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{"after": {"end": 1244, "start": 0, "text": "Efficacy and safety of 120 mg denosumab SC every 4 weeks or 4 mg zoledronic acid (dose-adjusted for reduced renal function) IV every 4 weeks were compared in three randomised, double-blind, active-controlled studies, in IV-bisphosphonate naïve patients with advanced malignancies involving bone: adults with breast cancer (study 1), other solid tumours or multiple myeloma (study 2), and castrate-resistant prostate cancer (study 3). Within these active-controlled clinical trials, safety was evaluated in 5,931 patients. Patients with prior history of ONJ or osteomyelitis of the jaw, an active dental or jaw condition requiring oral surgery, non-healed dental/oral surgery, or any planned invasive dental procedure, were not eligible for inclusion in these studies. The primary and secondary endpoints evaluated the occurrence of one or more skeletal related events (SREs). In studies demonstrating superiority of denosumab to zoledronic acid, patients were offered open-label denosumab in a pre-specified 2-year extension treatment phase. An SRE was defined as any of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression.", "truncated": false}, "after_length": 1244, "after_sha256": "37ef927f6dd1e0302c237ad3b08cb85d0e01138a67ab091ef6abb165561a4518", "annex": "I", "before": {"end": 1244, "start": 0, "text": "Efficacy and safety of 120 mg denosumab SC every 4 weeks or 4 mg zoledronic acid (dose-adjusted for reduced renal function) IV every 4 weeks were compared in three randomised, double-blind, active-controlled studies, in IV-bisphosphonate naïve patients with advanced malignancies involving bone: adults with breast cancer (study 1), other solid tumours or multiple myeloma (study 2), and castrate-resistant prostate cancer (study 3). Within these active-controlled clinical trials, safety was evaluated in 5,931 patients. Patients with prior history of ONJ or osteomyelitis of the jaw, an active dental or jaw condition requiring oral surgery, non-healed dental/oral surgery, or any planned invasive dental procedure, were not eligible for inclusion in these studies. The primary and secondary endpoints evaluated the occurrence of one or more skeletal related events (SREs). In studies demonstrating superiority of denosumab to zoledronic acid, patients were offered open-label denosumab in a pre-specified 2-year extension treatment phase. An SRE was defined as any of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression.", "truncated": false}, "before_length": 1244, "before_sha256": "37ef927f6dd1e0302c237ad3b08cb85d0e01138a67ab091ef6abb165561a4518", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0024e653c4035486b7e20766", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006199", "medicine_name": "Denbrayce", "medicine_slug": "denbrayce", "observed_at": "2026-10-12T17:30:39Z", "pipeline_version": "2.0.0", "presentation_label": "Denbrayce 120 mg 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": "7aec92539e38d6a35a948dd8af777fe2fa290d7c53f1bc8753c739d81fc9d6af", "source_snapshot_id": "source-c7f1d27d710651a01c0c1c6a", "source_updated_at": "2025-11-24", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/denbrayce-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 387}
{"after": {"end": 347, "start": 0, "text": "Une diminution de grade 3 de la calcémie a été observée chez 2,5 % des patients traités par le dénosumab et chez 1,2 % des patients traités par acide zolédronique. Une diminution de grade 4 de la calcémie a été observée chez 0,6 % des patients traités par le dénosumab et chez 0,2 % des patients traités par acide zolédronique (voir rubrique 4.4).", "truncated": false}, "after_length": 347, "after_sha256": "f1a78902091af3858be537cbbc38e565ed0459efbf37882324a64de85ab393b3", "annex": "I", "before": {"end": 347, "start": 0, "text": "Une diminution de grade 3 de la calcémie a été observée chez 2,5 % des patients traités par le dénosumab et chez 1,2 % des patients traités par acide zolédronique. Une diminution de grade 4 de la calcémie a été observée chez 0,6 % des patients traités par le dénosumab et chez 0,2 % des patients traités par acide zolédronique (voir rubrique 4.4).", "truncated": false}, "before_length": 347, "before_sha256": "f1a78902091af3858be537cbbc38e565ed0459efbf37882324a64de85ab393b3", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00292f7487c981962bd3fbe7", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006199", "medicine_name": "Denbrayce", "medicine_slug": "denbrayce", "observed_at": "2026-10-12T17:30:41Z", "pipeline_version": "2.0.0", "presentation_label": "Denbrayce 120 mg 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": "f51ec503f06d59511692af7270ce02849f960a5c46c54a26062e8d75d770e1d9", "source_snapshot_id": "source-83c0fdc326769f6bc39fbc44", "source_updated_at": "2025-11-24", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/denbrayce-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 294}
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{"after": {"end": 629, "start": 0, "text": "Des analyses PK de population ont été effectuées chez des patients atteints de myélome multiple traités par DARZALEX administré par voie sous-cutanée en monothérapie ou dans diverses associations chez des patients atteints de myélome multiple et d’amylose AL. Aucune différence cliniquement importante en termes d’exposition au daratumumab n’a été observée entre les patients ayant une fonction hépatique normale et ceux atteints d’insuffisance hépatique légère. Les patients atteints d’insuffisance hépatique modérée à sévère étaient trop peu nombreux pour permettre de tirer des conclusions significatives pour ces populations.", "truncated": false}, "after_length": 629, "after_sha256": "6dc24273e45197258e410c3791f7cbf954d9a38650160e890d44034c010f8f1a", "annex": "I", "before": {"end": 629, "start": 0, "text": "Des analyses PK de population ont été effectuées chez des patients atteints de myélome multiple traités par DARZALEX administré par voie sous-cutanée en monothérapie ou dans diverses associations chez des patients atteints de myélome multiple et d’amylose AL. Aucune différence cliniquement importante en termes d’exposition au daratumumab n’a été observée entre les patients ayant une fonction hépatique normale et ceux atteints d’insuffisance hépatique légère. Les patients atteints d’insuffisance hépatique modérée à sévère étaient trop peu nombreux pour permettre de tirer des conclusions significatives pour ces populations.", "truncated": false}, "before_length": 629, "before_sha256": "6dc24273e45197258e410c3791f7cbf954d9a38650160e890d44034c010f8f1a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01067f9222dea43be10c52f2", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004077", "medicine_name": "Darzalex", "medicine_slug": "darzalex", "observed_at": "2026-10-12T19:04:45Z", "pipeline_version": "2.0.0", "presentation_label": "DARZALEX 1800 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": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "ca7cec9127a023f1d64c4a23c66b64befc174186e07b1c71ff1195cffd627a2d", "source_snapshot_id": "source-a448ba148103c6e4f8bfa602", "source_updated_at": "2025-10-27", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/darzalex-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2965}
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{"after": {"end": 388, "start": 0, "text": "The adverse reactions are listed by system organ class and frequency using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.", "truncated": false}, "after_length": 388, "after_sha256": "ee807cc21e56029b9cc213f6eb97707dca082c8f5e0dbbc86de64d757f9932d8", "annex": "I", "before": {"end": 388, "start": 0, "text": "The adverse reactions are listed by system organ class and frequency using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.", "truncated": false}, "before_length": 388, "before_sha256": "ee807cc21e56029b9cc213f6eb97707dca082c8f5e0dbbc86de64d757f9932d8", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0132ad2c5a3b9c2686726a75", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000715", "medicine_name": "Lucentis", "medicine_slug": "lucentis", "observed_at": "2026-10-12T12:55:10Z", "pipeline_version": "2.0.0", "presentation_label": "Lucentis 10 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": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "612293565adc0504c607d89baf03ff2fc1b364a1fa3d139f8647ac4ebe52cf1b", "source_snapshot_id": "source-bb1b3bad89ae8fb8d3480e7d", "source_updated_at": "2026-10-08", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/lucentis-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 246}
{"after": {"end": 50, "start": 0, "text": "Table 2 Fracture incidence in postmenopausal women", "truncated": false}, "after_length": 50, "after_sha256": "dc07ed560eae6111294efbddc6868fc5113807274970b6acdd38349a67d91cd9", "annex": "I", "before": {"end": 50, "start": 0, "text": "Table 2 Fracture incidence in postmenopausal women", "truncated": false}, "before_length": 50, "before_sha256": "dc07ed560eae6111294efbddc6868fc5113807274970b6acdd38349a67d91cd9", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-013e626b15b0c40ac93df46c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005793", "medicine_name": "Teriparatide Sun", "medicine_slug": "teriparatide-sun", "observed_at": "2026-10-12T19:05:41Z", "pipeline_version": "2.0.0", "presentation_label": "Teriparatide SUN 20 micrograms/80 microliters solution for injection in pre-filled pen", "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": "e990fae050964facd21ce7ae0109adc633aa02622a0c275b8a736f4a8c13cd01", "source_snapshot_id": "source-2347d5a94b07194fbdc46b4e", "source_updated_at": "2025-10-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/teriparatide-sun-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 326}
{"after": {"end": 160, "start": 0, "text": "Comprimés oblongs (19 mm de longueur et 8,1 mm de largeur) de couleur jaune à orange, avec la mention en creux « ibr » sur une face et « 560 » sur l’autre face.", "truncated": false}, "after_length": 160, "after_sha256": "7964efcfa9aafb41c16a99a191e59265444147e0e0f1606a2cf4b7cc9658ca28", "annex": "I", "before": {"end": 160, "start": 0, "text": "Comprimés oblongs (19 mm de longueur et 8,1 mm de largeur) de couleur jaune à orange, avec la mention en creux « ibr » sur une face et « 560 » sur l’autre face.", "truncated": false}, "before_length": 160, "before_sha256": "7964efcfa9aafb41c16a99a191e59265444147e0e0f1606a2cf4b7cc9658ca28", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-014347fa22493ad26beb9725", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003791", "medicine_name": "Imbruvica", "medicine_slug": "imbruvica", "observed_at": "2026-10-12T19:04:40Z", "pipeline_version": "2.0.0", "presentation_label": "IMBRUVICA 140 mg comprimés pelliculés IMBRUVICA 280 mg comprimés pelliculés IMBRUVICA 420 mg comprimés pelliculés IMBRUVICA 560 mg 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": "3", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "4b0b32ce32024a965e4ce48fb2cbdea69dafe9803472bdd5e64e2c6b939c8445", "source_snapshot_id": "source-2f9ae65220663d4e0dbb5c63", "source_updated_at": "2025-10-27", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/imbruvica-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2084}
{"after": {"end": 191, "start": 0, "text": "Avant administration, la solution doit être inspectée. Ne pas injecter la solution si celle-ci contient des particules visibles ou si elle est trouble ou présente un changement de coloration.", "truncated": false}, "after_length": 191, "after_sha256": "ed370cbf03c2cc5ee76f3f315a8d238fb05224ddadbc3dbbaed6d0bb47fd0621", "annex": "I", "before": {"end": 191, "start": 0, "text": "Avant administration, la solution doit être inspectée. Ne pas injecter la solution si celle-ci contient des particules visibles ou si elle est trouble ou présente un changement de coloration.", "truncated": false}, "before_length": 191, "before_sha256": "ed370cbf03c2cc5ee76f3f315a8d238fb05224ddadbc3dbbaed6d0bb47fd0621", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0144ef6cc990ed9a21d75fc7", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006156", "medicine_name": "Stoboclo", "medicine_slug": "stoboclo", "observed_at": "2026-10-12T19:08:48Z", "pipeline_version": "2.0.0", "presentation_label": "Stoboclo 60 mg solution injectable en seringue préremplie", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "333f6c97855028e7dd6c52dd3e41e946d4c139c14aa4b6bab97c81affa0ae504", "source_snapshot_id": "source-6b2f9808dc7b5721775c9280", "source_updated_at": "2025-09-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/stoboclo-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 604}
{"after": {"end": 928, "start": 0, "text": "Dans cette étude, 1 718 patients présentant un myélome multiple avec au moins une lésion osseuse ont été randomisés pour recevoir une administration sous-cutanée de 120 mg de dénosumab toutes les 4 semaines (Q4W) ou une administration intraveineuse (IV) de 4 mg d’acide zolédronique toutes les 4 semaines (dose ajustée à la fonction rénale). Le critère d’évaluation principal était le délai de survenue du premier SRE en analyse de non-infériorité comparé à l’acide zolédronique. Les critères d’évaluation secondaires incluaient le délai de survenue du premier SRE en analyse de supériorité, le délai de survenue du premier SRE et des suivants en analyse de supériorité, et la survie globale. Un SRE est défini comme l’un des événements suivants : une fracture pathologique (vertébrale ou non vertébrale), une radiothérapie osseuse (incluant l’utilisation de radio-isotopes), une chirurgie osseuse ou une compression médullaire.", "truncated": false}, "after_length": 928, "after_sha256": "bcb04a42fc0e54fa0a6eaa49520ac7881a173c500a5451a7e4a976ccb734cbc4", "annex": "I", "before": {"end": 928, "start": 0, "text": "Dans cette étude, 1 718 patients présentant un myélome multiple avec au moins une lésion osseuse ont été randomisés pour recevoir une administration sous-cutanée de 120 mg de dénosumab toutes les 4 semaines (Q4W) ou une administration intraveineuse (IV) de 4 mg d’acide zolédronique toutes les 4 semaines (dose ajustée à la fonction rénale). Le critère d’évaluation principal était le délai de survenue du premier SRE en analyse de non-infériorité comparé à l’acide zolédronique. Les critères d’évaluation secondaires incluaient le délai de survenue du premier SRE en analyse de supériorité, le délai de survenue du premier SRE et des suivants en analyse de supériorité, et la survie globale. Un SRE est défini comme l’un des événements suivants : une fracture pathologique (vertébrale ou non vertébrale), une radiothérapie osseuse (incluant l’utilisation de radio-isotopes), une chirurgie osseuse ou une compression médullaire.", "truncated": false}, "before_length": 928, "before_sha256": "bcb04a42fc0e54fa0a6eaa49520ac7881a173c500a5451a7e4a976ccb734cbc4", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-014be86ea36cc14a4396714f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006199", "medicine_name": "Denbrayce", "medicine_slug": "denbrayce", "observed_at": "2026-10-12T17:30:41Z", "pipeline_version": "2.0.0", "presentation_label": "Denbrayce 120 mg 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": "f51ec503f06d59511692af7270ce02849f960a5c46c54a26062e8d75d770e1d9", "source_snapshot_id": "source-83c0fdc326769f6bc39fbc44", "source_updated_at": "2025-11-24", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/denbrayce-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 716}
{"after": {"end": 480, "start": 0, "text": "The safety of amlodipine/valsartan has been evaluated in five controlled clinical studies with 5,175 patients, 2,613 of whom received valsartan in combination with amlodipine. The following adverse reactions were found to be the most frequently occurring or the most significant or severe: nasopharyngitis, influenza, hypersensitivity, headache, syncope, orthostatic hypotension, oedema, pitting oedema, facial oedema, oedema peripheral, fatigue, flushing, asthenia and hot flush.", "truncated": false}, "after_length": 480, "after_sha256": "c4daed0d367a1394d11587ee3b64565df4eb507609740ca1377fcb0515f1ecb6", "annex": "I", "before": {"end": 480, "start": 0, "text": "The safety of amlodipine/valsartan has been evaluated in five controlled clinical studies with 5,175 patients, 2,613 of whom received valsartan in combination with amlodipine. The following adverse reactions were found to be the most frequently occurring or the most significant or severe: nasopharyngitis, influenza, hypersensitivity, headache, syncope, orthostatic hypotension, oedema, pitting oedema, facial oedema, oedema peripheral, fatigue, flushing, asthenia and hot flush.", "truncated": false}, "before_length": 480, "before_sha256": "c4daed0d367a1394d11587ee3b64565df4eb507609740ca1377fcb0515f1ecb6", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-014f1e914bbc21c5608f8709", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004037", "medicine_name": "Amlodipine / Valsartan Mylan", "medicine_slug": "amlodipine-valsartan-mylan", "observed_at": "2026-10-12T13:35:38Z", "pipeline_version": "2.0.0", "presentation_label": "Amlodipine/Valsartan Mylan 5 mg/80 mg film-coated tablets Amlodipine/Valsartan Mylan 5 mg/160 mg film-coated tablets Amlodipine/Valsartan Mylan 10 mg/160 mg film-coated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "dbb2d241391f1842fbe2af8d495fce7a68c0dd1274b21dbba2b09bd9bc167702", "source_snapshot_id": "source-11d0beb027751f1d533d1385", "source_updated_at": "2026-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/amlodipine-valsartan-mylan-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 306}
{"after": {"end": 230, "start": 0, "text": "La sécurité et l’efficacité de XGEVA n’ont pas été établies dans la population pédiatrique (âge < 18 ans), excepté chez les adolescents (âgés de 12 à 17 ans) à maturité squelettique atteints de tumeurs osseuses à cellules géantes.", "truncated": false}, "after_length": 230, "after_sha256": "ca657ca4c92858463d85441754bdbe482de2ad67e216a40d9468ace77bdf95e8", "annex": "I", "before": {"end": 230, "start": 0, "text": "La sécurité et l’efficacité de XGEVA n’ont pas été établies dans la population pédiatrique (âge < 18 ans), excepté chez les adolescents (âgés de 12 à 17 ans) à maturité squelettique atteints de tumeurs osseuses à cellules géantes.", "truncated": false}, "before_length": 230, "before_sha256": "ca657ca4c92858463d85441754bdbe482de2ad67e216a40d9468ace77bdf95e8", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-014f7ea6696a86da4e455a74", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002173", "medicine_name": "Xgeva", "medicine_slug": "xgeva", "observed_at": "2026-10-12T13:34:02Z", "pipeline_version": "2.0.0", "presentation_label": "XGEVA 120 mg solution injectable XGEVA 120 mg solution injectable en seringue préremplie", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "47551aac60917b2ed3f8c2e52c27dd3450c19003b7f0c7922ab6afa6357572e5", "source_snapshot_id": "source-a91ac33cdc893a4fbfb3ad37", "source_updated_at": "2026-06-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xgeva-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 94}
{"after": {"end": 561, "start": 0, "text": "There are no data available on the use of lamivudine in children with renal impairment. Based on the assumption that creatinine clearance and lamivudine clearance are correlated similarly in children as in adults; it is recommended that the dosage in children with renal impairment be reduced according to their creatinine clearance by the same proportion as in adults. The Epivir 10 mg/mL oral solution may be the most appropriate formulation to achieve the recommended dose in children with renal impairment aged at least 3 months and weighing less than 25kg.", "truncated": false}, "after_length": 561, "after_sha256": "b71e084536ffbe566f3a16226eae7d70add5a49ed9e6a4ab6ef4bafddf4c9dc9", "annex": "I", "before": {"end": 561, "start": 0, "text": "There are no data available on the use of lamivudine in children with renal impairment. Based on the assumption that creatinine clearance and lamivudine clearance are correlated similarly in children as in adults; it is recommended that the dosage in children with renal impairment be reduced according to their creatinine clearance by the same proportion as in adults. The Epivir 10 mg/mL oral solution may be the most appropriate formulation to achieve the recommended dose in children with renal impairment aged at least 3 months and weighing less than 25kg.", "truncated": false}, "before_length": 561, "before_sha256": "b71e084536ffbe566f3a16226eae7d70add5a49ed9e6a4ab6ef4bafddf4c9dc9", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01527e76aa88bb5d0852bf47", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000107", "medicine_name": "Epivir", "medicine_slug": "epivir", "observed_at": "2026-10-12T13:28:26Z", "pipeline_version": "2.0.0", "presentation_label": "Epivir 10 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": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "0719999535f36d1593098041092a62a85b74621a9bc5998fad6b31917f9b03b2", "source_snapshot_id": "source-633d511d05f1fff2eb0de73a", "source_updated_at": "2026-08-20", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/epivir-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 742}
{"after": {"end": 1125, "start": 0, "text": "Daratumumab has been shown to potently inhibit the in vivo growth of CD38expressing tumour cells. Based on in vitro studies, daratumumab may utilise multiple effector functions, resulting in immune mediated tumour cell death. These studies suggest that daratumumab can induce tumour cell lysis through complementdependent cytotoxicity, antibodydependent cellmediated cytotoxicity, and antibodydependent cellular phagocytosis in malignancies expressing CD38. A subset of myeloid derived suppressor cells (CD38+MDSCs), regulatory T cells (CD38+Tregs) and B cells (CD38+Bregs) are decreased by daratumumab mediated cell lysis. T cells (CD3+, CD4+, and CD8+) are also known to express CD38 depending on the stage of development and the level of activation. Significant increases in CD4+ and CD8+ T cell absolute counts, and percentages of lymphocytes, were observed with daratumumab treatment in peripheral whole blood and bone marrow. In addition, Tcell receptor DNA sequencing verified that Tcell clonality was increased with daratumumab treatment, indicating immune modulatory effects that may contribute to clinical response.", "truncated": false}, "after_length": 1125, "after_sha256": "ac18716e5af136e683754080678177c2e9068e5329152ccbff62d7bab29da2b3", "annex": "I", "before": {"end": 1125, "start": 0, "text": "Daratumumab has been shown to potently inhibit the in vivo growth of CD38expressing tumour cells. Based on in vitro studies, daratumumab may utilise multiple effector functions, resulting in immune mediated tumour cell death. These studies suggest that daratumumab can induce tumour cell lysis through complementdependent cytotoxicity, antibodydependent cellmediated cytotoxicity, and antibodydependent cellular phagocytosis in malignancies expressing CD38. A subset of myeloid derived suppressor cells (CD38+MDSCs), regulatory T cells (CD38+Tregs) and B cells (CD38+Bregs) are decreased by daratumumab mediated cell lysis. T cells (CD3+, CD4+, and CD8+) are also known to express CD38 depending on the stage of development and the level of activation. Significant increases in CD4+ and CD8+ T cell absolute counts, and percentages of lymphocytes, were observed with daratumumab treatment in peripheral whole blood and bone marrow. In addition, Tcell receptor DNA sequencing verified that Tcell clonality was increased with daratumumab treatment, indicating immune modulatory effects that may contribute to clinical response.", "truncated": false}, "before_length": 1125, "before_sha256": "ac18716e5af136e683754080678177c2e9068e5329152ccbff62d7bab29da2b3", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-015484a8e7424248cdc22e8e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004077", "medicine_name": "Darzalex", "medicine_slug": "darzalex", "observed_at": "2026-10-12T19:04:42Z", "pipeline_version": "2.0.0", "presentation_label": "DARZALEX 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8c36ebbab8d2aa40602da934a729cc4f66032e3fc0f846c0bd7d789721c39d9a", "source_snapshot_id": "source-d8c400cd5cb9c5e2404ceb92", "source_updated_at": "2025-10-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/darzalex-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 675}
{"after": {"end": 226, "start": 0, "text": "Une médication pré et post-injection doit être administrée afin de réduire le risque de réactions liées à la perfusion (RLP) associé au daratumumab. Voir « Traitements concomitants recommandés », et la rubrique 4.4 ci-dessous.", "truncated": false}, "after_length": 226, "after_sha256": "fd41a5ec0747651f05c2eb0c8130beeeaa5ab12d1d2bb3f6894a224b5517ecb0", "annex": "I", "before": {"end": 226, "start": 0, "text": "Une médication pré et post-injection doit être administrée afin de réduire le risque de réactions liées à la perfusion (RLP) associé au daratumumab. Voir « Traitements concomitants recommandés », et la rubrique 4.4 ci-dessous.", "truncated": false}, "before_length": 226, "before_sha256": "fd41a5ec0747651f05c2eb0c8130beeeaa5ab12d1d2bb3f6894a224b5517ecb0", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0157fbc75da5682616087e49", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004077", "medicine_name": "Darzalex", "medicine_slug": "darzalex", "observed_at": "2026-10-12T19:04:45Z", "pipeline_version": "2.0.0", "presentation_label": "DARZALEX 1800 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": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "ca7cec9127a023f1d64c4a23c66b64befc174186e07b1c71ff1195cffd627a2d", "source_snapshot_id": "source-a448ba148103c6e4f8bfa602", "source_updated_at": "2025-10-27", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/darzalex-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1284}
{"after": {"end": 565, "start": 0, "text": "Le délai d’amélioration de la douleur (soit une diminution ≥ 2 points du score BPISF de douleur augmentée par rapport à l’entrée dans l’étude) a été comparable entre les groupes denosumab et acide zolédronique de chaque étude et dans l’analyse intégrée. Dans une analyse post hoc des données combinées, le délai médian d’aggravation de la douleur (score de douleur augmentée > 4 points) chez les patients ayant une douleur légère ou aucune douleur à l'entrée dans l’étude, a été plus long avec XGEVA qu’avec l’acide zolédronique (198 jours contre 143) (p = 0,0002).", "truncated": false}, "after_length": 565, "after_sha256": "2bb3fabaeea9cd28e5b60253bf5e62b3140020dbadb1a8093ae7f0db0e2d5421", "annex": "I", "before": {"end": 565, "start": 0, "text": "Le délai d’amélioration de la douleur (soit une diminution ≥ 2 points du score BPISF de douleur augmentée par rapport à l’entrée dans l’étude) a été comparable entre les groupes denosumab et acide zolédronique de chaque étude et dans l’analyse intégrée. Dans une analyse post hoc des données combinées, le délai médian d’aggravation de la douleur (score de douleur augmentée > 4 points) chez les patients ayant une douleur légère ou aucune douleur à l'entrée dans l’étude, a été plus long avec XGEVA qu’avec l’acide zolédronique (198 jours contre 143) (p = 0,0002).", "truncated": false}, "before_length": 565, "before_sha256": "2bb3fabaeea9cd28e5b60253bf5e62b3140020dbadb1a8093ae7f0db0e2d5421", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0159a72812fe6386ee7c6072", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002173", "medicine_name": "Xgeva", "medicine_slug": "xgeva", "observed_at": "2026-10-12T13:34:02Z", "pipeline_version": "2.0.0", "presentation_label": "XGEVA 120 mg solution injectable XGEVA 120 mg solution injectable en seringue préremplie", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "47551aac60917b2ed3f8c2e52c27dd3450c19003b7f0c7922ab6afa6357572e5", "source_snapshot_id": "source-a91ac33cdc893a4fbfb3ad37", "source_updated_at": "2026-06-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xgeva-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 628}
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{"after": {"end": 282, "start": 0, "text": "Efficacy and safety of denosumab once every 6 months for 1 year were investigated in 242 men aged 31-84 years. Subjects with an eGFR < 30 mL/min/1.73 m2 were excluded from the study. All men received calcium (at least 1,000 mg) and vitamin D (at least 800 IU) supplementation daily.", "truncated": false}, "after_length": 282, "after_sha256": "812ceb18ed73bff6d257e7b8ad297263136dd0a4d21e4049d21725718099e6bb", "annex": "I", "before": {"end": 282, "start": 0, "text": "Efficacy and safety of denosumab once every 6 months for 1 year were investigated in 242 men aged 31-84 years. Subjects with an eGFR < 30 mL/min/1.73 m2 were excluded from the study. All men received calcium (at least 1,000 mg) and vitamin D (at least 800 IU) supplementation daily.", "truncated": false}, "before_length": 282, "before_sha256": "812ceb18ed73bff6d257e7b8ad297263136dd0a4d21e4049d21725718099e6bb", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-015c81091f439bd33bb7308b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006156", "medicine_name": "Stoboclo", "medicine_slug": "stoboclo", "observed_at": "2026-10-12T19:08:45Z", "pipeline_version": "2.0.0", "presentation_label": "Stoboclo 60 mg solution for injection in pre-filled syringe", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "e0001db1d3c6b508fa269c3573cfe47a0de6261319a8651cee96a5472648b7f3", "source_snapshot_id": "source-21d50f23fabc205dafb30654", "source_updated_at": "2025-09-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/stoboclo-epar-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}
{"after": {"end": 454, "start": 0, "text": "The clinical safety and efficacy of Lucentis in patients with visual impairment due to macular oedema secondary to RVO have been assessed in the randomised, double-masked, controlled studies BRAVO and CRUISE that recruited subjects with BRVO (n=397) and CRVO (n=392), respectively. In both studies, subjects received either 0.3 mg or 0.5 mg ranibizumab or sham injections. After 6 months, patients in the sham-control arms switched to 0.5 mg ranibizumab.", "truncated": false}, "after_length": 454, "after_sha256": "f3f2f0d585c1aaa189de86fe81d2a08a339c68b3bdd8ab148c562a6ce4f9c4b2", "annex": "I", "before": {"end": 454, "start": 0, "text": "The clinical safety and efficacy of Lucentis in patients with visual impairment due to macular oedema secondary to RVO have been assessed in the randomised, double-masked, controlled studies BRAVO and CRUISE that recruited subjects with BRVO (n=397) and CRVO (n=392), respectively. In both studies, subjects received either 0.3 mg or 0.5 mg ranibizumab or sham injections. After 6 months, patients in the sham-control arms switched to 0.5 mg ranibizumab.", "truncated": false}, "before_length": 454, "before_sha256": "f3f2f0d585c1aaa189de86fe81d2a08a339c68b3bdd8ab148c562a6ce4f9c4b2", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01605119dc947fa5ff4dafa3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000715", "medicine_name": "Lucentis", "medicine_slug": "lucentis", "observed_at": "2026-10-12T12:55:10Z", "pipeline_version": "2.0.0", "presentation_label": "Lucentis 10 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": "612293565adc0504c607d89baf03ff2fc1b364a1fa3d139f8647ac4ebe52cf1b", "source_snapshot_id": "source-bb1b3bad89ae8fb8d3480e7d", "source_updated_at": "2026-10-08", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/lucentis-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 800}
{"after": {"end": 984, "start": 0, "text": "La demi-vie d’élimination plasmatique de l’uméclidinium était en moyenne de 19 heures après administration par voie inhalée pendant 10 jours. A l'état d'équilibre, 3 à 4 % de la substance active étant éliminés sous forme inchangée par voie urinaire. La clairance plasmatique, après administration intraveineuse, était de 151 litres/heure. Après administration intraveineuse, environ 58 % de la dose radiomarquée administrée ont été excrétés dans les fèces et environ 22 % de la dose radiomarquée administrée ont été excrétés dans les urines. L’excrétion de composés de l'uméclidinium dans les fèces après administration intraveineuse est le reflet d'une sécrétion biliaire. Après administration orale, 92 % de la dose radiomarquée administrée ont été essentiellement excrétés dans les fèces. Moins de 1 % de la dose administrée par voie orale (1 % de la radioactivité retrouvée) était éliminé dans les urines, suggérant une absorption digestive négligeable après administration orale.", "truncated": false}, "after_length": 984, "after_sha256": "6555f45a554880c34afee6df8cb63aab6b42a7b68cc4deabb6acd2b4a4e04e85", "annex": "I", "before": {"end": 984, "start": 0, "text": "La demi-vie d’élimination plasmatique de l’uméclidinium était en moyenne de 19 heures après administration par voie inhalée pendant 10 jours. A l'état d'équilibre, 3 à 4 % de la substance active étant éliminés sous forme inchangée par voie urinaire. La clairance plasmatique, après administration intraveineuse, était de 151 litres/heure. Après administration intraveineuse, environ 58 % de la dose radiomarquée administrée ont été excrétés dans les fèces et environ 22 % de la dose radiomarquée administrée ont été excrétés dans les urines. L’excrétion de composés de l'uméclidinium dans les fèces après administration intraveineuse est le reflet d'une sécrétion biliaire. Après administration orale, 92 % de la dose radiomarquée administrée ont été essentiellement excrétés dans les fèces. Moins de 1 % de la dose administrée par voie orale (1 % de la radioactivité retrouvée) était éliminé dans les urines, suggérant une absorption digestive négligeable après administration orale.", "truncated": false}, "before_length": 984, "before_sha256": "6555f45a554880c34afee6df8cb63aab6b42a7b68cc4deabb6acd2b4a4e04e85", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-016816c1ae50930d4f331ac5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004363", "medicine_name": "Trelegy Ellipta", "medicine_slug": "trelegy-ellipta", "observed_at": "2026-10-12T13:38:42Z", "pipeline_version": "2.0.0", "presentation_label": "Trelegy Ellipta 92 microgrammes/55 microgrammes/22 microgrammes, poudre pour inhalation en récipient unidose", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a9f1d1d6919f0a44d696093c8975d807ec0428c4fece680a70c4b87fc6c20c2e", "source_snapshot_id": "source-1b6beccd35df03f141828236", "source_updated_at": "2026-05-08", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/trelegy-ellipta-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 541}
{"after": {"end": 448, "start": 0, "text": "In patients with preexisting atrial fibrillation requiring anticoagulant therapy, alternative treatment options to IMBRUVICA should be considered. In patients who develop atrial fibrillation on therapy with IMBRUVICA a thorough assessment of the risk for thromboembolic disease should be undertaken. In patients at high risk and where alternatives to IMBRUVICA are nonsuitable, tightly controlled treatment with anticoagulants should be considered.", "truncated": false}, "after_length": 448, "after_sha256": "c535913e0e814ce99b406258683d28b713ef0fdd5c9ebb84dfec597474b9ed92", "annex": "I", "before": {"end": 448, "start": 0, "text": "In patients with preexisting atrial fibrillation requiring anticoagulant therapy, alternative treatment options to IMBRUVICA should be considered. In patients who develop atrial fibrillation on therapy with IMBRUVICA a thorough assessment of the risk for thromboembolic disease should be undertaken. In patients at high risk and where alternatives to IMBRUVICA are nonsuitable, tightly controlled treatment with anticoagulants should be considered.", "truncated": false}, "before_length": 448, "before_sha256": "c535913e0e814ce99b406258683d28b713ef0fdd5c9ebb84dfec597474b9ed92", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01864cd8073c80f518f96edf", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003791", "medicine_name": "Imbruvica", "medicine_slug": "imbruvica", "observed_at": "2026-10-12T19:04:37Z", "pipeline_version": "2.0.0", "presentation_label": "IMBRUVICA 140 mg hard capsules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "21bfa7a97b1dbb4cfcbb1d14bfa960d84c5eee81bfc4425b19e34ad257c6619b", "source_snapshot_id": "source-4a801f62cfb41d9c873d7b83", "source_updated_at": "2025-10-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imbruvica-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 267}
{"after": {"end": 64, "start": 0, "text": "Fréquence indéterminée : Encéphalopathie / Leucoencéphalopathie.", "truncated": false}, "after_length": 64, "after_sha256": "f9edf07235c072042709f23f01a95b4d6e9de81e111fd070ceefed19719f094d", "annex": "I", "before": {"end": 64, "start": 0, "text": "Fréquence indéterminée : Encéphalopathie / Leucoencéphalopathie.", "truncated": false}, "before_length": 64, "before_sha256": "f9edf07235c072042709f23f01a95b4d6e9de81e111fd070ceefed19719f094d", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-018a2f5765736744a49f5732", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003983", "medicine_name": "Nordimet", "medicine_slug": "nordimet", "observed_at": "2026-10-12T19:23:42Z", "pipeline_version": "2.0.0", "presentation_label": "Nordimet 7,5 mg solution injectable en stylo prérempli Nordimet 10 mg solution injectable en stylo prérempli Nordimet 12,5 mg solution injectable en stylo prérempli Nordimet 15 mg solution injectable en stylo prérempli Nordimet 17,5 mg solution injectable en stylo prérempli Nordimet 20 mg solution i", "presentation_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": "e7f04a283520007c0c784b04639c89eb37457990c57bdf9680c88f34ad56058f", "source_snapshot_id": "source-63c315f99ed4b0a7abc474b7", "source_updated_at": "2025-07-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nordimet-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 448}
{"after": {"end": 148, "start": 0, "text": "The bottle should be shaken vigourously for at least 20 seconds until the solid cake at the bottom of the bottle is completely dispersed (Figure A).", "truncated": false}, "after_length": 148, "after_sha256": "520ac4014055371bb4d93775d4aca2de9df67728efad7a4e684622d472e83a96", "annex": "I", "before": {"end": 148, "start": 0, "text": "The bottle should be shaken vigourously for at least 20 seconds until the solid cake at the bottom of the bottle is completely dispersed (Figure A).", "truncated": false}, "before_length": 148, "before_sha256": "520ac4014055371bb4d93775d4aca2de9df67728efad7a4e684622d472e83a96", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01923a7fd0aababd77f6f860", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000555", "medicine_name": "Orfadin", "medicine_slug": "orfadin", "observed_at": "2026-10-12T19:30:18Z", "pipeline_version": "2.0.0", "presentation_label": "Orfadin 4 mg/ml oral suspension", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "533dc10df9dc5e7196f7ae7905ac9713dfd2c7e1613a9dcca0737cd53105b807", "source_snapshot_id": "source-27cd4c5d901ffff4936dfe84", "source_updated_at": "2025-07-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/orfadin-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 986}
{"after": {"end": 317, "start": 0, "text": "Since the biological activity of denosumab in animals is specific to nonhuman primates, evaluation of genetically engineered (knockout) mice or use of other biological inhibitors of the RANK/RANKL pathway, such as OPG-Fc and RANK-Fc, were used to evaluate the pharmacodynamic properties of denosumab in rodent models.", "truncated": false}, "after_length": 317, "after_sha256": "e6b134dbd8bca5590ef6d5f03c6cf55e6b3be661d71030d71de11bc22fd7f0da", "annex": "I", "before": {"end": 317, "start": 0, "text": "Since the biological activity of denosumab in animals is specific to nonhuman primates, evaluation of genetically engineered (knockout) mice or use of other biological inhibitors of the RANK/RANKL pathway, such as OPG-Fc and RANK-Fc, were used to evaluate the pharmacodynamic properties of denosumab in rodent models.", "truncated": false}, "before_length": 317, "before_sha256": "e6b134dbd8bca5590ef6d5f03c6cf55e6b3be661d71030d71de11bc22fd7f0da", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-019db892fb56f6deff1cc94b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006199", "medicine_name": "Denbrayce", "medicine_slug": "denbrayce", "observed_at": "2026-10-12T17:30:39Z", "pipeline_version": "2.0.0", "presentation_label": "Denbrayce 120 mg 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": "5.3", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "7aec92539e38d6a35a948dd8af777fe2fa290d7c53f1bc8753c739d81fc9d6af", "source_snapshot_id": "source-c7f1d27d710651a01c0c1c6a", "source_updated_at": "2025-11-24", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/denbrayce-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 665}
{"after": {"end": 424, "start": 0, "text": "The results for clinically relevant responders pooled from two flexible dose studies out of the three pivotal 26week multicentre studies in patients with mild-to-moderately severe Alzheimer’s Dementia, are provided in Table 4 below. Clinically relevant improvement in these studies was defined a priori as at least 4point improvement on the ADAS-Cog, improvement on the CIBIC-Plus, or at least a 10 % improvement on the PDS.", "truncated": false}, "after_length": 424, "after_sha256": "7668960553499b087d1175a7ca99838217e0a4d703ee6c9743ef4d1ab769d848", "annex": "I", "before": {"end": 424, "start": 0, "text": "The results for clinically relevant responders pooled from two flexible dose studies out of the three pivotal 26week multicentre studies in patients with mild-to-moderately severe Alzheimer’s Dementia, are provided in Table 4 below. Clinically relevant improvement in these studies was defined a priori as at least 4point improvement on the ADAS-Cog, improvement on the CIBIC-Plus, or at least a 10 % improvement on the PDS.", "truncated": false}, "before_length": 424, "before_sha256": "7668960553499b087d1175a7ca99838217e0a4d703ee6c9743ef4d1ab769d848", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-019e2995b97771dd5310d57b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002036", "medicine_name": "Rivastigmine Actavis", "medicine_slug": "rivastigmine-actavis", "observed_at": "2026-10-12T19:35:40Z", "pipeline_version": "2.0.0", "presentation_label": "Rivastigmine Actavis 1.5 mg hard capsules Rivastigmine Actavis 3 mg hard capsules Rivastigmine Actavis 4.5 mg hard capsules Rivastigmine Actavis 6 mg hard capsules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "6b737beef96eb51218b255a06528670449f27251eca6788fca29bc0450313d54", "source_snapshot_id": "source-e4f1d7cc9ec32637ea4dab98", "source_updated_at": "2025-06-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/rivastigmine-actavis-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 520}
{"after": {"end": 240, "start": 0, "text": "Une atrophie du thymus, des tissus lymphoïdes et des testicules, ainsi qu’une hypertrophie des glandes surrénales, ont été rapportées à des doses supérieures ou égales à 100 mg/kg/jour chez les animaux ne présentant pas de surcharge en fer.", "truncated": false}, "after_length": 240, "after_sha256": "7081c6f4a87ea97b135f4675f37b706054c95a898148943be42e6b098879573d", "annex": "I", "before": {"end": 240, "start": 0, "text": "Une atrophie du thymus, des tissus lymphoïdes et des testicules, ainsi qu’une hypertrophie des glandes surrénales, ont été rapportées à des doses supérieures ou égales à 100 mg/kg/jour chez les animaux ne présentant pas de surcharge en fer.", "truncated": false}, "before_length": 240, "before_sha256": "7081c6f4a87ea97b135f4675f37b706054c95a898148943be42e6b098879573d", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01a25fc15150fbcb660a544c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000236", "medicine_name": "Ferriprox", "medicine_slug": "ferriprox", "observed_at": "2026-10-12T19:16:47Z", "pipeline_version": "2.0.0", "presentation_label": "Ferriprox 100 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": "5.3", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "cc461deb7027b3031d2b09d601fe7fec7c79c9f0f3a5864ba1024008d1a91dfa", "source_snapshot_id": "source-043b4003f4c66df240947f28", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/ferriprox-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 945}
{"after": {"end": 243, "start": 0, "text": "ranibizumab 0.5 mg at baseline, followed by an individualised dosing regimen driven by disease activity as assessed by visual acuity and/or anatomical parameters (e.g. visual acuity impairment, intra/sub-retinal fluid, haemorrhage or leakage);", "truncated": false}, "after_length": 243, "after_sha256": "54d78608b7f478127124f8d5bfe75966378bf4fca716cf83632d755750647ab2", "annex": "I", "before": {"end": 243, "start": 0, "text": "ranibizumab 0.5 mg at baseline, followed by an individualised dosing regimen driven by disease activity as assessed by visual acuity and/or anatomical parameters (e.g. visual acuity impairment, intra/sub-retinal fluid, haemorrhage or leakage);", "truncated": false}, "before_length": 243, "before_sha256": "54d78608b7f478127124f8d5bfe75966378bf4fca716cf83632d755750647ab2", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01ac760840b3e353a434bc15", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000715", "medicine_name": "Lucentis", "medicine_slug": "lucentis", "observed_at": "2026-10-12T12:55:10Z", "pipeline_version": "2.0.0", "presentation_label": "Lucentis 10 mg/ml solution for injection in pre-filled 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": "612293565adc0504c607d89baf03ff2fc1b364a1fa3d139f8647ac4ebe52cf1b", "source_snapshot_id": "source-bb1b3bad89ae8fb8d3480e7d", "source_updated_at": "2026-10-08", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/lucentis-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1596}
{"after": {"end": 229, "start": 0, "text": "** Incluant CPNPC, cancer du rein, cancer colorectal, cancer du poumon à petites cellules, cancer de la vessie, cancer de la tête et du cou, cancer GI/génito-urinaire et autres à l’exclusion des cancers du sein et de la prostate.", "truncated": false}, "after_length": 229, "after_sha256": "ca050c5bc774e531be86c9cee5cdfbb62afb19bb8e7781750582192537b60cf0", "annex": "I", "before": {"end": 229, "start": 0, "text": "** Incluant CPNPC, cancer du rein, cancer colorectal, cancer du poumon à petites cellules, cancer de la vessie, cancer de la tête et du cou, cancer GI/génito-urinaire et autres à l’exclusion des cancers du sein et de la prostate.", "truncated": false}, "before_length": 229, "before_sha256": "ca050c5bc774e531be86c9cee5cdfbb62afb19bb8e7781750582192537b60cf0", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01acb23bb52b3c4c04efb304", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006199", "medicine_name": "Denbrayce", "medicine_slug": "denbrayce", "observed_at": "2026-10-12T17:30:41Z", "pipeline_version": "2.0.0", "presentation_label": "Denbrayce 120 mg 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": "f51ec503f06d59511692af7270ce02849f960a5c46c54a26062e8d75d770e1d9", "source_snapshot_id": "source-83c0fdc326769f6bc39fbc44", "source_updated_at": "2025-11-24", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/denbrayce-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 536}
{"after": {"end": 675, "start": 0, "text": "No specific clinical studies have been conducted in patients with renal impairment. Patients with mild or moderate renal impairment were treated in IMBRUVICA clinical studies. No dose adjustment is needed for patients with mild or moderate renal impairment (greater than 30 mL/min creatinine clearance). Hydration should be maintained and serum creatinine levels monitored periodically. Administer IMBRUVICA to patients with severe renal impairment (<30 mL/min creatinine clearance) only if the benefit outweighs the risk and monitor patients closely for signs of toxicity. There are no data in patients with severe renal impairment or patients on dialysis (see section 5.2).", "truncated": false}, "after_length": 675, "after_sha256": "1dddbd8a1f7f95dc3bef200498e24ecfa5326e405ab0f424e455eb2a87b983a8", "annex": "I", "before": {"end": 675, "start": 0, "text": "No specific clinical studies have been conducted in patients with renal impairment. Patients with mild or moderate renal impairment were treated in IMBRUVICA clinical studies. No dose adjustment is needed for patients with mild or moderate renal impairment (greater than 30 mL/min creatinine clearance). Hydration should be maintained and serum creatinine levels monitored periodically. Administer IMBRUVICA to patients with severe renal impairment (<30 mL/min creatinine clearance) only if the benefit outweighs the risk and monitor patients closely for signs of toxicity. There are no data in patients with severe renal impairment or patients on dialysis (see section 5.2).", "truncated": false}, "before_length": 675, "before_sha256": "1dddbd8a1f7f95dc3bef200498e24ecfa5326e405ab0f424e455eb2a87b983a8", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01b18a9a87d621cbd6f76318", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003791", "medicine_name": "Imbruvica", "medicine_slug": "imbruvica", "observed_at": "2026-10-12T19:04:37Z", "pipeline_version": "2.0.0", "presentation_label": "IMBRUVICA 140 mg film-coated tablets IMBRUVICA 280 mg film-coated tablets IMBRUVICA 420 mg film-coated tablets IMBRUVICA 560 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": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "21bfa7a97b1dbb4cfcbb1d14bfa960d84c5eee81bfc4425b19e34ad257c6619b", "source_snapshot_id": "source-4a801f62cfb41d9c873d7b83", "source_updated_at": "2025-10-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imbruvica-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2176}
{"after": {"end": 108, "start": 0, "text": "Table 7: DARZALEX dosing schedule for smouldering multiple myeloma monotherapy (4week cycle dosing regimen)a", "truncated": false}, "after_length": 108, "after_sha256": "1c2b6a7c9a0e8d8c85c9c3d93614b41e058d3514690695d7560718d7184f27d2", "annex": "I", "before": {"end": 108, "start": 0, "text": "Table 7: DARZALEX dosing schedule for smouldering multiple myeloma monotherapy (4week cycle dosing regimen)a", "truncated": false}, "before_length": 108, "before_sha256": "1c2b6a7c9a0e8d8c85c9c3d93614b41e058d3514690695d7560718d7184f27d2", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01b575c123d44746bb4a5e56", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004077", "medicine_name": "Darzalex", "medicine_slug": "darzalex", "observed_at": "2026-10-12T19:04:42Z", "pipeline_version": "2.0.0", "presentation_label": "DARZALEX 1800 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": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "8c36ebbab8d2aa40602da934a729cc4f66032e3fc0f846c0bd7d789721c39d9a", "source_snapshot_id": "source-d8c400cd5cb9c5e2404ceb92", "source_updated_at": "2025-10-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/darzalex-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1399}
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{"after": {"end": 1194, "start": 0, "text": "The majority of patients in AMY3001 had AL amyloidosis-related cardiomyopathy at baseline (DVCd 72% vs. VCd 71%). Grade 3 or 4 cardiac disorders occurred in 11% of D-VCd patients compared to 10% of VCd patients, while serious cardiac disorders occurred in 16% vs. 13% of D-VCd and VCd patients, respectively. Serious cardiac disorders occurring in ≥ 2% of patients included cardiac failure (D-VCd 6.2% vs. VCd 4.3%), cardiac arrest (D-VCd 3.6% vs. VCd 1.6%) and atrial fibrillation (D-VCd 2.1% vs. VCd 1.1%). All D-VCd patients who experienced serious or fatal cardiac disorders had AL amyloidosis-related cardiomyopathy at baseline. The longer median duration of treatment in the D-VCd arm compared to the VCd arm (9.6 months vs. 5.3 months, respectively) should be taken into consideration when comparing the frequency of cardiac disorders between the two treatment groups. Exposure-adjusted incidence rates (number of patients with the event per 100 patient-months at risk) of overall grade 3 or 4 cardiac disorders (1.2 vs. 2.3), cardiac failure (0.5 vs. 0.6), cardiac arrest (0.1 vs. 0.0) and atrial fibrillation (0.2 vs. 0.1) were comparable in the DVCd arm vs. the VCd arm, respectively.", "truncated": false}, "after_length": 1194, "after_sha256": "25f4a9042512bd8a415c2c7e9a03ce5ca2e2aacb5c979476354fab1a0954b9d6", "annex": "I", "before": {"end": 1194, "start": 0, "text": "The majority of patients in AMY3001 had AL amyloidosis-related cardiomyopathy at baseline (DVCd 72% vs. VCd 71%). Grade 3 or 4 cardiac disorders occurred in 11% of D-VCd patients compared to 10% of VCd patients, while serious cardiac disorders occurred in 16% vs. 13% of D-VCd and VCd patients, respectively. Serious cardiac disorders occurring in ≥ 2% of patients included cardiac failure (D-VCd 6.2% vs. VCd 4.3%), cardiac arrest (D-VCd 3.6% vs. VCd 1.6%) and atrial fibrillation (D-VCd 2.1% vs. VCd 1.1%). All D-VCd patients who experienced serious or fatal cardiac disorders had AL amyloidosis-related cardiomyopathy at baseline. The longer median duration of treatment in the D-VCd arm compared to the VCd arm (9.6 months vs. 5.3 months, respectively) should be taken into consideration when comparing the frequency of cardiac disorders between the two treatment groups. Exposure-adjusted incidence rates (number of patients with the event per 100 patient-months at risk) of overall grade 3 or 4 cardiac disorders (1.2 vs. 2.3), cardiac failure (0.5 vs. 0.6), cardiac arrest (0.1 vs. 0.0) and atrial fibrillation (0.2 vs. 0.1) were comparable in the DVCd arm vs. the VCd arm, respectively.", "truncated": false}, "before_length": 1194, "before_sha256": "25f4a9042512bd8a415c2c7e9a03ce5ca2e2aacb5c979476354fab1a0954b9d6", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-02d86aa4430264db846df99d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004077", "medicine_name": "Darzalex", "medicine_slug": "darzalex", "observed_at": "2026-10-12T19:04:42Z", "pipeline_version": "2.0.0", "presentation_label": "DARZALEX 1800 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": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "8c36ebbab8d2aa40602da934a729cc4f66032e3fc0f846c0bd7d789721c39d9a", "source_snapshot_id": "source-d8c400cd5cb9c5e2404ceb92", "source_updated_at": "2025-10-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/darzalex-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1929}
{"after": {"end": 45, "start": 0, "text": "Date of first authorisation: 21 February 2005", "truncated": false}, "after_length": 45, "after_sha256": "fbfe1128fbdc6946286322939471e14006bdafa4069a8f505faca44e299a9628", "annex": "I", "before": {"end": 45, "start": 0, "text": "Date of first authorisation: 21 February 2005", "truncated": false}, "before_length": 45, "before_sha256": "fbfe1128fbdc6946286322939471e14006bdafa4069a8f505faca44e299a9628", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-02e5eca1bec4db0283d791d1", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000555", "medicine_name": "Orfadin", "medicine_slug": "orfadin", "observed_at": "2026-10-12T19:30:18Z", "pipeline_version": "2.0.0", "presentation_label": "Orfadin 2 mg hard capsules Orfadin 5 mg hard capsules Orfadin 10 mg hard capsules Orfadin 20 mg hard capsules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "9", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "533dc10df9dc5e7196f7ae7905ac9713dfd2c7e1613a9dcca0737cd53105b807", "source_snapshot_id": "source-27cd4c5d901ffff4936dfe84", "source_updated_at": "2025-07-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/orfadin-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 421}
{"after": {"end": 296, "start": 0, "text": "IMBRUVICA + ASCT Arm: IMBRUVICA 560 mg daily (Days 1-19) in combination with RCHOP for three 21-day cycles (Cycles 1, 3, 5) alternating with three 21-day cycles of R-DHAP (Cycles 2, 4, 6) as induction therapy followed by high-dose chemotherapy and ASCT followed by 2 years IMBRUVICA 560 mg daily;", "truncated": false}, "after_length": 296, "after_sha256": "49c468e36caf6e51996ab12a890540a29d80d8e750bba9cbde17c7f413ff126e", "annex": "I", "before": {"end": 296, "start": 0, "text": "IMBRUVICA + ASCT Arm: IMBRUVICA 560 mg daily (Days 1-19) in combination with RCHOP for three 21-day cycles (Cycles 1, 3, 5) alternating with three 21-day cycles of R-DHAP (Cycles 2, 4, 6) as induction therapy followed by high-dose chemotherapy and ASCT followed by 2 years IMBRUVICA 560 mg daily;", "truncated": false}, "before_length": 296, "before_sha256": "49c468e36caf6e51996ab12a890540a29d80d8e750bba9cbde17c7f413ff126e", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-02faa6a91ab38784d02c68fe", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003791", "medicine_name": "Imbruvica", "medicine_slug": "imbruvica", "observed_at": "2026-10-12T19:04:37Z", "pipeline_version": "2.0.0", "presentation_label": "IMBRUVICA 140 mg hard capsules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "21bfa7a97b1dbb4cfcbb1d14bfa960d84c5eee81bfc4425b19e34ad257c6619b", "source_snapshot_id": "source-4a801f62cfb41d9c873d7b83", "source_updated_at": "2025-10-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/imbruvica-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 948}
{"after": {"end": 350, "start": 0, "text": "IMBRUVICA doit être administré par voie orale une fois par jour avec un verre d’eau approximativement au même moment chaque jour. Les gélules doivent être avalées entières avec de l’eau, sans être ouvertes, cassées ni mâchées. IMBRUVICA ne doit pas être pris avec du jus de pamplemousse ou des oranges de Séville (oranges amères) (voir rubrique 4.5).", "truncated": false}, "after_length": 350, "after_sha256": "f6505c033bd8457dc7934e867f41863104c12ac643690eebdb8b61ae37d806d8", "annex": "I", "before": {"end": 350, "start": 0, "text": "IMBRUVICA doit être administré par voie orale une fois par jour avec un verre d’eau approximativement au même moment chaque jour. Les gélules doivent être avalées entières avec de l’eau, sans être ouvertes, cassées ni mâchées. IMBRUVICA ne doit pas être pris avec du jus de pamplemousse ou des oranges de Séville (oranges amères) (voir rubrique 4.5).", "truncated": false}, "before_length": 350, "before_sha256": "f6505c033bd8457dc7934e867f41863104c12ac643690eebdb8b61ae37d806d8", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-02ff01fe815db1433ad323ef", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003791", "medicine_name": "Imbruvica", "medicine_slug": "imbruvica", "observed_at": "2026-10-12T19:04:40Z", "pipeline_version": "2.0.0", "presentation_label": "IMBRUVICA 140 mg gélules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "4b0b32ce32024a965e4ce48fb2cbdea69dafe9803472bdd5e64e2c6b939c8445", "source_snapshot_id": "source-2f9ae65220663d4e0dbb5c63", "source_updated_at": "2025-10-27", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/imbruvica-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 202}
{"after": {"end": 284, "start": 0, "text": "Le flacon est seulement à usage unique. Après l’injection, tout produit non utilisé doit être éliminé. Tout flacon présentant des signes de dommage ou d’altération ne doit pas être utilisé. La stérilité ne peut être garantie que si le système de fermeture de l’emballage reste intact.", "truncated": false}, "after_length": 284, "after_sha256": "a0cf3be7e827d8a639ba8cda151c5a3fcd4a7101e32c5d38262ed5f480a5d46a", "annex": "I", "before": {"end": 284, "start": 0, "text": "Le flacon est seulement à usage unique. Après l’injection, tout produit non utilisé doit être éliminé. Tout flacon présentant des signes de dommage ou d’altération ne doit pas être utilisé. La stérilité ne peut être garantie que si le système de fermeture de l’emballage reste intact.", "truncated": false}, "before_length": 284, "before_sha256": "a0cf3be7e827d8a639ba8cda151c5a3fcd4a7101e32c5d38262ed5f480a5d46a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0319049d0a4f41330133e441", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000715", "medicine_name": "Lucentis", "medicine_slug": "lucentis", "observed_at": "2026-10-12T12:55:14Z", "pipeline_version": "2.0.0", "presentation_label": "Lucentis 10 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": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "2258e54d672ce23513dcfdf067fa41c102c485fdf481a19758666450c867671e", "source_snapshot_id": "source-f85d2111b5e1c18a6ab8027e", "source_updated_at": "2026-10-08", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/lucentis-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1034}
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{"after": {"end": 764, "start": 0, "text": "Dans une étude clinique menée chez des patients n’étant pas atteints de cancer avancé, insuffisants rénaux sévères (clairance de la créatinine < 30 mL/min) ou dialysés, le risque de développer une hypocalcémie était plus élevé en l’absence de supplémentation en calcium. Le risque de développer une hypocalcémie pendant le traitement par le dénosumab augmente avec le degré d’insuffisance rénale. Au cours d’un essai clinique mené chez des patients ne présentant pas de cancer avancé, 19 % des patients présentant une insuffisance rénale sévère (clairance de la créatinine < 30 mL/min) et 63 % des patients dialysés ont développé une hypocalcémie malgré une supplémentation en calcium. L’incidence globale de l’hypocalcémie cliniquement significative était de 9 %.", "truncated": false}, "after_length": 764, "after_sha256": "6cd2fd5b4cab379720b85598879f050a8099e028a7d91f7a1d5d4f49ea120ae0", "annex": "I", "before": {"end": 764, "start": 0, "text": "Dans une étude clinique menée chez des patients n’étant pas atteints de cancer avancé, insuffisants rénaux sévères (clairance de la créatinine < 30 mL/min) ou dialysés, le risque de développer une hypocalcémie était plus élevé en l’absence de supplémentation en calcium. Le risque de développer une hypocalcémie pendant le traitement par le dénosumab augmente avec le degré d’insuffisance rénale. Au cours d’un essai clinique mené chez des patients ne présentant pas de cancer avancé, 19 % des patients présentant une insuffisance rénale sévère (clairance de la créatinine < 30 mL/min) et 63 % des patients dialysés ont développé une hypocalcémie malgré une supplémentation en calcium. L’incidence globale de l’hypocalcémie cliniquement significative était de 9 %.", "truncated": false}, "before_length": 764, "before_sha256": "6cd2fd5b4cab379720b85598879f050a8099e028a7d91f7a1d5d4f49ea120ae0", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0329bdab2848508ff96cb70c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006199", "medicine_name": "Denbrayce", "medicine_slug": "denbrayce", "observed_at": "2026-10-12T17:30:41Z", "pipeline_version": "2.0.0", "presentation_label": "Denbrayce 120 mg 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": "f51ec503f06d59511692af7270ce02849f960a5c46c54a26062e8d75d770e1d9", "source_snapshot_id": "source-83c0fdc326769f6bc39fbc44", "source_updated_at": "2025-11-24", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/denbrayce-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 351}
{"after": {"end": 280, "start": 0, "text": "Data from two studies (MONT BLANC, BPD952A2308 and DENALI, BPD952A2309) conducted post approval confirmed the efficacy of Lucentis but did not demonstrate additional effect of the combined administration of verteporfin (Visudyne PDT) and Lucentis compared to Lucentis monotherapy.", "truncated": false}, "after_length": 280, "after_sha256": "f8d6170d48d543cc42b2167ca60290168d5d94963dbdebfaed2cd9cc89387e2f", "annex": "I", "before": {"end": 280, "start": 0, "text": "Data from two studies (MONT BLANC, BPD952A2308 and DENALI, BPD952A2309) conducted post approval confirmed the efficacy of Lucentis but did not demonstrate additional effect of the combined administration of verteporfin (Visudyne PDT) and Lucentis compared to Lucentis monotherapy.", "truncated": false}, "before_length": 280, "before_sha256": "f8d6170d48d543cc42b2167ca60290168d5d94963dbdebfaed2cd9cc89387e2f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0330c4032065a987b9aa3ea0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000715", "medicine_name": "Lucentis", "medicine_slug": "lucentis", "observed_at": "2026-10-12T12:55:10Z", "pipeline_version": "2.0.0", "presentation_label": "Lucentis 10 mg/ml solution for injection in pre-filled 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": "612293565adc0504c607d89baf03ff2fc1b364a1fa3d139f8647ac4ebe52cf1b", "source_snapshot_id": "source-bb1b3bad89ae8fb8d3480e7d", "source_updated_at": "2026-10-08", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/lucentis-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1512}
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{"after": {"end": 296, "start": 0, "text": "No data are available on the use of deferiprone in HIV positive or in other immunocompromised patients. Given that deferiprone can be associated with neutropenia and agranulocytosis, therapy in immunocompromised patients should not be initiated unless potential benefits outweigh potential risks.", "truncated": false}, "after_length": 296, "after_sha256": "c8ce067b07a26b84770826a33a717c75e1dcf23c5e435e3ba42e21b935cad7c0", "annex": "I", "before": {"end": 296, "start": 0, "text": "No data are available on the use of deferiprone in HIV positive or in other immunocompromised patients. Given that deferiprone can be associated with neutropenia and agranulocytosis, therapy in immunocompromised patients should not be initiated unless potential benefits outweigh potential risks.", "truncated": false}, "before_length": 296, "before_sha256": "c8ce067b07a26b84770826a33a717c75e1dcf23c5e435e3ba42e21b935cad7c0", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03f1d609e79585843215655c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000236", "medicine_name": "Ferriprox", "medicine_slug": "ferriprox", "observed_at": "2026-10-12T19:16:46Z", "pipeline_version": "2.0.0", "presentation_label": "Ferriprox 100 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": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "47f97c701962e81f7f15f37dc4a75d8ea756178013085f22dba6f616a512622c", "source_snapshot_id": "source-3b8f8e4357eb2da16aa8b50f", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/ferriprox-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 729}
{"after": {"end": 224, "start": 0, "text": "For patients currently receiving daratumamab intravenous formulation, DARZALEX solution for subcutaneous injection may be used as an alternative to the intravenous daratumumab formulation starting at the next scheduled dose.", "truncated": false}, "after_length": 224, "after_sha256": "6aeb45af790747b30d7bd2e11881993fdaeb04c6e93fbb251ddc0e86c4c158b4", "annex": "I", "before": {"end": 224, "start": 0, "text": "For patients currently receiving daratumamab intravenous formulation, DARZALEX solution for subcutaneous injection may be used as an alternative to the intravenous daratumumab formulation starting at the next scheduled dose.", "truncated": false}, "before_length": 224, "before_sha256": "6aeb45af790747b30d7bd2e11881993fdaeb04c6e93fbb251ddc0e86c4c158b4", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03f8a5d2fa1a30eaf2e6ad11", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004077", "medicine_name": "Darzalex", "medicine_slug": "darzalex", "observed_at": "2026-10-12T19:04:42Z", "pipeline_version": "2.0.0", "presentation_label": "DARZALEX 1800 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": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "8c36ebbab8d2aa40602da934a729cc4f66032e3fc0f846c0bd7d789721c39d9a", "source_snapshot_id": "source-d8c400cd5cb9c5e2404ceb92", "source_updated_at": "2025-10-27", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/darzalex-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1255}
{"after": {"end": 244, "start": 0, "text": "Hazard ratio pour D-VMPRd vs. VMP (IC à 95%)Hazard ratio pour D-VMPRd vs. VMP (IC à 95%)Proportion de Survie GlobaleProportion de Survie GlobalePatients à risquePatients à risqueMoisMoisSurvie Globale médiane - moisSurvie Globale médiane - mois", "truncated": false}, "after_length": 244, "after_sha256": "db058e45135b9afa15967212db618251c0c7ab7cd2fe5049de835ce33de3bd2d", "annex": "I", "before": {"end": 244, "start": 0, "text": "Hazard ratio pour D-VMPRd vs. VMP (IC à 95%)Hazard ratio pour D-VMPRd vs. VMP (IC à 95%)Proportion de Survie GlobaleProportion de Survie GlobalePatients à risquePatients à risqueMoisMoisSurvie Globale médiane - moisSurvie Globale médiane - mois", "truncated": false}, "before_length": 244, "before_sha256": "db058e45135b9afa15967212db618251c0c7ab7cd2fe5049de835ce33de3bd2d", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03fb79bbe220080c9868b6c5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004077", "medicine_name": "Darzalex", "medicine_slug": "darzalex", "observed_at": "2026-10-12T19:04:45Z", "pipeline_version": "2.0.0", "presentation_label": "DARZALEX 1800 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "ca7cec9127a023f1d64c4a23c66b64befc174186e07b1c71ff1195cffd627a2d", "source_snapshot_id": "source-a448ba148103c6e4f8bfa602", "source_updated_at": "2025-10-27", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/darzalex-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2525}
{"after": {"end": 533, "start": 0, "text": "Teriparatide was not genotoxic in a standard battery of tests. It produced no teratogenic effects in rats, mice or rabbits. There were no important effects observed in pregnant rats or mice administered teriparatide at daily doses of 30 to 1 000 µg/kg. However, fetal resorption and reduced litter size occurred in pregnant rabbits administered daily doses of 3 to 100 µg/kg. The embryotoxicity observed in rabbits may be related to their much greater sensitivity to the effects of PTH on blood ionised calcium compared with rodents.", "truncated": false}, "after_length": 533, "after_sha256": "242e809ac302e5fe3aff92c2979792097effd31dbefe02efe0332da1eeff2b35", "annex": "I", "before": {"end": 533, "start": 0, "text": "Teriparatide was not genotoxic in a standard battery of tests. It produced no teratogenic effects in rats, mice or rabbits. There were no important effects observed in pregnant rats or mice administered teriparatide at daily doses of 30 to 1 000 µg/kg. However, fetal resorption and reduced litter size occurred in pregnant rabbits administered daily doses of 3 to 100 µg/kg. The embryotoxicity observed in rabbits may be related to their much greater sensitivity to the effects of PTH on blood ionised calcium compared with rodents.", "truncated": false}, "before_length": 533, "before_sha256": "242e809ac302e5fe3aff92c2979792097effd31dbefe02efe0332da1eeff2b35", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0406d2d2afdde8f37ffbc561", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005793", "medicine_name": "Teriparatide Sun", "medicine_slug": "teriparatide-sun", "observed_at": "2026-10-12T19:05:41Z", "pipeline_version": "2.0.0", "presentation_label": "Teriparatide SUN 20 micrograms/80 microliters solution for injection in pre-filled pen", "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": "e990fae050964facd21ce7ae0109adc633aa02622a0c275b8a736f4a8c13cd01", "source_snapshot_id": "source-2347d5a94b07194fbdc46b4e", "source_updated_at": "2025-10-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/teriparatide-sun-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 409}
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{"after": {"end": 744, "start": 0, "text": "In this study, 1,718 multiple myeloma patients with at least one bone lesion were randomised to receive 120 mg denosumab subcutaneously every 4 weeks (Q4W) or 4 mg zoledronic acid intravenously (IV) every 4 weeks (dose-adjusted for renal function). The primary outcome measure was demonstration of non-inferiority of time to first on study skeletal related event (SRE) as compared to zoledronic acid. Secondary outcome measures included superiority of time to first SRE, superiority of time to first and subsequent SRE, and overall survival. An SRE was defined as any of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression.", "truncated": false}, "after_length": 744, "after_sha256": "c2284b07352fe054df3f1aaa8711c63cfa0ec373db238a3f024670779c51c2d1", "annex": "I", "before": {"end": 744, "start": 0, "text": "In this study, 1,718 multiple myeloma patients with at least one bone lesion were randomised to receive 120 mg denosumab subcutaneously every 4 weeks (Q4W) or 4 mg zoledronic acid intravenously (IV) every 4 weeks (dose-adjusted for renal function). The primary outcome measure was demonstration of non-inferiority of time to first on study skeletal related event (SRE) as compared to zoledronic acid. Secondary outcome measures included superiority of time to first SRE, superiority of time to first and subsequent SRE, and overall survival. An SRE was defined as any of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression.", "truncated": false}, "before_length": 744, "before_sha256": "c2284b07352fe054df3f1aaa8711c63cfa0ec373db238a3f024670779c51c2d1", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0427368072fdd68a1355b973", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006199", "medicine_name": "Denbrayce", "medicine_slug": "denbrayce", "observed_at": "2026-10-12T17:30:39Z", "pipeline_version": "2.0.0", "presentation_label": "Denbrayce 120 mg 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": "7aec92539e38d6a35a948dd8af777fe2fa290d7c53f1bc8753c739d81fc9d6af", "source_snapshot_id": "source-c7f1d27d710651a01c0c1c6a", "source_updated_at": "2025-11-24", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/denbrayce-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 548}
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{"after": {"end": 446, "start": 0, "text": "Trois autres analyses PK de population (analyse 2, analyse 3 et analyse 4) ont été réalisées chez des patients atteints de myélome multiple ayant reçu daratumumab en association. Les courbes de concentration du daratumumab en fonction du temps ont été similaires après les traitements en monothérapie et en association. La valeur moyenne de la demi-vie terminale estimée associée à la clairance linéaire en association a été d’environ 1523 jours.", "truncated": false}, "after_length": 446, "after_sha256": "2b2ae7688fbaefcc25751f777164559790c2c635ef77b81e413326a1d5980003", "annex": "I", "before": {"end": 446, "start": 0, "text": "Trois autres analyses PK de population (analyse 2, analyse 3 et analyse 4) ont été réalisées chez des patients atteints de myélome multiple ayant reçu daratumumab en association. Les courbes de concentration du daratumumab en fonction du temps ont été similaires après les traitements en monothérapie et en association. La valeur moyenne de la demi-vie terminale estimée associée à la clairance linéaire en association a été d’environ 1523 jours.", "truncated": false}, "before_length": 446, "before_sha256": "2b2ae7688fbaefcc25751f777164559790c2c635ef77b81e413326a1d5980003", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0431fa25035da6e951ce3744", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004077", "medicine_name": "Darzalex", "medicine_slug": "darzalex", "observed_at": "2026-10-12T19:04:45Z", "pipeline_version": "2.0.0", "presentation_label": "DARZALEX 20 mg/mL solution à diluer pour perfusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "ca7cec9127a023f1d64c4a23c66b64befc174186e07b1c71ff1195cffd627a2d", "source_snapshot_id": "source-a448ba148103c6e4f8bfa602", "source_updated_at": "2025-10-27", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/darzalex-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1102}
{"after": {"end": 235, "start": 0, "text": "Les modalités suggérées pour la prise en charge des cas de neutropénie sont présentées ci-dessous. Il est recommandé de mettre en place ce protocole de prise en charge avant d’instaurer un traitement par la défériprone chez un patient.", "truncated": false}, "after_length": 235, "after_sha256": "b949f59d59015d1e21dd3a413800740c92e9ed144615c891f80c4a2e628d04f6", "annex": "I", "before": {"end": 235, "start": 0, "text": "Les modalités suggérées pour la prise en charge des cas de neutropénie sont présentées ci-dessous. Il est recommandé de mettre en place ce protocole de prise en charge avant d’instaurer un traitement par la défériprone chez un patient.", "truncated": false}, "before_length": 235, "before_sha256": "b949f59d59015d1e21dd3a413800740c92e9ed144615c891f80c4a2e628d04f6", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-043da82bac76cbcdff237b76", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000236", "medicine_name": "Ferriprox", "medicine_slug": "ferriprox", "observed_at": "2026-10-12T19:16:47Z", "pipeline_version": "2.0.0", "presentation_label": "Ferriprox 500 mg comprimés pelliculés Ferriprox 1 000 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": "cc461deb7027b3031d2b09d601fe7fec7c79c9f0f3a5864ba1024008d1a91dfa", "source_snapshot_id": "source-043b4003f4c66df240947f28", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/ferriprox-epar-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": 272, "start": 0, "text": "Group II (ranibizumab 0.5 mg, dosing regimen driven by “disease activity” criteria defined as vision impairment attributable to intra- or subretinal fluid or active leakage due to the CNV lesion as assessed by optical coherence tomography and/or fluorescence angiography).", "truncated": false}, "after_length": 272, "after_sha256": "597cc5ba71f479646cc878bed2e5300abdbf392cd272f681a5054ee3d88d6883", "annex": "I", "before": {"end": 272, "start": 0, "text": "Group II (ranibizumab 0.5 mg, dosing regimen driven by “disease activity” criteria defined as vision impairment attributable to intra- or subretinal fluid or active leakage due to the CNV lesion as assessed by optical coherence tomography and/or fluorescence angiography).", "truncated": false}, "before_length": 272, "before_sha256": "597cc5ba71f479646cc878bed2e5300abdbf392cd272f681a5054ee3d88d6883", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-050be028ecb402f379eccfbf", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000715", "medicine_name": "Lucentis", "medicine_slug": "lucentis", "observed_at": "2026-10-12T12:55:10Z", "pipeline_version": "2.0.0", "presentation_label": "Lucentis 10 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": "612293565adc0504c607d89baf03ff2fc1b364a1fa3d139f8647ac4ebe52cf1b", "source_snapshot_id": "source-bb1b3bad89ae8fb8d3480e7d", "source_updated_at": "2026-10-08", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/lucentis-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 435}
{"after": {"end": 366, "start": 0, "text": "Les effets indésirables signalés sont énumérés ci-après, par classe de systèmes d’organe et par fréquence. Les fréquences sont définies ainsi : très fréquent (≥ 1/10), fréquent (≥ 1/100, < 1/10), peu fréquent (≥1/1 000, < 1/100), rare (≥ 1/10 000, < 1/1 000), très rare (< 1/10 000), fréquence indéterminée (ne peut être estimée sur la base des données disponibles).", "truncated": false}, "after_length": 366, "after_sha256": "76d2f146a2c3f34bab26600c3ecd8e38ea76250a699c632ac00d598fd4b2dd8e", "annex": "I", "before": {"end": 366, "start": 0, "text": "Les effets indésirables signalés sont énumérés ci-après, par classe de systèmes d’organe et par fréquence. Les fréquences sont définies ainsi : très fréquent (≥ 1/10), fréquent (≥ 1/100, < 1/10), peu fréquent (≥1/1 000, < 1/100), rare (≥ 1/10 000, < 1/1 000), très rare (< 1/10 000), fréquence indéterminée (ne peut être estimée sur la base des données disponibles).", "truncated": false}, "before_length": 366, "before_sha256": "76d2f146a2c3f34bab26600c3ecd8e38ea76250a699c632ac00d598fd4b2dd8e", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-050cd3c3333153175e0366e7", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000461", "medicine_name": "Carbaglu", "medicine_slug": "carbaglu", "observed_at": "2026-10-12T17:28:33Z", "pipeline_version": "2.0.0", "presentation_label": "Carbaglu 200 mg, comprimé dispersible", "presentation_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": "aa9661ca3f9b552f45bacfdb4824be5bf399f9d95a1940ec175ce2f05566bcf4", "source_snapshot_id": "source-3bd1523a1889a3e131d42db6", "source_updated_at": "2025-12-09", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/carbaglu-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 135}
{"after": {"end": 148, "start": 0, "text": "Comprimé pelliculé biconvexe, rond, jaune clair, d’un diamètre d’environ 9 mm, portant l’inscription « AV1 » sur une face et « M » sur l’autre face.", "truncated": false}, "after_length": 148, "after_sha256": "69df4aa63412e4285c1eb05e92118a686096e870be018883512c15e513944721", "annex": "I", "before": {"end": 148, "start": 0, "text": "Comprimé pelliculé biconvexe, rond, jaune clair, d’un diamètre d’environ 9 mm, portant l’inscription « AV1 » sur une face et « M » sur l’autre face.", "truncated": false}, "before_length": 148, "before_sha256": "69df4aa63412e4285c1eb05e92118a686096e870be018883512c15e513944721", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0512a58b3e1eec6d6a33d0ef", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004037", "medicine_name": "Amlodipine / Valsartan Mylan", "medicine_slug": "amlodipine-valsartan-mylan", "observed_at": "2026-10-12T13:35:39Z", "pipeline_version": "2.0.0", "presentation_label": "Amlodipine/Valsartan Mylan 5 mg/80 mg, comprimés pelliculés Amlodipine/Valsartan Mylan 5 mg/160 mg, comprimés pelliculés Amlodipine/Valsartan Mylan 10 mg/160 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": "3", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "fef655284bc3e833ca7b4a2070cc1afbef5e73f7f31bf45aa3565d9df88381f0", "source_snapshot_id": "source-48f6182a78cf7770947302ab", "source_updated_at": "2026-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/amlodipine-valsartan-mylan-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 63}
{"after": {"end": 361, "start": 0, "text": "Chez les patients atteints de thalassémie, il existe une association entre fibrose hépatique et surcharge en fer et/ou hépatite C. Des mesures particulières doivent être prises afin de s’assurer que la chélation du fer est optimale chez les patients atteints d’hépatite C. Chez de tels patients, une surveillance étroite de l’histologie du foie est recommandée.", "truncated": false}, "after_length": 361, "after_sha256": "3eb457754665c52be6d78991e3b869a5254f64440471eff68083ce142d703438", "annex": "I", "before": {"end": 361, "start": 0, "text": "Chez les patients atteints de thalassémie, il existe une association entre fibrose hépatique et surcharge en fer et/ou hépatite C. Des mesures particulières doivent être prises afin de s’assurer que la chélation du fer est optimale chez les patients atteints d’hépatite C. Chez de tels patients, une surveillance étroite de l’histologie du foie est recommandée.", "truncated": false}, "before_length": 361, "before_sha256": "3eb457754665c52be6d78991e3b869a5254f64440471eff68083ce142d703438", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-051324f592b0caf4f41b192f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000236", "medicine_name": "Ferriprox", "medicine_slug": "ferriprox", "observed_at": "2026-10-12T19:16:47Z", "pipeline_version": "2.0.0", "presentation_label": "Ferriprox 500 mg comprimés pelliculés Ferriprox 1 000 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": "cc461deb7027b3031d2b09d601fe7fec7c79c9f0f3a5864ba1024008d1a91dfa", "source_snapshot_id": "source-043b4003f4c66df240947f28", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/ferriprox-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 251}
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{"after": {"end": 279, "start": 0, "text": "Dans les études cliniques portant sur le traitement de la baisse visuelle due à l’OMD, l’évolution de l’acuité visuelle ou de l’épaisseur centrale de la rétine (ECR) chez les patients traités par Lucentis, n’était pas impacté par un traitement concomitant par thiazolidinediones.", "truncated": false}, "after_length": 279, "after_sha256": "f586de062a60d84a6ee9a99822745b11943868bea5e6ed9500707fe6292d2f05", "annex": "I", "before": {"end": 279, "start": 0, "text": "Dans les études cliniques portant sur le traitement de la baisse visuelle due à l’OMD, l’évolution de l’acuité visuelle ou de l’épaisseur centrale de la rétine (ECR) chez les patients traités par Lucentis, n’était pas impacté par un traitement concomitant par thiazolidinediones.", "truncated": false}, "before_length": 279, "before_sha256": "f586de062a60d84a6ee9a99822745b11943868bea5e6ed9500707fe6292d2f05", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-056adadda2d332484f100e46", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000715", "medicine_name": "Lucentis", "medicine_slug": "lucentis", "observed_at": "2026-10-12T12:55:14Z", "pipeline_version": "2.0.0", "presentation_label": "Lucentis 10 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": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "2258e54d672ce23513dcfdf067fa41c102c485fdf481a19758666450c867671e", "source_snapshot_id": "source-f85d2111b5e1c18a6ab8027e", "source_updated_at": "2026-10-08", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/lucentis-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 201}
{"after": {"end": 55, "start": 0, "text": "Très rare : Lymphome (voir « description » ci-dessous).", "truncated": false}, "after_length": 55, "after_sha256": "14582f4e6d8e20b5da0baf984a41d3c1708b9e604d711ccf22c385e3139fece1", "annex": "I", "before": {"end": 55, "start": 0, "text": "Très rare : Lymphome (voir « description » ci-dessous).", "truncated": false}, "before_length": 55, "before_sha256": "14582f4e6d8e20b5da0baf984a41d3c1708b9e604d711ccf22c385e3139fece1", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0574f7089928932fc8290a0d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003983", "medicine_name": "Nordimet", "medicine_slug": "nordimet", "observed_at": "2026-10-12T19:23:42Z", "pipeline_version": "2.0.0", "presentation_label": "Nordimet 7,5 mg solution injectable en stylo prérempli Nordimet 10 mg solution injectable en stylo prérempli Nordimet 12,5 mg solution injectable en stylo prérempli Nordimet 15 mg solution injectable en stylo prérempli Nordimet 17,5 mg solution injectable en stylo prérempli Nordimet 20 mg solution i", "presentation_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": "e7f04a283520007c0c784b04639c89eb37457990c57bdf9680c88f34ad56058f", "source_snapshot_id": "source-63c315f99ed4b0a7abc474b7", "source_updated_at": "2025-07-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nordimet-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 426}
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{"after": {"end": 344, "start": 0, "text": "L’administration d’autres médicaments hématotoxiques accroît la probabilité d’effets hématotoxiques sévères du méthotrexate. L’administration concomitante de métamizole et de méthotrexate peut augmenter l’effet hématotoxique du méthotrexate, en particulier chez les patients âgés. Par conséquent, l’administration concomitante doit être évitée.", "truncated": false}, "after_length": 344, "after_sha256": "d6e7de00f1ff8602ac8539683fce87c14a31a58582f8399ad006842002841b36", "annex": "I", "before": {"end": 344, "start": 0, "text": "L’administration d’autres médicaments hématotoxiques accroît la probabilité d’effets hématotoxiques sévères du méthotrexate. L’administration concomitante de métamizole et de méthotrexate peut augmenter l’effet hématotoxique du méthotrexate, en particulier chez les patients âgés. Par conséquent, l’administration concomitante doit être évitée.", "truncated": false}, "before_length": 344, "before_sha256": "d6e7de00f1ff8602ac8539683fce87c14a31a58582f8399ad006842002841b36", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-07385078aedfd7798ed21baa", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003983", "medicine_name": "Nordimet", "medicine_slug": "nordimet", "observed_at": "2026-10-12T19:23:42Z", "pipeline_version": "2.0.0", "presentation_label": "Nordimet 7,5 mg solution injectable en stylo prérempli Nordimet 10 mg solution injectable en stylo prérempli Nordimet 12,5 mg solution injectable en stylo prérempli Nordimet 15 mg solution injectable en stylo prérempli Nordimet 17,5 mg solution injectable en stylo prérempli Nordimet 20 mg solution i", "presentation_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": "e7f04a283520007c0c784b04639c89eb37457990c57bdf9680c88f34ad56058f", "source_snapshot_id": "source-63c315f99ed4b0a7abc474b7", "source_updated_at": "2025-07-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nordimet-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 326}
{"after": {"end": 315, "start": 0, "text": "Upon co-administration of known inducers of the CYP3A4, the plasma concentration of amlodipine may vary. Therefore, blood pressure should be monitored and dose regulation considered both during and after concomitant medicinal product particularly with strong CYP3A4 inducers (e.g. rifampicin, hypericum perforatum).", "truncated": false}, "after_length": 315, "after_sha256": "20c99958b39a2cd6a73fdd5c8dc51a8e8b933d55a6d52371d2eba68de83be896", "annex": "I", "before": {"end": 315, "start": 0, "text": "Upon co-administration of known inducers of the CYP3A4, the plasma concentration of amlodipine may vary. Therefore, blood pressure should be monitored and dose regulation considered both during and after concomitant medicinal product particularly with strong CYP3A4 inducers (e.g. rifampicin, hypericum perforatum).", "truncated": false}, "before_length": 315, "before_sha256": "20c99958b39a2cd6a73fdd5c8dc51a8e8b933d55a6d52371d2eba68de83be896", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0748f78e6e975628bd07758c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004037", "medicine_name": "Amlodipine / Valsartan Mylan", "medicine_slug": "amlodipine-valsartan-mylan", "observed_at": "2026-10-12T13:35:38Z", "pipeline_version": "2.0.0", "presentation_label": "Amlodipine/Valsartan Mylan 5 mg/80 mg film-coated tablets Amlodipine/Valsartan Mylan 5 mg/160 mg film-coated tablets Amlodipine/Valsartan Mylan 10 mg/160 mg film-coated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "dbb2d241391f1842fbe2af8d495fce7a68c0dd1274b21dbba2b09bd9bc167702", "source_snapshot_id": "source-11d0beb027751f1d533d1385", "source_updated_at": "2026-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/amlodipine-valsartan-mylan-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 223}
{"after": {"end": 159, "start": 0, "text": "Si le traitement par nitisinone est instauré avec de la nourriture, il est recommandé de le poursuivre dans les mêmes conditions, se référer à la rubrique 4.5.", "truncated": false}, "after_length": 159, "after_sha256": "9404590fe1277706eb016922a0c5b5f4fa04bbda4eac9b31933f59f335858c2b", "annex": "I", "before": {"end": 159, "start": 0, "text": "Si le traitement par nitisinone est instauré avec de la nourriture, il est recommandé de le poursuivre dans les mêmes conditions, se référer à la rubrique 4.5.", "truncated": false}, "before_length": 159, "before_sha256": "9404590fe1277706eb016922a0c5b5f4fa04bbda4eac9b31933f59f335858c2b", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-075308c3272fbf1ba51088ce", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000555", "medicine_name": "Orfadin", "medicine_slug": "orfadin", "observed_at": "2026-10-12T19:30:21Z", "pipeline_version": "2.0.0", "presentation_label": "Orfadin Gélules 2 mg Orfadin Gélules 5 mg Orfadin Gélules 10 mg Orfadin Gélules 20 mg", "presentation_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": "b7b9a2d5ecfeab85a4c9cb5e331a674393a38d8254108796684c5afed9c090b3", "source_snapshot_id": "source-2791fc535da292a795b4176e", "source_updated_at": "2025-07-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/orfadin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 105}
{"after": {"end": 600, "start": 0, "text": "It is unknown whether denosumab is excreted in human milk. In genetically engineered mice in which RANKL has been turned off by gene removal (a “knockout mouse”), studies suggest absence of RANKL (the target of denosumab see section 5.1) during pregnancy may interfere with maturation of the mammary gland leading to impaired lactation post-partum (see section 5.3). A decision on whether to abstain from breast-feeding or to abstain from therapy with denosumab should be made, taking into account the benefit of breast-feeding to the newborn/infant and the benefit of denosumab therapy to the woman.", "truncated": false}, "after_length": 600, "after_sha256": "76bc49cfe1f09ade01cbbe398c456f265441476f1ec752b47fbb29ef8257eb3c", "annex": "I", "before": {"end": 600, "start": 0, "text": "It is unknown whether denosumab is excreted in human milk. In genetically engineered mice in which RANKL has been turned off by gene removal (a “knockout mouse”), studies suggest absence of RANKL (the target of denosumab see section 5.1) during pregnancy may interfere with maturation of the mammary gland leading to impaired lactation post-partum (see section 5.3). A decision on whether to abstain from breast-feeding or to abstain from therapy with denosumab should be made, taking into account the benefit of breast-feeding to the newborn/infant and the benefit of denosumab therapy to the woman.", "truncated": false}, "before_length": 600, "before_sha256": "76bc49cfe1f09ade01cbbe398c456f265441476f1ec752b47fbb29ef8257eb3c", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0754de2a637f1b7ffa39c689", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006156", "medicine_name": "Stoboclo", "medicine_slug": "stoboclo", "observed_at": "2026-10-12T19:08:45Z", "pipeline_version": "2.0.0", "presentation_label": "Stoboclo 60 mg solution for injection in pre-filled syringe", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.6", "section_type": "pregnancy", "source_provider": "European Medicines Agency", "source_sha256": "e0001db1d3c6b508fa269c3573cfe47a0de6261319a8651cee96a5472648b7f3", "source_snapshot_id": "source-21d50f23fabc205dafb30654", "source_updated_at": "2025-09-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/stoboclo-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 186}
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{"after": {"end": 524, "start": 0, "text": "Une ingestion accidentelle de nitisinone par un sujet suivant un régime alimentaire normal sans restriction en tyrosine et en phénylalanine conduit à une augmentation des taux en tyrosine. Des taux élevés en tyrosine ont été associés à une toxicité oculaire, cutanée et du système nerveux. Un apport restreint en tyrosine et en phénylalanine dans le régime alimentaire devrait limiter la toxicité associée à ce type de tyrosinémie. Aucune information concernant un traitement spécifique en cas de surdosage n’est disponible.", "truncated": false}, "after_length": 524, "after_sha256": "9cbda44373ebed3d6f3f0b4439002457a68f1d90a6ea8a07457201d7deafba7f", "annex": "I", "before": {"end": 524, "start": 0, "text": "Une ingestion accidentelle de nitisinone par un sujet suivant un régime alimentaire normal sans restriction en tyrosine et en phénylalanine conduit à une augmentation des taux en tyrosine. Des taux élevés en tyrosine ont été associés à une toxicité oculaire, cutanée et du système nerveux. Un apport restreint en tyrosine et en phénylalanine dans le régime alimentaire devrait limiter la toxicité associée à ce type de tyrosinémie. Aucune information concernant un traitement spécifique en cas de surdosage n’est disponible.", "truncated": false}, "before_length": 524, "before_sha256": "9cbda44373ebed3d6f3f0b4439002457a68f1d90a6ea8a07457201d7deafba7f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-09caf696c553f9ded86c9de0", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000555", "medicine_name": "Orfadin", "medicine_slug": "orfadin", "observed_at": "2026-10-12T19:30:21Z", "pipeline_version": "2.0.0", "presentation_label": "Orfadin Gélules 2 mg Orfadin Gélules 5 mg Orfadin Gélules 10 mg Orfadin Gélules 20 mg", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.9", "section_type": "overdose", "source_provider": "European Medicines Agency", "source_sha256": "b7b9a2d5ecfeab85a4c9cb5e331a674393a38d8254108796684c5afed9c090b3", "source_snapshot_id": "source-2791fc535da292a795b4176e", "source_updated_at": "2025-07-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/orfadin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 224}
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{"after": {"end": 187, "start": 0, "text": "Le métabolisme de la lamivudine ne fait pas intervenir l’isoenzyme CYP3A, les interactions avec d’autres médicaments métabolisés par le cytochrome P450 sont donc peu probables (ex. : IP).", "truncated": false}, "after_length": 187, "after_sha256": "d0902ccfd1a5e5dd8d57e8065d4f03bfbadd9eb3994d51efa60a95bd28a8f4d9", "annex": "I", "before": {"end": 187, "start": 0, "text": "Le métabolisme de la lamivudine ne fait pas intervenir l’isoenzyme CYP3A, les interactions avec d’autres médicaments métabolisés par le cytochrome P450 sont donc peu probables (ex. : IP).", "truncated": false}, "before_length": 187, "before_sha256": "d0902ccfd1a5e5dd8d57e8065d4f03bfbadd9eb3994d51efa60a95bd28a8f4d9", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0a0bc5edc2939f4b7b070c3e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000107", "medicine_name": "Epivir", "medicine_slug": "epivir", "observed_at": "2026-10-12T13:28:29Z", "pipeline_version": "2.0.0", "presentation_label": "Epivir 10 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": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "904a2bee5f9c3c7a487325fb08ed809c65fa98667b82cab8453987f0747cdd99", "source_snapshot_id": "source-9b98b8a63a7126a69f539d31", "source_updated_at": "2026-08-20", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/epivir-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 904}
{"after": {"end": 619, "start": 0, "text": "La convention suivante a été utilisée pour la classification des effets indésirables basée sur les taux d’incidence au cours de quatre études cliniques de phase III, de deux études de phase II et de l’expérience après commercialisation (voir tableau 1) : très fréquent (≥ 1/10), fréquent (≥ 1/100, < 1/10), peu fréquent (≥ 1/1 000, < 1/100), rare (≥ 1/10 000, < 1/1 000), très rare (< 1/10 000) et fréquence indéterminée (ne peut être estimée sur la base des données disponibles). Dans chaque groupe de fréquence et de classe de système d’organe, les effets indésirables sont présentés par ordre décroissant de gravité.", "truncated": false}, "after_length": 619, "after_sha256": "dbcba2c21fe651c61224ce96fd23be4b97ab292628fd5e39f504787576c59680", "annex": "I", "before": {"end": 619, "start": 0, "text": "La convention suivante a été utilisée pour la classification des effets indésirables basée sur les taux d’incidence au cours de quatre études cliniques de phase III, de deux études de phase II et de l’expérience après commercialisation (voir tableau 1) : très fréquent (≥ 1/10), fréquent (≥ 1/100, < 1/10), peu fréquent (≥ 1/1 000, < 1/100), rare (≥ 1/10 000, < 1/1 000), très rare (< 1/10 000) et fréquence indéterminée (ne peut être estimée sur la base des données disponibles). Dans chaque groupe de fréquence et de classe de système d’organe, les effets indésirables sont présentés par ordre décroissant de gravité.", "truncated": false}, "before_length": 619, "before_sha256": "dbcba2c21fe651c61224ce96fd23be4b97ab292628fd5e39f504787576c59680", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0a18697e06ee9444f8531819", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002173", "medicine_name": "Xgeva", "medicine_slug": "xgeva", "observed_at": "2026-10-12T13:34:02Z", "pipeline_version": "2.0.0", "presentation_label": "XGEVA 120 mg solution injectable XGEVA 120 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": "47551aac60917b2ed3f8c2e52c27dd3450c19003b7f0c7922ab6afa6357572e5", "source_snapshot_id": "source-a91ac33cdc893a4fbfb3ad37", "source_updated_at": "2026-06-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xgeva-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 236}
{"after": {"end": 162, "start": 0, "text": "Ce stylo est personnel, ne partagez avec aucune autre personne votre stylo et vos aiguilles car cela peut entraîner un risque de transmission d’agents infectieux.", "truncated": false}, "after_length": 162, "after_sha256": "dd34fa0f6a0621c3079ed62358082045f0609f225b573ecc6700d944192aec9c", "annex": "IIIB", "before": {"end": 162, "start": 0, "text": "Ce stylo est personnel, ne partagez avec aucune autre personne votre stylo et vos aiguilles car cela peut entraîner un risque de transmission d’agents infectieux.", "truncated": false}, "before_length": 162, "before_sha256": "dd34fa0f6a0621c3079ed62358082045f0609f225b573ecc6700d944192aec9c", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0a1fa3f411386a6bfef9f2ce", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005793", "medicine_name": "Teriparatide Sun", "medicine_slug": "teriparatide-sun", "observed_at": "2026-10-12T19:05:45Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": 1, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5", "section_type": "patient_leaflet", "source_provider": "European Medicines Agency", "source_sha256": "5313b2498f0c94c017ef88553e06a1b7ef2cad8ee469210d9e9a5e0dbdb6628e", "source_snapshot_id": "source-232735ecebf2ef9fd5dde897", "source_updated_at": "2025-10-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/teriparatide-sun-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1063}
{"after": {"end": 207, "start": 0, "text": "The inhaler is a multi-component device composed of polypropylene, high density polyethylene, polyoxymethylene, polybutylene terephthalate, acrylonitrile butadiene styrene, polycarbonate and stainless steel.", "truncated": false}, "after_length": 207, "after_sha256": "278c502dcefba6cd4313b81e7f14368d26d6ab47047296caa1f21fb3d7e79b0f", "annex": "I", "before": {"end": 207, "start": 0, "text": "The inhaler is a multi-component device composed of polypropylene, high density polyethylene, polyoxymethylene, polybutylene terephthalate, acrylonitrile butadiene styrene, polycarbonate and stainless steel.", "truncated": false}, "before_length": 207, "before_sha256": "278c502dcefba6cd4313b81e7f14368d26d6ab47047296caa1f21fb3d7e79b0f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0a1ff0b2cbc6dd5ac8e392a9", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004363", "medicine_name": "Trelegy Ellipta", "medicine_slug": "trelegy-ellipta", "observed_at": "2026-10-12T13:38:40Z", "pipeline_version": "2.0.0", "presentation_label": "Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.5", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "0294b56482c18349cad8906f87bbe5fea1c07b54c1e62f4ee4615ab5c518b287", "source_snapshot_id": "source-112702cb422c8868fda09ffd", "source_updated_at": "2026-05-08", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/trelegy-ellipta-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 629}
{"after": {"end": 340, "start": 0, "text": "Children from three months to one year of age: The recommended dose is 0.5 mL/kg (5 mg/kg) twice daily. If a twice daily regimen is not feasible, a once daily regimen (10 mg/kg/day) could be considered. It should be taken into account that data for the once daily regimen are very limited in this population (see sections 4.4, 5.1 and 5.2).", "truncated": false}, "after_length": 340, "after_sha256": "32f06318167c5b0b019ba21d48e4676251963fb72f10fa5b1efdb170c6165654", "annex": "I", "before": {"end": 340, "start": 0, "text": "Children from three months to one year of age: The recommended dose is 0.5 mL/kg (5 mg/kg) twice daily. If a twice daily regimen is not feasible, a once daily regimen (10 mg/kg/day) could be considered. It should be taken into account that data for the once daily regimen are very limited in this population (see sections 4.4, 5.1 and 5.2).", "truncated": false}, "before_length": 340, "before_sha256": "32f06318167c5b0b019ba21d48e4676251963fb72f10fa5b1efdb170c6165654", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0a3236305f4c9c97a34ac8b5", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000107", "medicine_name": "Epivir", "medicine_slug": "epivir", "observed_at": "2026-10-12T13:28:26Z", "pipeline_version": "2.0.0", "presentation_label": "Epivir 10 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": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "0719999535f36d1593098041092a62a85b74621a9bc5998fad6b31917f9b03b2", "source_snapshot_id": "source-633d511d05f1fff2eb0de73a", "source_updated_at": "2026-08-20", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/epivir-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 703}
{"after": {"end": 885, "start": 0, "text": "La réaction indésirable la plus grave rapportée au cours des études cliniques portant sur la défériprone a été l’agranulocytose (taux de polynucléaires neutrophiles < 0,5 x 109/l), avec une incidence de 1,1 % (0,6 cas pour 100 années-patients de traitement) (voir rubrique 4.4). Les données tirées d'études cliniques regroupées chez des patients présentant une surcharge en fer systémique ont montré que 63 % des épisodes d'agranulocytose sont survenus au cours des six premiers mois de traitement, 74 % au cours de la première année et 26 % après un an de traitement. Le délai médian avant le début du premier épisode d'agranulocytose était de 190 jours (intervalle de 22 jours - 17,6 ans) et la durée médiane était de 10 jours dans les études cliniques. Un décès a été observé dans 8,3 % des épisodes d'agranulocytose signalés lors des études cliniques et après la commercialisation.", "truncated": false}, "after_length": 885, "after_sha256": "23d0049eb7889c7b9907487af2855ce825b3766edc45a2d357e95b62510ac177", "annex": "I", "before": {"end": 885, "start": 0, "text": "La réaction indésirable la plus grave rapportée au cours des études cliniques portant sur la défériprone a été l’agranulocytose (taux de polynucléaires neutrophiles < 0,5 x 109/l), avec une incidence de 1,1 % (0,6 cas pour 100 années-patients de traitement) (voir rubrique 4.4). Les données tirées d'études cliniques regroupées chez des patients présentant une surcharge en fer systémique ont montré que 63 % des épisodes d'agranulocytose sont survenus au cours des six premiers mois de traitement, 74 % au cours de la première année et 26 % après un an de traitement. Le délai médian avant le début du premier épisode d'agranulocytose était de 190 jours (intervalle de 22 jours - 17,6 ans) et la durée médiane était de 10 jours dans les études cliniques. Un décès a été observé dans 8,3 % des épisodes d'agranulocytose signalés lors des études cliniques et après la commercialisation.", "truncated": false}, "before_length": 885, "before_sha256": "23d0049eb7889c7b9907487af2855ce825b3766edc45a2d357e95b62510ac177", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0a43c0a964e7599eab1b05f5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000236", "medicine_name": "Ferriprox", "medicine_slug": "ferriprox", "observed_at": "2026-10-12T19:16:47Z", "pipeline_version": "2.0.0", "presentation_label": "Ferriprox 500 mg comprimés pelliculés Ferriprox 1 000 mg comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "cc461deb7027b3031d2b09d601fe7fec7c79c9f0f3a5864ba1024008d1a91dfa", "source_snapshot_id": "source-043b4003f4c66df240947f28", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/ferriprox-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 365}
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{"after": {"end": 166, "start": 0, "text": "En cas d’anurie ou d’oligurie significative après la première ou la deuxième dose, attendre le retour à la normale de la diurèse avant d’administrer la dose suivante.", "truncated": false}, "after_length": 166, "after_sha256": "bfdeb7dc20d75ec7e858097dbe373731b066963b93faf3cd18a5e457ee2d0236", "annex": "I", "before": {"end": 166, "start": 0, "text": "En cas d’anurie ou d’oligurie significative après la première ou la deuxième dose, attendre le retour à la normale de la diurèse avant d’administrer la dose suivante.", "truncated": false}, "before_length": 166, "before_sha256": "bfdeb7dc20d75ec7e858097dbe373731b066963b93faf3cd18a5e457ee2d0236", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0ae95fe18837825d44f25172", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000549", "medicine_name": "Pedea", "medicine_slug": "pedea", "observed_at": "2026-10-12T17:30:20Z", "pipeline_version": "2.0.0", "presentation_label": "Pedea 5 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": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "b96fb2edd6bc9020520cccfda4ced68bd04fe64aa9e697eb6b067c7d3c233a35", "source_snapshot_id": "source-8fa0c575edbf5bd4c0e6ac03", "source_updated_at": "2025-11-25", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/pedea-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 61}
{"after": {"end": 667, "start": 0, "text": "L’ONM a été rarement rapportée, chez 16 patients, dans les essais cliniques menés chez des patients atteints d’ostéoporose et chez des patients atteints d’un cancer du sein ou de la prostate recevant un traitement hormono-ablatif incluant un total de 23 148 patients (voir rubrique 4.4). Treize de ces cas d’ONM sont survenus chez des femmes atteintes d’ostéoporose post-ménopausique pendant l’extension de l’essai clinique de phase III allant jusqu’à 10 ans de traitement par dénosumab. L’incidence de l’ONM était de 0,04 % à 3 ans, 0,06 % à 5 ans et 0,44 % à 10 ans de traitement par dénosumab. Le risque d’ONM a augmenté avec la durée de l’exposition au dénosumab.", "truncated": false}, "after_length": 667, "after_sha256": "7c4bfb1eb6083c4579fbb3d2c205c069ce914ba00d49b1cb5d65f1246b03ddc2", "annex": "I", "before": {"end": 667, "start": 0, "text": "L’ONM a été rarement rapportée, chez 16 patients, dans les essais cliniques menés chez des patients atteints d’ostéoporose et chez des patients atteints d’un cancer du sein ou de la prostate recevant un traitement hormono-ablatif incluant un total de 23 148 patients (voir rubrique 4.4). Treize de ces cas d’ONM sont survenus chez des femmes atteintes d’ostéoporose post-ménopausique pendant l’extension de l’essai clinique de phase III allant jusqu’à 10 ans de traitement par dénosumab. L’incidence de l’ONM était de 0,04 % à 3 ans, 0,06 % à 5 ans et 0,44 % à 10 ans de traitement par dénosumab. Le risque d’ONM a augmenté avec la durée de l’exposition au dénosumab.", "truncated": false}, "before_length": 667, "before_sha256": "7c4bfb1eb6083c4579fbb3d2c205c069ce914ba00d49b1cb5d65f1246b03ddc2", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0af41a26e2ff397731e824b6", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006156", "medicine_name": "Stoboclo", "medicine_slug": "stoboclo", "observed_at": "2026-10-12T19:08:48Z", "pipeline_version": "2.0.0", "presentation_label": "Stoboclo 60 mg solution injectable en seringue préremplie", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "333f6c97855028e7dd6c52dd3e41e946d4c139c14aa4b6bab97c81affa0ae504", "source_snapshot_id": "source-6b2f9808dc7b5721775c9280", "source_updated_at": "2025-09-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/stoboclo-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 293}
{"after": {"end": 232, "start": 0, "text": "Data from the published literature are consistent with the results from the company-sponsored studies, demonstrating less heart disease and/or increased survival in Ferriprox-treated patients than in those treated with deferoxamine.", "truncated": false}, "after_length": 232, "after_sha256": "515cc014dbf1f783cc8bcb70e755c47e64c78e9e5ea681afa2689fc88fe78839", "annex": "I", "before": {"end": 232, "start": 0, "text": "Data from the published literature are consistent with the results from the company-sponsored studies, demonstrating less heart disease and/or increased survival in Ferriprox-treated patients than in those treated with deferoxamine.", "truncated": false}, "before_length": 232, "before_sha256": "515cc014dbf1f783cc8bcb70e755c47e64c78e9e5ea681afa2689fc88fe78839", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0b1ae3a45cef6909682d98eb", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000236", "medicine_name": "Ferriprox", "medicine_slug": "ferriprox", "observed_at": "2026-10-12T19:16:46Z", "pipeline_version": "2.0.0", "presentation_label": "Ferriprox 500 mg film-coated tablets Ferriprox 1 000 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": "47f97c701962e81f7f15f37dc4a75d8ea756178013085f22dba6f616a512622c", "source_snapshot_id": "source-3b8f8e4357eb2da16aa8b50f", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/ferriprox-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 422}
{"after": {"end": 250, "start": 0, "text": "Chez l’animal, la rivastigmine est excrétée dans le lait. Dans l’espèce humaine il n'existe pas de données concernant le passage de la rivastigmine dans le lait maternel. En conséquence, les femmes traitées par la rivastigmine ne doivent pas allaiter", "truncated": false}, "after_length": 250, "after_sha256": "f655c11c66d9d92a9fec6a54369528f725801f4e5bbee86c69e412806240375c", "annex": "I", "before": {"end": 250, "start": 0, "text": "Chez l’animal, la rivastigmine est excrétée dans le lait. Dans l’espèce humaine il n'existe pas de données concernant le passage de la rivastigmine dans le lait maternel. En conséquence, les femmes traitées par la rivastigmine ne doivent pas allaiter", "truncated": false}, "before_length": 250, "before_sha256": "f655c11c66d9d92a9fec6a54369528f725801f4e5bbee86c69e412806240375c", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0b2ac29f966b6e4b94b4805b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002036", "medicine_name": "Rivastigmine Actavis", "medicine_slug": "rivastigmine-actavis", "observed_at": "2026-10-12T19:36:31Z", "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": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "2dc5a31daa72546008bd6fc537e9d469bc1b67d5ac3c177552df4e8957e42f91", "source_snapshot_id": "source-66a9b311e221786e939d11cd", "source_updated_at": "2025-06-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/rivastigmine-actavis-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 187}
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{"after": {"end": 560, "start": 0, "text": "Chez l’adulte et l’adolescent, les taux plasmatiques de desloratadine peuvent être détectés dans les 30 minutes qui suivent l’administration. La desloratadine est bien absorbée avec une concentration maximale atteinte après approximativement 3 heures ; la demivie de la phase terminale est approximativement de 27 heures. Le facteur d’accumulation de la desloratadine correspond à sa demivie (27 heures environ) et son rythme d’administration en une prise par jour. La biodisponibilité de la desloratadine est dose-dépendante sur un intervalle de 5 mg à 20 mg.", "truncated": false}, "after_length": 560, "after_sha256": "54f7bfe87785bef79e1f8408b4ddfa7cebcd820912e997137c0377fe610100b8", "annex": "I", "before": {"end": 560, "start": 0, "text": "Chez l’adulte et l’adolescent, les taux plasmatiques de desloratadine peuvent être détectés dans les 30 minutes qui suivent l’administration. La desloratadine est bien absorbée avec une concentration maximale atteinte après approximativement 3 heures ; la demivie de la phase terminale est approximativement de 27 heures. Le facteur d’accumulation de la desloratadine correspond à sa demivie (27 heures environ) et son rythme d’administration en une prise par jour. La biodisponibilité de la desloratadine est dose-dépendante sur un intervalle de 5 mg à 20 mg.", "truncated": false}, "before_length": 560, "before_sha256": "54f7bfe87785bef79e1f8408b4ddfa7cebcd820912e997137c0377fe610100b8", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0bc5220267bda6d4f0cee313", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000314", "medicine_name": "Neoclarityn", "medicine_slug": "neoclarityn", "observed_at": "2026-10-12T13:47:27Z", "pipeline_version": "2.0.0", "presentation_label": "Neoclarityn 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": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "95c77b8bb79a4be584e66485b8cba7ae8d117f73ed71304c72deeb2fdaf1bdd6", "source_snapshot_id": "source-6d8e9743211a1bd771234a79", "source_updated_at": "2026-03-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/neoclarityn-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 602}
{"after": {"end": 209, "start": 0, "text": "Dose adjustment is not required in patients with mild, moderate, or severe renal impairment (see section 5.2). The safety and pharmacokinetics of Ferriprox in patients with end stage renal disease are unknown.", "truncated": false}, "after_length": 209, "after_sha256": "d851aa1a384daee2b8cad08d7af0ae1cc2004bc235053bf974b531262394896f", "annex": "I", "before": {"end": 209, "start": 0, "text": "Dose adjustment is not required in patients with mild, moderate, or severe renal impairment (see section 5.2). The safety and pharmacokinetics of Ferriprox in patients with end stage renal disease are unknown.", "truncated": false}, "before_length": 209, "before_sha256": "d851aa1a384daee2b8cad08d7af0ae1cc2004bc235053bf974b531262394896f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0c19c504c28044bac1806355", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000236", "medicine_name": "Ferriprox", "medicine_slug": "ferriprox", "observed_at": "2026-10-12T19:16:46Z", "pipeline_version": "2.0.0", "presentation_label": "Ferriprox 100 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": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "47f97c701962e81f7f15f37dc4a75d8ea756178013085f22dba6f616a512622c", "source_snapshot_id": "source-3b8f8e4357eb2da16aa8b50f", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/ferriprox-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 672}
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{"after": {"end": 391, "start": 0, "text": "Neurological disorders have been observed in children treated with more than 2.5 times the maximum recommended dose for several years but have also been observed with standard doses of deferiprone. Prescribers are reminded that the use of doses above 100 mg/kg/day are not recommended. Deferiprone use should be discontinued if neurological disorders are observed (see sections 4.8 and 4.9).", "truncated": false}, "after_length": 391, "after_sha256": "939b5e1d7907c59c3681d93d2c87c507d655e3a49b9f86fb46a999759691b17c", "annex": "I", "before": {"end": 391, "start": 0, "text": "Neurological disorders have been observed in children treated with more than 2.5 times the maximum recommended dose for several years but have also been observed with standard doses of deferiprone. Prescribers are reminded that the use of doses above 100 mg/kg/day are not recommended. Deferiprone use should be discontinued if neurological disorders are observed (see sections 4.8 and 4.9).", "truncated": false}, "before_length": 391, "before_sha256": "939b5e1d7907c59c3681d93d2c87c507d655e3a49b9f86fb46a999759691b17c", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0d930ff63c42785126ff6b7d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000236", "medicine_name": "Ferriprox", "medicine_slug": "ferriprox", "observed_at": "2026-10-12T19:16:46Z", "pipeline_version": "2.0.0", "presentation_label": "Ferriprox 500 mg film-coated tablets Ferriprox 1 000 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": "47f97c701962e81f7f15f37dc4a75d8ea756178013085f22dba6f616a512622c", "source_snapshot_id": "source-3b8f8e4357eb2da16aa8b50f", "source_updated_at": "2025-08-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/ferriprox-epar-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}
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{"after": {"end": 248, "start": 0, "text": "Orfadin has minor influence on the ability to drive and use machines. Adverse reactions involving the eyes (see section 4.8) can affect the vision. If the vision is affected the patient should not drive or use machines until the event has subsided.", "truncated": false}, "after_length": 248, "after_sha256": "a827cc329254cbc86214f94fd898f5f0fc05643cfdf318a6fbcb40731bb6f1c6", "annex": "I", "before": {"end": 248, "start": 0, "text": "Orfadin has minor influence on the ability to drive and use machines. Adverse reactions involving the eyes (see section 4.8) can affect the vision. If the vision is affected the patient should not drive or use machines until the event has subsided.", "truncated": false}, "before_length": 248, "before_sha256": "a827cc329254cbc86214f94fd898f5f0fc05643cfdf318a6fbcb40731bb6f1c6", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0e27baa1fbb8bb6520fca60c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000555", "medicine_name": "Orfadin", "medicine_slug": "orfadin", "observed_at": "2026-10-12T19:30:18Z", "pipeline_version": "2.0.0", "presentation_label": "Orfadin 2 mg hard capsules Orfadin 5 mg hard capsules Orfadin 10 mg hard capsules Orfadin 20 mg hard capsules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.7", "section_type": "driving", "source_provider": "European Medicines Agency", "source_sha256": "533dc10df9dc5e7196f7ae7905ac9713dfd2c7e1613a9dcca0737cd53105b807", "source_snapshot_id": "source-27cd4c5d901ffff4936dfe84", "source_updated_at": "2025-07-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/orfadin-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 155}
{"after": {"end": 517, "start": 0, "text": "Excessive hypotension was seen in 0.4 % of patients with uncomplicated hypertension treated with amlodipine/valsartan in placebo-controlled studies. In patients with an activated renin-angiotensin system (such as volume- and/or salt-depleted patients receiving high doses of diuretics) who are receiving angiotensin receptor blockers, symptomatic hypotension may occur. Correction of this condition prior to administration of amlodipine/valsartan or close medical supervision at the start of treatment is recommended.", "truncated": false}, "after_length": 517, "after_sha256": "82e2b6e680e43bf3220d45dbde7cf9d6e66463cb4700df2b777714548dd35626", "annex": "I", "before": {"end": 517, "start": 0, "text": "Excessive hypotension was seen in 0.4 % of patients with uncomplicated hypertension treated with amlodipine/valsartan in placebo-controlled studies. In patients with an activated renin-angiotensin system (such as volume- and/or salt-depleted patients receiving high doses of diuretics) who are receiving angiotensin receptor blockers, symptomatic hypotension may occur. Correction of this condition prior to administration of amlodipine/valsartan or close medical supervision at the start of treatment is recommended.", "truncated": false}, "before_length": 517, "before_sha256": "82e2b6e680e43bf3220d45dbde7cf9d6e66463cb4700df2b777714548dd35626", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0e412748da150eaea908bc6f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004037", "medicine_name": "Amlodipine / Valsartan Mylan", "medicine_slug": "amlodipine-valsartan-mylan", "observed_at": "2026-10-12T13:35:38Z", "pipeline_version": "2.0.0", "presentation_label": "Amlodipine/Valsartan Mylan 5 mg/80 mg film-coated tablets Amlodipine/Valsartan Mylan 5 mg/160 mg film-coated tablets Amlodipine/Valsartan Mylan 10 mg/160 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": "dbb2d241391f1842fbe2af8d495fce7a68c0dd1274b21dbba2b09bd9bc167702", "source_snapshot_id": "source-11d0beb027751f1d533d1385", "source_updated_at": "2026-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/amlodipine-valsartan-mylan-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 140}
{"after": {"end": 638, "start": 0, "text": "Lors des études non cliniques de sécurité, l’administration chez le rat de fortes doses de valsartan (200 à 600 mg/kg de poids corporel) a entraîné une diminution des paramètres relatifs aux globules rouges (érythrocytes, hémoglobine, hématocrite) et l’apparition de signes probants d’altération de l’hémodynamique rénale (urée sanguine légèrement augmentée, hyperplasie tubulaire rénale et basophilie chez les mâles). Ces doses chez le rat (200 à 600 mg/kg/jour) représentent environ 6 à 18 fois la dose maximale recommandée chez l’humain sur la base de mg/m² (les calculs supposent une dose orale de 320 mg/jour et un patient de 60 kg).", "truncated": false}, "after_length": 638, "after_sha256": "60d453ef79eb0f31e7101999791714fa6b64585f872ceb32edcaaa4861b8836d", "annex": "I", "before": {"end": 638, "start": 0, "text": "Lors des études non cliniques de sécurité, l’administration chez le rat de fortes doses de valsartan (200 à 600 mg/kg de poids corporel) a entraîné une diminution des paramètres relatifs aux globules rouges (érythrocytes, hémoglobine, hématocrite) et l’apparition de signes probants d’altération de l’hémodynamique rénale (urée sanguine légèrement augmentée, hyperplasie tubulaire rénale et basophilie chez les mâles). Ces doses chez le rat (200 à 600 mg/kg/jour) représentent environ 6 à 18 fois la dose maximale recommandée chez l’humain sur la base de mg/m² (les calculs supposent une dose orale de 320 mg/jour et un patient de 60 kg).", "truncated": false}, "before_length": 638, "before_sha256": "60d453ef79eb0f31e7101999791714fa6b64585f872ceb32edcaaa4861b8836d", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0e7a7711d66af2dcee166543", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004037", "medicine_name": "Amlodipine / Valsartan Mylan", "medicine_slug": "amlodipine-valsartan-mylan", "observed_at": "2026-10-12T13:35:39Z", "pipeline_version": "2.0.0", "presentation_label": "Amlodipine/Valsartan Mylan 5 mg/80 mg, comprimés pelliculés Amlodipine/Valsartan Mylan 5 mg/160 mg, comprimés pelliculés Amlodipine/Valsartan Mylan 10 mg/160 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": "5.3", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "fef655284bc3e833ca7b4a2070cc1afbef5e73f7f31bf45aa3565d9df88381f0", "source_snapshot_id": "source-48f6182a78cf7770947302ab", "source_updated_at": "2026-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/amlodipine-valsartan-mylan-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1095}
{"after": {"end": 94, "start": 0, "text": "Hypersensibilité aux substances actives ou à l’un des excipients mentionnés à la rubrique 6.1.", "truncated": false}, "after_length": 94, "after_sha256": "e5f635c7e75bbe1ce8b17e93458aff8137ac5bd2a522df286c52684cc0ab6393", "annex": "I", "before": {"end": 94, "start": 0, "text": "Hypersensibilité aux substances actives ou à l’un des excipients mentionnés à la rubrique 6.1.", "truncated": false}, "before_length": 94, "before_sha256": "e5f635c7e75bbe1ce8b17e93458aff8137ac5bd2a522df286c52684cc0ab6393", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0e7fb0367e1c57fd4b036039", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004363", "medicine_name": "Trelegy Ellipta", "medicine_slug": "trelegy-ellipta", "observed_at": "2026-10-12T13:38:42Z", "pipeline_version": "2.0.0", "presentation_label": "Trelegy Ellipta 92 microgrammes/55 microgrammes/22 microgrammes, poudre pour inhalation en récipient unidose", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.3", "section_type": "contraindication", "source_provider": "European Medicines Agency", "source_sha256": "a9f1d1d6919f0a44d696093c8975d807ec0428c4fece680a70c4b87fc6c20c2e", "source_snapshot_id": "source-1b6beccd35df03f141828236", "source_updated_at": "2026-05-08", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/trelegy-ellipta-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 131}
{"after": {"end": 327, "start": 0, "text": "L'utilisation de bêta bloquant cardiosélectif ne doit être envisagé qu'en cas d'effets de surdosage en vilantérol graves, préoccupants sur le plan clinique et ne répondant pas aux soins standards. Les bêta-bloquants cardiosélectifs doivent être utilisés avec précaution chez les patients ayant des antécédents de bronchospasme.", "truncated": false}, "after_length": 327, "after_sha256": "3bbb322841f1e5f9b853b8018439b8751383cf4e5537902d25023e96dcdb0162", "annex": "I", "before": {"end": 327, "start": 0, "text": "L'utilisation de bêta bloquant cardiosélectif ne doit être envisagé qu'en cas d'effets de surdosage en vilantérol graves, préoccupants sur le plan clinique et ne répondant pas aux soins standards. Les bêta-bloquants cardiosélectifs doivent être utilisés avec précaution chez les patients ayant des antécédents de bronchospasme.", "truncated": false}, "before_length": 327, "before_sha256": "3bbb322841f1e5f9b853b8018439b8751383cf4e5537902d25023e96dcdb0162", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0efc6a5123fc0b85c70d9888", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004363", "medicine_name": "Trelegy Ellipta", "medicine_slug": "trelegy-ellipta", "observed_at": "2026-10-12T13:38:42Z", "pipeline_version": "2.0.0", "presentation_label": "Trelegy Ellipta 92 microgrammes/55 microgrammes/22 microgrammes, poudre pour inhalation en récipient unidose", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.9", "section_type": "overdose", "source_provider": "European Medicines Agency", "source_sha256": "a9f1d1d6919f0a44d696093c8975d807ec0428c4fece680a70c4b87fc6c20c2e", "source_snapshot_id": "source-1b6beccd35df03f141828236", "source_updated_at": "2026-05-08", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/trelegy-ellipta-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 365}
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{"after": {"end": 332, "start": 0, "text": "Une augmentation de la consommation de bronchodilatateurs de courte durée d’action pour soulager les symptômes peut indiquer une détérioration du contrôle de la maladie. En cas d'aggravation de la BPCO au cours du traitement par Trelegy Ellipta, l'état clinique du patient, ainsi que le traitement de la BPCO devront être réévalués.", "truncated": false}, "after_length": 332, "after_sha256": "6279890d53aa5e43ae1cb7af79965c673262ced8c183d406a1484a254d16f208", "annex": "I", "before": {"end": 332, "start": 0, "text": "Une augmentation de la consommation de bronchodilatateurs de courte durée d’action pour soulager les symptômes peut indiquer une détérioration du contrôle de la maladie. En cas d'aggravation de la BPCO au cours du traitement par Trelegy Ellipta, l'état clinique du patient, ainsi que le traitement de la BPCO devront être réévalués.", "truncated": false}, "before_length": 332, "before_sha256": "6279890d53aa5e43ae1cb7af79965c673262ced8c183d406a1484a254d16f208", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-10423b7631bf29398a0be07d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004363", "medicine_name": "Trelegy Ellipta", "medicine_slug": "trelegy-ellipta", "observed_at": "2026-10-12T13:38:42Z", "pipeline_version": "2.0.0", "presentation_label": "Trelegy Ellipta 92 microgrammes/55 microgrammes/22 microgrammes, poudre pour inhalation en récipient unidose", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "a9f1d1d6919f0a44d696093c8975d807ec0428c4fece680a70c4b87fc6c20c2e", "source_snapshot_id": "source-1b6beccd35df03f141828236", "source_updated_at": "2026-05-08", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/trelegy-ellipta-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 145}
{"after": {"end": 416, "start": 0, "text": "The frequency of the clinical trial adverse reactions reported in excess of placebo and other undesirable effects reported during the post-marketing period are listed in the following table. Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).", "truncated": false}, "after_length": 416, "after_sha256": "b7cd3759d6466371c5b644934d1e22875a871193dffb9a1cb49e30b6fa3758a8", "annex": "I", "before": {"end": 416, "start": 0, "text": "The frequency of the clinical trial adverse reactions reported in excess of placebo and other undesirable effects reported during the post-marketing period are listed in the following table. Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).", "truncated": false}, "before_length": 416, "before_sha256": "b7cd3759d6466371c5b644934d1e22875a871193dffb9a1cb49e30b6fa3758a8", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-1059a8128e8e0ad9013f0139", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000314", "medicine_name": "Neoclarityn", "medicine_slug": "neoclarityn", "observed_at": "2026-10-12T13:47:25Z", "pipeline_version": "2.0.0", "presentation_label": "Neoclarityn 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": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "25896e98eab63098c1d9838e445dacbb3a7ac7671e4bd73ccf2164e00bde12d6", "source_snapshot_id": "source-b5626359fbb77de0c67bbc56", "source_updated_at": "2026-03-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/neoclarityn-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 466}
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{"after": {"end": 232, "start": 0, "text": "As for all parenteral products, ampoules of Pedea should be visually inspected for particulate matter and the integrity of the container prior to use. Ampoules are intended for single use only, any unused portions must be discarded.", "truncated": false}, "after_length": 232, "after_sha256": "38d49aae6caa383598f4bc107a34d9096c7b3190a1ed4d04414f975d4d11dd48", "annex": "I", "before": {"end": 232, "start": 0, "text": "As for all parenteral products, ampoules of Pedea should be visually inspected for particulate matter and the integrity of the container prior to use. Ampoules are intended for single use only, any unused portions must be discarded.", "truncated": false}, "before_length": 232, "before_sha256": "38d49aae6caa383598f4bc107a34d9096c7b3190a1ed4d04414f975d4d11dd48", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-1c41a73ffb2e8b946810fac0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000549", "medicine_name": "Pedea", "medicine_slug": "pedea", "observed_at": "2026-10-12T17:30:15Z", "pipeline_version": "2.0.0", "presentation_label": "Pedea 5 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": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "1b0ae9decebab370100622495823d25b927417291dd97be35e9a7f3d03b76c5e", "source_snapshot_id": "source-1da886f479e0d9ae42b86f77", "source_updated_at": "2025-11-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pedea-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 240}
{"after": {"end": 190, "start": 0, "text": "Reported adverse reactions are listed below, by system organ class and by frequency. Frequencies are defined as: very common (≥ 1/10), common (≥1/100, <1/10) and uncommon (≥1/1,000, <1/100).", "truncated": false}, "after_length": 190, "after_sha256": "bed421500d2862e6db6518db79e3e6fa5c5870710ce0fa60cad75b11ea325040", "annex": "I", "before": {"end": 190, "start": 0, "text": "Reported adverse reactions are listed below, by system organ class and by frequency. Frequencies are defined as: very common (≥ 1/10), common (≥1/100, <1/10) and uncommon (≥1/1,000, <1/100).", "truncated": false}, "before_length": 190, "before_sha256": "bed421500d2862e6db6518db79e3e6fa5c5870710ce0fa60cad75b11ea325040", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-1f362143fd909ba9af15caf8", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000549", "medicine_name": "Pedea", "medicine_slug": "pedea", "observed_at": "2026-10-12T17:30:15Z", "pipeline_version": "2.0.0", "presentation_label": "Pedea 5 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": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "1b0ae9decebab370100622495823d25b927417291dd97be35e9a7f3d03b76c5e", "source_snapshot_id": "source-1da886f479e0d9ae42b86f77", "source_updated_at": "2025-11-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/pedea-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 130}