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{"after": {"end": 666, "start": 0, "text": "The safety and efficacy of 50 mg Enbrel (two 25 mg SC injections) administered once weekly were evaluated in a double-blind, placebo-controlled study of 420 patients with active RA. In this study, 53 patients received placebo, 214 patients received 50 mg Enbrel once weekly and 153 patients received 25 mg Enbrel twice weekly. The safety and efficacy profiles of the two Enbrel treatment regimens were comparable at week 8 in their effect on signs and symptoms of RA; data at week 16 did not show comparability (non-inferiority) between the two regimens. A single 50 mg/ml injection of Enbrel was found to be bioequivalent to two simultaneous injections of 25 mg/ml.", "truncated": false}, "after_length": 666, "after_sha256": "733ce59b45c4eb3cf55e0a8a44509ac7f8242d40113e11c37fe4b92d8a756704", "annex": "I", "before": {"end": 666, "start": 0, "text": "The safety and efficacy of 50 mg Enbrel (two 25 mg SC injections) administered once weekly were evaluated in a double-blind, placebo-controlled study of 420 patients with active RA. In this study, 53 patients received placebo, 214 patients received 50 mg Enbrel once weekly and 153 patients received 25 mg Enbrel twice weekly. The safety and efficacy profiles of the two Enbrel treatment regimens were comparable at week 8 in their effect on signs and symptoms of RA; data at week 16 did not show comparability (non-inferiority) between the two regimens. A single 50 mg/ml injection of Enbrel was found to be bioequivalent to two simultaneous injections of 25 mg/ml.", "truncated": false}, "before_length": 666, "before_sha256": "733ce59b45c4eb3cf55e0a8a44509ac7f8242d40113e11c37fe4b92d8a756704", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00b39b50971342e19f721cdc", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000262", "medicine_name": "Enbrel", "medicine_slug": "enbrel", "observed_at": "2026-10-12T19:16:34Z", "pipeline_version": "2.0.0", "presentation_label": "Enbrel 25 mg solution for injection in dose-dispenser cartridge Enbrel 50 mg solution for injection in dose-dispenser cartridge", "presentation_occurrence": 6, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "878ae96bd12ba62b45d781081f86186d8ffd76bcb5ca365a21fb706a93d76b91", "source_snapshot_id": "source-4e7682c382d4a48311174234", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/enbrel-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 5974}
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{"after": {"end": 115, "start": 0, "text": "b For additional information refer below within section \"Further information on selected serious adverse reactions\"", "truncated": false}, "after_length": 115, "after_sha256": "088126d3bc1ca5a800b5826ba3c8c0399c2cda7436d50e677cbbc8d5e6666e51", "annex": "I", "before": {"end": 115, "start": 0, "text": "b For additional information refer below within section \"Further information on selected serious adverse reactions\"", "truncated": false}, "before_length": 115, "before_sha256": "088126d3bc1ca5a800b5826ba3c8c0399c2cda7436d50e677cbbc8d5e6666e51", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01819c2a71d5d6f7c41479e7", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:18Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml concentrate for solution for infusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "89a938df5e41f86548301270084e3d1ecf171802e24b5429f62e3bede7ee32dd", "source_snapshot_id": "source-b71aeee5a07abebc34c02e28", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 773}
{"after": {"end": 167, "start": 0, "text": "For medically treated patients eligible for thrombolytic/fibrinolytic therapy: in patients over 75 years of age clopidogrel should be initiated without a loading dose.", "truncated": false}, "after_length": 167, "after_sha256": "88ef9376f17f7bd5f3fbd1ea4fd79cda48473bcc81147875d0c3bf9774d64b31", "annex": "I", "before": {"end": 167, "start": 0, "text": "For medically treated patients eligible for thrombolytic/fibrinolytic therapy: in patients over 75 years of age clopidogrel should be initiated without a loading dose.", "truncated": false}, "before_length": 167, "before_sha256": "88ef9376f17f7bd5f3fbd1ea4fd79cda48473bcc81147875d0c3bf9774d64b31", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0185ef18fb8dbb0743ff5589", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000174", "medicine_name": "Plavix", "medicine_slug": "plavix", "observed_at": "2026-10-12T19:27:50Z", "pipeline_version": "2.0.0", "presentation_label": "Plavix 75 mg filmcoated tablets Plavix 300 mg filmcoated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "3818c2e3c9979bf5f8be3f164dfce187fccfccf62bbd1e3227c64ca7c00ad02f", "source_snapshot_id": "source-4aff1b64c7cf58337d33ecfa", "source_updated_at": "2025-07-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/plavix-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 122}
{"after": {"end": 1248, "start": 0, "text": "This randomized, double-blind, placebo-controlled trial was conducted in the United States and Canada to evaluate the benefit of long-term (12 month) treatment with clopidogrel after PCI. There were 2,116 patients randomized to receive a 300 mg clopidogrel LD (n=1,053) or placebo (n=1,063) 3 to 24 hours before PCI. All patients also received 325 mg of aspirin. Thereafter, all patients received clopidogrel 75 mg/day through Day 28 in both groups. From Day 29 through 12 months, patients in clopidogrel group received 75 mg/day clopidogrel and in control group received placebo. Both groups received ASA throughout the study (81 to 325 mg/day). At 1-year, significant reduction in the combined risk of death, MI or stroke was observed with clopidogrel (26.9% relative reduction, 95% CI: 3.9%-44.4%; p=0.02; absolute reduction 3%) compared to placebo. No significant increase in the rate of major bleeding (8.8% with clopidogrel versus 6.7% with placebo, p=0.07) or minor bleeding (5.3% with clopidogrel versus 5.6% with placebo, p=0.84) at 1-year was observed. The major finding of this study is that continuation of clopidogrel and ASA for at least 1-year leads to a statistically and clinically significant reduction in major thrombotic events.", "truncated": false}, "after_length": 1248, "after_sha256": "4aa4f11da5711304d5136ecb9c470bfc80f9a3a0e1466e73c9f3682680449b6b", "annex": "I", "before": {"end": 1248, "start": 0, "text": "This randomized, double-blind, placebo-controlled trial was conducted in the United States and Canada to evaluate the benefit of long-term (12 month) treatment with clopidogrel after PCI. There were 2,116 patients randomized to receive a 300 mg clopidogrel LD (n=1,053) or placebo (n=1,063) 3 to 24 hours before PCI. All patients also received 325 mg of aspirin. Thereafter, all patients received clopidogrel 75 mg/day through Day 28 in both groups. From Day 29 through 12 months, patients in clopidogrel group received 75 mg/day clopidogrel and in control group received placebo. Both groups received ASA throughout the study (81 to 325 mg/day). At 1-year, significant reduction in the combined risk of death, MI or stroke was observed with clopidogrel (26.9% relative reduction, 95% CI: 3.9%-44.4%; p=0.02; absolute reduction 3%) compared to placebo. No significant increase in the rate of major bleeding (8.8% with clopidogrel versus 6.7% with placebo, p=0.07) or minor bleeding (5.3% with clopidogrel versus 5.6% with placebo, p=0.84) at 1-year was observed. The major finding of this study is that continuation of clopidogrel and ASA for at least 1-year leads to a statistically and clinically significant reduction in major thrombotic events.", "truncated": false}, "before_length": 1248, "before_sha256": "4aa4f11da5711304d5136ecb9c470bfc80f9a3a0e1466e73c9f3682680449b6b", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0191b43b91015fc176fa2454", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000174", "medicine_name": "Plavix", "medicine_slug": "plavix", "observed_at": "2026-10-12T19:27:50Z", "pipeline_version": "2.0.0", "presentation_label": "Plavix 75 mg filmcoated tablets Plavix 300 mg filmcoated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "3818c2e3c9979bf5f8be3f164dfce187fccfccf62bbd1e3227c64ca7c00ad02f", "source_snapshot_id": "source-4aff1b64c7cf58337d33ecfa", "source_updated_at": "2025-07-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/plavix-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 464}
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{"after": {"end": 589, "start": 0, "text": "Cette étude comprenait une phase de traitement en aveugle, une phase optionnelle en ouvert après progression et une phase de suivi de la survie. Durant la phase de traitement en aveugle, les patients ont reçu une chimiothérapie en association au médicament (Avastin ou au placebo) toutes les 3 semaines jusqu’à progression de la maladie, toxicité limitant le traitement, ou décès. Après progression documentée de la maladie, les patients qui entraient dans la phase optionnelle en ouvert pouvaient recevoir Avastin en ouvert en association à un large choix de traitement de deuxième ligne.", "truncated": false}, "after_length": 589, "after_sha256": "b6cdbbfdb5d436fa27bbd95ec95bcb662daecbf504cfc4fbb3384954a280d6c7", "annex": "I", "before": {"end": 589, "start": 0, "text": "Cette étude comprenait une phase de traitement en aveugle, une phase optionnelle en ouvert après progression et une phase de suivi de la survie. Durant la phase de traitement en aveugle, les patients ont reçu une chimiothérapie en association au médicament (Avastin ou au placebo) toutes les 3 semaines jusqu’à progression de la maladie, toxicité limitant le traitement, ou décès. Après progression documentée de la maladie, les patients qui entraient dans la phase optionnelle en ouvert pouvaient recevoir Avastin en ouvert en association à un large choix de traitement de deuxième ligne.", "truncated": false}, "before_length": 589, "before_sha256": "b6cdbbfdb5d436fa27bbd95ec95bcb662daecbf504cfc4fbb3384954a280d6c7", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01b8640a47da9930838e128b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:21Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8ef22a54b74bb234ed68489d904e9509f2ab58faeab1688109ec72b9aa5a8ea1", "source_snapshot_id": "source-722a64f3e6551937da0b93d9", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1410}
{"after": {"end": 454, "start": 0, "text": "La pharmacocinétique du pérampanel a été étudiée chez des volontaires sains adultes (âgés de 18 à 79 ans), des adultes, adolescents et patients pédiatriques présentant des crises d’épilepsie partielles et des crises généralisées tonicocloniques primaires, des adultes atteints de la maladie de Parkinson, des adultes présentant une neuropathie diabétique, des adultes atteints de sclérose en plaques et des patients présentant une insuffisance hépatique.", "truncated": false}, "after_length": 454, "after_sha256": "b0bbbfe6e788a499ddc525266b83690b13419a63c469141d5904807daf7a69f5", "annex": "I", "before": {"end": 454, "start": 0, "text": "La pharmacocinétique du pérampanel a été étudiée chez des volontaires sains adultes (âgés de 18 à 79 ans), des adultes, adolescents et patients pédiatriques présentant des crises d’épilepsie partielles et des crises généralisées tonicocloniques primaires, des adultes atteints de la maladie de Parkinson, des adultes présentant une neuropathie diabétique, des adultes atteints de sclérose en plaques et des patients présentant une insuffisance hépatique.", "truncated": false}, "before_length": 454, "before_sha256": "b0bbbfe6e788a499ddc525266b83690b13419a63c469141d5904807daf7a69f5", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01c8224ef3690ad2d259f8e8", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002434", "medicine_name": "Fycompa", "medicine_slug": "fycompa", "observed_at": "2026-10-12T13:32:00Z", "pipeline_version": "2.0.0", "presentation_label": "Fycompa 2 mg comprimés pelliculés Fycompa 4 mg comprimés pelliculés Fycompa 6 mg comprimés pelliculés Fycompa 8 mg comprimés pelliculés Fycompa 10 mg comprimés pelliculés Fycompa 12 mg comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "3ff8cd4d67d22ba799aa348aeda944d6d896a16dcf54b030db101cbc095fc8ad", "source_snapshot_id": "source-a79a7cba8bf5dbc72fd40574", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/fycompa-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 646}
{"after": {"end": 222, "start": 0, "text": "The safety and efficacy of bevacizumab in children aged less than 18 years old have not been established. Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.", "truncated": false}, "after_length": 222, "after_sha256": "5fc4b88a0d8ff455f536a4d146b69148ff31b03360afb02c4b0d2c0b809cf730", "annex": "I", "before": {"end": 222, "start": 0, "text": "The safety and efficacy of bevacizumab in children aged less than 18 years old have not been established. Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.", "truncated": false}, "before_length": 222, "before_sha256": "5fc4b88a0d8ff455f536a4d146b69148ff31b03360afb02c4b0d2c0b809cf730", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01de7c28d98353177a1ff92a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000582", "medicine_name": "Avastin", "medicine_slug": "avastin", "observed_at": "2026-10-12T17:27:18Z", "pipeline_version": "2.0.0", "presentation_label": "Avastin 25 mg/ml concentrate for solution for infusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "89a938df5e41f86548301270084e3d1ecf171802e24b5429f62e3bede7ee32dd", "source_snapshot_id": "source-b71aeee5a07abebc34c02e28", "source_updated_at": "2025-12-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/avastin-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 150}
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{"after": {"end": 396, "start": 0, "text": "In a clinical study the highest dose of riociguat (2.5 mg tablets 3 times daily) potentiated the blood pressure lowering effect of sublingual nitroglycerin (0.4 mg) taken 4 and 8 hours after intake. Therefore coadministration of riociguat with nitrates or nitric oxide donors (such as amyl nitrite) in any form, including recreational drugs called ‘poppers’, is contraindicated (see section 4.3).", "truncated": false}, "after_length": 396, "after_sha256": "a982c9eda53c4d473290aa349af54d0599ae72791a639a71db4fc7a30f5331be", "annex": "I", "before": {"end": 396, "start": 0, "text": "In a clinical study the highest dose of riociguat (2.5 mg tablets 3 times daily) potentiated the blood pressure lowering effect of sublingual nitroglycerin (0.4 mg) taken 4 and 8 hours after intake. Therefore coadministration of riociguat with nitrates or nitric oxide donors (such as amyl nitrite) in any form, including recreational drugs called ‘poppers’, is contraindicated (see section 4.3).", "truncated": false}, "before_length": 396, "before_sha256": "a982c9eda53c4d473290aa349af54d0599ae72791a639a71db4fc7a30f5331be", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-02206d95a358048222ce5d1e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "Adempas 0.5 mg filmcoated tablets Adempas 1 mg filmcoated tablets Adempas 1.5 mg filmcoated tablets Adempas 2 mg filmcoated tablets Adempas 2.5 mg filmcoated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 254}
{"after": {"end": 734, "start": 0, "text": "In the POSEIDON study in patients treated with tremelimumab in combination with durvalumab and platinum-based chemotherapy, some differences in safety were reported between elderly (≥ 65 years) and younger patients. The safety data from patients 75 years of age or older are limited to a total of 74 patients. There was a higher frequency of serious adverse reactions and discontinuation of any study treatment due to adverse reactions in 35 patients aged 75 years of age or older treated with tremelimumab in combination with durvalumab and platinum-based chemotherapy (45.7% and 28.6%, respectively) relative to 39 patients aged 75 years of age or older who received platinum-based chemotherapy only (35.9% and 20.5%, respectively).", "truncated": false}, "after_length": 734, "after_sha256": "b1942d445da5bdb1c4df405edc65775aa81ffe1dc17ef78ff73f5218eadd2bb9", "annex": "I", "before": {"end": 734, "start": 0, "text": "In the POSEIDON study in patients treated with tremelimumab in combination with durvalumab and platinum-based chemotherapy, some differences in safety were reported between elderly (≥ 65 years) and younger patients. The safety data from patients 75 years of age or older are limited to a total of 74 patients. There was a higher frequency of serious adverse reactions and discontinuation of any study treatment due to adverse reactions in 35 patients aged 75 years of age or older treated with tremelimumab in combination with durvalumab and platinum-based chemotherapy (45.7% and 28.6%, respectively) relative to 39 patients aged 75 years of age or older who received platinum-based chemotherapy only (35.9% and 20.5%, respectively).", "truncated": false}, "before_length": 734, "before_sha256": "b1942d445da5bdb1c4df405edc65775aa81ffe1dc17ef78ff73f5218eadd2bb9", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0225917cc6d9631ba173300d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "IMJUDO 20 mg/ml concentrate for solution for infusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1033}
{"after": {"end": 307, "start": 0, "text": "Teriparatide increases serum uric acid concentrations. In clinical trials, 2.8% of teriparatide patients had serum uric acid concentrations above the upper limit of normal compared with 0.7% of placebo patients. However, the hyperuricaemia did not result in an increase in gout, arthralgia, or urolithiasis.", "truncated": false}, "after_length": 307, "after_sha256": "86e316c5a1b27650616463ef52f22a7c5a772a82fc6b0596e6c55e1ffb8edabd", "annex": "I", "before": {"end": 307, "start": 0, "text": "Teriparatide increases serum uric acid concentrations. In clinical trials, 2.8% of teriparatide patients had serum uric acid concentrations above the upper limit of normal compared with 0.7% of placebo patients. However, the hyperuricaemia did not result in an increase in gout, arthralgia, or urolithiasis.", "truncated": false}, "before_length": 307, "before_sha256": "86e316c5a1b27650616463ef52f22a7c5a772a82fc6b0596e6c55e1ffb8edabd", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0225d1f5e7b38a1bbbb6bb2e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "Terrosa 20 micrograms/80 microliters solution for injection", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 271}
{"after": {"end": 392, "start": 0, "text": "If systolic blood pressure falls below these specified levels the dosage should be maintained as long as the patient does not show any signs or symptoms of hypotension. If at any time during the up-titration phase systolic blood pressure decreases below the specified levels, and the patient shows signs or symptoms of hypotension the current dose should be decreased by 0.5 mg 3 times daily.", "truncated": false}, "after_length": 392, "after_sha256": "90801d055877a723b83e8b56a8cf598ce4612cc143883afabfe164d15e8ec042", "annex": "I", "before": {"end": 392, "start": 0, "text": "If systolic blood pressure falls below these specified levels the dosage should be maintained as long as the patient does not show any signs or symptoms of hypotension. If at any time during the up-titration phase systolic blood pressure decreases below the specified levels, and the patient shows signs or symptoms of hypotension the current dose should be decreased by 0.5 mg 3 times daily.", "truncated": false}, "before_length": 392, "before_sha256": "90801d055877a723b83e8b56a8cf598ce4612cc143883afabfe164d15e8ec042", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0227d30fbce7fec8e9226765", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002737", "medicine_name": "Adempas", "medicine_slug": "adempas", "observed_at": "2026-10-12T13:36:27Z", "pipeline_version": "2.0.0", "presentation_label": "Adempas 0.5 mg filmcoated tablets Adempas 1 mg filmcoated tablets Adempas 1.5 mg filmcoated tablets Adempas 2 mg filmcoated tablets Adempas 2.5 mg filmcoated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "3093e732540208856cb2992ea8ae6e038d4f781977b6d5add99346618903df39", "source_snapshot_id": "source-88ecf756a74bf162aa58c75a", "source_updated_at": "2026-05-22", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/adempas-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 124}
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{"after": {"end": 127, "start": 0, "text": "L’éladocagène exuparvovec est produit dans des cellules rénales embryonnaires humaines par la technologie de l’ADN recombinant.", "truncated": false}, "after_length": 127, "after_sha256": "42f5540f535d5accc5308fcc67515c52b6186393b8d993eb7154557f9b1bf775", "annex": "I", "before": {"end": 127, "start": 0, "text": "L’éladocagène exuparvovec est produit dans des cellules rénales embryonnaires humaines par la technologie de l’ADN recombinant.", "truncated": false}, "before_length": 127, "before_sha256": "42f5540f535d5accc5308fcc67515c52b6186393b8d993eb7154557f9b1bf775", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03ab0985f27c9cd6343bd940", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005352", "medicine_name": "Upstaza", "medicine_slug": "upstaza", "observed_at": "2026-10-12T13:36:09Z", "pipeline_version": "2.0.0", "presentation_label": "Upstaza 2,8 × 1011 génomes de vecteur (vg)/0,5 mL, solution pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "2", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "42d7861913c7c415a9acf1067eeb3f9f1287a4e4718affc1402af95754bd6fed", "source_snapshot_id": "source-1e1e567efddae34509b5de34", "source_updated_at": "2026-06-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/upstaza-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 36}
{"after": {"end": 319, "start": 0, "text": "L’aprémilast n’est pas un inhibiteur ni un inducteur des isoenzymes du cytochrome P450 in vitro. Par conséquent, il est peu probable que l’aprémilast administré de façon concomitante avec des substrats des isoenzymes CYP modifie l’exposition aux substances actives qui sont métabolisées par ces voies ni leur clairance.", "truncated": false}, "after_length": 319, "after_sha256": "0d25ab14dc468cc9d73cce2dd805014d43e0ef26c070b53777c7cffe2857a621", "annex": "I", "before": {"end": 319, "start": 0, "text": "L’aprémilast n’est pas un inhibiteur ni un inducteur des isoenzymes du cytochrome P450 in vitro. Par conséquent, il est peu probable que l’aprémilast administré de façon concomitante avec des substrats des isoenzymes CYP modifie l’exposition aux substances actives qui sont métabolisées par ces voies ni leur clairance.", "truncated": false}, "before_length": 319, "before_sha256": "0d25ab14dc468cc9d73cce2dd805014d43e0ef26c070b53777c7cffe2857a621", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03b55a3baaf13c18f1e9c653", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:31Z", "pipeline_version": "2.0.0", "presentation_label": "Otezla 10 mg comprimés pelliculés Otezla 20 mg comprimés pelliculés Otezla 30 mg comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "9ac80b0d56ebad4970f7a8335a177613af59ef25517bcd0bdd3397c207cc1bac", "source_snapshot_id": "source-c11aa9e32420f125a88005bc", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1305}
{"after": {"end": 769, "start": 0, "text": "Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction): clopidogrel treatment should be initiated with a single 300 mg or 600 mg loading dose. A 600 mg loading dose may be considered in patients <75 years of age when percutaneous coronary intervention is intended (see section 4.4). Clopidogrel treatment should be continued at 75 mg once a day (with acetylsalicylic acid (ASA) 75 mg-325 mg daily). Since higher doses of ASA were associated with higher bleeding risk it is recommended that the dose of ASA should not be higher than 100 mg. The optimal duration of treatment has not been formally established. Clinical trial data support use up to 12 months, and the maximum benefit was seen at 3 months (see section 5.1).", "truncated": false}, "after_length": 769, "after_sha256": "a59036fc586dcf36df23f2f6f76e8758555930efed5e615babd3e15fc3b5cdd4", "annex": "I", "before": {"end": 769, "start": 0, "text": "Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction): clopidogrel treatment should be initiated with a single 300 mg or 600 mg loading dose. A 600 mg loading dose may be considered in patients <75 years of age when percutaneous coronary intervention is intended (see section 4.4). Clopidogrel treatment should be continued at 75 mg once a day (with acetylsalicylic acid (ASA) 75 mg-325 mg daily). Since higher doses of ASA were associated with higher bleeding risk it is recommended that the dose of ASA should not be higher than 100 mg. The optimal duration of treatment has not been formally established. Clinical trial data support use up to 12 months, and the maximum benefit was seen at 3 months (see section 5.1).", "truncated": false}, "before_length": 769, "before_sha256": "a59036fc586dcf36df23f2f6f76e8758555930efed5e615babd3e15fc3b5cdd4", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03b6cb6a326bad2e03b30084", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000174", "medicine_name": "Plavix", "medicine_slug": "plavix", "observed_at": "2026-10-12T19:27:50Z", "pipeline_version": "2.0.0", "presentation_label": "Plavix 75 mg filmcoated tablets Plavix 300 mg filmcoated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "3818c2e3c9979bf5f8be3f164dfce187fccfccf62bbd1e3227c64ca7c00ad02f", "source_snapshot_id": "source-4aff1b64c7cf58337d33ecfa", "source_updated_at": "2025-07-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/plavix-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 99}
{"after": {"end": 269, "start": 0, "text": "La protéinurie a été observée avec le cabozantinib. Les urines doivent être surveillées régulièrement pendant le traitement par cabozantinib pour détecter la présence de protéines. Cabozantinib doit être arrêté chez les patients qui développent un syndrome néphrotique.", "truncated": false}, "after_length": 269, "after_sha256": "341ba226f9eddb830f3946da322ff1b5376d557aaf7c0261d4d98a336d3335cc", "annex": "I", "before": {"end": 269, "start": 0, "text": "La protéinurie a été observée avec le cabozantinib. Les urines doivent être surveillées régulièrement pendant le traitement par cabozantinib pour détecter la présence de protéines. Cabozantinib doit être arrêté chez les patients qui développent un syndrome néphrotique.", "truncated": false}, "before_length": 269, "before_sha256": "341ba226f9eddb830f3946da322ff1b5376d557aaf7c0261d4d98a336d3335cc", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03b884fd9af593248a3b4ec5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002640", "medicine_name": "Cometriq", "medicine_slug": "cometriq", "observed_at": "2026-10-12T19:00:55Z", "pipeline_version": "2.0.0", "presentation_label": "COMETRIQ 20 mg, gélules COMETRIQ 80 mg, gélules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "c7f8aa8da9127064263770c4aed5506128bacd0c40693b863c48a757d735203e", "source_snapshot_id": "source-e4fa0b9c95a2e427d4c95a33", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/cometriq-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 153}
{"after": {"end": 54, "start": 0, "text": "aa Includes dermatitis and immune-mediated dermatitis.", "truncated": false}, "after_length": 54, "after_sha256": "abebd6d391dbf3d5031d2e14dd3950767116c0c1a9a88a5382f8e3a43d15b2bd", "annex": "I", "before": {"end": 54, "start": 0, "text": "aa Includes dermatitis and immune-mediated dermatitis.", "truncated": false}, "before_length": 54, "before_sha256": "abebd6d391dbf3d5031d2e14dd3950767116c0c1a9a88a5382f8e3a43d15b2bd", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03c1700715bb99872124ffba", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006016", "medicine_name": "Imjudo", "medicine_slug": "imjudo", "observed_at": "2026-10-12T19:16:15Z", "pipeline_version": "2.0.0", "presentation_label": "IMJUDO 20 mg/ml concentrate for solution for infusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "82f0e8242ee995348d54ec34bfb83b1be80ea917a347d059c060033f40386298", "source_snapshot_id": "source-91efe2c3ce20ff3bf6cd2173", "source_updated_at": "2025-08-14", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imjudo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 930}
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{"after": {"end": 834, "start": 0, "text": "Parmi les 104 patients initialement randomisés pour recevoir l’aprémilast 30 mg deux fois par jour, 75 patients (environ 72 %) ont continué à suivre ce traitement à la semaine 64. Une réduction significative du nombre moyen d’ulcères buccaux et de la douleur liée aux ulcères buccaux a été observée dans le groupe de traitement de l’aprémilast 30 mg deux fois par jour comparativement au groupe de traitement du placebo à chaque visite, dès la semaine 1, jusqu’à la semaine 12 pour le nombre d’ulcères buccaux (p ≤ 0,0015) et pour la douleur liée aux ulcères buccaux (p ≤ 0,0035). Chez les patients qui ont été traités de façon continue avec l’aprémilast et qui sont restés dans l’étude, les améliorations des ulcères buccaux et la réduction de la douleur des ulcères buccaux se sont maintenues jusqu’à la semaine 64 (figures 3 et 4).", "truncated": false}, "after_length": 834, "after_sha256": "173038631c3ded1c1124fad79d96e1769d0f013575284885266f482db1a16d66", "annex": "I", "before": {"end": 834, "start": 0, "text": "Parmi les 104 patients initialement randomisés pour recevoir l’aprémilast 30 mg deux fois par jour, 75 patients (environ 72 %) ont continué à suivre ce traitement à la semaine 64. Une réduction significative du nombre moyen d’ulcères buccaux et de la douleur liée aux ulcères buccaux a été observée dans le groupe de traitement de l’aprémilast 30 mg deux fois par jour comparativement au groupe de traitement du placebo à chaque visite, dès la semaine 1, jusqu’à la semaine 12 pour le nombre d’ulcères buccaux (p ≤ 0,0015) et pour la douleur liée aux ulcères buccaux (p ≤ 0,0035). Chez les patients qui ont été traités de façon continue avec l’aprémilast et qui sont restés dans l’étude, les améliorations des ulcères buccaux et la réduction de la douleur des ulcères buccaux se sont maintenues jusqu’à la semaine 64 (figures 3 et 4).", "truncated": false}, "before_length": 834, "before_sha256": "173038631c3ded1c1124fad79d96e1769d0f013575284885266f482db1a16d66", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0a2797d266020791484305f5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:31Z", "pipeline_version": "2.0.0", "presentation_label": "Otezla 10 mg comprimés pelliculés Otezla 20 mg comprimés pelliculés Otezla 30 mg comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "9ac80b0d56ebad4970f7a8335a177613af59ef25517bcd0bdd3397c207cc1bac", "source_snapshot_id": "source-c11aa9e32420f125a88005bc", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 965}
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{"after": {"end": 134, "start": 0, "text": "L’exposition accidentelle à l’éladocagène exuparvovec, y compris le contact avec la peau, les yeux et les muqueuses, doit être évitée.", "truncated": false}, "after_length": 134, "after_sha256": "393b922c0bb6756681a3df3b4b348ed7b85516d9bde7def4ea2f4037c164a3bf", "annex": "I", "before": {"end": 134, "start": 0, "text": "L’exposition accidentelle à l’éladocagène exuparvovec, y compris le contact avec la peau, les yeux et les muqueuses, doit être évitée.", "truncated": false}, "before_length": 134, "before_sha256": "393b922c0bb6756681a3df3b4b348ed7b85516d9bde7def4ea2f4037c164a3bf", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0b4d519919981e8d9a971543", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005352", "medicine_name": "Upstaza", "medicine_slug": "upstaza", "observed_at": "2026-10-12T13:36:09Z", "pipeline_version": "2.0.0", "presentation_label": "Upstaza 2,8 × 1011 génomes de vecteur (vg)/0,5 mL, solution pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "42d7861913c7c415a9acf1067eeb3f9f1287a4e4718affc1402af95754bd6fed", "source_snapshot_id": "source-1e1e567efddae34509b5de34", "source_updated_at": "2026-06-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/upstaza-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 466}
{"after": {"end": 554, "start": 0, "text": "Des complications des plaies ont été observées avec le cabozantinib. Dans la mesure du possible, le traitement par cabozantinib doit être arrêté au moins 28 jours avant une chirurgie programmée, y compris une chirurgie dentaire ou des soins dentaires invasifs. La décision de réinstaurer la thérapie par cabozantinib après la chirurgie doit être basée sur le jugement clinique d’une cicatrisation adéquate des plaies. Cabozantinib doit être arrêté chez les patients qui présentent des complications de cicatrisation nécessitant une intervention médicale.", "truncated": false}, "after_length": 554, "after_sha256": "73d3a8c2a663cccbf0be65193ed27b6be4d8fa46417d94fc45a0fa18b9cde8a1", "annex": "I", "before": {"end": 554, "start": 0, "text": "Des complications des plaies ont été observées avec le cabozantinib. Dans la mesure du possible, le traitement par cabozantinib doit être arrêté au moins 28 jours avant une chirurgie programmée, y compris une chirurgie dentaire ou des soins dentaires invasifs. La décision de réinstaurer la thérapie par cabozantinib après la chirurgie doit être basée sur le jugement clinique d’une cicatrisation adéquate des plaies. Cabozantinib doit être arrêté chez les patients qui présentent des complications de cicatrisation nécessitant une intervention médicale.", "truncated": false}, "before_length": 554, "before_sha256": "73d3a8c2a663cccbf0be65193ed27b6be4d8fa46417d94fc45a0fa18b9cde8a1", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0b4e462f6a4c9c641c444605", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002640", "medicine_name": "Cometriq", "medicine_slug": "cometriq", "observed_at": "2026-10-12T19:00:55Z", "pipeline_version": "2.0.0", "presentation_label": "COMETRIQ 20 mg, gélules COMETRIQ 80 mg, gélules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "c7f8aa8da9127064263770c4aed5506128bacd0c40693b863c48a757d735203e", "source_snapshot_id": "source-e4fa0b9c95a2e427d4c95a33", "source_updated_at": "2026-02-27", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/cometriq-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 138}
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{"after": {"end": 181, "start": 0, "text": "NovoRapid dosing is individual and determined in accordance with the needs of the patient. It should normally be used in combination with intermediate-acting or long-acting insulin.", "truncated": false}, "after_length": 181, "after_sha256": "dfffe85ef33a8318762a383654c53371d58646bd627499a4b256425b1fb017df", "annex": "I", "before": {"end": 181, "start": 0, "text": "NovoRapid dosing is individual and determined in accordance with the needs of the patient. It should normally be used in combination with intermediate-acting or long-acting insulin.", "truncated": false}, "before_length": 181, "before_sha256": "dfffe85ef33a8318762a383654c53371d58646bd627499a4b256425b1fb017df", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0bc3b0c4896b50177bae8b75", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000258", "medicine_name": "NovoRapid", "medicine_slug": "novorapid", "observed_at": "2026-10-12T19:05:17Z", "pipeline_version": "2.0.0", "presentation_label": "NovoRapid 100 units/ml solution for injection in vial NovoRapid Penfill 100 units/ml solution for injection in cartridge NovoRapid FlexPen 100 units/ml solution for injection in pre-filled pen NovoRapid InnoLet 100 units/ml solution for injection in pre-filled pen NovoRapid FlexTouch 100 units/ml so", "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": "1f523a448c243ca0c7f4a7a256aecf542f6d2937ca52c9e9a8051cbe652ac962", "source_snapshot_id": "source-a33d4e91086c5c029de837c3", "source_updated_at": "2025-10-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/novorapid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 76}
{"after": {"end": 625, "start": 0, "text": "In 8 adult subjects with severe renal impairment to whom a single dose of 30 mg apremilast was administered, the AUC and Cmax of apremilast increased by approximately 89% and 42%, respectively. The dose of apremilast should be reduced to 30 mg once daily in adult patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2 or CLcr < 30 mL/min). In paediatric patients 6 years of age and older with severe renal impairment, the dose of apremilast should be reduced to 30 mg once daily for children who weigh at least 50 kg and to 20 mg once daily for children who weigh 20 kg to less than 50 kg (see section 4.2).", "truncated": false}, "after_length": 625, "after_sha256": "1db64ab3d3238e6326203b346784da633d82e9cc7d8171a518dda734dff87aea", "annex": "I", "before": {"end": 625, "start": 0, "text": "In 8 adult subjects with severe renal impairment to whom a single dose of 30 mg apremilast was administered, the AUC and Cmax of apremilast increased by approximately 89% and 42%, respectively. The dose of apremilast should be reduced to 30 mg once daily in adult patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2 or CLcr < 30 mL/min). In paediatric patients 6 years of age and older with severe renal impairment, the dose of apremilast should be reduced to 30 mg once daily for children who weigh at least 50 kg and to 20 mg once daily for children who weigh 20 kg to less than 50 kg (see section 4.2).", "truncated": false}, "before_length": 625, "before_sha256": "1db64ab3d3238e6326203b346784da633d82e9cc7d8171a518dda734dff87aea", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0bcf84974f78fcf567be1a03", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:30Z", "pipeline_version": "2.0.0", "presentation_label": "Otezla 10 mg film-coated tablets Otezla 20 mg film-coated tablets Otezla 30 mg film-coated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "35ab6716aa09492c14ac6849111486ec47235c0bc65ef055350de950f316c5e6", "source_snapshot_id": "source-f20a60110d1f8fef5225317d", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 944}
{"after": {"end": 580, "start": 0, "text": "La sécurité et l’efficacité de l’aprémilast ont été évaluées dans trois études multicentriques randomisées en double aveugle, contrôlées versus placebo (études PALACE 1, PALACE 2 et PALACE 3) menées selon la même méthodologie chez des patients adultes atteints de RP actif (≥ 3 articulations gonflées et ≥ 3 articulations douloureuses) malgré un traitement de fond antérieur par une petite molécule ou un agent biologique (DMARDs). Au total, 1 493 patients ont été randomisés et ont reçu soit le placebo, l’aprémilast 20 mg ou l’aprémilast 30 mg par voie orale deux fois par jour.", "truncated": false}, "after_length": 580, "after_sha256": "6effdaf06b9116f5d03a9e3b34c3371aa7d050bcd6f2a1af1d38facb3f9c8409", "annex": "I", "before": {"end": 580, "start": 0, "text": "La sécurité et l’efficacité de l’aprémilast ont été évaluées dans trois études multicentriques randomisées en double aveugle, contrôlées versus placebo (études PALACE 1, PALACE 2 et PALACE 3) menées selon la même méthodologie chez des patients adultes atteints de RP actif (≥ 3 articulations gonflées et ≥ 3 articulations douloureuses) malgré un traitement de fond antérieur par une petite molécule ou un agent biologique (DMARDs). Au total, 1 493 patients ont été randomisés et ont reçu soit le placebo, l’aprémilast 20 mg ou l’aprémilast 30 mg par voie orale deux fois par jour.", "truncated": false}, "before_length": 580, "before_sha256": "6effdaf06b9116f5d03a9e3b34c3371aa7d050bcd6f2a1af1d38facb3f9c8409", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0c0c12ffd52b7eb6af414549", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003746", "medicine_name": "Otezla", "medicine_slug": "otezla", "observed_at": "2026-10-12T19:00:31Z", "pipeline_version": "2.0.0", "presentation_label": "Otezla 10 mg comprimés pelliculés Otezla 20 mg comprimés pelliculés Otezla 30 mg comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "9ac80b0d56ebad4970f7a8335a177613af59ef25517bcd0bdd3397c207cc1bac", "source_snapshot_id": "source-c11aa9e32420f125a88005bc", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/otezla-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 450}
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{"after": {"end": 472, "start": 0, "text": "(162 mg/jour) pendant 28 jours ou jusqu’à la sortie de l’hôpital. Les 2 critères principaux d’évaluation étaient les décès de toutes causes et la 1ère survenue d’un évènement du critère combiné associant récidive d’infarctus, accident vasculaire cérébral ou décès. Dans la population de l’étude 27,8% des patients inclus étaient des femmes, 58,4% des patients avaient 60 ans ou plus (26% avaient 70 ans ou plus) et 54,5% des patients ont reçu un traitement fibrinolytique.", "truncated": false}, "after_length": 472, "after_sha256": "8d32e1f618102c8b438b8c6005d8d2d54a88428b1abd554b93f6667c6e38b803", "annex": "I", "before": {"end": 472, "start": 0, "text": "(162 mg/jour) pendant 28 jours ou jusqu’à la sortie de l’hôpital. Les 2 critères principaux d’évaluation étaient les décès de toutes causes et la 1ère survenue d’un évènement du critère combiné associant récidive d’infarctus, accident vasculaire cérébral ou décès. Dans la population de l’étude 27,8% des patients inclus étaient des femmes, 58,4% des patients avaient 60 ans ou plus (26% avaient 70 ans ou plus) et 54,5% des patients ont reçu un traitement fibrinolytique.", "truncated": false}, "before_length": 472, "before_sha256": "8d32e1f618102c8b438b8c6005d8d2d54a88428b1abd554b93f6667c6e38b803", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0d46db85e0d73917b293d766", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000174", "medicine_name": "Plavix", "medicine_slug": "plavix", "observed_at": "2026-10-12T19:26:25Z", "pipeline_version": "2.0.0", "presentation_label": "Plavix 75 mg comprimés pelliculés Plavix 300 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": "8d1630f20e7a86728cac32eaccf248b0a0e88d4d9a2a9cfa6e6429b883e20247", "source_snapshot_id": "source-77d6cc5bd19bd71f20e22a8e", "source_updated_at": "2025-07-14", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/plavix-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 506}
{"after": {"end": 1298, "start": 0, "text": "A 24-month, randomised, double-blind, comparator-controlled Phase 4 study included 1 360 postmenopausal women with established osteoporosis. 680 subjects were randomised to teriparatide and 680 subjects were randomised to oral risedronate 35 mg/week. At baseline, the women had a mean age of 72.1 years and a median of 2 prevalent vertebral fractures; 57.9% of patients had received previous bisphosphonate therapy and 18.8% took concomitant glucocorticoids during the study. 1 013 (74.5%) patients completed the 24-month follow-up. The mean (median) cumulative dose of glucocorticoid was 474.3 (66.2) mg in the teriparatide arm and 898.0 (100.0) mg in the risedronate arm. The mean (median) vitamin D intake for the teriparatide arm was 1 433 IU/day (1 400 IU/day) and for the risedronate arm was 1 191 IU/day (900 IU/day). For those subjects who had baseline and follow-up spine radiographs, the incidence of new vertebral fractures was 28/516 (5.4%) in teriparatide- and 64/533 (12.0%) in risedronate-treated patients, relative risk (95% CI) = 0.44 (0.29-0.68), p< 0.0001. The cumulative incidence of pooled clinical fractures (clinical vertebral and nonvertebral fractures) was 4.8% in teriparatide and 9.8% in risedronate-treated patients, hazard ratio (95% CI) = 0.48 (0.32-0.74), p = 0.0009.", "truncated": false}, "after_length": 1298, "after_sha256": "9c25c29247cd522498957fb4e7cbf727c721c7ebbccfae5e0a087844fb549c53", "annex": "I", "before": {"end": 1298, "start": 0, "text": "A 24-month, randomised, double-blind, comparator-controlled Phase 4 study included 1 360 postmenopausal women with established osteoporosis. 680 subjects were randomised to teriparatide and 680 subjects were randomised to oral risedronate 35 mg/week. At baseline, the women had a mean age of 72.1 years and a median of 2 prevalent vertebral fractures; 57.9% of patients had received previous bisphosphonate therapy and 18.8% took concomitant glucocorticoids during the study. 1 013 (74.5%) patients completed the 24-month follow-up. The mean (median) cumulative dose of glucocorticoid was 474.3 (66.2) mg in the teriparatide arm and 898.0 (100.0) mg in the risedronate arm. The mean (median) vitamin D intake for the teriparatide arm was 1 433 IU/day (1 400 IU/day) and for the risedronate arm was 1 191 IU/day (900 IU/day). For those subjects who had baseline and follow-up spine radiographs, the incidence of new vertebral fractures was 28/516 (5.4%) in teriparatide- and 64/533 (12.0%) in risedronate-treated patients, relative risk (95% CI) = 0.44 (0.29-0.68), p< 0.0001. The cumulative incidence of pooled clinical fractures (clinical vertebral and nonvertebral fractures) was 4.8% in teriparatide and 9.8% in risedronate-treated patients, hazard ratio (95% CI) = 0.48 (0.32-0.74), p = 0.0009.", "truncated": false}, "before_length": 1298, "before_sha256": "9c25c29247cd522498957fb4e7cbf727c721c7ebbccfae5e0a087844fb549c53", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0d501b7c67627f42c6734bba", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003916", "medicine_name": "Terrosa", "medicine_slug": "terrosa", "observed_at": "2026-10-12T13:39:28Z", "pipeline_version": "2.0.0", "presentation_label": "Terrosa 20 micrograms/80 microliters 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": "124ca3471ef7192c011d303ca5375c8fbd010a74ab7a9d5500fd62987b007d1a", "source_snapshot_id": "source-3efca388cb26b8b5cc1ea4a0", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/terrosa-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 853}
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{"after": {"end": 486, "start": 0, "text": "The half value duration (HVD) values for intranasal administration were longer than for intramuscular administration (intranasal, 2 mg, 1.27h, intramuscular, 0.4 mg 1.09h) from which we can infer a longer duration of action of naloxone given by the intranasal rather than the intramuscular route. If the duration of action of the opioid agonist exceeds that of intranasal naloxone, the effects of the opioid agonist may return, necessitating a second intranasal naloxone administration.", "truncated": false}, "after_length": 486, "after_sha256": "cd0994c9d4dff8dee86fcdcf17f6683c19de5153f85307d562a3f331eebad9c2", "annex": "I", "before": {"end": 486, "start": 0, "text": "The half value duration (HVD) values for intranasal administration were longer than for intramuscular administration (intranasal, 2 mg, 1.27h, intramuscular, 0.4 mg 1.09h) from which we can infer a longer duration of action of naloxone given by the intranasal rather than the intramuscular route. If the duration of action of the opioid agonist exceeds that of intranasal naloxone, the effects of the opioid agonist may return, necessitating a second intranasal naloxone administration.", "truncated": false}, "before_length": 486, "before_sha256": "cd0994c9d4dff8dee86fcdcf17f6683c19de5153f85307d562a3f331eebad9c2", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0e69a2c48a060b89ef04759b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:33Z", "pipeline_version": "2.0.0", "presentation_label": "Nyxoid 1.8 mg nasal spray, solution in singledose container", "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": "21d66bf1e9a74479f577de09da3cf8517d65c1ce1b1d8bbdfe4bc38f79410def", "source_snapshot_id": "source-2c39c998fdaf05159687c016", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 259}
{"after": {"end": 331, "start": 0, "text": "NovoRapid (insuline asparte) peut être utilisé pendant la grossesse. Les données de deux essais cliniques randomisés contrôlés (322 et 27 femmes enceintes exposées) ne montrent pas d’effets délétères de l’insuline asparte sur la grossesse ou sur la santé du fœtus/nouveau-né en comparaison à l’insuline humaine (voir rubrique 5.1).", "truncated": false}, "after_length": 331, "after_sha256": "745acd6f2bc9a232eec7db3320f035f00a91c1ad89df9a5fc13cbe154d36339f", "annex": "I", "before": {"end": 331, "start": 0, "text": "NovoRapid (insuline asparte) peut être utilisé pendant la grossesse. Les données de deux essais cliniques randomisés contrôlés (322 et 27 femmes enceintes exposées) ne montrent pas d’effets délétères de l’insuline asparte sur la grossesse ou sur la santé du fœtus/nouveau-né en comparaison à l’insuline humaine (voir rubrique 5.1).", "truncated": false}, "before_length": 331, "before_sha256": "745acd6f2bc9a232eec7db3320f035f00a91c1ad89df9a5fc13cbe154d36339f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0ebbc7ac556a734c25a51187", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000258", "medicine_name": "NovoRapid", "medicine_slug": "novorapid", "observed_at": "2026-10-12T19:05:20Z", "pipeline_version": "2.0.0", "presentation_label": "NovoRapid 100 unités/ml, solution injectable en flacon NovoRapid Penfill 100 unités/ml, solution injectable en cartouche NovoRapid FlexPen 100 unités/ml, solution injectable en stylo prérempli NovoRapid InnoLet 100 unités/ml, solution injectable en stylo prérempli NovoRapid FlexTouch 100 unités/ml, ", "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": "7a2e275dc85e326e218371029d27a1433946e84b3ea473376b27254ac744b108", "source_snapshot_id": "source-a7dd2dd81f4bb5f7de078b9c", "source_updated_at": "2025-10-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/novorapid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 248}
{"after": {"end": 672, "start": 0, "text": "Un nombre de leucocytes égal ou supérieur à 100 x 109/L a été observé chez moins de 1 % des sujets recevant pegfilgrastim. Aucun effet indésirable directement attribuable à ce niveau de leucocytose n’a été rapporté. Une telle élévation de leucocytes est transitoire, spécifiquement observée 24 à 48 heures après l’administration et conforme aux effets pharmacodynamiques de ce médicament. Compte tenu des effets cliniques et du potentiel de leucocytose, une numération leucocytaire doit être réalisée à intervalles réguliers pendant le traitement. Si, après la date prévue du nadir, le nombre de leucocytes dépasse 50 x 109/L, ce médicament doit être arrêté immédiatement.", "truncated": false}, "after_length": 672, "after_sha256": "f51ffc058efb5690447b2860045ba8a1259e7fc427986d92931f716088f5cdfc", "annex": "I", "before": {"end": 672, "start": 0, "text": "Un nombre de leucocytes égal ou supérieur à 100 x 109/L a été observé chez moins de 1 % des sujets recevant pegfilgrastim. Aucun effet indésirable directement attribuable à ce niveau de leucocytose n’a été rapporté. Une telle élévation de leucocytes est transitoire, spécifiquement observée 24 à 48 heures après l’administration et conforme aux effets pharmacodynamiques de ce médicament. Compte tenu des effets cliniques et du potentiel de leucocytose, une numération leucocytaire doit être réalisée à intervalles réguliers pendant le traitement. Si, après la date prévue du nadir, le nombre de leucocytes dépasse 50 x 109/L, ce médicament doit être arrêté immédiatement.", "truncated": false}, "before_length": 672, "before_sha256": "f51ffc058efb5690447b2860045ba8a1259e7fc427986d92931f716088f5cdfc", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0ed8202c775f18f7255009c2", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004700", "medicine_name": "Pelmeg", "medicine_slug": "pelmeg", "observed_at": "2026-10-12T13:47:36Z", "pipeline_version": "2.0.0", "presentation_label": "Pelmeg 6 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": "b2be0edbf6bc3269641de1889e40a199aac2620ad26bd538c7d647e7fd351f7a", "source_snapshot_id": "source-c0cfff56629ca53898dd4709", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pelmeg-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 138}
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{"after": {"end": 197, "start": 0, "text": "Opioid withdrawal may be lifethreatening in neonates if not recognised and properly treated and may include the following signs and symptoms: convulsions, excessive crying and hyperactive reflexes.", "truncated": false}, "after_length": 197, "after_sha256": "c112e23f25e239d28a638d93dc05e39b8f80efb1bf7c439c1a67337eaffef917", "annex": "I", "before": {"end": 197, "start": 0, "text": "Opioid withdrawal may be lifethreatening in neonates if not recognised and properly treated and may include the following signs and symptoms: convulsions, excessive crying and hyperactive reflexes.", "truncated": false}, "before_length": 197, "before_sha256": "c112e23f25e239d28a638d93dc05e39b8f80efb1bf7c439c1a67337eaffef917", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0f17f6a91ea3efaa112458b6", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004325", "medicine_name": "Nyxoid", "medicine_slug": "nyxoid", "observed_at": "2026-10-12T19:36:33Z", "pipeline_version": "2.0.0", "presentation_label": "Nyxoid 1.8 mg nasal spray, solution in singledose container", "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": "21d66bf1e9a74479f577de09da3cf8517d65c1ce1b1d8bbdfe4bc38f79410def", "source_snapshot_id": "source-2c39c998fdaf05159687c016", "source_updated_at": "2025-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nyxoid-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 115}
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