d246308818d2cb0b12eaa5", "source_snapshot_id": "source-5d0ddbcbf15bf2217dcd7d29", "source_updated_at": "2025-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/evotaz-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1220}
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{"after": {"end": 140, "start": 0, "text": "Cases of allergic/pseudoallergic reactions, including life-threatening anaphylaxis with the first dose have been reported (see section 4.8).", "truncated": false}, "after_length": 140, "after_sha256": "84100eb4931fadbb88f71b0d62d349597e26ed24a8d9dc2bbbf6b243a664817e", "annex": "I", "before": {"end": 140, "start": 0, "text": "Cases of allergic/pseudoallergic reactions, including life-threatening anaphylaxis with the first dose have been reported (see section 4.8).", "truncated": false}, "before_length": 140, "before_sha256": "84100eb4931fadbb88f71b0d62d349597e26ed24a8d9dc2bbbf6b243a664817e", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00182685c4c11b5b25aec370", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000233", "medicine_name": "Cetrotide", "medicine_slug": "cetrotide", "observed_at": "2026-10-12T17:27:47Z", "pipeline_version": "2.0.0", "presentation_label": "Cetrotide 0.25 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": "5d18abdd764867aa439779cae36dd92d76d95af5e69b1bf04f0ec3a40fa10ee1", "source_snapshot_id": "source-9d1f1e17c888e8c5e5b171c3", "source_updated_at": "2025-12-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/cetrotide-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 100}
{"after": {"end": 327, "start": 0, "text": "Ustekinumab treated patients who were not in response at week 8 of UNIFI-I received an administration of 90 mg SC ustekinumab at week 8 (36% of patients). Of those patients, 9% of patients who were initially randomised to the recommended induction dose achieved clinical remission and 58% achieved clinical response at week 16.", "truncated": false}, "after_length": 327, "after_sha256": "8a6215ca7783ab8e520afe2869524bbea17e9b08560431e9dafb258625a67287", "annex": "I", "before": {"end": 327, "start": 0, "text": "Ustekinumab treated patients who were not in response at week 8 of UNIFI-I received an administration of 90 mg SC ustekinumab at week 8 (36% of patients). Of those patients, 9% of patients who were initially randomised to the recommended induction dose achieved clinical remission and 58% achieved clinical response at week 16.", "truncated": false}, "before_length": 327, "before_sha256": "8a6215ca7783ab8e520afe2869524bbea17e9b08560431e9dafb258625a67287", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0019f7ff6b0178d8ffba712d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000958", "medicine_name": "Stelara", "medicine_slug": "stelara", "observed_at": "2026-10-12T13:28:47Z", "pipeline_version": "2.0.0", "presentation_label": "STELARA 45 mg solution for injection STELARA 45 mg solution for injection in prefilled syringe STELARA 90 mg solution for injection in prefilled syringe", "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": "223b087541b035bf595b883823a1738a2f9006e4d21f8d9e30dd814609e4bce2", "source_snapshot_id": "source-f6dcfff809498910a6b321e7", "source_updated_at": "2026-08-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/stelara-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2163}
{"after": {"end": 754, "start": 0, "text": "Serum sickness and serum sickness-like reactions, which are delayed allergic type III reactions, have been seen in patients treated with humanised monoclonal antibodies including omalizumab. The suggested pathophysiologic mechanism includes immune-complex formation and deposition due to development of antibodies against omalizumab. The onset has typically been 15 days after administration of the first or subsequent injections, also after long duration of treatment. Symptoms suggestive of serum sickness include arthritis/arthralgias, rash (urticaria or other forms), fever and lymphadenopathy. Antihistamines and corticosteroids may be useful for preventing or treating this disorder, and patients should be advised to report any suspected symptoms.", "truncated": false}, "after_length": 754, "after_sha256": "859e574e85da00645c2fb7429e1a5fb9439ff171d50caa37ec77b44902482b8b", "annex": "I", "before": {"end": 754, "start": 0, "text": "Serum sickness and serum sickness-like reactions, which are delayed allergic type III reactions, have been seen in patients treated with humanised monoclonal antibodies including omalizumab. The suggested pathophysiologic mechanism includes immune-complex formation and deposition due to development of antibodies against omalizumab. The onset has typically been 15 days after administration of the first or subsequent injections, also after long duration of treatment. Symptoms suggestive of serum sickness include arthritis/arthralgias, rash (urticaria or other forms), fever and lymphadenopathy. Antihistamines and corticosteroids may be useful for preventing or treating this disorder, and patients should be advised to report any suspected symptoms.", "truncated": false}, "before_length": 754, "before_sha256": "859e574e85da00645c2fb7429e1a5fb9439ff171d50caa37ec77b44902482b8b", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-001b38a93d428d3c01f58e7b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000606", "medicine_name": "Xolair", "medicine_slug": "xolair", "observed_at": "2026-10-12T19:37:39Z", "pipeline_version": "2.0.0", "presentation_label": "Xolair 75 mg powder and solvent for solution for injection", "presentation_occurrence": 3, "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": "bf3628eaab0eb0c7c232c7bcfee7453350e1572a5b69bac92d44d7179b37484d", "source_snapshot_id": "source-4c8d17fb79a74816821e816e", "source_updated_at": "2025-05-28", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/xolair-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3186}
{"after": {"end": 680, "start": 0, "text": "Les concentrations d’indacatérol augmentent en cas d’administrations quotidiennes répétées. L’état d’équilibre est atteint en 12 à 14 jours. Le taux d’accumulation moyen de l’indacatérol, évalué par l’aire sous la courbe des concentrations plasmatiques mesurées sur un intervalle de 24 heures, pour des administrations en une prise quotidienne de doses allant de 60 mcg à 480 mcg (dose délivrée), du 1er au 14ème jour était de 2,9 à 3,8. L’exposition systémique est le résultat combiné d’une absorption pulmonaire et d’une absorption gastro-intestinale ; environ 75 % de l’exposition systémique sont dus à l’absorption pulmonaire et environ 25 % à l’absorption gastro-intestinale.", "truncated": false}, "after_length": 680, "after_sha256": "3f7a584400797789b9e0e31400b3acb18b50d75057fd2ac1c89a6dc4809b5782", "annex": "I", "before": {"end": 680, "start": 0, "text": "Les concentrations d’indacatérol augmentent en cas d’administrations quotidiennes répétées. L’état d’équilibre est atteint en 12 à 14 jours. Le taux d’accumulation moyen de l’indacatérol, évalué par l’aire sous la courbe des concentrations plasmatiques mesurées sur un intervalle de 24 heures, pour des administrations en une prise quotidienne de doses allant de 60 mcg à 480 mcg (dose délivrée), du 1er au 14ème jour était de 2,9 à 3,8. L’exposition systémique est le résultat combiné d’une absorption pulmonaire et d’une absorption gastro-intestinale ; environ 75 % de l’exposition systémique sont dus à l’absorption pulmonaire et environ 25 % à l’absorption gastro-intestinale.", "truncated": false}, "before_length": 680, "before_sha256": "3f7a584400797789b9e0e31400b3acb18b50d75057fd2ac1c89a6dc4809b5782", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-001e9cabcadcb7f21e99c644", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005516", "medicine_name": "Bemrist Breezhaler", "medicine_slug": "bemrist-breezhaler", "observed_at": "2026-10-12T19:06:19Z", "pipeline_version": "2.0.0", "presentation_label": "Bemrist Breezhaler 125 microgrammes/62,5 microgrammes poudre pour inhalation en gélules Bemrist Breezhaler 125 microgrammes/127,5 microgrammes poudre pour inhalation en gélules Bemrist Breezhaler 125 microgrammes/260 microgrammes poudre pour inhalation en 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": "5f0012a578cd881ab97415e33afca4a210635c0e983f8e71e80bae88a39cb6ae", "source_snapshot_id": "source-cf28c695dfc5d2d050f95285", "source_updated_at": "2025-10-07", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/bemrist-breezhaler-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 643}
{"after": {"end": 232, "start": 0, "text": "Le cétrorélix inhibe de façon dose-dépendante la sécrétion de la LH et de la FSH par l’hypophyse. La suppression se produit pratiquement immédiatement et se maintient pendant la poursuite du traitement, sans effet stimulant initial.", "truncated": false}, "after_length": 232, "after_sha256": "70d9ab3667e341bf4df439cd521994ef3a02528a87c5777e206dd6d1d1d24eed", "annex": "I", "before": {"end": 232, "start": 0, "text": "Le cétrorélix inhibe de façon dose-dépendante la sécrétion de la LH et de la FSH par l’hypophyse. La suppression se produit pratiquement immédiatement et se maintient pendant la poursuite du traitement, sans effet stimulant initial.", "truncated": false}, "before_length": 232, "before_sha256": "70d9ab3667e341bf4df439cd521994ef3a02528a87c5777e206dd6d1d1d24eed", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-001fb881642b151ec2ecef5e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000233", "medicine_name": "Cetrotide", "medicine_slug": "cetrotide", "observed_at": "2026-10-12T17:28:04Z", "pipeline_version": "2.0.0", "presentation_label": "Cetrotide 0,25 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": "89d004f7601b8a9380386ff1b89ed00c999b773b8e823e5c4c6e181d4a2f4a5b", "source_snapshot_id": "source-d85ced16d4719c906781e81c", "source_updated_at": "2025-12-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/cetrotide-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 188}
{"after": {"end": 65, "start": 0, "text": "Haematological criteria in Table 2 are not met and fever resolved", "truncated": false}, "after_length": 65, "after_sha256": "063d6209005ca32d8ff62f4cb1efab64dbd014b2adca09d364a5c1776a357d16", "annex": "I", "before": {"end": 65, "start": 0, "text": "Haematological criteria in Table 2 are not met and fever resolved", "truncated": false}, "before_length": 65, "before_sha256": "063d6209005ca32d8ff62f4cb1efab64dbd014b2adca09d364a5c1776a357d16", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0021a41d2c4eb0a300b5db9d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002829", "medicine_name": "Cyramza", "medicine_slug": "cyramza", "observed_at": "2026-10-12T19:31:10Z", "pipeline_version": "2.0.0", "presentation_label": "Cyramza 10 mg/ml concentrate for solution for infusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "a7dbfe2516b330337c471624de6f529d539aca7620e7282bbc16b09bdbd63e2f", "source_snapshot_id": "source-fc5f396b773e2ce2361a4ea2", "source_updated_at": "2025-06-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/cyramza-epar-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": 110, "start": 0, "text": "Si vous avez de nouvelles lésions ou des lésions qui évoluent sur les zones de psoriasis ou sur la peau saine.", "truncated": false}, "after_length": 110, "after_sha256": "7647cc1ea5bf9463510572cdbb8c64fdf2b47ede3be1f4d9a2f7cf191f040ad2", "annex": "I", "before": {"end": 110, "start": 0, "text": "Si vous avez de nouvelles lésions ou des lésions qui évoluent sur les zones de psoriasis ou sur la peau saine.", "truncated": false}, "before_length": 110, "before_sha256": "7647cc1ea5bf9463510572cdbb8c64fdf2b47ede3be1f4d9a2f7cf191f040ad2", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-002522cc5207bb04fbdfac35", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000958", "medicine_name": "Stelara", "medicine_slug": "stelara", "observed_at": "2026-10-12T13:28:52Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 3, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "7", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "36cb13a54d5f0df5b6079c2519692ebf03eafdbb7ada52f141382055515c3f2d", "source_snapshot_id": "source-8cfbc5bdcf23531eac428df5", "source_updated_at": "2026-08-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/stelara-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 6269}
{"after": {"end": 87, "start": 0, "text": "La dose recommandée d’Aerius est de 10 ml (5 mg) de solution buvable une fois par jour.", "truncated": false}, "after_length": 87, "after_sha256": "9c2720d2d0578d02171c9c695e5c6f140438ab1d9911ec6eaf7b0b41a4bd3a0e", "annex": "I", "before": {"end": 87, "start": 0, "text": "La dose recommandée d’Aerius est de 10 ml (5 mg) de solution buvable une fois par jour.", "truncated": false}, "before_length": 87, "before_sha256": "9c2720d2d0578d02171c9c695e5c6f140438ab1d9911ec6eaf7b0b41a4bd3a0e", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00254b0e333aa9323587782c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000313", "medicine_name": "Aerius", "medicine_slug": "aerius", "observed_at": "2026-10-12T13:47:23Z", "pipeline_version": "2.0.0", "presentation_label": "Aerius 0,5 mg/ml solution buvable", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "8089714a236ecbb1faa000fb644ac965ee1e9f984f6c5143625f5e9e54bac743", "source_snapshot_id": "source-f7c26df9492b886958386672", "source_updated_at": "2026-03-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/aerius-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 374}
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{"after": {"end": 171, "start": 0, "text": "*L’omalizumab est un anticorps monoclonal humanisé produit sur une lignée cellulaire ovarienne de hamster chinois (CHO) (mammifères) par la technique de l’ADN recombinant.", "truncated": false}, "after_length": 171, "after_sha256": "5e34699715aabfce07d22e4c62b303ce5c3b8d2bfca9f42d2159ae8d7d18d11e", "annex": "I", "before": {"end": 171, "start": 0, "text": "*L’omalizumab est un anticorps monoclonal humanisé produit sur une lignée cellulaire ovarienne de hamster chinois (CHO) (mammifères) par la technique de l’ADN recombinant.", "truncated": false}, "before_length": 171, "before_sha256": "5e34699715aabfce07d22e4c62b303ce5c3b8d2bfca9f42d2159ae8d7d18d11e", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-008ab963638c28be425345e6", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000606", "medicine_name": "Xolair", "medicine_slug": "xolair", "observed_at": "2026-10-12T19:37:51Z", "pipeline_version": "2.0.0", "presentation_label": "Xolair 75 mg poudre et solvant pour solution injectable", "presentation_occurrence": 3, "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": "704c69c96cf5db1d067b68163d9912e82fd9d7a67320b120383df0a0657ec624", "source_snapshot_id": "source-e5fe1986f77f9e93b3fefd24", "source_updated_at": "2025-05-28", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xolair-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2742}
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{"after": {"end": 68, "start": 0, "text": "C Difference is aflibercept group minus active control (laser) group", "truncated": false}, "after_length": 68, "after_sha256": "4f9a361e9da9f551d695664b1c9dad1f1cf08491038ed69f12dfc8d72e8c5d8f", "annex": "I", "before": {"end": 68, "start": 0, "text": "C Difference is aflibercept group minus active control (laser) group", "truncated": false}, "before_length": 68, "before_sha256": "4f9a361e9da9f551d695664b1c9dad1f1cf08491038ed69f12dfc8d72e8c5d8f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01cdb2f04ab5b4f09aa10855", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006056", "medicine_name": "Opuviz", "medicine_slug": "opuviz", "observed_at": "2026-10-12T17:26:18Z", "pipeline_version": "2.0.0", "presentation_label": "Opuviz 40 mg/mL solution for injection in a vial.", "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": "2c2be666a9b04d0af84a1d378a2c46c81f50e575f3332cae8a7fd3bd6e77ff36", "source_snapshot_id": "source-9602626838996ff4c1707059", "source_updated_at": "2026-01-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/opuviz-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 960}
{"after": {"end": 531, "start": 0, "text": "One of the secondary endpoints in LEROS was the proportion of eyes with CRB in patients treated with Raxone >1 year after the onset of symptoms, with CRR of VA from Baseline or CRS in which Baseline VA better than 1.0 logMAR was maintained at Month 12 compared to an external NH control group. CRB was observed in 50.3% eyes of LEROS patients and 38.6% eyes of NH patients. The difference between the two groups was statistically significant in favor of Raxone presenting a pvalue of 0.0087 and OR [95% CI] of 1.925 [1.179, 3.173].", "truncated": false}, "after_length": 531, "after_sha256": "247e54efa5e2328f7d699154e3ee169edb53c88d64d842e19b285f337e744102", "annex": "I", "before": {"end": 531, "start": 0, "text": "One of the secondary endpoints in LEROS was the proportion of eyes with CRB in patients treated with Raxone >1 year after the onset of symptoms, with CRR of VA from Baseline or CRS in which Baseline VA better than 1.0 logMAR was maintained at Month 12 compared to an external NH control group. CRB was observed in 50.3% eyes of LEROS patients and 38.6% eyes of NH patients. The difference between the two groups was statistically significant in favor of Raxone presenting a pvalue of 0.0087 and OR [95% CI] of 1.925 [1.179, 3.173].", "truncated": false}, "before_length": 531, "before_sha256": "247e54efa5e2328f7d699154e3ee169edb53c88d64d842e19b285f337e744102", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01d3d95efc62b33d81f20551", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003834", "medicine_name": "Raxone", "medicine_slug": "raxone", "observed_at": "2026-10-12T19:16:09Z", "pipeline_version": "2.0.0", "presentation_label": "Raxone 150 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": "a40c25bc9b88de4a3f9b4f2cd0c01f61082db69fffcf0a3823764ce0c0015e71", "source_snapshot_id": "source-99f1e23086a54d8376a1bb52", "source_updated_at": "2025-08-20", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/raxone-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 290}
{"after": {"end": 68, "start": 0, "text": "^ Le bras A est le groupe de comparaison pour tous les hazard ratios", "truncated": false}, "after_length": 68, "after_sha256": "05173d8c14a13b05bc2c2a35aa2c15e337eed09558ca88b10cac1e2d5cfc4332", "annex": "I", "before": {"end": 68, "start": 0, "text": "^ Le bras A est le groupe de comparaison pour tous les hazard ratios", "truncated": false}, "before_length": 68, "before_sha256": "05173d8c14a13b05bc2c2a35aa2c15e337eed09558ca88b10cac1e2d5cfc4332", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01db9bdb817865ebe8cf4ea8", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004143", "medicine_name": "Tecentriq", "medicine_slug": "tecentriq", "observed_at": "2026-10-12T13:39:12Z", "pipeline_version": "2.0.0", "presentation_label": "Tecentriq 840 mg, solution à diluer pour perfusion Tecentriq 1 200 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": "4d03af56762f7d9410ef220dd9b1e6fb4fdfebb4eb8cac9c908fa6281d5e2b5a", "source_snapshot_id": "source-275a21c44e4c091ce5ff0c4d", "source_updated_at": "2026-04-28", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/tecentriq-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1559}
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{"after": {"end": 272, "start": 0, "text": "Chez le chien, les effets sur le système cardiovasculaire imputables aux propriétés bêta2agonistes de l’indacatérol ont été une tachycardie, des arythmies et des lésions myocardiques. Une irritation légère de la cavité nasale et du larynx a été observée chez les rongeurs.", "truncated": false}, "after_length": 272, "after_sha256": "bdab311531fac5eacfbc912fe297e401bd293a659b04c9559b649d814d575b93", "annex": "I", "before": {"end": 272, "start": 0, "text": "Chez le chien, les effets sur le système cardiovasculaire imputables aux propriétés bêta2agonistes de l’indacatérol ont été une tachycardie, des arythmies et des lésions myocardiques. Une irritation légère de la cavité nasale et du larynx a été observée chez les rongeurs.", "truncated": false}, "before_length": 272, "before_sha256": "bdab311531fac5eacfbc912fe297e401bd293a659b04c9559b649d814d575b93", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-02299d83d4d1d3e4e50817de", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005516", "medicine_name": "Bemrist Breezhaler", "medicine_slug": "bemrist-breezhaler", "observed_at": "2026-10-12T19:06:19Z", "pipeline_version": "2.0.0", "presentation_label": "Bemrist Breezhaler 125 microgrammes/62,5 microgrammes poudre pour inhalation en gélules Bemrist Breezhaler 125 microgrammes/127,5 microgrammes poudre pour inhalation en gélules Bemrist Breezhaler 125 microgrammes/260 microgrammes poudre pour inhalation en 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": "5.3", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "5f0012a578cd881ab97415e33afca4a210635c0e983f8e71e80bae88a39cb6ae", "source_snapshot_id": "source-cf28c695dfc5d2d050f95285", "source_updated_at": "2025-10-07", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/bemrist-breezhaler-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 722}
{"after": {"end": 721, "start": 0, "text": "Long-term data were generated from 38 of the 41 paediatric patients with PAH aged 8 to less than 18 years who were treated with ambrisentan in the 24-week randomised study. Most of the subjects who transitioned into this long-term extension had idiopathic or heritable PAH (68%) as per AMB112529 Baseline. The mean duration of exposure (± standard deviation) to ambrisentan treatment was approximately 4.0 ± 2.5 years (range: 3 months to 10.0 years). Patients could receive additional PAH treatment as required in the open-label extension and ambrisentan dose could be adjusted by 2.5 mg increments. Overall, 66% of patients who continued in the extension study remained on the same dose of ambrisentan used in AMB112529.", "truncated": false}, "after_length": 721, "after_sha256": "dcbbddbe44006151b94671d6bee76eb6fdde3521bca33c6d997252000e34b3cb", "annex": "I", "before": {"end": 721, "start": 0, "text": "Long-term data were generated from 38 of the 41 paediatric patients with PAH aged 8 to less than 18 years who were treated with ambrisentan in the 24-week randomised study. Most of the subjects who transitioned into this long-term extension had idiopathic or heritable PAH (68%) as per AMB112529 Baseline. The mean duration of exposure (± standard deviation) to ambrisentan treatment was approximately 4.0 ± 2.5 years (range: 3 months to 10.0 years). Patients could receive additional PAH treatment as required in the open-label extension and ambrisentan dose could be adjusted by 2.5 mg increments. Overall, 66% of patients who continued in the extension study remained on the same dose of ambrisentan used in AMB112529.", "truncated": false}, "before_length": 721, "before_sha256": "dcbbddbe44006151b94671d6bee76eb6fdde3521bca33c6d997252000e34b3cb", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-022c032c301aeafdad6c59ef", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000839", "medicine_name": "Volibris", "medicine_slug": "volibris", "observed_at": "2026-10-12T13:40:11Z", "pipeline_version": "2.0.0", "presentation_label": "Volibris 2.5 mg film-coated tablets Volibris 5 mg film-coated tablets Volibris 10 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": "5770c82d9b364a43432b3e3eae3867596d43761f9b107d92fd6d5245cc8956b2", "source_snapshot_id": "source-4b9528e2c46a08a33304e20c", "source_updated_at": "2026-04-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/volibris-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 584}
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{"after": {"end": 229, "start": 0, "text": "Des données concernant le traitement continu par l’idébénone sur une durée allant jusqu’à 24 mois sont disponibles dans le cadre d’une étude clinique contrôlée en ouvert sur l’histoire naturelle de la maladie (voir rubrique 5.1).", "truncated": false}, "after_length": 229, "after_sha256": "e2fa0a5a7895c1890c1a26bf2e6d010ff23c0d3611c3b22fcc46209ce15d6c83", "annex": "I", "before": {"end": 229, "start": 0, "text": "Des données concernant le traitement continu par l’idébénone sur une durée allant jusqu’à 24 mois sont disponibles dans le cadre d’une étude clinique contrôlée en ouvert sur l’histoire naturelle de la maladie (voir rubrique 5.1).", "truncated": false}, "before_length": 229, "before_sha256": "e2fa0a5a7895c1890c1a26bf2e6d010ff23c0d3611c3b22fcc46209ce15d6c83", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0241c08f311cb3f2142a81af", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003834", "medicine_name": "Raxone", "medicine_slug": "raxone", "observed_at": "2026-10-12T19:16:11Z", "pipeline_version": "2.0.0", "presentation_label": "Raxone 150 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": "3c9106f28c895cd4529e4e66d50ab94bd3fc5a59a122fe743109596f56a68266", "source_snapshot_id": "source-d44fd57709b8f42bd1785b41", "source_updated_at": "2025-08-20", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/raxone-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 69}
{"after": {"end": 473, "start": 0, "text": "On ne dispose d’aucune donnée concernant la réponse après vaccination par des vaccins vivants chez les patients traités par baricitinib. L’utilisation de vaccins vivants, atténués, n’est pas recommandée pendant ou juste avant le traitement par baricitinib. Avant d’initier le traitement, il est recommandé que tous les patients, et particulièrement les patients pédiatriques, mettent à jour toutes leurs vaccinations en accord avec les recommandations vaccinales actuelles.", "truncated": false}, "after_length": 473, "after_sha256": "92bf3491fec2b9bab649113eb74bbf4f9e21a90772884d3d2274a1c8d53983dd", "annex": "I", "before": {"end": 473, "start": 0, "text": "On ne dispose d’aucune donnée concernant la réponse après vaccination par des vaccins vivants chez les patients traités par baricitinib. L’utilisation de vaccins vivants, atténués, n’est pas recommandée pendant ou juste avant le traitement par baricitinib. Avant d’initier le traitement, il est recommandé que tous les patients, et particulièrement les patients pédiatriques, mettent à jour toutes leurs vaccinations en accord avec les recommandations vaccinales actuelles.", "truncated": false}, "before_length": 473, "before_sha256": "92bf3491fec2b9bab649113eb74bbf4f9e21a90772884d3d2274a1c8d53983dd", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-02453ffba6aa049a42c362ed", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004085", "medicine_name": "Olumiant", "medicine_slug": "olumiant", "observed_at": "2026-10-12T17:27:28Z", "pipeline_version": "2.0.0", "presentation_label": "Olumiant 1 mg comprimés pelliculés Olumiant 2 mg comprimés pelliculés Olumiant 4 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": "9049552843769a05b49a25684fff9b60d7f008e41b645e511bc2f49211970f77", "source_snapshot_id": "source-cd4d5cdd1491321c9fafe27b", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/olumiant-epar-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}
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{"after": {"end": 191, "start": 0, "text": "Aucune différence pertinente concernant l’efficacité et la sécurité n’a été observée dans les sous-groupes définis par type de DMARDs concomitants utilisés en association avec le baricitinib.", "truncated": false}, "after_length": 191, "after_sha256": "b60cb23aef952b1606bcb838c0683bb4a277a5e7ac8868d1814d161b787902cf", "annex": "I", "before": {"end": 191, "start": 0, "text": "Aucune différence pertinente concernant l’efficacité et la sécurité n’a été observée dans les sous-groupes définis par type de DMARDs concomitants utilisés en association avec le baricitinib.", "truncated": false}, "before_length": 191, "before_sha256": "b60cb23aef952b1606bcb838c0683bb4a277a5e7ac8868d1814d161b787902cf", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-025667c9e10a38c177aa0e27", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004085", "medicine_name": "Olumiant", "medicine_slug": "olumiant", "observed_at": "2026-10-12T17:27:28Z", "pipeline_version": "2.0.0", "presentation_label": "Olumiant 1 mg comprimés pelliculés Olumiant 2 mg comprimés pelliculés Olumiant 4 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": "9049552843769a05b49a25684fff9b60d7f008e41b645e511bc2f49211970f77", "source_snapshot_id": "source-cd4d5cdd1491321c9fafe27b", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/olumiant-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 608}
{"after": {"end": 246, "start": 0, "text": "In a single dose trial using a 7.5 mg dose of desloratadine, there was no effect of food (high-fat, high caloric breakfast) on the disposition of desloratadine. In another study, grapefruit juice had no effect on the disposition of desloratadine.", "truncated": false}, "after_length": 246, "after_sha256": "3d53c377aa94b8265606f97ecedb2c1d3d303688514939f86f85afbc0286f59e", "annex": "I", "before": {"end": 246, "start": 0, "text": "In a single dose trial using a 7.5 mg dose of desloratadine, there was no effect of food (high-fat, high caloric breakfast) on the disposition of desloratadine. In another study, grapefruit juice had no effect on the disposition of desloratadine.", "truncated": false}, "before_length": 246, "before_sha256": "3d53c377aa94b8265606f97ecedb2c1d3d303688514939f86f85afbc0286f59e", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-025a3d9ddbc0e0e48644cbb0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000313", "medicine_name": "Aerius", "medicine_slug": "aerius", "observed_at": "2026-10-12T13:47:21Z", "pipeline_version": "2.0.0", "presentation_label": "Aerius 0.5 mg/ml oral solution", "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": "43d4d2570e3f779a989b1a5737f419e2d3c0856cd6f669e029d53be57a3447a3", "source_snapshot_id": "source-ecd1373044751ffb95a74e7d", "source_updated_at": "2026-03-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/aerius-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 625}
{"after": {"end": 42, "start": 0, "text": "SNOT-22 total score: mean (SD) range 0-110", "truncated": false}, "after_length": 42, "after_sha256": "8d4e072963b9605548dff424494cc12f563acb342337c7cc54ae96a545637835", "annex": "I", "before": {"end": 42, "start": 0, "text": "SNOT-22 total score: mean (SD) range 0-110", "truncated": false}, "before_length": 42, "before_sha256": "8d4e072963b9605548dff424494cc12f563acb342337c7cc54ae96a545637835", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-025cceaf8afbb83ceb509375", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000606", "medicine_name": "Xolair", "medicine_slug": "xolair", "observed_at": "2026-10-12T19:37:39Z", "pipeline_version": "2.0.0", "presentation_label": "Xolair 150 mg powder and solvent for solution for injection", "presentation_occurrence": 4, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "bf3628eaab0eb0c7c232c7bcfee7453350e1572a5b69bac92d44d7179b37484d", "source_snapshot_id": "source-4c8d17fb79a74816821e816e", "source_updated_at": "2025-05-28", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/xolair-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 4742}
{"after": {"end": 550, "start": 0, "text": "Clinical trial data on adolescents (12 to 17 years) included a total of 39 patients, of whom 11 received the 300 mg dose. Results for the 300 mg are available for 9 patients at week 12 and 6 patients at week 24, and show a similar magnitude of response to omalizumab treatment compared to the adult population. Mean change from baseline in weekly itch severity score showed a reduction of 8.25 at week 12 and of 8.95 at week 24. The responder rates were: 33% at week 12 and 67% at week 24 for UAS7=0, and 56% at week 12 and 67% at week 24 for UAS7≤6.", "truncated": false}, "after_length": 550, "after_sha256": "59214c68f4c3cd7fb4bcb66ad456bdcfcb0d59713ac455312bbe9e756e1ad8ef", "annex": "I", "before": {"end": 550, "start": 0, "text": "Clinical trial data on adolescents (12 to 17 years) included a total of 39 patients, of whom 11 received the 300 mg dose. Results for the 300 mg are available for 9 patients at week 12 and 6 patients at week 24, and show a similar magnitude of response to omalizumab treatment compared to the adult population. Mean change from baseline in weekly itch severity score showed a reduction of 8.25 at week 12 and of 8.95 at week 24. The responder rates were: 33% at week 12 and 67% at week 24 for UAS7=0, and 56% at week 12 and 67% at week 24 for UAS7≤6.", "truncated": false}, "before_length": 550, "before_sha256": "59214c68f4c3cd7fb4bcb66ad456bdcfcb0d59713ac455312bbe9e756e1ad8ef", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-025f224766d899fc965dced2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000606", "medicine_name": "Xolair", "medicine_slug": "xolair", "observed_at": "2026-10-12T19:37:39Z", "pipeline_version": "2.0.0", "presentation_label": "Xolair 150 mg solution for injection in pre-filled syringe Xolair 300 mg solution for injection in pre-filled syringe Xolair 150 mg solution for injection in pre-filled pen Xolair 300 mg solution for injection in pre-filled pen", "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": "bf3628eaab0eb0c7c232c7bcfee7453350e1572a5b69bac92d44d7179b37484d", "source_snapshot_id": "source-4c8d17fb79a74816821e816e", "source_updated_at": "2025-05-28", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/xolair-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2537}
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{"after": {"end": 279, "start": 0, "text": "Chez les patients atteints de rhinite allergique, Aerius a soulagé les symptômes tels qu’éternuements, écoulement nasal et prurit mais également prurit oculaire, larmoiement et rougeurs, et prurit du palais. Aerius a correctement contrôlé les symptômes durant tout le nycthémère.", "truncated": false}, "after_length": 279, "after_sha256": "d953d29c774a67e2c225d82da47d6776e2f5fd23ef215331af95f5977255367c", "annex": "I", "before": {"end": 279, "start": 0, "text": "Chez les patients atteints de rhinite allergique, Aerius a soulagé les symptômes tels qu’éternuements, écoulement nasal et prurit mais également prurit oculaire, larmoiement et rougeurs, et prurit du palais. Aerius a correctement contrôlé les symptômes durant tout le nycthémère.", "truncated": false}, "before_length": 279, "before_sha256": "d953d29c774a67e2c225d82da47d6776e2f5fd23ef215331af95f5977255367c", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0269acd1c438fdbd060be7a1", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000313", "medicine_name": "Aerius", "medicine_slug": "aerius", "observed_at": "2026-10-12T13:47:23Z", "pipeline_version": "2.0.0", "presentation_label": "Aerius 5 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": "8089714a236ecbb1faa000fb644ac965ee1e9f984f6c5143625f5e9e54bac743", "source_snapshot_id": "source-f7c26df9492b886958386672", "source_updated_at": "2026-03-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/aerius-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 237}
{"after": {"end": 529, "start": 0, "text": "No clinically meaningful effect in the pharmacokinetics of amivantamab was observed based on mild [(total bilirubin ≤ ULN and AST > ULN) or (ULN < total bilirubin ≤ 1.5 x ULN)] or moderate (1.5×ULN < total bilirubin ≤ 3×ULN and any AST) hepatic impairment. Data in patients with moderate hepatic impairment are limited (n=1), but there is no evidence to suggest that dose adjustment is required in these patients. The effect of severe (total bilirubin > 3 times ULN) hepatic impairment on amivantamab pharmacokinetics is unknown.", "truncated": false}, "after_length": 529, "after_sha256": "4f9c01ea1047449b5991c7f65bc8ef15a2a38d550e7deb6cdfc58e7e502cebff", "annex": "I", "before": {"end": 529, "start": 0, "text": "No clinically meaningful effect in the pharmacokinetics of amivantamab was observed based on mild [(total bilirubin ≤ ULN and AST > ULN) or (ULN < total bilirubin ≤ 1.5 x ULN)] or moderate (1.5×ULN < total bilirubin ≤ 3×ULN and any AST) hepatic impairment. Data in patients with moderate hepatic impairment are limited (n=1), but there is no evidence to suggest that dose adjustment is required in these patients. The effect of severe (total bilirubin > 3 times ULN) hepatic impairment on amivantamab pharmacokinetics is unknown.", "truncated": false}, "before_length": 529, "before_sha256": "4f9c01ea1047449b5991c7f65bc8ef15a2a38d550e7deb6cdfc58e7e502cebff", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-026eb3c816956351cd34c566", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005454", "medicine_name": "Rybrevant", "medicine_slug": "rybrevant", "observed_at": "2026-10-12T19:04:12Z", "pipeline_version": "2.0.0", "presentation_label": "Rybrevant 350 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": "9aa934a48518b69f018f71c82168012a9f9d72adc1ba01912c663610d73a23fb", "source_snapshot_id": "source-f17f3851e8eda9452c21fbe7", "source_updated_at": "2025-10-29", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/rybrevant-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1291}
{"after": {"end": 187, "start": 0, "text": "WEZENLA contient 0,02 mg (45 mg/0,5 mL) ou 0,04 mg (90 mg/1,0 mL) de polysorbate 80 (E 433) par dose équivalent à 0,04 mg/mL. Les polysorbates peuvent provoquer des réactions allergiques.", "truncated": false}, "after_length": 187, "after_sha256": "e8e1daf3b88531b0a1344a3b8f7ce7553073a5f6c193c30db6dbb1958b847f70", "annex": "I", "before": {"end": 187, "start": 0, "text": "WEZENLA contient 0,02 mg (45 mg/0,5 mL) ou 0,04 mg (90 mg/1,0 mL) de polysorbate 80 (E 433) par dose équivalent à 0,04 mg/mL. Les polysorbates peuvent provoquer des réactions allergiques.", "truncated": false}, "before_length": 187, "before_sha256": "e8e1daf3b88531b0a1344a3b8f7ce7553073a5f6c193c30db6dbb1958b847f70", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-027e6f69105d41d96a1ddddd", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006132", "medicine_name": "Wezenla", "medicine_slug": "wezenla", "observed_at": "2026-10-12T13:33:47Z", "pipeline_version": "2.0.0", "presentation_label": "WEZENLA 45 mg solution injectable WEZENLA 45 mg solution injectable en seringue préremplie WEZENLA 90 mg solution injectable en seringue préremplie", "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": "98ed3f6ec1b7b67abb7889752d3ad5436b80b4d025384c0cf0266ec36ca6e462", "source_snapshot_id": "source-8dfd14917c0bce8a02f32447", "source_updated_at": "2026-07-01", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/wezenla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1104}
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{"after": {"end": 517, "start": 0, "text": "In the AMBITION study, patients received 5 mg ambrisentan daily for the first 8 weeks before up titrating to 10 mg, dependent on tolerability (see section 5.1). When used in combination with tadalafil, patients were initiated with 5 mg ambrisentan and 20 mg tadalafil. Dependent on tolerability the dose of tadalafil was increased to 40 mg after 4 weeks and the dose of ambrisentan was increased to 10 mg after 8 weeks. More than 90% of patients achieved this. Doses could also be decreased depending on tolerability.", "truncated": false}, "after_length": 517, "after_sha256": "6f9272fb240c84f54d6cd7f90659a3abd9a9dd45246aab25fdaeb7e9505d33f8", "annex": "I", "before": {"end": 517, "start": 0, "text": "In the AMBITION study, patients received 5 mg ambrisentan daily for the first 8 weeks before up titrating to 10 mg, dependent on tolerability (see section 5.1). When used in combination with tadalafil, patients were initiated with 5 mg ambrisentan and 20 mg tadalafil. Dependent on tolerability the dose of tadalafil was increased to 40 mg after 4 weeks and the dose of ambrisentan was increased to 10 mg after 8 weeks. More than 90% of patients achieved this. Doses could also be decreased depending on tolerability.", "truncated": false}, "before_length": 517, "before_sha256": "6f9272fb240c84f54d6cd7f90659a3abd9a9dd45246aab25fdaeb7e9505d33f8", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-028696b70c773ec399c6737e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000839", "medicine_name": "Volibris", "medicine_slug": "volibris", "observed_at": "2026-10-12T13:40:11Z", "pipeline_version": "2.0.0", "presentation_label": "Volibris 2.5 mg film-coated tablets Volibris 5 mg film-coated tablets Volibris 10 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": "5770c82d9b364a43432b3e3eae3867596d43761f9b107d92fd6d5245cc8956b2", "source_snapshot_id": "source-4b9528e2c46a08a33304e20c", "source_updated_at": "2026-04-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/volibris-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 101}
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{"after": {"end": 487, "start": 0, "text": "In older people, females and in nonCaucasians, total PDE4 inhibitory activity was increased. Total PDE4 inhibitory activity was slightly decreased in smokers. None of these changes were considered to be clinically meaningful. No dose adjustment is recommended in these patients. A combination of factors, such as in black, nonsmoking females, might lead to an increase of exposure and persistent intolerability. In this case, roflumilast treatment should be reassessed (see section 4.4).", "truncated": false}, "after_length": 487, "after_sha256": "4dcdc891158d41a795ec4622778c40281a0435028f59df892aedaa9ab80e3ab2", "annex": "I", "before": {"end": 487, "start": 0, "text": "In older people, females and in nonCaucasians, total PDE4 inhibitory activity was increased. Total PDE4 inhibitory activity was slightly decreased in smokers. None of these changes were considered to be clinically meaningful. No dose adjustment is recommended in these patients. A combination of factors, such as in black, nonsmoking females, might lead to an increase of exposure and persistent intolerability. In this case, roflumilast treatment should be reassessed (see section 4.4).", "truncated": false}, "before_length": 487, "before_sha256": "4dcdc891158d41a795ec4622778c40281a0435028f59df892aedaa9ab80e3ab2", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-02a93f3c4b449251a9d552dd", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001179", "medicine_name": "Daxas", "medicine_slug": "daxas", "observed_at": "2026-10-12T19:06:09Z", "pipeline_version": "2.0.0", "presentation_label": "Daxas 250 micrograms 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": "5a46f173703a8685205dd61d80eb3f1ec4682dddeec32928c7ecab73f8f7da95", "source_snapshot_id": "source-c4e1e345673be2109418f4dc", "source_updated_at": "2025-10-07", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/daxas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 420}
{"after": {"end": 316, "start": 0, "text": "Relapse: In all conditioning treatments containing thiotepa, relapse rates at more than 1 year have been reported as being lower than 60%, which was considered by the physicians as the threshold to prove efficacy. In some cases, relapse rates of 35% and of 45% have been reported at 5 years and 6 years respectively.", "truncated": false}, "after_length": 316, "after_sha256": "bfd90d407f3aa6ff1c83d0aca5c666b2d18b438fb63b5020f85bdadf1bd92fb5", "annex": "I", "before": {"end": 316, "start": 0, "text": "Relapse: In all conditioning treatments containing thiotepa, relapse rates at more than 1 year have been reported as being lower than 60%, which was considered by the physicians as the threshold to prove efficacy. In some cases, relapse rates of 35% and of 45% have been reported at 5 years and 6 years respectively.", "truncated": false}, "before_length": 316, "before_sha256": "bfd90d407f3aa6ff1c83d0aca5c666b2d18b438fb63b5020f85bdadf1bd92fb5", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-02b041a245070043eb8b3b9c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001046", "medicine_name": "Tepadina", "medicine_slug": "tepadina", "observed_at": "2026-10-12T19:06:03Z", "pipeline_version": "2.0.0", "presentation_label": "TEPADINA 15 mg powder for concentrate for solution for infusion TEPADINA 100 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": "4721504163a0ab5d0a4c8fb87f19b5756cc2e933f45bad0cd7861c410d97638c", "source_snapshot_id": "source-16253f9b4da5fbf06c04c7d0", "source_updated_at": "2025-10-07", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/tepadina-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 643}
{"after": {"end": 367, "start": 0, "text": "Le baricitinib est contre-indiqué pendant la grossesse (voir rubrique 4.3). Les femmes en âge de procréer doivent utiliser une contraception efficace pendant le traitement et au moins 1 semaine après l’arrêt du traitement. Si une patiente débute une grossesse pendant le traitement par baricitinib, les parents doivent être informés du risque potentiel pour le fœtus.", "truncated": false}, "after_length": 367, "after_sha256": "d4679be828417e96dde63eef83e04fb691b3ad3eea89ed6f35fcac41ccabd0b1", "annex": "I", "before": {"end": 367, "start": 0, "text": "Le baricitinib est contre-indiqué pendant la grossesse (voir rubrique 4.3). Les femmes en âge de procréer doivent utiliser une contraception efficace pendant le traitement et au moins 1 semaine après l’arrêt du traitement. Si une patiente débute une grossesse pendant le traitement par baricitinib, les parents doivent être informés du risque potentiel pour le fœtus.", "truncated": false}, "before_length": 367, "before_sha256": "d4679be828417e96dde63eef83e04fb691b3ad3eea89ed6f35fcac41ccabd0b1", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-02b1da3f5b1e23bc4018e9b6", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004085", "medicine_name": "Olumiant", "medicine_slug": "olumiant", "observed_at": "2026-10-12T17:27:28Z", "pipeline_version": "2.0.0", "presentation_label": "Olumiant 1 mg comprimés pelliculés Olumiant 2 mg comprimés pelliculés Olumiant 4 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": "9049552843769a05b49a25684fff9b60d7f008e41b645e511bc2f49211970f77", "source_snapshot_id": "source-cd4d5cdd1491321c9fafe27b", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/olumiant-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 346}
{"after": {"end": 409, "start": 0, "text": "Levetiracetam is not extensively metabolised in humans. The major metabolic pathway (24 % of the dose) is an enzymatic hydrolysis of the acetamide group. Production of the primary metabolite, ucb L057, is not supported by liver cytochrome P450 isoforms. Hydrolysis of the acetamide group was measurable in a large number of tissues including blood cells. The metabolite ucb L057 is pharmacologically inactive.", "truncated": false}, "after_length": 409, "after_sha256": "c4546f524352f445600f0a0b968e2ddb9b41fab65735b50559ee1f334f7a0bf3", "annex": "I", "before": {"end": 409, "start": 0, "text": "Levetiracetam is not extensively metabolised in humans. The major metabolic pathway (24 % of the dose) is an enzymatic hydrolysis of the acetamide group. Production of the primary metabolite, ucb L057, is not supported by liver cytochrome P450 isoforms. Hydrolysis of the acetamide group was measurable in a large number of tissues including blood cells. The metabolite ucb L057 is pharmacologically inactive.", "truncated": false}, "before_length": 409, "before_sha256": "c4546f524352f445600f0a0b968e2ddb9b41fab65735b50559ee1f334f7a0bf3", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-02b6dbe4c6ba1932b598abe7", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000277", "medicine_name": "Keppra", "medicine_slug": "keppra", "observed_at": "2026-10-12T13:40:48Z", "pipeline_version": "2.0.0", "presentation_label": "Keppra 750 mg film-coated tablets", "presentation_occurrence": 3, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "74ef623005d36ee5c55466c546571211e70d55ed0682dc86570d24204be5a004", "source_snapshot_id": "source-5cc7e60b7ce7491db0871744", "source_updated_at": "2026-04-01", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/keppra-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2424}
{"after": {"end": 645, "start": 0, "text": "La durée du traitement doit être aussi courte que nécessaire afin de contrôler les symptômes et ne doit pas dépasser 12 semaines. Une efficacité accrue à des doses supérieures à la dose quotidienne de 10 mg n'a pas été démontrée et une dose quotidienne de 30 mg a été associée à une augmentation substantielle de l'incidence des effets indésirables significatifs incluant les symptômes extrapyramidaux (SEP), la fatigue et la prise de poids (voir rubrique 4.8). Par conséquent, des doses supérieures à 10 mg/jour doivent être utilisées pour des cas exceptionnels et associées à une surveillance clinique étroite (voir rubriques 4.4, 4.8 et 5.1).", "truncated": false}, "after_length": 645, "after_sha256": "125661b2636b87035c6e9765aa98d5f4c44cab72f1b825adae77a56c32528456", "annex": "I", "before": {"end": 645, "start": 0, "text": "La durée du traitement doit être aussi courte que nécessaire afin de contrôler les symptômes et ne doit pas dépasser 12 semaines. Une efficacité accrue à des doses supérieures à la dose quotidienne de 10 mg n'a pas été démontrée et une dose quotidienne de 30 mg a été associée à une augmentation substantielle de l'incidence des effets indésirables significatifs incluant les symptômes extrapyramidaux (SEP), la fatigue et la prise de poids (voir rubrique 4.8). Par conséquent, des doses supérieures à 10 mg/jour doivent être utilisées pour des cas exceptionnels et associées à une surveillance clinique étroite (voir rubriques 4.4, 4.8 et 5.1).", "truncated": false}, "before_length": 645, "before_sha256": "125661b2636b87035c6e9765aa98d5f4c44cab72f1b825adae77a56c32528456", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-02bc1a3cdf86dcf00c7c6f19", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004008", "medicine_name": "Aripiprazole Sandoz", "medicine_slug": "aripiprazole-sandoz", "observed_at": "2026-10-12T13:40:26Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "e22ec2e1091ba644789161695b2abedce706b1188f584dcce10bbbc43adf986a", "source_snapshot_id": "source-0a9efa4639b121b1b78dabf2", "source_updated_at": "2026-04-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/aripiprazole-sandoz-epar-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}
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{"after": {"end": 803, "start": 0, "text": "Les profils sériques de concentration de l’ustekinumab en fonction du temps étaient généralement prévisibles après administration en sous-cutanée d’une dose unique ou de doses multiples. Chez les patients atteints de psoriasis, les concentrations sériques à l’équilibre de l’ustekinumab ont été atteintes à la semaine 28 après des doses initiales en sous-cutanée aux semaines 0 et 4 suivies d’une dose toutes les 12 semaines. La concentration médiane à l’équilibre était comprise entre 0,21 microgramme/mL et 0,26 microgramme/mL (45 mg) et entre 0,47 microgramme/mL et 0,49 microgramme/mL (90 mg) chez les patients atteints de psoriasis. Il n’y avait pas d’accumulation apparente de la concentration sérique de l’ustekinumab au cours du temps lors d’administrations sous-cutanées toutes les 12 semaines.", "truncated": false}, "after_length": 803, "after_sha256": "54191d9a60488db6fb6bcfc4a18e440b8602148ba8028ad2e744a46d97683312", "annex": "I", "before": {"end": 803, "start": 0, "text": "Les profils sériques de concentration de l’ustekinumab en fonction du temps étaient généralement prévisibles après administration en sous-cutanée d’une dose unique ou de doses multiples. Chez les patients atteints de psoriasis, les concentrations sériques à l’équilibre de l’ustekinumab ont été atteintes à la semaine 28 après des doses initiales en sous-cutanée aux semaines 0 et 4 suivies d’une dose toutes les 12 semaines. La concentration médiane à l’équilibre était comprise entre 0,21 microgramme/mL et 0,26 microgramme/mL (45 mg) et entre 0,47 microgramme/mL et 0,49 microgramme/mL (90 mg) chez les patients atteints de psoriasis. Il n’y avait pas d’accumulation apparente de la concentration sérique de l’ustekinumab au cours du temps lors d’administrations sous-cutanées toutes les 12 semaines.", "truncated": false}, "before_length": 803, "before_sha256": "54191d9a60488db6fb6bcfc4a18e440b8602148ba8028ad2e744a46d97683312", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0336bfa3018dc42bb12e829b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006132", "medicine_name": "Wezenla", "medicine_slug": "wezenla", "observed_at": "2026-10-12T13:33:47Z", "pipeline_version": "2.0.0", "presentation_label": "WEZENLA 45 mg solution injectable WEZENLA 45 mg solution injectable en seringue préremplie WEZENLA 90 mg solution injectable en seringue préremplie", "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": "98ed3f6ec1b7b67abb7889752d3ad5436b80b4d025384c0cf0266ec36ca6e462", "source_snapshot_id": "source-8dfd14917c0bce8a02f32447", "source_updated_at": "2026-07-01", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/wezenla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2005}
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{"after": {"end": 225, "start": 0, "text": "d Nonresponder imputation: patients who received rescue treatment or with missing data were considered as nonresponders. Results shown in subset of patients eligible for assessment (patients with ADSS Item 2 ≥ 2 at baseline).", "truncated": false}, "after_length": 225, "after_sha256": "87c98427019f428dd421811d7d3c08ffcd56cbc0714ec5a7a42e26be53f585ca", "annex": "I", "before": {"end": 225, "start": 0, "text": "d Nonresponder imputation: patients who received rescue treatment or with missing data were considered as nonresponders. Results shown in subset of patients eligible for assessment (patients with ADSS Item 2 ≥ 2 at baseline).", "truncated": false}, "before_length": 225, "before_sha256": "87c98427019f428dd421811d7d3c08ffcd56cbc0714ec5a7a42e26be53f585ca", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-034b33887e8782d39563133a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004085", "medicine_name": "Olumiant", "medicine_slug": "olumiant", "observed_at": "2026-10-12T17:27:24Z", "pipeline_version": "2.0.0", "presentation_label": "Olumiant 1 mg film-coated tablets Olumiant 2 mg filmcoated tablets Olumiant 4 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": "b4ca079a8e59619a86bb4d5c48f047c56c3216b31a07e1e31daf02679a924865", "source_snapshot_id": "source-ce77e606b3e62d5f6fef575d", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/olumiant-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1245}
{"after": {"end": 282, "start": 0, "text": "A two-stage skin carcinogenesis bioassay in mice showed no development of skin masses following treatment with 2 mg/g or 8 mg/g sirolimus gel indicating that sirolimus gel does not promote skin carcinogenesis when administered after initiation with dimethylbenz[a]anthracene (DMBA).", "truncated": false}, "after_length": 282, "after_sha256": "0dae365f306666d862f96f69862938b82b7a7ac8b536996f895b33c281cbe49f", "annex": "I", "before": {"end": 282, "start": 0, "text": "A two-stage skin carcinogenesis bioassay in mice showed no development of skin masses following treatment with 2 mg/g or 8 mg/g sirolimus gel indicating that sirolimus gel does not promote skin carcinogenesis when administered after initiation with dimethylbenz[a]anthracene (DMBA).", "truncated": false}, "before_length": 282, "before_sha256": "0dae365f306666d862f96f69862938b82b7a7ac8b536996f895b33c281cbe49f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-034b6e116bfa50e2a80c0108", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005896", "medicine_name": "Hyftor", "medicine_slug": "hyftor", "observed_at": "2026-10-12T19:30:24Z", "pipeline_version": "2.0.0", "presentation_label": "Hyftor 2 mg/g gel", "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": "20b87f11031a18aee940ad1e4d2b615fe687dbead6d8f219db8e214b814f1acc", "source_snapshot_id": "source-44df4a8e5513d920d46cd291", "source_updated_at": "2025-07-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/hyftor-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 408}
{"after": {"end": 363, "start": 0, "text": "Une exacerbation cliniquement significative était définie comme une aggravation des symptômes asthmatiques selon le jugement clinique de l’investigateur, nécessitant le doublement de la dose initiale de corticoïde inhalé pendant au moins trois jours et/ou la prise d’une cure courte de corticoïdes systémiques (oraux ou intraveineux) pendant au moins trois jours.", "truncated": false}, "after_length": 363, "after_sha256": "68e5e615ca5c50efbed87671b383cf9eeba3bac98b6c93949974092d455160aa", "annex": "I", "before": {"end": 363, "start": 0, "text": "Une exacerbation cliniquement significative était définie comme une aggravation des symptômes asthmatiques selon le jugement clinique de l’investigateur, nécessitant le doublement de la dose initiale de corticoïde inhalé pendant au moins trois jours et/ou la prise d’une cure courte de corticoïdes systémiques (oraux ou intraveineux) pendant au moins trois jours.", "truncated": false}, "before_length": 363, "before_sha256": "68e5e615ca5c50efbed87671b383cf9eeba3bac98b6c93949974092d455160aa", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0355cc303ad4525da6127432", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000606", "medicine_name": "Xolair", "medicine_slug": "xolair", "observed_at": "2026-10-12T19:37:51Z", "pipeline_version": "2.0.0", "presentation_label": "Xolair 150 mg solution injectable en seringue préremplie Xolair 300 mg solution injectable en seringue préremplie Xolair 150 mg solution injectable en stylo prérempli Xolair 300 mg solution injectable en stylo prérempli", "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": "704c69c96cf5db1d067b68163d9912e82fd9d7a67320b120383df0a0657ec624", "source_snapshot_id": "source-e5fe1986f77f9e93b3fefd24", "source_updated_at": "2025-05-28", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xolair-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2085}
{"after": {"end": 504, "start": 0, "text": "Des anticorps dirigés contre l’ustekinumab peuvent se développer durant le traitement par ustekinumab, et la plupart sont neutralisants. La formation d’anticorps dirigés contre l’ustekinumab est associée à une augmentation de la clairance de l’ustekinumab chez les patients atteints de la maladie de Crohn. Aucune diminution de l’efficacité n’a été observée. Il n’y a pas de corrélation apparente entre la présence d’anticorps dirigés contre l’ustekinumab et la survenue de réactions au site d’injection.", "truncated": false}, "after_length": 504, "after_sha256": "57a9ca6b967af926261816544f26e69fe1c293272b5ac25cdda4623fd8b14ce6", "annex": "I", "before": {"end": 504, "start": 0, "text": "Des anticorps dirigés contre l’ustekinumab peuvent se développer durant le traitement par ustekinumab, et la plupart sont neutralisants. La formation d’anticorps dirigés contre l’ustekinumab est associée à une augmentation de la clairance de l’ustekinumab chez les patients atteints de la maladie de Crohn. Aucune diminution de l’efficacité n’a été observée. Il n’y a pas de corrélation apparente entre la présence d’anticorps dirigés contre l’ustekinumab et la survenue de réactions au site d’injection.", "truncated": false}, "before_length": 504, "before_sha256": "57a9ca6b967af926261816544f26e69fe1c293272b5ac25cdda4623fd8b14ce6", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-036260c6a54e08e54fdb45a9", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006132", "medicine_name": "Wezenla", "medicine_slug": "wezenla", "observed_at": "2026-10-12T13:33:47Z", "pipeline_version": "2.0.0", "presentation_label": "WEZENLA 130 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": "98ed3f6ec1b7b67abb7889752d3ad5436b80b4d025384c0cf0266ec36ca6e462", "source_snapshot_id": "source-8dfd14917c0bce8a02f32447", "source_updated_at": "2026-07-01", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/wezenla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 509}
{"after": {"end": 156, "start": 0, "text": "Il n’existe aucune donnée en faveur de l’administration de sugammadex pour une décurarisation immédiate après un bloc neuromusculaire induit par vécuronium.", "truncated": false}, "after_length": 156, "after_sha256": "ccac8e22ed38627e272897403354e4f7b173d7d005bd8e1988e7f42d74388487", "annex": "I", "before": {"end": 156, "start": 0, "text": "Il n’existe aucune donnée en faveur de l’administration de sugammadex pour une décurarisation immédiate après un bloc neuromusculaire induit par vécuronium.", "truncated": false}, "before_length": 156, "before_sha256": "ccac8e22ed38627e272897403354e4f7b173d7d005bd8e1988e7f42d74388487", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-036a8174175941d9571accad", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005935", "medicine_name": "Sugammadex Amomed", "medicine_slug": "sugammadex-amomed", "observed_at": "2026-10-12T19:02:25Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.1", "section_type": "indication", "source_provider": "European Medicines Agency", "source_sha256": "ae645c25161b6a41ea1078df5adc6903473670747f6e918de1e9cf3271e56a85", "source_snapshot_id": "source-7e9edf5440112867feba4dfd", "source_updated_at": "2026-02-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/sugammadex-amomed-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1435}
{"after": {"end": 354, "start": 0, "text": "If there is a clinical need for immediate reversal following administration of rocuronium a dose of 16 mg/kg sugammadex is recommended. When 16 mg/kg sugammadex is administered 3 minutes after a bolus dose of 1.2 mg/kg rocuronium bromide, a median time to recovery of the T4/T1 ratio to 0.9 of approximately 1.5 minutes can be expected (see section 5.1).", "truncated": false}, "after_length": 354, "after_sha256": "a1534619988b31c006e0971fc1f11a5385c91587db2581c7490c5b7641b4f01d", "annex": "I", "before": {"end": 354, "start": 0, "text": "If there is a clinical need for immediate reversal following administration of rocuronium a dose of 16 mg/kg sugammadex is recommended. When 16 mg/kg sugammadex is administered 3 minutes after a bolus dose of 1.2 mg/kg rocuronium bromide, a median time to recovery of the T4/T1 ratio to 0.9 of approximately 1.5 minutes can be expected (see section 5.1).", "truncated": false}, "before_length": 354, "before_sha256": "a1534619988b31c006e0971fc1f11a5385c91587db2581c7490c5b7641b4f01d", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03743c7809dc3c17b7c8a8a7", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005935", "medicine_name": "Sugammadex Amomed", "medicine_slug": "sugammadex-amomed", "observed_at": "2026-10-12T19:02:23Z", "pipeline_version": "2.0.0", "presentation_label": "Sugammadex Amomed 100 mg/ml 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": "943c70dddd097ee185a75ee1a225ccc92223423f733612478da8f4be33f3295a", "source_snapshot_id": "source-4456be6b996cfeb28427785f", "source_updated_at": "2026-02-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/sugammadex-amomed-epar-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}
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{"after": {"end": 84, "start": 0, "text": "Un traitement symptomatique et des mesures thérapeutiques adaptées sont recommandés.", "truncated": false}, "after_length": 84, "after_sha256": "f8bda64af775a5e14c06e5e71c33ac9a3d53e1b091ca460b4c544fef356d6b49", "annex": "I", "before": {"end": 84, "start": 0, "text": "Un traitement symptomatique et des mesures thérapeutiques adaptées sont recommandés.", "truncated": false}, "before_length": 84, "before_sha256": "f8bda64af775a5e14c06e5e71c33ac9a3d53e1b091ca460b4c544fef356d6b49", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0385150a61302e40617422c6", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000313", "medicine_name": "Aerius", "medicine_slug": "aerius", "observed_at": "2026-10-12T13:47:23Z", "pipeline_version": "2.0.0", "presentation_label": "Aerius 0,5 mg/ml solution buvable", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.9", "section_type": "overdose", "source_provider": "European Medicines Agency", "source_sha256": "8089714a236ecbb1faa000fb644ac965ee1e9f984f6c5143625f5e9e54bac743", "source_snapshot_id": "source-f7c26df9492b886958386672", "source_updated_at": "2026-03-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/aerius-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 562}
{"after": {"end": 54, "start": 0, "text": "A After treatment initiation with 5 monthly injections", "truncated": false}, "after_length": 54, "after_sha256": "fe07d4ccbec6abdf7417951ee2ae872186ec66a580aa4d540bdc78f32f3c5cb2", "annex": "I", "before": {"end": 54, "start": 0, "text": "A After treatment initiation with 5 monthly injections", "truncated": false}, "before_length": 54, "before_sha256": "fe07d4ccbec6abdf7417951ee2ae872186ec66a580aa4d540bdc78f32f3c5cb2", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0393ad0c17dd614cdbf5a7b4", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006056", "medicine_name": "Opuviz", "medicine_slug": "opuviz", "observed_at": "2026-10-12T17:26:18Z", "pipeline_version": "2.0.0", "presentation_label": "Opuviz 40 mg/mL solution for injection in a vial.", "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": "2c2be666a9b04d0af84a1d378a2c46c81f50e575f3332cae8a7fd3bd6e77ff36", "source_snapshot_id": "source-9602626838996ff4c1707059", "source_updated_at": "2026-01-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/opuviz-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 958}
{"after": {"end": 61, "start": 0, "text": "Les données sont insuffisantes pour recommander une posologie", "truncated": false}, "after_length": 61, "after_sha256": "591b9edb2e4dfd32cc8908020e6cae62e0137ba745d0d70f84f16f997de07b98", "annex": "I", "before": {"end": 61, "start": 0, "text": "Les données sont insuffisantes pour recommander une posologie", "truncated": false}, "before_length": 61, "before_sha256": "591b9edb2e4dfd32cc8908020e6cae62e0137ba745d0d70f84f16f997de07b98", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-039511d7bbd51b143502ef6d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000606", "medicine_name": "Xolair", "medicine_slug": "xolair", "observed_at": "2026-10-12T19:37:51Z", "pipeline_version": "2.0.0", "presentation_label": "Xolair 150 mg solution injectable en seringue préremplie Xolair 300 mg solution injectable en seringue préremplie Xolair 150 mg solution injectable en stylo prérempli Xolair 300 mg solution injectable en stylo prérempli", "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": "704c69c96cf5db1d067b68163d9912e82fd9d7a67320b120383df0a0657ec624", "source_snapshot_id": "source-e5fe1986f77f9e93b3fefd24", "source_updated_at": "2025-05-28", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xolair-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1649}
{"after": {"end": 572, "start": 0, "text": "Dans une étude clinique menée chez des patients présentant une obésité morbide, 2 mg/kg et 4 mg/kg de sugammadex ont été administrés, avec une dose calculée en fonction du poids corporel réel (n = 76) ou du poids corporel idéal (n = 74). Après administration, l’exposition au sugammadex a augmenté de manière linéaire et dose-dépendante, selon le poids corporel réel ou le poids corporel idéal. Aucune différence cliniquement significative n’a été observée dans les paramètres pharmacocinétiques entre les patients présentant une obésité morbide et la population générale.", "truncated": false}, "after_length": 572, "after_sha256": "1ae1c1b61142bbc32ce13660c0d097104094ac99ea8d3725c9c3ace606569be2", "annex": "I", "before": {"end": 572, "start": 0, "text": "Dans une étude clinique menée chez des patients présentant une obésité morbide, 2 mg/kg et 4 mg/kg de sugammadex ont été administrés, avec une dose calculée en fonction du poids corporel réel (n = 76) ou du poids corporel idéal (n = 74). Après administration, l’exposition au sugammadex a augmenté de manière linéaire et dose-dépendante, selon le poids corporel réel ou le poids corporel idéal. Aucune différence cliniquement significative n’a été observée dans les paramètres pharmacocinétiques entre les patients présentant une obésité morbide et la population générale.", "truncated": false}, "before_length": 572, "before_sha256": "1ae1c1b61142bbc32ce13660c0d097104094ac99ea8d3725c9c3ace606569be2", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03a375eae71263cf369f91c3", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005935", "medicine_name": "Sugammadex Amomed", "medicine_slug": "sugammadex-amomed", "observed_at": "2026-10-12T19:02:25Z", "pipeline_version": "2.0.0", "presentation_label": "Sugammadex Amomed 100 mg/mL, solution injectable.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "ae645c25161b6a41ea1078df5adc6903473670747f6e918de1e9cf3271e56a85", "source_snapshot_id": "source-7e9edf5440112867feba4dfd", "source_updated_at": "2026-02-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/sugammadex-amomed-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 771}
{"after": {"end": 153, "start": 0, "text": "Dose escalation is not recommended for paediatric patients with Ph+ ALL, as dasatinib is administered in combination with chemotherapy in these patients.", "truncated": false}, "after_length": 153, "after_sha256": "7c866738080c22ebebd679ead32c370175c84323eacf8005cbe24bfe44398f6a", "annex": "I", "before": {"end": 153, "start": 0, "text": "Dose escalation is not recommended for paediatric patients with Ph+ ALL, as dasatinib is administered in combination with chemotherapy in these patients.", "truncated": false}, "before_length": 153, "before_sha256": "7c866738080c22ebebd679ead32c370175c84323eacf8005cbe24bfe44398f6a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03ab87fc7a3688d2dfe5f61c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006251", "medicine_name": "Dasatinib Accord Healthcare", "medicine_slug": "dasatinib-accord-healthcare", "observed_at": "2026-10-12T19:02:15Z", "pipeline_version": "2.0.0", "presentation_label": "Dasatinib Accord Healthcare 20 mg film-coated tablets Dasatinib Accord Healthcare 50 mg film-coated tablets Dasatinib Accord Healthcare 70 mg film-coated tablets Dasatinib Accord Healthcare 80 mg film-coated tablets Dasatinib Accord Healthcare 100 mg film-coated tablets Dasatinib Accord Healthcare 1", "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": "e13a7646ebab278a72a53434793d7181faab9ffa758b839f8b4c7b1a344a02b4", "source_snapshot_id": "source-9e22e0e7bcb86d8e1dedf0f1", "source_updated_at": "2026-02-05", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/dasatinib-accord-healthcare-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 178}
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{"after": {"end": 795, "start": 0, "text": "There are no human data to assess the risk of amivantamab use during pregnancy. No animal reproductive studies were conducted to inform a drugassociated risk. Administration of EGFR and MET inhibitor molecules in pregnant animals resulted in an increased incidence of impairment of embryofoetal development, embryo lethality, and abortion. Therefore, based on its mechanism of action and findings in animal models, amivantamab could cause foetal harm when administered to a pregnant woman. Amivantamab should not be given during pregnancy unless the benefit of treatment of the woman is considered to outweigh potential risks to the foetus. If the patient becomes pregnant while taking this medicinal product, the patient should be informed of the potential risk to the foetus (see section 5.3).", "truncated": false}, "after_length": 795, "after_sha256": "0b33df3ffc1cf0a42b19d002105b6324f17e80a0ae04b9ab48846224512e3f94", "annex": "I", "before": {"end": 795, "start": 0, "text": "There are no human data to assess the risk of amivantamab use during pregnancy. No animal reproductive studies were conducted to inform a drugassociated risk. Administration of EGFR and MET inhibitor molecules in pregnant animals resulted in an increased incidence of impairment of embryofoetal development, embryo lethality, and abortion. Therefore, based on its mechanism of action and findings in animal models, amivantamab could cause foetal harm when administered to a pregnant woman. Amivantamab should not be given during pregnancy unless the benefit of treatment of the woman is considered to outweigh potential risks to the foetus. If the patient becomes pregnant while taking this medicinal product, the patient should be informed of the potential risk to the foetus (see section 5.3).", "truncated": false}, "before_length": 795, "before_sha256": "0b33df3ffc1cf0a42b19d002105b6324f17e80a0ae04b9ab48846224512e3f94", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03c4cc760cfd7bcad6a308f6", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005454", "medicine_name": "Rybrevant", "medicine_slug": "rybrevant", "observed_at": "2026-10-12T19:04:12Z", "pipeline_version": "2.0.0", "presentation_label": "Rybrevant 1600 mg solution for injection Rybrevant 2240 mg 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": "4.6", "section_type": "pregnancy", "source_provider": "European Medicines Agency", "source_sha256": "9aa934a48518b69f018f71c82168012a9f9d72adc1ba01912c663610d73a23fb", "source_snapshot_id": "source-f17f3851e8eda9452c21fbe7", "source_updated_at": "2025-10-29", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/rybrevant-epar-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}
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{"after": {"end": 711, "start": 0, "text": "The consequence of treatment with thiotepa at the recommended dose and schedule is profound myelosuppression, occurring in all patients. Severe granulocytopenia, thrombocytopenia, anaemia or any combination thereof may develop. Frequent complete blood counts, including differential white blood cell counts, and platelet counts need to be performed during the treatment and until recovery is achieved. Platelet and red blood cell support, as well as the use of growth factors such as Granulocyte-colony stimulating factor (G-CSF), should be employed as medically indicated. Daily white blood cell counts and platelet counts are recommended during therapy with thiotepa and after transplant for at least 30 days.", "truncated": false}, "after_length": 711, "after_sha256": "4c2606d537e21343e879f8692509e121c0fcd13fab52db518ff537a479e52c48", "annex": "I", "before": {"end": 711, "start": 0, "text": "The consequence of treatment with thiotepa at the recommended dose and schedule is profound myelosuppression, occurring in all patients. Severe granulocytopenia, thrombocytopenia, anaemia or any combination thereof may develop. Frequent complete blood counts, including differential white blood cell counts, and platelet counts need to be performed during the treatment and until recovery is achieved. Platelet and red blood cell support, as well as the use of growth factors such as Granulocyte-colony stimulating factor (G-CSF), should be employed as medically indicated. Daily white blood cell counts and platelet counts are recommended during therapy with thiotepa and after transplant for at least 30 days.", "truncated": false}, "before_length": 711, "before_sha256": "4c2606d537e21343e879f8692509e121c0fcd13fab52db518ff537a479e52c48", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-046db880b772c49edb77409f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001046", "medicine_name": "Tepadina", "medicine_slug": "tepadina", "observed_at": "2026-10-12T19:06:03Z", "pipeline_version": "2.0.0", "presentation_label": "TEPADINA 200 mg powder and solvent for solution for infusion TEPADINA 400 mg powder and solvent for solution for infusion", "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": "4721504163a0ab5d0a4c8fb87f19b5756cc2e933f45bad0cd7861c410d97638c", "source_snapshot_id": "source-16253f9b4da5fbf06c04c7d0", "source_updated_at": "2025-10-07", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/tepadina-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 978}
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{"after": {"end": 67, "start": 0, "text": "Table 6. Summary of Secondary endpoints through Maintenance week 44", "truncated": false}, "after_length": 67, "after_sha256": "157ce42632a5ce288c7dfc75b7fe7216ba2feeca28938b70f375a983337496f6", "annex": "I", "before": {"end": 67, "start": 0, "text": "Table 6. Summary of Secondary endpoints through Maintenance week 44", "truncated": false}, "before_length": 67, "before_sha256": "157ce42632a5ce288c7dfc75b7fe7216ba2feeca28938b70f375a983337496f6", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0519f49f647f44b79d75a1fa", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006132", "medicine_name": "Wezenla", "medicine_slug": "wezenla", "observed_at": "2026-10-12T13:33:41Z", "pipeline_version": "2.0.0", "presentation_label": "WEZENLA 130 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": "d63fed33f96ccb747354bdd140e7ab8ff082b8871d5bc4a447e3b85b09c23b43", "source_snapshot_id": "source-5f59e83e3e217d7dc0e9cce4", "source_updated_at": "2026-07-01", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/wezenla-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 532}
{"after": {"end": 467, "start": 0, "text": "Au total, 32 enfants et adolescents (8 enfants âgés de 2 à 11 ans et 24 adolescents âgés de 12 à 17 ans) atteints d’AOH ont été traités par l’icatibant au cours des études cliniques. Trente et un patients ont reçu une dose unique d’icatibant et un patient (un adolescent) a reçu l’icatibant pour deux crises d’AOH (deux doses au total). Icatibant était administré en injection sous-cutanée à la dose de 0,4 mg/kg de poids corporel, jusqu’à une dose maximale de 30 mg.", "truncated": false}, "after_length": 467, "after_sha256": "65996ebd9146ffad604f4b9e3954caa8adbac17dc9af058458a60d680e84c651", "annex": "I", "before": {"end": 467, "start": 0, "text": "Au total, 32 enfants et adolescents (8 enfants âgés de 2 à 11 ans et 24 adolescents âgés de 12 à 17 ans) atteints d’AOH ont été traités par l’icatibant au cours des études cliniques. Trente et un patients ont reçu une dose unique d’icatibant et un patient (un adolescent) a reçu l’icatibant pour deux crises d’AOH (deux doses au total). Icatibant était administré en injection sous-cutanée à la dose de 0,4 mg/kg de poids corporel, jusqu’à une dose maximale de 30 mg.", "truncated": false}, "before_length": 467, "before_sha256": "65996ebd9146ffad604f4b9e3954caa8adbac17dc9af058458a60d680e84c651", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-052769563e95052f697af749", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005083", "medicine_name": "Icatibant Accord", "medicine_slug": "icatibant-accord", "observed_at": "2026-10-12T19:15:36Z", "pipeline_version": "2.0.0", "presentation_label": "Icatibant Accord 30 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": "e4637cbeed8a956ecec8a1d24e94e8dde692b1ee7a85e801838f6b55b52fe17f", "source_snapshot_id": "source-3928189033effb8c51e260d8", "source_updated_at": "2025-08-27", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/icatibant-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": 238}
{"after": {"end": 760, "start": 0, "text": "A trial of 145 patients from birth to < 2 years of age investigated the safety and efficacy of sugammadex versus neostigmine as a reversal agent for neuromuscular blockade induced by rocuronium or vecuronium. Time to neuromuscular recovery from moderate block was significantly faster (p = 0.0002) in participants dosed with sugammadex 2 mg/kg compared with neostigmine (median of 1.4 minutes for sugammadex 2 mg/kg and 4.4 minutes for neostigmine; hazard ratio= 2.40, 95% CI: 1.37, 4.18). Sugammadex 4 mg/kg achieved rapid neuromuscular recovery from deep block with a median of 1.1 minutes. These effects were consistent for all age cohorts studied (birth to 27 days; 28 days to < 3 months; 3 months to < 6 months and 6 months to < 2 years). See section 4.2.", "truncated": false}, "after_length": 760, "after_sha256": "fc825f1dfd16344734bc2f7eda0c68c457c7c567c77bb6958181adf2890a73f1", "annex": "I", "before": {"end": 760, "start": 0, "text": "A trial of 145 patients from birth to < 2 years of age investigated the safety and efficacy of sugammadex versus neostigmine as a reversal agent for neuromuscular blockade induced by rocuronium or vecuronium. Time to neuromuscular recovery from moderate block was significantly faster (p = 0.0002) in participants dosed with sugammadex 2 mg/kg compared with neostigmine (median of 1.4 minutes for sugammadex 2 mg/kg and 4.4 minutes for neostigmine; hazard ratio= 2.40, 95% CI: 1.37, 4.18). Sugammadex 4 mg/kg achieved rapid neuromuscular recovery from deep block with a median of 1.1 minutes. These effects were consistent for all age cohorts studied (birth to 27 days; 28 days to < 3 months; 3 months to < 6 months and 6 months to < 2 years). See section 4.2.", "truncated": false}, "before_length": 760, "before_sha256": "fc825f1dfd16344734bc2f7eda0c68c457c7c567c77bb6958181adf2890a73f1", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-05281d03c718dba2742a3cef", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005935", "medicine_name": "Sugammadex Amomed", "medicine_slug": "sugammadex-amomed", "observed_at": "2026-10-12T19:02:23Z", "pipeline_version": "2.0.0", "presentation_label": "Sugammadex Amomed 100 mg/ml 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": "943c70dddd097ee185a75ee1a225ccc92223423f733612478da8f4be33f3295a", "source_snapshot_id": "source-4456be6b996cfeb28427785f", "source_updated_at": "2026-02-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/sugammadex-amomed-epar-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": 52, "start": 0, "text": "* Bemrist Breezhaler, dose faible : 125/62,5 mcg od.", "truncated": false}, "after_length": 52, "after_sha256": "a42e9d744392368d4438dda61c597d332e481dffd5880b5c40a874d16eec467d", "annex": "I", "before": {"end": 52, "start": 0, "text": "* Bemrist Breezhaler, dose faible : 125/62,5 mcg od.", "truncated": false}, "before_length": 52, "before_sha256": "a42e9d744392368d4438dda61c597d332e481dffd5880b5c40a874d16eec467d", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0529b51d98e8b0ad9a868562", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005516", "medicine_name": "Bemrist Breezhaler", "medicine_slug": "bemrist-breezhaler", "observed_at": "2026-10-12T19:06:19Z", "pipeline_version": "2.0.0", "presentation_label": "Bemrist Breezhaler 125 microgrammes/62,5 microgrammes poudre pour inhalation en gélules Bemrist Breezhaler 125 microgrammes/127,5 microgrammes poudre pour inhalation en gélules Bemrist Breezhaler 125 microgrammes/260 microgrammes poudre pour inhalation en 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": "5f0012a578cd881ab97415e33afca4a210635c0e983f8e71e80bae88a39cb6ae", "source_snapshot_id": "source-cf28c695dfc5d2d050f95285", "source_updated_at": "2025-10-07", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/bemrist-breezhaler-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 616}
{"after": {"end": 375, "start": 0, "text": "Aucune étude n’a été conduite chez l’animal pour établir le potentiel cancérogène de l’amivantamab. Les études de génotoxicité et de cancérogénicité de routine ne sont généralement pas applicables aux médicaments biologiques car les protéines de grande taille ne peuvent pas diffuser dans les cellules et ne peuvent pas interagir avec l’ADN ni avec le matériel chromosomique.", "truncated": false}, "after_length": 375, "after_sha256": "9a47138f98ce981e508a10afa8b90d5694c3acaf9537688a0f7cf1ff307639c2", "annex": "I", "before": {"end": 375, "start": 0, "text": "Aucune étude n’a été conduite chez l’animal pour établir le potentiel cancérogène de l’amivantamab. Les études de génotoxicité et de cancérogénicité de routine ne sont généralement pas applicables aux médicaments biologiques car les protéines de grande taille ne peuvent pas diffuser dans les cellules et ne peuvent pas interagir avec l’ADN ni avec le matériel chromosomique.", "truncated": false}, "before_length": 375, "before_sha256": "9a47138f98ce981e508a10afa8b90d5694c3acaf9537688a0f7cf1ff307639c2", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-05324b616b3a48bdcc955d5a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005454", "medicine_name": "Rybrevant", "medicine_slug": "rybrevant", "observed_at": "2026-10-12T19:04:15Z", "pipeline_version": "2.0.0", "presentation_label": "Rybrevant 1 600 mg solution injectable Rybrevant 2 240 mg 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": "5.3", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "3ef9bd56fbe6c15ccababe40c1535aea96b8b8199d25d4af26558d1c455a58dd", "source_snapshot_id": "source-1d08df56b69f3a568c16d538", "source_updated_at": "2025-10-29", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/rybrevant-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2259}
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{"after": {"end": 828, "start": 0, "text": "Dans une étude menée chez 188 patients, diagnostiqués comme présentant une obésité morbide, le temps de récupération après un bloc neuromusculaire modéré ou profond induit par rocuronium ou vécuronium a été évalué. Dans cette étude randomisée en double insu, les patients ont reçu, en fonction du niveau de bloc neuromusculaire, 2 mg/kg ou 4 mg/kg de sugammadex ; la dose a été calculée en fonction du poids corporel réel ou du poids corporel idéal. Regroupé par profondeur du bloc et par curare, le délai médian pour revenir à un rapport train de quatre (TOF) ≥ 0,9 a été statistiquement significativement plus court (p < 0,0001) chez les patients ayant reçu une dose calculée en fonction du poids corporel réel (1,8 minutes) que chez les patients ayant reçu une dose calculée en fonction du poids corporel idéal (3,3 minutes).", "truncated": false}, "after_length": 828, "after_sha256": "1cdec5128ee5c20ea69d1c9a11864d41c7658920eb565b8a6f355f9d835a6772", "annex": "I", "before": {"end": 828, "start": 0, "text": "Dans une étude menée chez 188 patients, diagnostiqués comme présentant une obésité morbide, le temps de récupération après un bloc neuromusculaire modéré ou profond induit par rocuronium ou vécuronium a été évalué. Dans cette étude randomisée en double insu, les patients ont reçu, en fonction du niveau de bloc neuromusculaire, 2 mg/kg ou 4 mg/kg de sugammadex ; la dose a été calculée en fonction du poids corporel réel ou du poids corporel idéal. Regroupé par profondeur du bloc et par curare, le délai médian pour revenir à un rapport train de quatre (TOF) ≥ 0,9 a été statistiquement significativement plus court (p < 0,0001) chez les patients ayant reçu une dose calculée en fonction du poids corporel réel (1,8 minutes) que chez les patients ayant reçu une dose calculée en fonction du poids corporel idéal (3,3 minutes).", "truncated": false}, "before_length": 828, "before_sha256": "1cdec5128ee5c20ea69d1c9a11864d41c7658920eb565b8a6f355f9d835a6772", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-05862cda09b7682f14905112", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005935", "medicine_name": "Sugammadex Amomed", "medicine_slug": "sugammadex-amomed", "observed_at": "2026-10-12T19:02:25Z", "pipeline_version": "2.0.0", "presentation_label": "Sugammadex Amomed 100 mg/mL, 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": "ae645c25161b6a41ea1078df5adc6903473670747f6e918de1e9cf3271e56a85", "source_snapshot_id": "source-7e9edf5440112867feba4dfd", "source_updated_at": "2026-02-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/sugammadex-amomed-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 483}
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{"after": {"end": 1014, "start": 0, "text": "The Phase III portion of BRAVEAA1 study and the Phase III BRAVEAA2 study included 1 200 adult patients. Across all treatment groups, the mean age was 37.5 years, 61 % of patients were female. The mean duration of alopecia areata from onset and the mean duration of current episode of hair loss were 12.2 and 3.9 years, respectively. The median SALT score across the studies was 96 (this equals 96 % scalp hair loss), and approximately 44 % of patients were reported as alopecia universalis. Across the studies, 69 % of patients had significant or complete eyebrow hair loss at baseline and 58 % had significant or complete eyelash hair loss, as measured by ClinRO Measures for eyebrow and eyelash scores of 2 or 3. Approximately 90 % of patients had received at least one treatment for alopecia areata at some point before entering the studies, and 50 % at least one systemic immunosuppressant. The use of authorised concomitant alopecia areata treatments was reported by only 4.3 % of patients during the studies.", "truncated": false}, "after_length": 1014, "after_sha256": "ef7fcb7bb2b800f6b5b53cc6779ffc77207727ea45f41cddb196f88ad98c3d7e", "annex": "I", "before": {"end": 1014, "start": 0, "text": "The Phase III portion of BRAVEAA1 study and the Phase III BRAVEAA2 study included 1 200 adult patients. Across all treatment groups, the mean age was 37.5 years, 61 % of patients were female. The mean duration of alopecia areata from onset and the mean duration of current episode of hair loss were 12.2 and 3.9 years, respectively. The median SALT score across the studies was 96 (this equals 96 % scalp hair loss), and approximately 44 % of patients were reported as alopecia universalis. Across the studies, 69 % of patients had significant or complete eyebrow hair loss at baseline and 58 % had significant or complete eyelash hair loss, as measured by ClinRO Measures for eyebrow and eyelash scores of 2 or 3. Approximately 90 % of patients had received at least one treatment for alopecia areata at some point before entering the studies, and 50 % at least one systemic immunosuppressant. The use of authorised concomitant alopecia areata treatments was reported by only 4.3 % of patients during the studies.", "truncated": false}, "before_length": 1014, "before_sha256": "ef7fcb7bb2b800f6b5b53cc6779ffc77207727ea45f41cddb196f88ad98c3d7e", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0594eeb782eabffc543e232d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004085", "medicine_name": "Olumiant", "medicine_slug": "olumiant", "observed_at": "2026-10-12T17:27:24Z", "pipeline_version": "2.0.0", "presentation_label": "Olumiant 1 mg film-coated tablets Olumiant 2 mg filmcoated tablets Olumiant 4 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": "b4ca079a8e59619a86bb4d5c48f047c56c3216b31a07e1e31daf02679a924865", "source_snapshot_id": "source-ce77e606b3e62d5f6fef575d", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/olumiant-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1300}
{"after": {"end": 91, "start": 0, "text": "Detailed results from the analysis of both studies are shown in Table 3 and Figure 2 below.", "truncated": false}, "after_length": 91, "after_sha256": "c6cb519ba05098e0e8299b8696f9fe57c2653a911347e52d868c616654c070ff", "annex": "I", "before": {"end": 91, "start": 0, "text": "Detailed results from the analysis of both studies are shown in Table 3 and Figure 2 below.", "truncated": false}, "before_length": 91, "before_sha256": "c6cb519ba05098e0e8299b8696f9fe57c2653a911347e52d868c616654c070ff", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-059744f66333cb12fa4e8dea", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006056", "medicine_name": "Opuviz", "medicine_slug": "opuviz", "observed_at": "2026-10-12T17:26:18Z", "pipeline_version": "2.0.0", "presentation_label": "Opuviz 40 mg/mL solution for injection in a vial.", "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": "2c2be666a9b04d0af84a1d378a2c46c81f50e575f3332cae8a7fd3bd6e77ff36", "source_snapshot_id": "source-9602626838996ff4c1707059", "source_updated_at": "2026-01-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/opuviz-epar-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": 512, "start": 0, "text": "L’utilisation concomitante de dasatinib et d’un antihistaminique-H2 (exemple : famotidine), d’un inhibiteur de pompe à protons (exemple : oméprazole) ou d’hydroxyde d’aluminium/hydroxyde de magnésium peut réduire l’exposition au dasatinib. Les antihistaminiques H2 et les inhibiteurs de pompe à protons ne sont pas recommandés. Les produits à base d’hydroxyde d’aluminium et/ou d’hydroxyde de magnésium doivent être administrés au moins 2 heures avant ou 2 heures après la prise de dasatinib (voir rubrique 4.5).", "truncated": false}, "after_length": 512, "after_sha256": "37b1323aa6b1e81542c4a95b8373320e0c0443e0dd5b684c0c2c41034f57b1fb", "annex": "I", "before": {"end": 512, "start": 0, "text": "L’utilisation concomitante de dasatinib et d’un antihistaminique-H2 (exemple : famotidine), d’un inhibiteur de pompe à protons (exemple : oméprazole) ou d’hydroxyde d’aluminium/hydroxyde de magnésium peut réduire l’exposition au dasatinib. Les antihistaminiques H2 et les inhibiteurs de pompe à protons ne sont pas recommandés. Les produits à base d’hydroxyde d’aluminium et/ou d’hydroxyde de magnésium doivent être administrés au moins 2 heures avant ou 2 heures après la prise de dasatinib (voir rubrique 4.5).", "truncated": false}, "before_length": 512, "before_sha256": "37b1323aa6b1e81542c4a95b8373320e0c0443e0dd5b684c0c2c41034f57b1fb", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-059cfd0f257a5670b33965a7", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006251", "medicine_name": "Dasatinib Accord Healthcare", "medicine_slug": "dasatinib-accord-healthcare", "observed_at": "2026-10-12T19:02:16Z", "pipeline_version": "2.0.0", "presentation_label": "Dasatinib Accord Healthcare 20 mg comprimés pelliculés Dasatinib Accord Healthcare 50 mg comprimés pelliculés Dasatinib Accord Healthcare 70 mg comprimés pelliculés Dasatinib Accord Healthcare 80 mg comprimés pelliculés Dasatinib Accord Healthcare 100 mg comprimés pelliculés Dasatinib Accord Healthc", "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": "eca8ba22f8dd4eba48fe7a21980c67d7ba9a4ed58ecce51bd42baf8fc0b3bb92", "source_snapshot_id": "source-ea5c43e2783a68c84a69e47d", "source_updated_at": "2026-02-05", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/dasatinib-accord-healthcare-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 281}
{"after": {"end": 165, "start": 0, "text": "Classe pharmacothérapeutique : antiviraux à usage systémique ; antiviraux pour le traitement de l’infection par le VIH, association de substances. Code ATC : J05AR15", "truncated": false}, "after_length": 165, "after_sha256": "aa15fdb9c388a159b9b2cd171d3d9524c70dc4eb246598c9b5904cb026918f5a", "annex": "I", "before": {"end": 165, "start": 0, "text": "Classe pharmacothérapeutique : antiviraux à usage systémique ; antiviraux pour le traitement de l’infection par le VIH, association de substances. Code ATC : J05AR15", "truncated": false}, "before_length": 165, "before_sha256": "aa15fdb9c388a159b9b2cd171d3d9524c70dc4eb246598c9b5904cb026918f5a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-05a20b8af075648e270771f2", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003904", "medicine_name": "Evotaz", "medicine_slug": "evotaz", "observed_at": "2026-10-12T19:30:04Z", "pipeline_version": "2.0.0", "presentation_label": "EVOTAZ 300 mg/150 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": "1aa5801b5983595d59ac5834392591fabad217600cd1f35ffe8622c2f2623e51", "source_snapshot_id": "source-b2fe72bcd921651203a0ff2e", "source_updated_at": "2025-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/evotaz-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1188}
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{"after": {"end": 1481, "start": 0, "text": "Over the entire study period of 12 weeks, the percentage of patients discontinuing treatment due to any reason was statistically significantly lower in patients initially receiving roflumilast 250 micrograms once a day for 4 weeks followed by roflumilast 500 micrograms once a day for 8 weeks (18.4%) compared to those receiving roflumilast 500 micrograms once a day for 12 weeks (24.6%; Odds Ratio 0.66, 95% CI [0.47, 0.93], p=0.017). The discontinuation rate for those receiving 500 micrograms every other day for 4 weeks followed by 500 micrograms once a day for 8 weeks was not statistically significantly different to those receiving 500 micrograms once a day for 12 weeks. The percentage of patients experiencing a Treatment Emergent Adverse Event (TEAE) of interest, defined as diarrhoea, nausea, headache, decreased appetite, insomnia, and abdominal pain (secondary endpoint), was nominally statistically significantly lower in patients initially receiving roflumilast 250 micrograms once a day for 4 weeks followed by roflumilast 500 micrograms once a day for 8 weeks (45.4%) compared to those receiving roflumilast 500 micrograms once a day for 12 weeks (54.2%, Odds Ratio 0.63, 95% CI [0.47, 0.83], p=0.001). The rate of experiencing a TEAE of interest for those receiving 500 micrograms every other day for 4 weeks followed by 500 micrograms once a day for 8 weeks was not statistically significantly different to those receiving 500 micrograms once a day for 12 weeks.", "truncated": false}, "after_length": 1481, "after_sha256": "4fb1f906781a157f182f83dec27ab46d4a88e8d9aa7bd16542ddb795d61404f7", "annex": "I", "before": {"end": 1481, "start": 0, "text": "Over the entire study period of 12 weeks, the percentage of patients discontinuing treatment due to any reason was statistically significantly lower in patients initially receiving roflumilast 250 micrograms once a day for 4 weeks followed by roflumilast 500 micrograms once a day for 8 weeks (18.4%) compared to those receiving roflumilast 500 micrograms once a day for 12 weeks (24.6%; Odds Ratio 0.66, 95% CI [0.47, 0.93], p=0.017). The discontinuation rate for those receiving 500 micrograms every other day for 4 weeks followed by 500 micrograms once a day for 8 weeks was not statistically significantly different to those receiving 500 micrograms once a day for 12 weeks. The percentage of patients experiencing a Treatment Emergent Adverse Event (TEAE) of interest, defined as diarrhoea, nausea, headache, decreased appetite, insomnia, and abdominal pain (secondary endpoint), was nominally statistically significantly lower in patients initially receiving roflumilast 250 micrograms once a day for 4 weeks followed by roflumilast 500 micrograms once a day for 8 weeks (45.4%) compared to those receiving roflumilast 500 micrograms once a day for 12 weeks (54.2%, Odds Ratio 0.63, 95% CI [0.47, 0.83], p=0.001). The rate of experiencing a TEAE of interest for those receiving 500 micrograms every other day for 4 weeks followed by 500 micrograms once a day for 8 weeks was not statistically significantly different to those receiving 500 micrograms once a day for 12 weeks.", "truncated": false}, "before_length": 1481, "before_sha256": "4fb1f906781a157f182f83dec27ab46d4a88e8d9aa7bd16542ddb795d61404f7", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-066c2d97d296a27e797e2c81", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001179", "medicine_name": "Daxas", "medicine_slug": "daxas", "observed_at": "2026-10-12T19:06:09Z", "pipeline_version": "2.0.0", "presentation_label": "Daxas 250 micrograms 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": "5a46f173703a8685205dd61d80eb3f1ec4682dddeec32928c7ecab73f8f7da95", "source_snapshot_id": "source-c4e1e345673be2109418f4dc", "source_updated_at": "2025-10-07", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/daxas-epar-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}
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{"after": {"end": 441, "start": 0, "text": "Les données pharmacodynamiques/toxicologiques disponibles chez l'animal ont mis en évidence l'excrétion de l'idébénone dans le lait (voir rubrique 5.3). Un risque pour l'enfant allaité ne peut être exclu. Une décision doit être prise soit d'interrompre l'allaitement soit d'interrompre/ de s’abstenir du traitement avec Raxone en prenant en compte le bénéfice de l'allaitement pour l'enfant au regard du bénéfice du traitement pour la femme.", "truncated": false}, "after_length": 441, "after_sha256": "65e29e2e1444426cd40fca9a51c0e0e89744d599e6f108c9425e056f7fd21ac0", "annex": "I", "before": {"end": 441, "start": 0, "text": "Les données pharmacodynamiques/toxicologiques disponibles chez l'animal ont mis en évidence l'excrétion de l'idébénone dans le lait (voir rubrique 5.3). Un risque pour l'enfant allaité ne peut être exclu. Une décision doit être prise soit d'interrompre l'allaitement soit d'interrompre/ de s’abstenir du traitement avec Raxone en prenant en compte le bénéfice de l'allaitement pour l'enfant au regard du bénéfice du traitement pour la femme.", "truncated": false}, "before_length": 441, "before_sha256": "65e29e2e1444426cd40fca9a51c0e0e89744d599e6f108c9425e056f7fd21ac0", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-069783d7c9a8fe38f689bbc4", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003834", "medicine_name": "Raxone", "medicine_slug": "raxone", "observed_at": "2026-10-12T19:16:11Z", "pipeline_version": "2.0.0", "presentation_label": "Raxone 150 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": "3c9106f28c895cd4529e4e66d50ab94bd3fc5a59a122fe743109596f56a68266", "source_snapshot_id": "source-d44fd57709b8f42bd1785b41", "source_updated_at": "2025-08-20", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/raxone-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 130}
{"after": {"end": 636, "start": 0, "text": "Le critère principal était la proportion de patients qui atteignaient un score PGA blanchi (0) ou minimal (1) à la semaine 12. Les critères secondaires incluaient les réponses PASI 75 et PASI 90, la variation par rapport à l’inclusion du score CDLQI (Children’s Dermatology Life Quality Index) et la variation par rapport à l’inclusion du score total PedsQL (Paediatric Quality of Life Inventory), à la semaine 12. À la semaine 12, les sujets traités par ustekinumab présentaient une amélioration significativement supérieure de leur psoriasis et de leur qualité de vie comparativement aux sujets ayant reçu un placebo (voir tableau 7).", "truncated": false}, "after_length": 636, "after_sha256": "e14767166a0acd431e73cfbccc3e4f5d990d8caa7251681725017db07a8898f6", "annex": "I", "before": {"end": 636, "start": 0, "text": "Le critère principal était la proportion de patients qui atteignaient un score PGA blanchi (0) ou minimal (1) à la semaine 12. Les critères secondaires incluaient les réponses PASI 75 et PASI 90, la variation par rapport à l’inclusion du score CDLQI (Children’s Dermatology Life Quality Index) et la variation par rapport à l’inclusion du score total PedsQL (Paediatric Quality of Life Inventory), à la semaine 12. À la semaine 12, les sujets traités par ustekinumab présentaient une amélioration significativement supérieure de leur psoriasis et de leur qualité de vie comparativement aux sujets ayant reçu un placebo (voir tableau 7).", "truncated": false}, "before_length": 636, "before_sha256": "e14767166a0acd431e73cfbccc3e4f5d990d8caa7251681725017db07a8898f6", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-06a11838974b3e83a2fc26bf", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006132", "medicine_name": "Wezenla", "medicine_slug": "wezenla", "observed_at": "2026-10-12T13:33:47Z", "pipeline_version": "2.0.0", "presentation_label": "WEZENLA 45 mg solution injectable WEZENLA 45 mg solution injectable en seringue préremplie WEZENLA 90 mg solution injectable en seringue préremplie", "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": "98ed3f6ec1b7b67abb7889752d3ad5436b80b4d025384c0cf0266ec36ca6e462", "source_snapshot_id": "source-8dfd14917c0bce8a02f32447", "source_updated_at": "2026-07-01", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/wezenla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1659}
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{"after": {"end": 370, "start": 0, "text": "Serious hypersensitivity reactions, including anaphylaxis have been reported in association with vemurafenib (see sections 4.3 and 4.8). Severe hypersensitivity reactions may include StevensJohnson syndrome, generalised rash, erythema or hypotension. In patients who experience severe hypersensitivity reactions, vemurafenib treatment should be permanently discontinued.", "truncated": false}, "after_length": 370, "after_sha256": "03c10440b19ff2f43f3db0ea5226a13ab231acb68e2a5a0d9143f9faf960251f", "annex": "I", "before": {"end": 370, "start": 0, "text": "Serious hypersensitivity reactions, including anaphylaxis have been reported in association with vemurafenib (see sections 4.3 and 4.8). Severe hypersensitivity reactions may include StevensJohnson syndrome, generalised rash, erythema or hypotension. In patients who experience severe hypersensitivity reactions, vemurafenib treatment should be permanently discontinued.", "truncated": false}, "before_length": 370, "before_sha256": "03c10440b19ff2f43f3db0ea5226a13ab231acb68e2a5a0d9143f9faf960251f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-06d2d515e6ad5f0724beb207", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002409", "medicine_name": "Zelboraf", "medicine_slug": "zelboraf", "observed_at": "2026-10-12T19:30:58Z", "pipeline_version": "2.0.0", "presentation_label": "Zelboraf 240 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": "d2c1ed89892b30b6f19c5fc01ea5297bc80b99c29d18597350ba0b58af7a4868", "source_snapshot_id": "source-1c63d4f729cc3118fafd2887", "source_updated_at": "2025-06-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/zelboraf-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 147}
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{"after": {"end": 908, "start": 0, "text": "Des études toxicologiques après administration répétées ont identifié le foie et la moelle osseuse comme les organes cibles chez le chien. Des effets toxiques hépatiques réversibles (nécrose et dégénérescence hépatocellulaires) ont été notés à des expositions inférieures à l’exposition clinique prévue (sur la base de la comparaison des AUC) lors de l’étude de 13 semaines chez le chien. Une nécrose focale de la moelle osseuse a été observée chez un chien lors d’une étude prématurément arrêtée d’un traitement de 39 semaines à raison de deux administrations par jour à des expositions similaires à l’exposition clinique prévue (sur la base de la comparaison des AUC). Dans une étude in vitro sur la cytotoxicité de la moelle osseuse, une légère cytotoxicité a été observée dans des populations de cellules lympho-hématopoiétiques de rat, de chien et humaines à des concentrations cliniquement pertinentes.", "truncated": false}, "after_length": 908, "after_sha256": "c8786eea44dd6c66926510d0ebaf6409c68a30480ae182ae74f0b6a303fc444f", "annex": "I", "before": {"end": 908, "start": 0, "text": "Des études toxicologiques après administration répétées ont identifié le foie et la moelle osseuse comme les organes cibles chez le chien. Des effets toxiques hépatiques réversibles (nécrose et dégénérescence hépatocellulaires) ont été notés à des expositions inférieures à l’exposition clinique prévue (sur la base de la comparaison des AUC) lors de l’étude de 13 semaines chez le chien. Une nécrose focale de la moelle osseuse a été observée chez un chien lors d’une étude prématurément arrêtée d’un traitement de 39 semaines à raison de deux administrations par jour à des expositions similaires à l’exposition clinique prévue (sur la base de la comparaison des AUC). Dans une étude in vitro sur la cytotoxicité de la moelle osseuse, une légère cytotoxicité a été observée dans des populations de cellules lympho-hématopoiétiques de rat, de chien et humaines à des concentrations cliniquement pertinentes.", "truncated": false}, "before_length": 908, "before_sha256": "c8786eea44dd6c66926510d0ebaf6409c68a30480ae182ae74f0b6a303fc444f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-06ec9c7815cb30d2e42c7bb6", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002409", "medicine_name": "Zelboraf", "medicine_slug": "zelboraf", "observed_at": "2026-10-12T19:31:02Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.3", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8a568de35f474060aade2baa4979d413864e5051a9a473f5aead5174400e6da4", "source_snapshot_id": "source-39ee8bf457d439dc02096a2b", "source_updated_at": "2025-06-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/zelboraf-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 925}
{"after": {"end": 237, "start": 0, "text": "Les effets indésirables les plus fréquemment rapportés durant les études cliniques contrôlées versus placebo étaient l’akathisie et les nausées, chacun apparaissant chez plus de 3% des patients traités avec l’aripiprazole par voie orale.", "truncated": false}, "after_length": 237, "after_sha256": "e027f73033ad97e1d50c197874092dd2570edd93603dde1e7b10eb4d6abd27ce", "annex": "I", "before": {"end": 237, "start": 0, "text": "Les effets indésirables les plus fréquemment rapportés durant les études cliniques contrôlées versus placebo étaient l’akathisie et les nausées, chacun apparaissant chez plus de 3% des patients traités avec l’aripiprazole par voie orale.", "truncated": false}, "before_length": 237, "before_sha256": "e027f73033ad97e1d50c197874092dd2570edd93603dde1e7b10eb4d6abd27ce", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-06ee54ab03e4858c8c925e05", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004008", "medicine_name": "Aripiprazole Sandoz", "medicine_slug": "aripiprazole-sandoz", "observed_at": "2026-10-12T13:40:26Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "e22ec2e1091ba644789161695b2abedce706b1188f584dcce10bbbc43adf986a", "source_snapshot_id": "source-0a9efa4639b121b1b78dabf2", "source_updated_at": "2026-04-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/aripiprazole-sandoz-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 288}
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{"after": {"end": 312, "start": 0, "text": "b ORR and DOR results by investigator assessment were consistent with those reported by BICR assessment; ORR by BICR assessment was 43% (34%, 53%), with a 3% CR rate and a 40% PR rate, median DOR by BICR assessment was 10.8 months (95% CI: 6.9, 15.0), and patients with DOR ≥ 6 months by BICR assessment was 55%.", "truncated": false}, "after_length": 312, "after_sha256": "6233f1be1ea5d39ddd5e95c477d3b2171fe5516fbb5b4eff31c653ac14e296a9", "annex": "I", "before": {"end": 312, "start": 0, "text": "b ORR and DOR results by investigator assessment were consistent with those reported by BICR assessment; ORR by BICR assessment was 43% (34%, 53%), with a 3% CR rate and a 40% PR rate, median DOR by BICR assessment was 10.8 months (95% CI: 6.9, 15.0), and patients with DOR ≥ 6 months by BICR assessment was 55%.", "truncated": false}, "before_length": 312, "before_sha256": "6233f1be1ea5d39ddd5e95c477d3b2171fe5516fbb5b4eff31c653ac14e296a9", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-07804a00637c23138eaf4f12", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005454", "medicine_name": "Rybrevant", "medicine_slug": "rybrevant", "observed_at": "2026-10-12T19:04:12Z", "pipeline_version": "2.0.0", "presentation_label": "Rybrevant 1600 mg solution for injection Rybrevant 2240 mg 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": "9aa934a48518b69f018f71c82168012a9f9d72adc1ba01912c663610d73a23fb", "source_snapshot_id": "source-f17f3851e8eda9452c21fbe7", "source_updated_at": "2025-10-29", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/rybrevant-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2187}
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{"after": {"end": 750, "start": 0, "text": "Des cas de diverticulite et de perforation gastro-intestinale ont été rapportés lors des études cliniques et dans les données issues de la pharmacovigilance (voir rubrique 4.8). Le baricitinib doit être utilisé avec prudence chez les patients atteints d’une affection diverticulaire, et tout particulièrement chez les patients traités de façon chronique par des médicaments concomitants qui sont associés à un risque accru de diverticulite : médicaments anti-inflammatoires non stéroïdiens, corticostéroïdes et opioïdes. Les patients présentant une nouvelle apparition de signes et symptômes abdominaux doivent faire l’objet d’une évaluation rapide de façon à pouvoir poser un diagnostic précoce de diverticulite ou de perforation gastro-intestinale.", "truncated": false}, "after_length": 750, "after_sha256": "f5e15691d0191cb0d382bf77041b84f5fbeda1d805b8de5113213fcab8e872ef", "annex": "I", "before": {"end": 750, "start": 0, "text": "Des cas de diverticulite et de perforation gastro-intestinale ont été rapportés lors des études cliniques et dans les données issues de la pharmacovigilance (voir rubrique 4.8). Le baricitinib doit être utilisé avec prudence chez les patients atteints d’une affection diverticulaire, et tout particulièrement chez les patients traités de façon chronique par des médicaments concomitants qui sont associés à un risque accru de diverticulite : médicaments anti-inflammatoires non stéroïdiens, corticostéroïdes et opioïdes. Les patients présentant une nouvelle apparition de signes et symptômes abdominaux doivent faire l’objet d’une évaluation rapide de façon à pouvoir poser un diagnostic précoce de diverticulite ou de perforation gastro-intestinale.", "truncated": false}, "before_length": 750, "before_sha256": "f5e15691d0191cb0d382bf77041b84f5fbeda1d805b8de5113213fcab8e872ef", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-08aaea42da4b7598a3e97257", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004085", "medicine_name": "Olumiant", "medicine_slug": "olumiant", "observed_at": "2026-10-12T17:27:28Z", "pipeline_version": "2.0.0", "presentation_label": "Olumiant 1 mg comprimés pelliculés Olumiant 2 mg comprimés pelliculés Olumiant 4 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": "9049552843769a05b49a25684fff9b60d7f008e41b645e511bc2f49211970f77", "source_snapshot_id": "source-cd4d5cdd1491321c9fafe27b", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/olumiant-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 304}
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{"after": {"end": 427, "start": 0, "text": "No formal drug-drug interaction studies have been performed with cetrorelix. In vitro investigations have shown that interactions are unlikely with medicinal products that are metabolised by cytochrome P450 or glucuronised or conjugated in some other way. However, the possibility of interactions with gonadotropins or medicinal products that may induce histamine release in susceptible individuals, cannot be totally excluded.", "truncated": false}, "after_length": 427, "after_sha256": "179cbc83a2676dbb96de7fba10eb9d2c234569de1955ece7275f2c07c5a27e27", "annex": "I", "before": {"end": 427, "start": 0, "text": "No formal drug-drug interaction studies have been performed with cetrorelix. In vitro investigations have shown that interactions are unlikely with medicinal products that are metabolised by cytochrome P450 or glucuronised or conjugated in some other way. However, the possibility of interactions with gonadotropins or medicinal products that may induce histamine release in susceptible individuals, cannot be totally excluded.", "truncated": false}, "before_length": 427, "before_sha256": "179cbc83a2676dbb96de7fba10eb9d2c234569de1955ece7275f2c07c5a27e27", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-08ec1912cc54905fdb3d3a80", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000233", "medicine_name": "Cetrotide", "medicine_slug": "cetrotide", "observed_at": "2026-10-12T17:27:47Z", "pipeline_version": "2.0.0", "presentation_label": "Cetrotide 0.25 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": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "5d18abdd764867aa439779cae36dd92d76d95af5e69b1bf04f0ec3a40fa10ee1", "source_snapshot_id": "source-9d1f1e17c888e8c5e5b171c3", "source_updated_at": "2025-12-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/cetrotide-epar-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": 89, "start": 0, "text": "Aucune donnée n’est disponible pour documenter les effets sur la fertilité chez l’humain.", "truncated": false}, "after_length": 89, "after_sha256": "6f6497526eb6427036a979b8778e2ac43dd8ed2ad23ddebdb1cab32b100d691f", "annex": "I", "before": {"end": 89, "start": 0, "text": "Aucune donnée n’est disponible pour documenter les effets sur la fertilité chez l’humain.", "truncated": false}, "before_length": 89, "before_sha256": "6f6497526eb6427036a979b8778e2ac43dd8ed2ad23ddebdb1cab32b100d691f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-08ec230da6ec5fe046bbbb9b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000313", "medicine_name": "Aerius", "medicine_slug": "aerius", "observed_at": "2026-10-12T13:47:23Z", "pipeline_version": "2.0.0", "presentation_label": "Aerius 5 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": "8089714a236ecbb1faa000fb644ac965ee1e9f984f6c5143625f5e9e54bac743", "source_snapshot_id": "source-f7c26df9492b886958386672", "source_updated_at": "2026-03-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/aerius-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 111}
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{"after": {"end": 166, "start": 0, "text": "Si l’arrêt de tout traitement opioïde est nécessaire, le patient doit être surveillé de près par le médecin afin de gérer le risque d’effets liés à un sevrage brutal.", "truncated": false}, "after_length": 166, "after_sha256": "bc4720d9c15b2b36e97c3898af9c38476c3c32a2b9418fcf514fe3f48ef77a15", "annex": "I", "before": {"end": 166, "start": 0, "text": "Si l’arrêt de tout traitement opioïde est nécessaire, le patient doit être surveillé de près par le médecin afin de gérer le risque d’effets liés à un sevrage brutal.", "truncated": false}, "before_length": 166, "before_sha256": "bc4720d9c15b2b36e97c3898af9c38476c3c32a2b9418fcf514fe3f48ef77a15", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0aec9585ae5cb742d84f2ae4", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000833", "medicine_name": "Effentora", "medicine_slug": "effentora", "observed_at": "2026-10-12T17:31:19Z", "pipeline_version": "2.0.0", "presentation_label": "Effentora 100 microgrammes, comprimés buccogingivaux Effentora 200 microgrammes, comprimés buccogingivaux Effentora 400 microgrammes, comprimés buccogingivaux Effentora 600 microgrammes, comprimés buccogingivaux Effentora 800 microgrammes, comprimés buccogingivaux", "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": "749511f6aeff319ec9a05c6e648fabc7d4309775f4c125aa9cf90c2000243ff9", "source_snapshot_id": "source-b3535d23eee1e8a9a1fb5da5", "source_updated_at": "2025-11-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/effentora-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 143}
{"after": {"end": 466, "start": 0, "text": "The contents of 1 vial are to be administered once daily, at 24 h intervals, either in the morning or in the evening. Each vial contains 0.25 mg of cetrorelix; however, due to losses during reconstitution and administration, only 0.21 mg can be administered (see section 6.6). Following the first administration, it is advised that the patient be kept under medical supervision for 30 minutes to ensure there is no allergic/pseudo-allergic reaction to the injection.", "truncated": false}, "after_length": 466, "after_sha256": "be6824723506200d216b45354e8ef66431a19528b36a2f767830ff1b474c2cfd", "annex": "I", "before": {"end": 466, "start": 0, "text": "The contents of 1 vial are to be administered once daily, at 24 h intervals, either in the morning or in the evening. Each vial contains 0.25 mg of cetrorelix; however, due to losses during reconstitution and administration, only 0.21 mg can be administered (see section 6.6). Following the first administration, it is advised that the patient be kept under medical supervision for 30 minutes to ensure there is no allergic/pseudo-allergic reaction to the injection.", "truncated": false}, "before_length": 466, "before_sha256": "be6824723506200d216b45354e8ef66431a19528b36a2f767830ff1b474c2cfd", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0b03971c0db69735091e30ca", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000233", "medicine_name": "Cetrotide", "medicine_slug": "cetrotide", "observed_at": "2026-10-12T17:27:47Z", "pipeline_version": "2.0.0", "presentation_label": "Cetrotide 0.25 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": "5d18abdd764867aa439779cae36dd92d76d95af5e69b1bf04f0ec3a40fa10ee1", "source_snapshot_id": "source-9d1f1e17c888e8c5e5b171c3", "source_updated_at": "2025-12-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/cetrotide-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 67}
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{"after": {"end": 605, "start": 0, "text": "A higher incidence of weight decrease, decreased appetite, headache and depression was observed during Study RO-2455-404-RD in patients receiving concomitant roflumilast and long-acting muscarinic antagonists (LAMA) plus concomitant inhaled corticosteroids (ICS) and long acting B2 agonists (LABA) compared to those treated only with concomitant roflumilast, ICS and LABA. Difference of incidence between roflumilast and placebo was quantitatively greater with concomitant LAMA for weight decreased (7.2% vs 4.2%), decreased appetite (3.7% vs 2.0%), headache (2.4% vs 1.1%) and depression (1.4% vs -0.3%).", "truncated": false}, "after_length": 605, "after_sha256": "1b30a89249c35ec66470b7de0d11520e70aaf26e7e7ed78447e938e97fba13a2", "annex": "I", "before": {"end": 605, "start": 0, "text": "A higher incidence of weight decrease, decreased appetite, headache and depression was observed during Study RO-2455-404-RD in patients receiving concomitant roflumilast and long-acting muscarinic antagonists (LAMA) plus concomitant inhaled corticosteroids (ICS) and long acting B2 agonists (LABA) compared to those treated only with concomitant roflumilast, ICS and LABA. Difference of incidence between roflumilast and placebo was quantitatively greater with concomitant LAMA for weight decreased (7.2% vs 4.2%), decreased appetite (3.7% vs 2.0%), headache (2.4% vs 1.1%) and depression (1.4% vs -0.3%).", "truncated": false}, "before_length": 605, "before_sha256": "1b30a89249c35ec66470b7de0d11520e70aaf26e7e7ed78447e938e97fba13a2", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0ce9f5c486e44e984d651bb6", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001179", "medicine_name": "Daxas", "medicine_slug": "daxas", "observed_at": "2026-10-12T19:06:09Z", "pipeline_version": "2.0.0", "presentation_label": "Daxas 250 micrograms 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": "5a46f173703a8685205dd61d80eb3f1ec4682dddeec32928c7ecab73f8f7da95", "source_snapshot_id": "source-c4e1e345673be2109418f4dc", "source_updated_at": "2025-10-07", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/daxas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 271}
{"after": {"end": 1178, "start": 0, "text": "L'efficacité du baricitinib jusqu'à 12 mg/jour a été évaluée chez 71 patients atteints d’un syndrome de dermatose neutrophile chronique atypique lipodystrophie fièvre (CANDLE, chronic atypical neutrophilic dermatosis with lipodystrophy and elevated temperature, n=10), d’affections liées au CANDLE (CANDLE-related conditions, n=9), de vasculopathie de l’enfant associée au Stimulateur des Gènes de l'Interféron ou STING (SAVI, Stimulator of interferon gene Associated Vasculopathy with onset during Infancy, n=8), de dermatomyosite juvénile (JDM, Juvenile DermatoMyositis, n=5) et de syndrome d'Aicardi-Goutières (AGS, AicardiGoutières syndrome, n=39). L’exposition totale était de 251 patients-années. En raison d'insuffisances méthodologiques, aucune conclusion définitive sur l'efficacité du baricitinib chez ces patients n’a pu être établie. Bien que le profil de tolérance présente des similitudes avec les indications chez l'adulte, les fréquences des événements indésirables étaient généralement plus élevées. Trois décès ont été observés chez les patients atteints de syndrome d'Aicardi-Goutières ; on ne sait pas si ces décès étaient liés au traitement par baricitinib.", "truncated": false}, "after_length": 1178, "after_sha256": "a1f945cee1c96ce3bbfa57cde869b020b3199329cce306dc7f8aa86d47707daa", "annex": "I", "before": {"end": 1178, "start": 0, "text": "L'efficacité du baricitinib jusqu'à 12 mg/jour a été évaluée chez 71 patients atteints d’un syndrome de dermatose neutrophile chronique atypique lipodystrophie fièvre (CANDLE, chronic atypical neutrophilic dermatosis with lipodystrophy and elevated temperature, n=10), d’affections liées au CANDLE (CANDLE-related conditions, n=9), de vasculopathie de l’enfant associée au Stimulateur des Gènes de l'Interféron ou STING (SAVI, Stimulator of interferon gene Associated Vasculopathy with onset during Infancy, n=8), de dermatomyosite juvénile (JDM, Juvenile DermatoMyositis, n=5) et de syndrome d'Aicardi-Goutières (AGS, AicardiGoutières syndrome, n=39). L’exposition totale était de 251 patients-années. En raison d'insuffisances méthodologiques, aucune conclusion définitive sur l'efficacité du baricitinib chez ces patients n’a pu être établie. Bien que le profil de tolérance présente des similitudes avec les indications chez l'adulte, les fréquences des événements indésirables étaient généralement plus élevées. Trois décès ont été observés chez les patients atteints de syndrome d'Aicardi-Goutières ; on ne sait pas si ces décès étaient liés au traitement par baricitinib.", "truncated": false}, "before_length": 1178, "before_sha256": "a1f945cee1c96ce3bbfa57cde869b020b3199329cce306dc7f8aa86d47707daa", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0cebcb76cbf4ea22a31d2495", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004085", "medicine_name": "Olumiant", "medicine_slug": "olumiant", "observed_at": "2026-10-12T17:27:28Z", "pipeline_version": "2.0.0", "presentation_label": "Olumiant 1 mg comprimés pelliculés Olumiant 2 mg comprimés pelliculés Olumiant 4 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": "9049552843769a05b49a25684fff9b60d7f008e41b645e511bc2f49211970f77", "source_snapshot_id": "source-cd4d5cdd1491321c9fafe27b", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/olumiant-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1447}
{"after": {"end": 487, "start": 0, "text": "Une amélioration de la fonction pulmonaire était observée au bout de 4 semaines (maintenue sur 52 semaines) avec le roflumilast. Le VEMS après utilisation d’un bronchodilatateur a augmenté dans le groupe roflumilast de 52 ml (IC à 95 % : 40, 65 ml) et diminué dans le groupe placebo de 4 ml (IC à 95 % : -16, 9 ml). Une amélioration cliniquement significative du VEMS post bronchodilatateur de 56 ml était observée en faveur du roflumilast par rapport au placebo (IC à 95 % : 38, 73 ml).", "truncated": false}, "after_length": 487, "after_sha256": "9c63f0b568eeb4c39c522cf6b72cee8537b646c2851b681397bb2f0b0bea4ba9", "annex": "I", "before": {"end": 487, "start": 0, "text": "Une amélioration de la fonction pulmonaire était observée au bout de 4 semaines (maintenue sur 52 semaines) avec le roflumilast. Le VEMS après utilisation d’un bronchodilatateur a augmenté dans le groupe roflumilast de 52 ml (IC à 95 % : 40, 65 ml) et diminué dans le groupe placebo de 4 ml (IC à 95 % : -16, 9 ml). Une amélioration cliniquement significative du VEMS post bronchodilatateur de 56 ml était observée en faveur du roflumilast par rapport au placebo (IC à 95 % : 38, 73 ml).", "truncated": false}, "before_length": 487, "before_sha256": "9c63f0b568eeb4c39c522cf6b72cee8537b646c2851b681397bb2f0b0bea4ba9", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0d02b2767fb479ed912d2314", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/001179", "medicine_name": "Daxas", "medicine_slug": "daxas", "observed_at": "2026-10-12T19:06:14Z", "pipeline_version": "2.0.0", "presentation_label": "Daxas 500 microgrammes comprimés pelliculés", "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": "51573d3273887901d699c87dba7c52b81c1185180f5c00a525c68be2e058db68", "source_snapshot_id": "source-b7e818c20a738636f06f7a00", "source_updated_at": "2025-10-07", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/daxas-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 827}
{"after": {"end": 374, "start": 0, "text": "In both of these short term trials, the clinical relevance of the efficacy findings has not been established, considering the magnitude of treatment effect compared to the large placebo effect and the unclear effects regarding psycho-social functioning. No long term data are available with regard to the efficacy and the safety of aripiprazole in this fluctuating disorder.", "truncated": false}, "after_length": 374, "after_sha256": "887dc25025bf528e3b6c6a21ef29b5f8c910050274fffc3caa4988802f887ae8", "annex": "I", "before": {"end": 374, "start": 0, "text": "In both of these short term trials, the clinical relevance of the efficacy findings has not been established, considering the magnitude of treatment effect compared to the large placebo effect and the unclear effects regarding psycho-social functioning. No long term data are available with regard to the efficacy and the safety of aripiprazole in this fluctuating disorder.", "truncated": false}, "before_length": 374, "before_sha256": "887dc25025bf528e3b6c6a21ef29b5f8c910050274fffc3caa4988802f887ae8", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0d1de7dbcde8e123c0ce8e0f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004008", "medicine_name": "Aripiprazole Sandoz", "medicine_slug": "aripiprazole-sandoz", "observed_at": "2026-10-12T13:40:24Z", "pipeline_version": "2.0.0", "presentation_label": "Aripiprazole Sandoz 5 mg tablets Aripiprazole Sandoz 10 mg tablets Aripiprazole Sandoz 15 mg tablets Aripiprazole Sandoz 20 mg tablets Aripiprazole Sandoz 30 mg 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": "f37989cf0022eda124c29183d5f5f16cecbd0193cbe3f6751427982688c92a40", "source_snapshot_id": "source-f253dfba07352f7dfac1b8d5", "source_updated_at": "2026-04-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/aripiprazole-sandoz-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 593}
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{"after": {"end": 205, "start": 0, "text": "La pharmacocinétique de l'aripiprazole et du déhydro-aripiprazole chez les patients pédiatriques âgés de 10 à 17 ans était similaire à celle des adultes après correction des différences de poids corporels.", "truncated": false}, "after_length": 205, "after_sha256": "9bc7890aed497a3ec96ac02b456f5513994bd6aa19aa1aed12d230e8ec444f7c", "annex": "I", "before": {"end": 205, "start": 0, "text": "La pharmacocinétique de l'aripiprazole et du déhydro-aripiprazole chez les patients pédiatriques âgés de 10 à 17 ans était similaire à celle des adultes après correction des différences de poids corporels.", "truncated": false}, "before_length": 205, "before_sha256": "9bc7890aed497a3ec96ac02b456f5513994bd6aa19aa1aed12d230e8ec444f7c", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0e027875a95d5ad8bfc3856c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004008", "medicine_name": "Aripiprazole Sandoz", "medicine_slug": "aripiprazole-sandoz", "observed_at": "2026-10-12T13:40:26Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "e22ec2e1091ba644789161695b2abedce706b1188f584dcce10bbbc43adf986a", "source_snapshot_id": "source-0a9efa4639b121b1b78dabf2", "source_updated_at": "2026-04-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/aripiprazole-sandoz-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 606}
{"after": {"end": 73, "start": 0, "text": "Plaquettes thermoformées pour délivrance à l’unité (Aluminium/Aluminium).", "truncated": false}, "after_length": 73, "after_sha256": "e20d45753022eb7df35361b063e43c7a725214313a5dd8a8048400bd75113736", "annex": "I", "before": {"end": 73, "start": 0, "text": "Plaquettes thermoformées pour délivrance à l’unité (Aluminium/Aluminium).", "truncated": false}, "before_length": 73, "before_sha256": "e20d45753022eb7df35361b063e43c7a725214313a5dd8a8048400bd75113736", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0e07f680eacc98a35465ef89", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002409", "medicine_name": "Zelboraf", "medicine_slug": "zelboraf", "observed_at": "2026-10-12T19:31:02Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.5", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "8a568de35f474060aade2baa4979d413864e5051a9a473f5aead5174400e6da4", "source_snapshot_id": "source-39ee8bf457d439dc02096a2b", "source_updated_at": "2025-06-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/zelboraf-epar-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": 1081, "start": 0, "text": "Le critère d’évaluation principal de l’étude LEROS était la proportion d’yeux ayant obtenu un bénéfice cliniquement pertinent (BCP) (c.-à-d. soit une récupération cliniquement pertinente [RCP] de l’AV par rapport à l’inclusion, soit une stabilisation cliniquement pertinente [SCP]) à 12 mois parmi les patients ayant débuté le traitement par Raxone ≤ 1 an après l’apparition des symptômes, par comparaison avec les yeux des patients du groupe contrôle externe correspondant à l’histoire naturelle (HN) de la maladie. Un BCP a été observé dans 42,3 % des yeux chez les patients de l’étude LEROS, contre 20,7 % des yeux parmi les patients du groupe HN. D’un point de vue clinique, cela représente une amélioration relative pertinente de 104 % par comparaison avec le BCP qui a pu être observé dans les yeux du groupe contrôle HN. La différence estimée entre groupe de traitement et groupe contrôle a été statistiquement significative (valeur de p de 0,0020), en faveur de Raxone, avec un rapport des chances (OR, Odds Ratio) de 2,286 (intervalle de confiance à 95 % : 1,352 ; 3,884).", "truncated": false}, "after_length": 1081, "after_sha256": "99430872a379e61e8ac81d6bdd926f9e239b1916cfacb34c8c9482b8ebd699cd", "annex": "I", "before": {"end": 1081, "start": 0, "text": "Le critère d’évaluation principal de l’étude LEROS était la proportion d’yeux ayant obtenu un bénéfice cliniquement pertinent (BCP) (c.-à-d. soit une récupération cliniquement pertinente [RCP] de l’AV par rapport à l’inclusion, soit une stabilisation cliniquement pertinente [SCP]) à 12 mois parmi les patients ayant débuté le traitement par Raxone ≤ 1 an après l’apparition des symptômes, par comparaison avec les yeux des patients du groupe contrôle externe correspondant à l’histoire naturelle (HN) de la maladie. Un BCP a été observé dans 42,3 % des yeux chez les patients de l’étude LEROS, contre 20,7 % des yeux parmi les patients du groupe HN. D’un point de vue clinique, cela représente une amélioration relative pertinente de 104 % par comparaison avec le BCP qui a pu être observé dans les yeux du groupe contrôle HN. La différence estimée entre groupe de traitement et groupe contrôle a été statistiquement significative (valeur de p de 0,0020), en faveur de Raxone, avec un rapport des chances (OR, Odds Ratio) de 2,286 (intervalle de confiance à 95 % : 1,352 ; 3,884).", "truncated": false}, "before_length": 1081, "before_sha256": "99430872a379e61e8ac81d6bdd926f9e239b1916cfacb34c8c9482b8ebd699cd", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0e12fe00895d5800f4fe2f42", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003834", "medicine_name": "Raxone", "medicine_slug": "raxone", "observed_at": "2026-10-12T19:16:11Z", "pipeline_version": "2.0.0", "presentation_label": "Raxone 150 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": "3c9106f28c895cd4529e4e66d50ab94bd3fc5a59a122fe743109596f56a68266", "source_snapshot_id": "source-d44fd57709b8f42bd1785b41", "source_updated_at": "2025-08-20", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/raxone-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 281}
{"after": {"end": 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-0e18bdeb698bf634e8f0bdf8", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000233", "medicine_name": "Cetrotide", "medicine_slug": "cetrotide", "observed_at": "2026-10-12T17:28:04Z", "pipeline_version": "2.0.0", "presentation_label": "Cetrotide 0,25 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": "89d004f7601b8a9380386ff1b89ed00c999b773b8e823e5c4c6e181d4a2f4a5b", "source_snapshot_id": "source-d85ced16d4719c906781e81c", "source_updated_at": "2025-12-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/cetrotide-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 89}
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{"after": {"end": 367, "start": 0, "text": "Roflumilast improved lung function after 4 weeks (sustained over 52 weeks). Post-bronchodilator FEV1 increased for the roflumilast group by 52 mL (95% CI: 40, 65 mL) and decreased for the placebo group by 4 mL (95% CI: -16, 9 mL). Post-bronchodilator FEV1 showed a clinically significant improvement in favour of roflumilast by 56 mL over placebo (95% CI: 38, 73 mL).", "truncated": false}, "after_length": 367, "after_sha256": "ab1b04c7f86663c37911b91255cab9b82899737743d04ea37b0f6e7dac630e57", "annex": "I", "before": {"end": 367, "start": 0, "text": "Roflumilast improved lung function after 4 weeks (sustained over 52 weeks). Post-bronchodilator FEV1 increased for the roflumilast group by 52 mL (95% CI: 40, 65 mL) and decreased for the placebo group by 4 mL (95% CI: -16, 9 mL). Post-bronchodilator FEV1 showed a clinically significant improvement in favour of roflumilast by 56 mL over placebo (95% CI: 38, 73 mL).", "truncated": false}, "before_length": 367, "before_sha256": "ab1b04c7f86663c37911b91255cab9b82899737743d04ea37b0f6e7dac630e57", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-10489b638bf0f21c6aa1156e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001179", "medicine_name": "Daxas", "medicine_slug": "daxas", "observed_at": "2026-10-12T19:06:09Z", "pipeline_version": "2.0.0", "presentation_label": "Daxas 500 micrograms filmcoated 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": "5a46f173703a8685205dd61d80eb3f1ec4682dddeec32928c7ecab73f8f7da95", "source_snapshot_id": "source-c4e1e345673be2109418f4dc", "source_updated_at": "2025-10-07", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/daxas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 836}
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{"after": {"end": 222, "start": 0, "text": "In phase I pharmacokinetic studies, proportional increases in plasma concentrations of idebenone were observed for doses from 150 mg to 1050 mg. Neither idebenone nor its metabolites showed time-dependent pharmacokinetics.", "truncated": false}, "after_length": 222, "after_sha256": "4017c41a98a5a904ca90686c45357263e5d6dab8ac801173ae412154fa45d7b1", "annex": "I", "before": {"end": 222, "start": 0, "text": "In phase I pharmacokinetic studies, proportional increases in plasma concentrations of idebenone were observed for doses from 150 mg to 1050 mg. Neither idebenone nor its metabolites showed time-dependent pharmacokinetics.", "truncated": false}, "before_length": 222, "before_sha256": "4017c41a98a5a904ca90686c45357263e5d6dab8ac801173ae412154fa45d7b1", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-13fae525ce67334747140f66", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003834", "medicine_name": "Raxone", "medicine_slug": "raxone", "observed_at": "2026-10-12T19:16:09Z", "pipeline_version": "2.0.0", "presentation_label": "Raxone 150 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": "a40c25bc9b88de4a3f9b4f2cd0c01f61082db69fffcf0a3823764ce0c0015e71", "source_snapshot_id": "source-99f1e23086a54d8376a1bb52", "source_updated_at": "2025-08-20", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/raxone-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 378}
{"after": {"end": 268, "start": 0, "text": "Chez des patients présentant une cirrhose, les concentrations plasmatiques de mélatonine étaient significativement augmentées durant les heures diurnes. L’excrétion totale de 6-sulfatoxymélatonine était significativement réduite chez ces patients, comparé aux témoins.", "truncated": false}, "after_length": 268, "after_sha256": "2650e9e3ddf11a361cfd3016258481551ca29da4cb1f55fa4f3bd430b59a5522", "annex": "I", "before": {"end": 268, "start": 0, "text": "Chez des patients présentant une cirrhose, les concentrations plasmatiques de mélatonine étaient significativement augmentées durant les heures diurnes. L’excrétion totale de 6-sulfatoxymélatonine était significativement réduite chez ces patients, comparé aux témoins.", "truncated": false}, "before_length": 268, "before_sha256": "2650e9e3ddf11a361cfd3016258481551ca29da4cb1f55fa4f3bd430b59a5522", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-14280f28877e62aeefd541d6", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000695", "medicine_name": "Circadin", "medicine_slug": "circadin", "observed_at": "2026-10-12T19:30:15Z", "pipeline_version": "2.0.0", "presentation_label": "Circadin 2 mg, comprimés à libération prolongée.", "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": "4ab777b767183ae5b19a056580dc77385a2608dea782bb5c982b76e169c52c1a", "source_snapshot_id": "source-488cc476f581f7601b0f7879", "source_updated_at": "2025-07-07", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/circadin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 327}
{"after": {"end": 234, "start": 0, "text": "The clinical data with roflumilast in patients with mild hepatic impairment classified as ChildPugh A are insufficient to recommend a dose adjustment (see section 5.2) and therefore Daxas should be used with caution in these patients.", "truncated": false}, "after_length": 234, "after_sha256": "81ec3cafecfe38f58b9eb9dcf41d23fc736ed40b7687a5070c8bab137e75e51e", "annex": "I", "before": {"end": 234, "start": 0, "text": "The clinical data with roflumilast in patients with mild hepatic impairment classified as ChildPugh A are insufficient to recommend a dose adjustment (see section 5.2) and therefore Daxas should be used with caution in these patients.", "truncated": false}, "before_length": 234, "before_sha256": "81ec3cafecfe38f58b9eb9dcf41d23fc736ed40b7687a5070c8bab137e75e51e", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-142be27b8d632804d52a3073", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001179", "medicine_name": "Daxas", "medicine_slug": "daxas", "observed_at": "2026-10-12T19:06:09Z", "pipeline_version": "2.0.0", "presentation_label": "Daxas 500 micrograms filmcoated 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": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "5a46f173703a8685205dd61d80eb3f1ec4682dddeec32928c7ecab73f8f7da95", "source_snapshot_id": "source-c4e1e345673be2109418f4dc", "source_updated_at": "2025-10-07", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/daxas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 549}
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{"after": {"end": 229, "start": 0, "text": "Raxone contient du lactose. Les patients présentant une intolérance au galactose, un déficit total en lactase ou un syndrome de malabsorption du glucose et du galactose (maladies héréditaires rares) ne doivent pas prendre Raxone.", "truncated": false}, "after_length": 229, "after_sha256": "52bab85d8a77172e894d8bd219c41faec3fed282e3b403eafd8b510a867b6279", "annex": "I", "before": {"end": 229, "start": 0, "text": "Raxone contient du lactose. Les patients présentant une intolérance au galactose, un déficit total en lactase ou un syndrome de malabsorption du glucose et du galactose (maladies héréditaires rares) ne doivent pas prendre Raxone.", "truncated": false}, "before_length": 229, "before_sha256": "52bab85d8a77172e894d8bd219c41faec3fed282e3b403eafd8b510a867b6279", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-144a90f18bc1400938f19341", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003834", "medicine_name": "Raxone", "medicine_slug": "raxone", "observed_at": "2026-10-12T19:16:11Z", "pipeline_version": "2.0.0", "presentation_label": "Raxone 150 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": "3c9106f28c895cd4529e4e66d50ab94bd3fc5a59a122fe743109596f56a68266", "source_snapshot_id": "source-d44fd57709b8f42bd1785b41", "source_updated_at": "2025-08-20", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/raxone-epar-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}
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{"after": {"end": 48, "start": 0, "text": "Chaque gramme de gel contient 2 mg de sirolimus.", "truncated": false}, "after_length": 48, "after_sha256": "3988c1b1320c1a2cd75a2b0b3ba49ad6446c037192d87f00ff7c9bf8554a5a3e", "annex": "I", "before": {"end": 48, "start": 0, "text": "Chaque gramme de gel contient 2 mg de sirolimus.", "truncated": false}, "before_length": 48, "before_sha256": "3988c1b1320c1a2cd75a2b0b3ba49ad6446c037192d87f00ff7c9bf8554a5a3e", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-19e1a15119b292d79e550894", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005896", "medicine_name": "Hyftor", "medicine_slug": "hyftor", "observed_at": "2026-10-12T19:30:26Z", "pipeline_version": "2.0.0", "presentation_label": "Hyftor 2 mg/g gel", "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": "fdea0f8c8beb5c50cf6d54a5697063734a2b59911599ae4cbcdbe750e6151540", "source_snapshot_id": "source-9d1f6f559b2868cf1e70df29", "source_updated_at": "2025-07-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/hyftor-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 33}
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{"after": {"end": 480, "start": 0, "text": "No interactions studies with Hyftor and oral contraceptives have been performed. Low systemic exposure to sirolimus during topical treatment with Hyftor makes pharmacokinetic drug interactions unlikely. The possibility of changes in the pharmacokinetics that might affect the efficacy of the oral contraceptive during long-term treatment with Hyftor cannot be fully excluded. For this reason, patients should be advised to use non-hormonal contraceptive measures during treatment.", "truncated": false}, "after_length": 480, "after_sha256": "134c2096d28c048a8582e7cb9dd51f63232be3b1dd18653066b0bbf8619818b6", "annex": "I", "before": {"end": 480, "start": 0, "text": "No interactions studies with Hyftor and oral contraceptives have been performed. Low systemic exposure to sirolimus during topical treatment with Hyftor makes pharmacokinetic drug interactions unlikely. The possibility of changes in the pharmacokinetics that might affect the efficacy of the oral contraceptive during long-term treatment with Hyftor cannot be fully excluded. For this reason, patients should be advised to use non-hormonal contraceptive measures during treatment.", "truncated": false}, "before_length": 480, "before_sha256": "134c2096d28c048a8582e7cb9dd51f63232be3b1dd18653066b0bbf8619818b6", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-1a33d2fc8a4cc0e819761aa6", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005896", "medicine_name": "Hyftor", "medicine_slug": "hyftor", "observed_at": "2026-10-12T19:30:24Z", "pipeline_version": "2.0.0", "presentation_label": "Hyftor 2 mg/g gel", "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": "20b87f11031a18aee940ad1e4d2b615fe687dbead6d8f219db8e214b814f1acc", "source_snapshot_id": "source-44df4a8e5513d920d46cd291", "source_updated_at": "2025-07-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/hyftor-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 163}
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{"after": {"end": 332, "start": 0, "text": "In females, cetrorelix delays the LH surge and consequently ovulation. In women undergoing ovarian stimulation the duration of action of cetrorelix is dose dependent. Repeated injections of Cetrotide 0.25 mg per vial (administered dose of 0.21 mg cetrorelix), every 24 hours will maintain the effect of cetrorelix (see section 4.2).", "truncated": false}, "after_length": 332, "after_sha256": "b7745dbbb7c72256f70618f67cb645fc9fd67b2a82feb005477f34233ebd3088", "annex": "I", "before": {"end": 332, "start": 0, "text": "In females, cetrorelix delays the LH surge and consequently ovulation. In women undergoing ovarian stimulation the duration of action of cetrorelix is dose dependent. Repeated injections of Cetrotide 0.25 mg per vial (administered dose of 0.21 mg cetrorelix), every 24 hours will maintain the effect of cetrorelix (see section 4.2).", "truncated": false}, "before_length": 332, "before_sha256": "b7745dbbb7c72256f70618f67cb645fc9fd67b2a82feb005477f34233ebd3088", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-1b5af5c5de529bd11b483683", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000233", "medicine_name": "Cetrotide", "medicine_slug": "cetrotide", "observed_at": "2026-10-12T17:27:47Z", "pipeline_version": "2.0.0", "presentation_label": "Cetrotide 0.25 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": "5d18abdd764867aa439779cae36dd92d76d95af5e69b1bf04f0ec3a40fa10ee1", "source_snapshot_id": "source-9d1f1e17c888e8c5e5b171c3", "source_updated_at": "2025-12-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/cetrotide-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 190}
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{"after": {"end": 303, "start": 0, "text": "La déclaration des effets indésirables suspectés après autorisation du médicament est importante. Elle permet une surveillance continue du rapport bénéfice/risque du médicament. Les professionnels de santé déclarent tout effet indésirable suspecté via le système national de déclaration – voir Annexe V.", "truncated": false}, "after_length": 303, "after_sha256": "4e737434993bbc285d9af39fc26c36342534d88c326034d63930ce74c3af58fc", "annex": "I", "before": {"end": 303, "start": 0, "text": "La déclaration des effets indésirables suspectés après autorisation du médicament est importante. Elle permet une surveillance continue du rapport bénéfice/risque du médicament. Les professionnels de santé déclarent tout effet indésirable suspecté via le système national de déclaration – voir Annexe V.", "truncated": false}, "before_length": 303, "before_sha256": "4e737434993bbc285d9af39fc26c36342534d88c326034d63930ce74c3af58fc", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-1d05630daaeb658a914a1631", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000233", "medicine_name": "Cetrotide", "medicine_slug": "cetrotide", "observed_at": "2026-10-12T17:28:04Z", "pipeline_version": "2.0.0", "presentation_label": "Cetrotide 0,25 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": "89d004f7601b8a9380386ff1b89ed00c999b773b8e823e5c4c6e181d4a2f4a5b", "source_snapshot_id": "source-d85ced16d4719c906781e81c", "source_updated_at": "2025-12-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/cetrotide-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 170}
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{"after": {"end": 254, "start": 0, "text": "Des précautions particulières seront prises chez les femmes présentant des signes et symptômes d’allergie active ou ayant un terrain allergique connu. Le traitement par Cetrotide n’est pas recommandé chez les femmes ayant des épisodes allergiques graves.", "truncated": false}, "after_length": 254, "after_sha256": "7d1e50ca27cc42cba7d656e29ab6e20bca60e6a39b358b30f6d0beb5e6c553df", "annex": "I", "before": {"end": 254, "start": 0, "text": "Des précautions particulières seront prises chez les femmes présentant des signes et symptômes d’allergie active ou ayant un terrain allergique connu. Le traitement par Cetrotide n’est pas recommandé chez les femmes ayant des épisodes allergiques graves.", "truncated": false}, "before_length": 254, "before_sha256": "7d1e50ca27cc42cba7d656e29ab6e20bca60e6a39b358b30f6d0beb5e6c553df", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-1deb78f1b4ef0cc63da4cda7", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000233", "medicine_name": "Cetrotide", "medicine_slug": "cetrotide", "observed_at": "2026-10-12T17:28:04Z", "pipeline_version": "2.0.0", "presentation_label": "Cetrotide 0,25 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": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "89d004f7601b8a9380386ff1b89ed00c999b773b8e823e5c4c6e181d4a2f4a5b", "source_snapshot_id": "source-d85ced16d4719c906781e81c", "source_updated_at": "2025-12-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/cetrotide-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 103}
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{"after": {"end": 705, "start": 0, "text": "Dans des essais cliniques (dans le cadre desquels un total de 1 931 patients ont pris Circadin et 1 642 patients un placebo), 48,8 % des patients recevant Circadin ont rapporté un effet indésirable, alors que ce pourcentage était de 37,8 % chez ceux ayant reçu un placebo. La comparaison des pourcentages de patients ayant eu des effets indésirables par 100 semaines-patients a montré un pourcentage supérieur pour le placebo que pour Circadin (5,743 – placebo vs. 3,013 – Circadin). Les effets indésirables les plus fréquents étaient : céphalées, rhinopharyngite, mal de dos et arthralgies, qui étaient fréquentes, d’après la définition MedDRA, dans le groupe sous Circadin comme dans celui sous placebo.", "truncated": false}, "after_length": 705, "after_sha256": "2e69eb97bcf03ce44341bc53fce90890d06e9a7daef09cc2837f5a2508e0056c", "annex": "I", "before": {"end": 705, "start": 0, "text": "Dans des essais cliniques (dans le cadre desquels un total de 1 931 patients ont pris Circadin et 1 642 patients un placebo), 48,8 % des patients recevant Circadin ont rapporté un effet indésirable, alors que ce pourcentage était de 37,8 % chez ceux ayant reçu un placebo. La comparaison des pourcentages de patients ayant eu des effets indésirables par 100 semaines-patients a montré un pourcentage supérieur pour le placebo que pour Circadin (5,743 – placebo vs. 3,013 – Circadin). Les effets indésirables les plus fréquents étaient : céphalées, rhinopharyngite, mal de dos et arthralgies, qui étaient fréquentes, d’après la définition MedDRA, dans le groupe sous Circadin comme dans celui sous placebo.", "truncated": false}, "before_length": 705, "before_sha256": "2e69eb97bcf03ce44341bc53fce90890d06e9a7daef09cc2837f5a2508e0056c", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-22c8e0d8b86cd26c0175f64c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000695", "medicine_name": "Circadin", "medicine_slug": "circadin", "observed_at": "2026-10-12T19:30:15Z", "pipeline_version": "2.0.0", "presentation_label": "Circadin 2 mg, comprimés à libération prolongée.", "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": "4ab777b767183ae5b19a056580dc77385a2608dea782bb5c982b76e169c52c1a", "source_snapshot_id": "source-488cc476f581f7601b0f7879", "source_updated_at": "2025-07-07", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/circadin-epar-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}
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{"after": {"end": 614, "start": 0, "text": "Un autre essai clinique randomisé (n=600) a comparé les effets de Circadin et du placebo pendant six mois. Les patients ont été à nouveau randomisés au bout de 3 semaines. L'étude a montré des améliorations de la latence du sommeil, de la qualité du sommeil et de la vigilance le matin, sans symptôme de sevrage ni insomnie de rebond. L'étude a montré que le bénéfice observé après 3 semaines était maintenu pendant 3 mois mais n’était pas présent lors de l'analyse principale effectuée au bout de 6 mois. Au bout de 3 mois, environ 10 % de répondeurs supplémentaires étaient observés dans le groupe sous Circadin.", "truncated": false}, "after_length": 614, "after_sha256": "71105ab7ecdf7cb257b528222fa7f7ff6a24b152bb198268eb52290bcb11a6b4", "annex": "I", "before": {"end": 614, "start": 0, "text": "Un autre essai clinique randomisé (n=600) a comparé les effets de Circadin et du placebo pendant six mois. Les patients ont été à nouveau randomisés au bout de 3 semaines. L'étude a montré des améliorations de la latence du sommeil, de la qualité du sommeil et de la vigilance le matin, sans symptôme de sevrage ni insomnie de rebond. L'étude a montré que le bénéfice observé après 3 semaines était maintenu pendant 3 mois mais n’était pas présent lors de l'analyse principale effectuée au bout de 6 mois. Au bout de 3 mois, environ 10 % de répondeurs supplémentaires étaient observés dans le groupe sous Circadin.", "truncated": false}, "before_length": 614, "before_sha256": "71105ab7ecdf7cb257b528222fa7f7ff6a24b152bb198268eb52290bcb11a6b4", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-25426cc4abc8b3e4998bbc62", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000695", "medicine_name": "Circadin", "medicine_slug": "circadin", "observed_at": "2026-10-12T19:30:15Z", "pipeline_version": "2.0.0", "presentation_label": "Circadin 2 mg, comprimés à libération prolongée.", "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": "4ab777b767183ae5b19a056580dc77385a2608dea782bb5c982b76e169c52c1a", "source_snapshot_id": "source-488cc476f581f7601b0f7879", "source_updated_at": "2025-07-07", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/circadin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 286}
{"after": {"end": 562, "start": 0, "text": "In clinical trials (in which a total of 1,931 patients were taking Circadin and 1,642 patients were taking placebo), 48.8% of patients receiving Circadin reported an adverse reaction compared with 37.8% taking placebo. Comparing the rate of patients with adverse reactions per 100 patient weeks, the rate was higher for placebo than Circadin (5.743– placebo vs. 3.013– Circadin). The most common adverse reactions were headache, nasopharyngitis, back pain, and arthralgia, which were common, by MedDRA definition, in both the Circadin and placebo treated groups.", "truncated": false}, "after_length": 562, "after_sha256": "97c8935746daaa25b6290400cf6440c59f356b217e48bcfe067516c70a9d7919", "annex": "I", "before": {"end": 562, "start": 0, "text": "In clinical trials (in which a total of 1,931 patients were taking Circadin and 1,642 patients were taking placebo), 48.8% of patients receiving Circadin reported an adverse reaction compared with 37.8% taking placebo. Comparing the rate of patients with adverse reactions per 100 patient weeks, the rate was higher for placebo than Circadin (5.743– placebo vs. 3.013– Circadin). The most common adverse reactions were headache, nasopharyngitis, back pain, and arthralgia, which were common, by MedDRA definition, in both the Circadin and placebo treated groups.", "truncated": false}, "before_length": 562, "before_sha256": "97c8935746daaa25b6290400cf6440c59f356b217e48bcfe067516c70a9d7919", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-2698bb42b07fc189a83d44db", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000695", "medicine_name": "Circadin", "medicine_slug": "circadin", "observed_at": "2026-10-12T19:30:12Z", "pipeline_version": "2.0.0", "presentation_label": "Circadin 2 mg prolonged-release 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": "8013697e7bd979b2aa97a7a73b435fd0f5d1c467cb0cdead18a103c8b4f947c3", "source_snapshot_id": "source-a0eb1b0c541fed5b530618e7", "source_updated_at": "2025-07-07", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/circadin-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 124}
{"after": {"end": 222, "start": 0, "text": "Circadin contient du lactose. Les patients présentant une intolérance héréditaire au galactose, un déficit en lactase de Lapp ou un syndrome de malabsorption du glucose et du galactose ne doivent pas prendre ce médicament.", "truncated": false}, "after_length": 222, "after_sha256": "7bdab6e58bf83911380f6bfce6694d64ef0d829cd8aecd9c26df6ccc0d6e78ca", "annex": "I", "before": {"end": 222, "start": 0, "text": "Circadin contient du lactose. Les patients présentant une intolérance héréditaire au galactose, un déficit en lactase de Lapp ou un syndrome de malabsorption du glucose et du galactose ne doivent pas prendre ce médicament.", "truncated": false}, "before_length": 222, "before_sha256": "7bdab6e58bf83911380f6bfce6694d64ef0d829cd8aecd9c26df6ccc0d6e78ca", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-27d889487b0e84c48f310dc2", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000695", "medicine_name": "Circadin", "medicine_slug": "circadin", "observed_at": "2026-10-12T19:30:15Z", "pipeline_version": "2.0.0", "presentation_label": "Circadin 2 mg, comprimés à libération prolongée.", "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": "4ab777b767183ae5b19a056580dc77385a2608dea782bb5c982b76e169c52c1a", "source_snapshot_id": "source-488cc476f581f7601b0f7879", "source_updated_at": "2025-07-07", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/circadin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 84}
{"after": {"end": 523, "start": 0, "text": "An additional randomised clinical trial (n=600) compared the effects of Circadin and placebo for up to six months. Patients were rerandomised at 3 weeks. The study demonstrated improvements in sleep latency, quality of sleep and morning alertness, with no withdrawal symptoms and rebound insomnia. The study showed that the benefit observed after 3 weeks is maintained for up to 3 months but failed the primary analysis set at 6 months. At 3 months, about an extra 10% of responders were seen in the Circadin treated group.", "truncated": false}, "after_length": 523, "after_sha256": "279d71fa3d5e53d364959abbef82f5d075e50a298afb7532a194780ed8393fb3", "annex": "I", "before": {"end": 523, "start": 0, "text": "An additional randomised clinical trial (n=600) compared the effects of Circadin and placebo for up to six months. Patients were rerandomised at 3 weeks. The study demonstrated improvements in sleep latency, quality of sleep and morning alertness, with no withdrawal symptoms and rebound insomnia. The study showed that the benefit observed after 3 weeks is maintained for up to 3 months but failed the primary analysis set at 6 months. At 3 months, about an extra 10% of responders were seen in the Circadin treated group.", "truncated": false}, "before_length": 523, "before_sha256": "279d71fa3d5e53d364959abbef82f5d075e50a298afb7532a194780ed8393fb3", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-287f4815eb5d6f0ba88480e7", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000695", "medicine_name": "Circadin", "medicine_slug": "circadin", "observed_at": "2026-10-12T19:30:12Z", "pipeline_version": "2.0.0", "presentation_label": "Circadin 2 mg prolonged-release 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": "8013697e7bd979b2aa97a7a73b435fd0f5d1c467cb0cdead18a103c8b4f947c3", "source_snapshot_id": "source-a0eb1b0c541fed5b530618e7", "source_updated_at": "2025-07-07", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/circadin-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 284}
{"after": {"end": 315, "start": 0, "text": "Dans les essais cliniques, un total de 9,5 % des patients recevant Circadin a rapporté un effet indésirable, comparé à 7,4 % de ceux sous placebo. Seuls les effets indésirables survenus pendant les essais cliniques chez les patients à une fréquence au moins égale à celle rapportée sous placebo figurent ci-dessous.", "truncated": false}, "after_length": 315, "after_sha256": "5f039d5dc2ee60b78bc3451d45daf275ff7aba5f207a092c56fa9245c9f69a00", "annex": "I", "before": {"end": 315, "start": 0, "text": "Dans les essais cliniques, un total de 9,5 % des patients recevant Circadin a rapporté un effet indésirable, comparé à 7,4 % de ceux sous placebo. Seuls les effets indésirables survenus pendant les essais cliniques chez les patients à une fréquence au moins égale à celle rapportée sous placebo figurent ci-dessous.", "truncated": false}, "before_length": 315, "before_sha256": "5f039d5dc2ee60b78bc3451d45daf275ff7aba5f207a092c56fa9245c9f69a00", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-28d9ddde7989009e759c283b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000695", "medicine_name": "Circadin", "medicine_slug": "circadin", "observed_at": "2026-10-12T19:30:15Z", "pipeline_version": "2.0.0", "presentation_label": "Circadin 2 mg, comprimés à libération prolongée.", "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": "4ab777b767183ae5b19a056580dc77385a2608dea782bb5c982b76e169c52c1a", "source_snapshot_id": "source-488cc476f581f7601b0f7879", "source_updated_at": "2025-07-07", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/circadin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 129}
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