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{"after": {"end": 670, "start": 0, "text": "In one study (n = 157), which used a 6 mg fixed dose of pegfilgrastim the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.8 days compared with 1.6 days in the filgrastim group (difference 0.23 days, 95 % CI −0.15, 0.63). Over the entire study, the rate of febrile neutropenia was 13 % of pegfilgrastim-treated patients compared with 20 % of filgrastim-treated patients (difference 7 %, 95 % CI of −19 %, 5 %). In a second study (n = 310), which used a weight-adjusted dose (100 mcg/kg), the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.7 days, compared with 1.8 days in the filgrastim group (difference 0.03 days, 95 % CI", "truncated": false}, "after_length": 670, "after_sha256": "0d1e941bffb9d862025733d18b283716dfe5c424c611fc3e2fed1f55da928f71", "annex": "I", "before": {"end": 670, "start": 0, "text": "In one study (n = 157), which used a 6 mg fixed dose of pegfilgrastim the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.8 days compared with 1.6 days in the filgrastim group (difference 0.23 days, 95 % CI −0.15, 0.63). Over the entire study, the rate of febrile neutropenia was 13 % of pegfilgrastim-treated patients compared with 20 % of filgrastim-treated patients (difference 7 %, 95 % CI of −19 %, 5 %). In a second study (n = 310), which used a weight-adjusted dose (100 mcg/kg), the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.7 days, compared with 1.8 days in the filgrastim group (difference 0.03 days, 95 % CI", "truncated": false}, "before_length": 670, "before_sha256": "0d1e941bffb9d862025733d18b283716dfe5c424c611fc3e2fed1f55da928f71", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0060c683d5cebf3f36f15f5c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005312", "medicine_name": "Cegfila (previously Pegfilgrastim Mundipharma)", "medicine_slug": "cegfila-previously-pegfilgrastim-mundipharma", "observed_at": "2026-10-12T13:47:30Z", "pipeline_version": "2.0.0", "presentation_label": "Cegfila 6 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": "dd41c573f3407f6620feeeb91d402c4e6ca914261a9adb23330819e3f620071e", "source_snapshot_id": "source-878eb702fff3865e274eac51", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/cegfila-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 386}
{"after": {"end": 465, "start": 0, "text": "D’après les données obtenues in vitro, le céritinib est également un inhibiteur du CYP2A6 et du CYP2E1 à des concentrations cliniquement significatives. Par conséquent, le céritinib pourrait augmenter la concentration plasmatique des médicaments concomitants qui sont principalement métabolisés par ces enzymes. La prudence est recommandée en cas d’utilisation concomitante de substrats du CYP2A6 et du CYP2E1, et l’apparition d’EI doit être étroitement surveillée.", "truncated": false}, "after_length": 465, "after_sha256": "55e1532506240f7345a409c0392f6d4b416a81118a216e3a1aaf3fdc25b3b784", "annex": "I", "before": {"end": 465, "start": 0, "text": "D’après les données obtenues in vitro, le céritinib est également un inhibiteur du CYP2A6 et du CYP2E1 à des concentrations cliniquement significatives. Par conséquent, le céritinib pourrait augmenter la concentration plasmatique des médicaments concomitants qui sont principalement métabolisés par ces enzymes. La prudence est recommandée en cas d’utilisation concomitante de substrats du CYP2A6 et du CYP2E1, et l’apparition d’EI doit être étroitement surveillée.", "truncated": false}, "before_length": 465, "before_sha256": "55e1532506240f7345a409c0392f6d4b416a81118a216e3a1aaf3fdc25b3b784", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-006a2211855b139f5cd317da", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003819", "medicine_name": "Zykadia", "medicine_slug": "zykadia", "observed_at": "2026-10-12T19:15:42Z", "pipeline_version": "2.0.0", "presentation_label": "Zykadia 150 mg gélules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "6b3aae395a85be44f16072cecfe58c284c9a0870255b00cbc21a8e89708a50ae", "source_snapshot_id": "source-ed9cf7f9565341980ec10144", "source_updated_at": "2025-08-26", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/zykadia-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 223}
{"after": {"end": 356, "start": 0, "text": "Aucune recommandation définitive de réduction des doses n’est possible chez les patients ayant une insuffisance hépatique légère en raison de la grande variabilité de l’imprégnation plasmatique en abacavir. Sur la base des données obtenues avec l'abacavir, Trizivir n'est pas recommandé chez les patients ayant une insuffisance hépatique modérée ou sévère.", "truncated": false}, "after_length": 356, "after_sha256": "4086e37d2d999af6d19c58f50186d35ba9cf87ece6fc4b23e5ca2070cf60ddd1", "annex": "I", "before": {"end": 356, "start": 0, "text": "Aucune recommandation définitive de réduction des doses n’est possible chez les patients ayant une insuffisance hépatique légère en raison de la grande variabilité de l’imprégnation plasmatique en abacavir. Sur la base des données obtenues avec l'abacavir, Trizivir n'est pas recommandé chez les patients ayant une insuffisance hépatique modérée ou sévère.", "truncated": false}, "before_length": 356, "before_sha256": "4086e37d2d999af6d19c58f50186d35ba9cf87ece6fc4b23e5ca2070cf60ddd1", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-006ae14725519e146ae49d40", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000338", "medicine_name": "Trizivir", "medicine_slug": "trizivir", "observed_at": "2026-10-12T17:26:52Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "5918b624a0dd76d2fd01e258a05f77b7fa5395dbe1676ed085e1af8fe8011b0e", "source_snapshot_id": "source-f614968be5cd56b9fe63ca36", "source_updated_at": "2026-01-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/trizivir-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 908}
{"after": {"end": 434, "start": 0, "text": "Adequate hydration should be ensured throughout treatment with cabazitaxel. The patient should be advised to report any significant change in daily urinary volume immediately. Serum creatinine should be measured at baseline, with each blood count and whenever the patient reports a change in urinary output. Cabazitaxel treatment should be discontinued in case of any degradation of renal function to renal failure ≥CTCAE 4.0 Grade 3.", "truncated": false}, "after_length": 434, "after_sha256": "6e70d770fa821c1ad128d62abc8c75467d74d63f44b91cc8f0258e48eb431220", "annex": "I", "before": {"end": 434, "start": 0, "text": "Adequate hydration should be ensured throughout treatment with cabazitaxel. The patient should be advised to report any significant change in daily urinary volume immediately. Serum creatinine should be measured at baseline, with each blood count and whenever the patient reports a change in urinary output. Cabazitaxel treatment should be discontinued in case of any degradation of renal function to renal failure ≥CTCAE 4.0 Grade 3.", "truncated": false}, "before_length": 434, "before_sha256": "6e70d770fa821c1ad128d62abc8c75467d74d63f44b91cc8f0258e48eb431220", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-006e7adf630dfd5d21a84e67", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002018", "medicine_name": "Jevtana", "medicine_slug": "jevtana", "observed_at": "2026-10-12T19:06:25Z", "pipeline_version": "2.0.0", "presentation_label": "JEVTANA 60 mg concentrate and solvent for solution for infusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "ecf065146b4b6b287568bb6d34740462cfc44772d77a68eaa16279ae7b0c29b3", "source_snapshot_id": "source-388b2751fe1c91dafb54f515", "source_updated_at": "2025-09-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/jevtana-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 168}
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{"after": {"end": 259, "start": 0, "text": "Le lacosamide montre une faible liaison aux protéines, inférieure à 15 %. Par conséquent, les interactions cliniquement significatives avec d’autres médicaments par compétition au niveau des sites de liaison aux protéines sont considérées comme peu probables.", "truncated": false}, "after_length": 259, "after_sha256": "9b572774c60f35ea5208a9215a71f029c2535d75da3f59c7fafd1150ac64db23", "annex": "I", "before": {"end": 259, "start": 0, "text": "Le lacosamide montre une faible liaison aux protéines, inférieure à 15 %. Par conséquent, les interactions cliniquement significatives avec d’autres médicaments par compétition au niveau des sites de liaison aux protéines sont considérées comme peu probables.", "truncated": false}, "before_length": 259, "before_sha256": "9b572774c60f35ea5208a9215a71f029c2535d75da3f59c7fafd1150ac64db23", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0096c13fa56b68034509f9bf", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004443", "medicine_name": "Lacosamide Accord", "medicine_slug": "lacosamide-accord", "observed_at": "2026-10-12T19:37:29Z", "pipeline_version": "2.0.0", "presentation_label": "Lacosamide Accord 10 mg/mL solution pour perfusion", "presentation_occurrence": 3, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "cd3a95dc2f796cdb53458047b58cf6dec86ec7f028409ac05a0a03ff71e51db0", "source_snapshot_id": "source-2d34a37c349a23ae85f81df9", "source_updated_at": "2025-05-28", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/lacosamide-accord-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1937}
{"after": {"end": 413, "start": 0, "text": "La duloxétine est bien absorbée après administration orale, avec une Cmax atteinte 6 heures après l’administration. La biodisponibilité absolue par voie orale de la duloxétine varie de 32% à 80% (moyenne à 50%). La prise d’aliments retarde l’apparition du pic de concentration de 6 à 10 heures et réduit de façon marginale le taux d’absorption (environ 11%). Ces modifications n’ont aucune signification clinique.", "truncated": false}, "after_length": 413, "after_sha256": "12da53240d7f495f8b9e81905004aa2eaea8d76c45af087f72d32da18a7bd908", "annex": "I", "before": {"end": 413, "start": 0, "text": "La duloxétine est bien absorbée après administration orale, avec une Cmax atteinte 6 heures après l’administration. La biodisponibilité absolue par voie orale de la duloxétine varie de 32% à 80% (moyenne à 50%). La prise d’aliments retarde l’apparition du pic de concentration de 6 à 10 heures et réduit de façon marginale le taux d’absorption (environ 11%). Ces modifications n’ont aucune signification clinique.", "truncated": false}, "before_length": 413, "before_sha256": "12da53240d7f495f8b9e81905004aa2eaea8d76c45af087f72d32da18a7bd908", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-009f8f8590546877bae2a441", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003981", "medicine_name": "Duloxetine Viatris (previously Duloxetine Mylan)", "medicine_slug": "duloxetine-viatris-previously-duloxetine-mylan", "observed_at": "2026-10-12T19:05:31Z", "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": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a3fcd41b075d15c850a0f367ebb6f0d92da2955806b88a6247a9bf6368228bcd", "source_snapshot_id": "source-9ec61c9d1156351893a29ca4", "source_updated_at": "2025-10-15", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/duloxetine-viatris-previously-duloxetine-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": 648}
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{"after": {"end": 183, "start": 0, "text": "Il y a eu des cas d’hépatite cytolytique et cholestatique et de défaillance hépatique. Dans certains cas l’issue fut fatale, notamment pour un patient sous dose élevée de paracétamol.", "truncated": false}, "after_length": 183, "after_sha256": "66387c56e5dc27eed35a683378d91749f053b221b85444bd926bffefe1b9f858", "annex": "I", "before": {"end": 183, "start": 0, "text": "Il y a eu des cas d’hépatite cytolytique et cholestatique et de défaillance hépatique. Dans certains cas l’issue fut fatale, notamment pour un patient sous dose élevée de paracétamol.", "truncated": false}, "before_length": 183, "before_sha256": "66387c56e5dc27eed35a683378d91749f053b221b85444bd926bffefe1b9f858", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00a8bdee4acd554f2de5edba", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000406", "medicine_name": "Glivec", "medicine_slug": "glivec", "observed_at": "2026-10-12T19:03:41Z", "pipeline_version": "2.0.0", "presentation_label": "Glivec 100 mg comprimés pelliculés Glivec 400 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": "0a7399d86623c6528f9f7bdca262048f57cb0f2cb325b4cb64a1012d75b5d47a", "source_snapshot_id": "source-9b05d28fe88db964e63adf77", "source_updated_at": "2025-11-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/glivec-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 569}
{"after": {"end": 438, "start": 0, "text": "Due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy‚ Cegfila should be administered at least 24 hours after administration of cytotoxic chemotherapy. In clinical trials, pegfilgrastim has been safely administered 14 days before chemotherapy. Concomitant use of Cegfila with any chemotherapy agent has not been evaluated in patients. In animal models concomitant administration of pegfilgrastim and", "truncated": false}, "after_length": 438, "after_sha256": "3e4baa02d941cd3a16b5889a979fbba27ccf51c699e10400e7b5a2be3e9b0d3d", "annex": "I", "before": {"end": 438, "start": 0, "text": "Due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy‚ Cegfila should be administered at least 24 hours after administration of cytotoxic chemotherapy. In clinical trials, pegfilgrastim has been safely administered 14 days before chemotherapy. Concomitant use of Cegfila with any chemotherapy agent has not been evaluated in patients. In animal models concomitant administration of pegfilgrastim and", "truncated": false}, "before_length": 438, "before_sha256": "3e4baa02d941cd3a16b5889a979fbba27ccf51c699e10400e7b5a2be3e9b0d3d", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00aaeee29d8e5605ca537f47", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005312", "medicine_name": "Cegfila (previously Pegfilgrastim Mundipharma)", "medicine_slug": "cegfila-previously-pegfilgrastim-mundipharma", "observed_at": "2026-10-12T13:47:30Z", "pipeline_version": "2.0.0", "presentation_label": "Cegfila 6 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": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "dd41c573f3407f6620feeeb91d402c4e6ca914261a9adb23330819e3f620071e", "source_snapshot_id": "source-878eb702fff3865e274eac51", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/cegfila-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 160}
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{"after": {"end": 373, "start": 0, "text": "1,0 x 109/L) (voir rubrique 4.2), une adaptation des doses de zidovudine peut être recommandée. Dans ce cas, et sachant qu’une adaptation des doses de Trizivir n’est pas possible, l’administration séparée de la zidovudine, de l’abacavir et de la lamivudine est recommandée. Le médecin devra alors se référer au résumé des caractéristiques correspondant à chaque médicament.", "truncated": false}, "after_length": 373, "after_sha256": "e4b8021957bc362f3a2de2bddf26f974b0c09589cdcf2a7eff40de87bac00f0a", "annex": "I", "before": {"end": 373, "start": 0, "text": "1,0 x 109/L) (voir rubrique 4.2), une adaptation des doses de zidovudine peut être recommandée. Dans ce cas, et sachant qu’une adaptation des doses de Trizivir n’est pas possible, l’administration séparée de la zidovudine, de l’abacavir et de la lamivudine est recommandée. Le médecin devra alors se référer au résumé des caractéristiques correspondant à chaque médicament.", "truncated": false}, "before_length": 373, "before_sha256": "e4b8021957bc362f3a2de2bddf26f974b0c09589cdcf2a7eff40de87bac00f0a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00c138137cc8f09fcb25751e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000338", "medicine_name": "Trizivir", "medicine_slug": "trizivir", "observed_at": "2026-10-12T17:26:52Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "5918b624a0dd76d2fd01e258a05f77b7fa5395dbe1676ed085e1af8fe8011b0e", "source_snapshot_id": "source-f614968be5cd56b9fe63ca36", "source_updated_at": "2026-01-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/trizivir-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 179}
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{"after": {"end": 944, "start": 0, "text": "Less than 1% of the administered dose is detected as unchanged lorlatinib in urine. Population pharmacokinetic analyses have shown that lorlatinib steadystate plasma exposure and Cmax values slightly increase with worsening baseline renal function. Based on a renal impairment study, no starting dose adjustments are recommended for patients with mild or moderate renal impairment [eGFR based on Modification of Diet in Renal Disease Study equation (MDRD)-derived eGFR (in mL/min/1.73 m2) × measured body surface area/1.73 ≥ 30 mL/min]. In this study, lorlatinib AUCinf increased by 41% in subjects with severe renal impairment (absolute eGFR < 30 mL/min) compared to subjects with normal renal function (absolute eGFR ≥ 90 mL/min). A reduced dose of lorlatinib is recommended in patients with severe renal impairment, e.g., a once daily oral starting dose of 75 mg (see section 4.2). No information is available for patients on renal dialysis.", "truncated": false}, "after_length": 944, "after_sha256": "554432c4f75d71bd52b0ef1b0194e795b069fc455cd8f64d47374e49e793b600", "annex": "I", "before": {"end": 944, "start": 0, "text": "Less than 1% of the administered dose is detected as unchanged lorlatinib in urine. Population pharmacokinetic analyses have shown that lorlatinib steadystate plasma exposure and Cmax values slightly increase with worsening baseline renal function. Based on a renal impairment study, no starting dose adjustments are recommended for patients with mild or moderate renal impairment [eGFR based on Modification of Diet in Renal Disease Study equation (MDRD)-derived eGFR (in mL/min/1.73 m2) × measured body surface area/1.73 ≥ 30 mL/min]. In this study, lorlatinib AUCinf increased by 41% in subjects with severe renal impairment (absolute eGFR < 30 mL/min) compared to subjects with normal renal function (absolute eGFR ≥ 90 mL/min). A reduced dose of lorlatinib is recommended in patients with severe renal impairment, e.g., a once daily oral starting dose of 75 mg (see section 4.2). No information is available for patients on renal dialysis.", "truncated": false}, "before_length": 944, "before_sha256": "554432c4f75d71bd52b0ef1b0194e795b069fc455cd8f64d47374e49e793b600", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01015b9f0c9ac965f7977bc3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004646", "medicine_name": "Lorviqua", "medicine_slug": "lorviqua", "observed_at": "2026-10-12T13:40:19Z", "pipeline_version": "2.0.0", "presentation_label": "Lorviqua 25 mg filmcoated tablets Lorviqua 100 mg filmcoated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "c1acad257653d9c3f32e8fa4b9483faa716876ef1368cf5d5cfe1c51bf6cd06f", "source_snapshot_id": "source-4b3a83613c1e7f4ba485af87", "source_updated_at": "2026-04-15", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/lorviqua-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 909}
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{"after": {"end": 923, "start": 0, "text": "Efavirenz : Il y a eu 7 cas rétrospectifs en lien avec des anomalies du tube neural, dont des méningomyélocèles, tous chez des mères exposées à des associations comprenant de l’éfavirenz (à l’exclusion des comprimés de l’association médicamenteuse fixe contenant de l’éfavirenz) au premier trimestre. Deux cas supplémentaires (1 prospectif et 1 rétrospectif) en lien avec des anomalies du tube neural ont été rapportés avec l’association médicamenteuse fixe contenant de l’éfavirenz, de l’emtricitabine et du ténofovir disoproxil. Une relation de causalité de ces anomalies avec l’utilisation de l’éfavirenz n’a pas été établie, et le dénominateur n’est pas connu. Sachant que les anomalies du tube neural apparaissent dans les 4 premières semaines du développement fœtal (période de fermeture du tube neural), le risque potentiel concernerait les femmes exposées à l’éfavirenz pendant le premier trimestre de la grossesse.", "truncated": false}, "after_length": 923, "after_sha256": "1537eee259514f695952fd3bd7ea32f7e53b796e612a44cf74903365fbab7c0a", "annex": "I", "before": {"end": 923, "start": 0, "text": "Efavirenz : Il y a eu 7 cas rétrospectifs en lien avec des anomalies du tube neural, dont des méningomyélocèles, tous chez des mères exposées à des associations comprenant de l’éfavirenz (à l’exclusion des comprimés de l’association médicamenteuse fixe contenant de l’éfavirenz) au premier trimestre. Deux cas supplémentaires (1 prospectif et 1 rétrospectif) en lien avec des anomalies du tube neural ont été rapportés avec l’association médicamenteuse fixe contenant de l’éfavirenz, de l’emtricitabine et du ténofovir disoproxil. Une relation de causalité de ces anomalies avec l’utilisation de l’éfavirenz n’a pas été établie, et le dénominateur n’est pas connu. Sachant que les anomalies du tube neural apparaissent dans les 4 premières semaines du développement fœtal (période de fermeture du tube neural), le risque potentiel concernerait les femmes exposées à l’éfavirenz pendant le premier trimestre de la grossesse.", "truncated": false}, "before_length": 923, "before_sha256": "1537eee259514f695952fd3bd7ea32f7e53b796e612a44cf74903365fbab7c0a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0124eca4a17a7fe618b3263b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004240", "medicine_name": "Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan", "medicine_slug": "efavirenz-emtricitabine-tenofovir-disoproxil-mylan", "observed_at": "2026-10-12T13:35:36Z", "pipeline_version": "2.0.0", "presentation_label": "Éfavirenz/Emtricitabine/Ténofovir disoproxil Mylan 600 mg/200 mg/245 mg, comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.6", "section_type": "pregnancy", "source_provider": "European Medicines Agency", "source_sha256": "b05a93fb60d054704516fe125d3f487de5110d2f458193666c1071a32ca9a361", "source_snapshot_id": "source-a6bf09d6be60fa69e08ca140", "source_updated_at": "2026-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/efavirenz-emtricitabine-tenofovir-disoproxil-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": 1136}
{"after": {"end": 203, "start": 0, "text": "The volume of distribution was 1050 L in healthy subjects given an intravenous dose of 2 mg. The apparent volume of distribution was 806 L in cancer patients based on population pharmacokinetic analysis.", "truncated": false}, "after_length": 203, "after_sha256": "439c184c4324e0f426d9f10756a09e9ee54cc6595f7c24d0123d66fe95846a3b", "annex": "I", "before": {"end": 203, "start": 0, "text": "The volume of distribution was 1050 L in healthy subjects given an intravenous dose of 2 mg. The apparent volume of distribution was 806 L in cancer patients based on population pharmacokinetic analysis.", "truncated": false}, "before_length": 203, "before_sha256": "439c184c4324e0f426d9f10756a09e9ee54cc6595f7c24d0123d66fe95846a3b", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0126f18635e316e019762684", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003960", "medicine_name": "Cotellic", "medicine_slug": "cotellic", "observed_at": "2026-10-12T19:30:44Z", "pipeline_version": "2.0.0", "presentation_label": "Cotellic 20 mg film-coated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "5b62f129f593b5079a0f5e9a47f83933bb019af62d7cc40ee07a9334d281bcf3", "source_snapshot_id": "source-0d296868a063a7fb7eaa3145", "source_updated_at": "2025-06-24", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/cotellic-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 807}
{"after": {"end": 147, "start": 0, "text": "Figure 1. Courbe de Kaplan-Meier de la survie sans progression par analyse centralisée en aveugle du comité de revue indépendant dans l’étude CROWN", "truncated": false}, "after_length": 147, "after_sha256": "b04c026b8263888bd9e532e3b5e5b5caddf127768bea6de0d1ced6465d1b7226", "annex": "I", "before": {"end": 147, "start": 0, "text": "Figure 1. Courbe de Kaplan-Meier de la survie sans progression par analyse centralisée en aveugle du comité de revue indépendant dans l’étude CROWN", "truncated": false}, "before_length": 147, "before_sha256": "b04c026b8263888bd9e532e3b5e5b5caddf127768bea6de0d1ced6465d1b7226", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-012898462b9a0724ba02d3cf", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004646", "medicine_name": "Lorviqua", "medicine_slug": "lorviqua", "observed_at": "2026-10-12T13:40:21Z", "pipeline_version": "2.0.0", "presentation_label": "Lorviqua 25 mg, comprimés pelliculés Lorviqua 100 mg, comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "60dc172f08ea3d561119e0d5bda985db037f78b0a16e1e39ca300b1f129588f1", "source_snapshot_id": "source-d3dc2424089c088062be259f", "source_updated_at": "2026-04-15", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/lorviqua-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 782}
{"after": {"end": 515, "start": 0, "text": "Des événements thromboemboliques veineux (ETV) ont été observés chez 12,2 % des patients (Pom + Btz + Dex) et 3,3 % des patients (Pom + Dex) (de grade 3 ou 4 chez 5,8 % des patients [Pom + Btz + Dex] et 1,3 % des patients [Pom + Dex]). Des ETV ont été décrits comme graves chez 4,7 % des patients (Pom + Btz + Dex) et 1,7 % des patients (Pom + Dex), aucun événement fatal n’a été rapporté et les ETV ont été associés à un arrêt du traitement par le pomalidomide chez 2,2 % des patients (Pom + Btz + Dex) au maximum.", "truncated": false}, "after_length": 515, "after_sha256": "6990b595bbd17f3f1fe05a6efea803d1ec9dfecfd3916128ef2552f9dfcd412c", "annex": "I", "before": {"end": 515, "start": 0, "text": "Des événements thromboemboliques veineux (ETV) ont été observés chez 12,2 % des patients (Pom + Btz + Dex) et 3,3 % des patients (Pom + Dex) (de grade 3 ou 4 chez 5,8 % des patients [Pom + Btz + Dex] et 1,3 % des patients [Pom + Dex]). Des ETV ont été décrits comme graves chez 4,7 % des patients (Pom + Btz + Dex) et 1,7 % des patients (Pom + Dex), aucun événement fatal n’a été rapporté et les ETV ont été associés à un arrêt du traitement par le pomalidomide chez 2,2 % des patients (Pom + Btz + Dex) au maximum.", "truncated": false}, "before_length": 515, "before_sha256": "6990b595bbd17f3f1fe05a6efea803d1ec9dfecfd3916128ef2552f9dfcd412c", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-012caf221226bdb44df4ea24", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002682", "medicine_name": "Imnovid (previously Pomalidomide Celgene)", "medicine_slug": "imnovid-previously-pomalidomide-celgene", "observed_at": "2026-10-12T17:29:04Z", "pipeline_version": "2.0.0", "presentation_label": "Imnovid 1 mg gélules Imnovid 2 mg gélules Imnovid 3 mg gélules Imnovid 4 mg gélules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "5583cc334bc038ccc5a55a97f36d59c566b5938a3732fd08845b50e84358a414", "source_snapshot_id": "source-4e152dde578b80a63ee2fcd5", "source_updated_at": "2025-12-05", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/imnovid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1267}
{"after": {"end": 613, "start": 0, "text": "En raison de la présence de propionate de fluticasone, un enrouement et une candidose (muguet) de la bouche et de la gorge et, dans de rares cas, de l’œsophage, peuvent survenir chez certains patients (voir rubrique 4.8). Le risque d’enrouement et de candidose de la bouche et de la gorge peut être réduit en se rinçant la bouche avec de l’eau et en recrachant l’eau et/ou en se brossant les dents après l’administration du produit. La candidose symptomatique de la bouche et de la gorge peut être traitée à l’aide d’un antifongique local tout en continuant le traitement par salmétérol/propionate de fluticasone.", "truncated": false}, "after_length": 613, "after_sha256": "c72027a6a54265c331005ea8dd41e658aeab8e6f01d48bf3314e9b7228454e1a", "annex": "I", "before": {"end": 613, "start": 0, "text": "En raison de la présence de propionate de fluticasone, un enrouement et une candidose (muguet) de la bouche et de la gorge et, dans de rares cas, de l’œsophage, peuvent survenir chez certains patients (voir rubrique 4.8). Le risque d’enrouement et de candidose de la bouche et de la gorge peut être réduit en se rinçant la bouche avec de l’eau et en recrachant l’eau et/ou en se brossant les dents après l’administration du produit. La candidose symptomatique de la bouche et de la gorge peut être traitée à l’aide d’un antifongique local tout en continuant le traitement par salmétérol/propionate de fluticasone.", "truncated": false}, "before_length": 613, "before_sha256": "c72027a6a54265c331005ea8dd41e658aeab8e6f01d48bf3314e9b7228454e1a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-012f8e5bdc7e54acea0cdc04", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004881", "medicine_name": "Seffalair Spiromax", "medicine_slug": "seffalair-spiromax", "observed_at": "2026-10-12T17:28:11Z", "pipeline_version": "2.0.0", "presentation_label": "Seffalair Spiromax 12,75 microgrammes/100 microgrammes poudre pour inhalation Seffalair Spiromax 12,75 microgrammes/202 microgrammes poudre pour inhalation", "presentation_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": "b400d80be8345a8bf3225fb16f1b348532237af04c82caaf20ff6e0cd46993e8", "source_snapshot_id": "source-87ebc6ce7e018f0368638099", "source_updated_at": "2025-12-16", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/seffalair-spiromax-epar-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": 327, "start": 0, "text": "Study V evaluated 499 patients who had an inadequate clinical response or were intolerant to one or more TNF antagonist therapies. The TNF antagonist therapy was discontinued prior to randomisation. Doses of 4 or 8 mg/kg tocilizumab or placebo were given every four weeks in combination with stable MTX (10 mg to 25 mg weekly).", "truncated": false}, "after_length": 327, "after_sha256": "83fa80a04348c81fa96391a4b1515d4c164ce4b9e88d848d629e59eeee34f970", "annex": "I", "before": {"end": 327, "start": 0, "text": "Study V evaluated 499 patients who had an inadequate clinical response or were intolerant to one or more TNF antagonist therapies. The TNF antagonist therapy was discontinued prior to randomisation. Doses of 4 or 8 mg/kg tocilizumab or placebo were given every four weeks in combination with stable MTX (10 mg to 25 mg weekly).", "truncated": false}, "before_length": 327, "before_sha256": "83fa80a04348c81fa96391a4b1515d4c164ce4b9e88d848d629e59eeee34f970", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-015c9e41f1f131a3f1e4f120", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005984", "medicine_name": "Tocilizumab STADA (previously Tofidence)", "medicine_slug": "tocilizumab-stada-previously-tofidence", "observed_at": "2026-10-12T17:26:01Z", "pipeline_version": "2.0.0", "presentation_label": "Tocilizumab STADA 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": "166002fb92b5521ba07ad6fe610d3bee67062afbdf0f0b85b848043e72e44b61", "source_snapshot_id": "source-152ac567a5f4fe2e6717ec74", "source_updated_at": "2026-01-20", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/tocilizumab-stada-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 901}
{"after": {"end": 427, "start": 0, "text": "Les effets indésirables répertoriés dans le tableau 2 sont présentés par classe de systèmes d’organes et catégories de fréquence, définies selon la convention suivante : 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). Au sein de chaque groupe de fréquence, les effets indésirables sont présentés selon un ordre décroissant de gravité.", "truncated": false}, "after_length": 427, "after_sha256": "198bdeaf553fac624af52988078a3a602287f40ebeed7897373a1286949fc1c5", "annex": "I", "before": {"end": 427, "start": 0, "text": "Les effets indésirables répertoriés dans le tableau 2 sont présentés par classe de systèmes d’organes et catégories de fréquence, définies selon la convention suivante : 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). Au sein de chaque groupe de fréquence, les effets indésirables sont présentés selon un ordre décroissant de gravité.", "truncated": false}, "before_length": 427, "before_sha256": "198bdeaf553fac624af52988078a3a602287f40ebeed7897373a1286949fc1c5", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-015f9fe7dbf7fd5ca85b2243", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004646", "medicine_name": "Lorviqua", "medicine_slug": "lorviqua", "observed_at": "2026-10-12T13:40:21Z", "pipeline_version": "2.0.0", "presentation_label": "Lorviqua 25 mg, comprimés pelliculés Lorviqua 100 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": "60dc172f08ea3d561119e0d5bda985db037f78b0a16e1e39ca300b1f129588f1", "source_snapshot_id": "source-d3dc2424089c088062be259f", "source_updated_at": "2026-04-15", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/lorviqua-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 406}
{"after": {"end": 466, "start": 0, "text": "Subjects with moderate hepatic impairment (Child-Pugh B) showed higher plasma concentrations of lacosamide (approximately 50 % higher AUCnorm). The higher exposure was partly due to a reduced renal function in the studied subjects. The decrease in non-renal clearance in the patients of the study was estimated to give a 20 % increase in the AUC of lacosamide. The pharmacokinetics of lacosamide has not been evaluated in severe hepatic impairment (see section 4.2).", "truncated": false}, "after_length": 466, "after_sha256": "4f9f2b59203ac0a63c7ce754d703d139f75a71c5eeef86a25e2f3dc34942b215", "annex": "I", "before": {"end": 466, "start": 0, "text": "Subjects with moderate hepatic impairment (Child-Pugh B) showed higher plasma concentrations of lacosamide (approximately 50 % higher AUCnorm). The higher exposure was partly due to a reduced renal function in the studied subjects. The decrease in non-renal clearance in the patients of the study was estimated to give a 20 % increase in the AUC of lacosamide. The pharmacokinetics of lacosamide has not been evaluated in severe hepatic impairment (see section 4.2).", "truncated": false}, "before_length": 466, "before_sha256": "4f9f2b59203ac0a63c7ce754d703d139f75a71c5eeef86a25e2f3dc34942b215", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-016728bf77e196ede7b2bc55", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004443", "medicine_name": "Lacosamide Accord", "medicine_slug": "lacosamide-accord", "observed_at": "2026-10-12T19:37:18Z", "pipeline_version": "2.0.0", "presentation_label": "Lacosamide Accord 50 mg film-coated tablets Lacosamide Accord 100 mg filmcoated tablets Lacosamide Accord 150 mg filmcoated tablets Lacosamide Accord 200 mg filmcoated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "9545e0873b112a71b2e986007eb48a83c9a8dbc1f9b46e449dc293355632f678", "source_snapshot_id": "source-d808ecdcc36d20bcbcc9522b", "source_updated_at": "2025-05-28", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/lacosamide-accord-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 658}
{"after": {"end": 376, "start": 0, "text": "After a 1hour intravenous infusion [14C]cabazitaxel at 25 mg/m2 in patients, approximately 80% of the administered dose was eliminated within 2 weeks. Cabazitaxel is mainly excreted in the faeces as numerous metabolites (76% of the dose); while renal excretion of cabazitaxel and metabolites account for less than 4% of the dose (2.3% as unchanged medicinal product in urine).", "truncated": false}, "after_length": 376, "after_sha256": "f66b0a77910d786842dcf761df79b9b44cf1cb01b8b4acbafd2f3d035cc68351", "annex": "I", "before": {"end": 376, "start": 0, "text": "After a 1hour intravenous infusion [14C]cabazitaxel at 25 mg/m2 in patients, approximately 80% of the administered dose was eliminated within 2 weeks. Cabazitaxel is mainly excreted in the faeces as numerous metabolites (76% of the dose); while renal excretion of cabazitaxel and metabolites account for less than 4% of the dose (2.3% as unchanged medicinal product in urine).", "truncated": false}, "before_length": 376, "before_sha256": "f66b0a77910d786842dcf761df79b9b44cf1cb01b8b4acbafd2f3d035cc68351", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01849cb16e68fc60e566e334", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002018", "medicine_name": "Jevtana", "medicine_slug": "jevtana", "observed_at": "2026-10-12T19:06:25Z", "pipeline_version": "2.0.0", "presentation_label": "JEVTANA 60 mg concentrate and solvent for solution for infusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "ecf065146b4b6b287568bb6d34740462cfc44772d77a68eaa16279ae7b0c29b3", "source_snapshot_id": "source-388b2751fe1c91dafb54f515", "source_updated_at": "2025-09-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/jevtana-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1197}
{"after": {"end": 356, "start": 0, "text": "Il n’existe pas de données suffisantes sur l’utilisation du lacosamide chez la femme enceinte. Des études chez l’animal n’ont pas indiqué d’effets tératogènes chez le rat ou le lapin, mais une embryotoxicité a été observée chez le rat et le lapin à des doses toxiques pour la mère (voir rubrique 5.3). Le risque potentiel dans l’espèce humaine est inconnu.", "truncated": false}, "after_length": 356, "after_sha256": "9e93931f2a6a21625efd5f16bcd9893f414d5bda1849e30e2d6bd3817f92fceb", "annex": "I", "before": {"end": 356, "start": 0, "text": "Il n’existe pas de données suffisantes sur l’utilisation du lacosamide chez la femme enceinte. Des études chez l’animal n’ont pas indiqué d’effets tératogènes chez le rat ou le lapin, mais une embryotoxicité a été observée chez le rat et le lapin à des doses toxiques pour la mère (voir rubrique 5.3). Le risque potentiel dans l’espèce humaine est inconnu.", "truncated": false}, "before_length": 356, "before_sha256": "9e93931f2a6a21625efd5f16bcd9893f414d5bda1849e30e2d6bd3817f92fceb", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01860bb0833e7a569ba21337", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004443", "medicine_name": "Lacosamide Accord", "medicine_slug": "lacosamide-accord", "observed_at": "2026-10-12T19:37:29Z", "pipeline_version": "2.0.0", "presentation_label": "Lacosamide Accord 10 mg/mL solution pour perfusion", "presentation_occurrence": 3, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.6", "section_type": "pregnancy", "source_provider": "European Medicines Agency", "source_sha256": "cd3a95dc2f796cdb53458047b58cf6dec86ec7f028409ac05a0a03ff71e51db0", "source_snapshot_id": "source-2d34a37c349a23ae85f81df9", "source_updated_at": "2025-05-28", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/lacosamide-accord-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1953}
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{"after": {"end": 294, "start": 0, "text": "As this medicinal product contains salmeterol and fluticasone propionate, the type and severity of adverse reactions associated with each of the active substance may be expected. No increased incidence of adverse reactions has been seen following concurrent administration of the two compounds.", "truncated": false}, "after_length": 294, "after_sha256": "8957936cae82ca0c85f276b8e47d419b79b40233a449cdd01732d226041967e3", "annex": "I", "before": {"end": 294, "start": 0, "text": "As this medicinal product contains salmeterol and fluticasone propionate, the type and severity of adverse reactions associated with each of the active substance may be expected. No increased incidence of adverse reactions has been seen following concurrent administration of the two compounds.", "truncated": false}, "before_length": 294, "before_sha256": "8957936cae82ca0c85f276b8e47d419b79b40233a449cdd01732d226041967e3", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01ae3a6ea3b27e925cb3df56", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004881", "medicine_name": "Seffalair Spiromax", "medicine_slug": "seffalair-spiromax", "observed_at": "2026-10-12T17:28:07Z", "pipeline_version": "2.0.0", "presentation_label": "Seffalair Spiromax 12.75 micrograms/100 micrograms inhalation powder Seffalair Spiromax 12.75 micrograms/202 micrograms inhalation powder", "presentation_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": "7eff81949b3d672e4e4d45be072c05d86664a74a9352fa76df2a19e6260c69b3", "source_snapshot_id": "source-a7a56afe8c7c3d12f12413ba", "source_updated_at": "2025-12-16", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/seffalair-spiromax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 263}
{"after": {"end": 299, "start": 0, "text": "Efavirenz plasma exposure may be increased in patients with homozygous G516T genetic variant of the CYP2B6 isozyme. The clinical implications of such an association are unknown; however, the potential for an increased frequency and severity of efavirenz-associated adverse events cannot be excluded.", "truncated": false}, "after_length": 299, "after_sha256": "d595df6adea99de6fa78940ddc2f100bd64f5624d205625b5dc1021880d79282", "annex": "I", "before": {"end": 299, "start": 0, "text": "Efavirenz plasma exposure may be increased in patients with homozygous G516T genetic variant of the CYP2B6 isozyme. The clinical implications of such an association are unknown; however, the potential for an increased frequency and severity of efavirenz-associated adverse events cannot be excluded.", "truncated": false}, "before_length": 299, "before_sha256": "d595df6adea99de6fa78940ddc2f100bd64f5624d205625b5dc1021880d79282", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01b0964a7954a52c0bfec6d4", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004240", "medicine_name": "Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan", "medicine_slug": "efavirenz-emtricitabine-tenofovir-disoproxil-mylan", "observed_at": "2026-10-12T13:35:34Z", "pipeline_version": "2.0.0", "presentation_label": "Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan 600 mg/200 mg/245 mg film-coated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "223e825c84e4f295da7ebf5574a88f09198b0a5ae258c643cee5369de2f2791d", "source_snapshot_id": "source-d143f566b93e470166b2b4f3", "source_updated_at": "2026-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/efavirenz-emtricitabine-tenofovir-disoproxil-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": 1714}
{"after": {"end": 1056, "start": 0, "text": "Dans l'étude en monothérapie comparant le lacosamide à la carbamazépine LP, les types d’effets indésirables liés au lacosamide chez les sujets âgés (≥ 65 ans) semblent être similaires à ceux observés chez les patients de moins de 65 ans. Cependant, une incidence plus élevée (différence ≥ 5 %) de chute, diarrhée et tremblement a été rapportée chez les patients âgés par rapport aux patients adultes plus jeunes. L’effet indésirable cardiaque le plus fréquemment rapporté chez les personnes âgées par rapport à la population adulte plus jeune a été un bloc AV du premier degré. Cela a été rapporté avec le lacosamide chez 4,8 % (3/62) des patients âgés versus 1,6 % (6/382) des patients adultes plus jeunes. Le taux d’arrêt de traitement en raison d’effets indésirables observés avec le lacosamide a été de 21,0 % (13/62) chez les patients âgés versus 9,2 % (35/382) chez les patients adultes plus jeunes. Ces différences entre les patients âgés et les patients adultes plus jeunes étaient similaires à celles observées dans le groupe du comparateur actif.", "truncated": false}, "after_length": 1056, "after_sha256": "b269b6ed4ad9d01b602c8ea822cccf227b0c7dffb45d6f6e78cd114c834ae224", "annex": "I", "before": {"end": 1056, "start": 0, "text": "Dans l'étude en monothérapie comparant le lacosamide à la carbamazépine LP, les types d’effets indésirables liés au lacosamide chez les sujets âgés (≥ 65 ans) semblent être similaires à ceux observés chez les patients de moins de 65 ans. Cependant, une incidence plus élevée (différence ≥ 5 %) de chute, diarrhée et tremblement a été rapportée chez les patients âgés par rapport aux patients adultes plus jeunes. L’effet indésirable cardiaque le plus fréquemment rapporté chez les personnes âgées par rapport à la population adulte plus jeune a été un bloc AV du premier degré. Cela a été rapporté avec le lacosamide chez 4,8 % (3/62) des patients âgés versus 1,6 % (6/382) des patients adultes plus jeunes. Le taux d’arrêt de traitement en raison d’effets indésirables observés avec le lacosamide a été de 21,0 % (13/62) chez les patients âgés versus 9,2 % (35/382) chez les patients adultes plus jeunes. Ces différences entre les patients âgés et les patients adultes plus jeunes étaient similaires à celles observées dans le groupe du comparateur actif.", "truncated": false}, "before_length": 1056, "before_sha256": "b269b6ed4ad9d01b602c8ea822cccf227b0c7dffb45d6f6e78cd114c834ae224", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01b47bcf68e8391d911f9df2", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004443", "medicine_name": "Lacosamide Accord", "medicine_slug": "lacosamide-accord", "observed_at": "2026-10-12T19:37:29Z", "pipeline_version": "2.0.0", "presentation_label": "Lacosamide Accord 10 mg/mL solution pour perfusion", "presentation_occurrence": 3, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "cd3a95dc2f796cdb53458047b58cf6dec86ec7f028409ac05a0a03ff71e51db0", "source_snapshot_id": "source-2d34a37c349a23ae85f81df9", "source_updated_at": "2025-05-28", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/lacosamide-accord-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2126}
{"after": {"end": 174, "start": 0, "text": "In phase 3 clinical studies in MF, median time to onset of first CTCAE grade 2 or higher anaemia was 1.5 months. One patient (0.3%) discontinued treatment because of anaemia.", "truncated": false}, "after_length": 174, "after_sha256": "f69721dcc6564b6f541a8d611e35db100b439e033f269ba5d6a6db6399bc1d8f", "annex": "I", "before": {"end": 174, "start": 0, "text": "In phase 3 clinical studies in MF, median time to onset of first CTCAE grade 2 or higher anaemia was 1.5 months. One patient (0.3%) discontinued treatment because of anaemia.", "truncated": false}, "before_length": 174, "before_sha256": "f69721dcc6564b6f541a8d611e35db100b439e033f269ba5d6a6db6399bc1d8f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01b92f9005ba0a310809abe7", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002464", "medicine_name": "Jakavi", "medicine_slug": "jakavi", "observed_at": "2026-10-12T19:03:48Z", "pipeline_version": "2.0.0", "presentation_label": "Jakavi 5 mg tablets Jakavi 10 mg tablets Jakavi 15 mg tablets Jakavi 20 mg tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "61869ebfe2680776654fa74d3c8410b0979ca573d1bd47d9bd6bc38201c69007", "source_snapshot_id": "source-c6766690c7b668e9ed97ac25", "source_updated_at": "2025-11-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/jakavi-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 916}
{"after": {"end": 271, "start": 0, "text": "For patients co-infected with hepatitis who are being treated with a lamivudine containing medicinal product such as Trizivir and subsequently become pregnant, consideration should be given to the possibility of a recurrence of hepatitis on discontinuation of lamivudine.", "truncated": false}, "after_length": 271, "after_sha256": "92823ba19eaca0bf7b813265be1d64ff7ba6dcaee273bd4d1faa039f80b75cf6", "annex": "I", "before": {"end": 271, "start": 0, "text": "For patients co-infected with hepatitis who are being treated with a lamivudine containing medicinal product such as Trizivir and subsequently become pregnant, consideration should be given to the possibility of a recurrence of hepatitis on discontinuation of lamivudine.", "truncated": false}, "before_length": 271, "before_sha256": "92823ba19eaca0bf7b813265be1d64ff7ba6dcaee273bd4d1faa039f80b75cf6", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01c3061a626e81413073fa97", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000338", "medicine_name": "Trizivir", "medicine_slug": "trizivir", "observed_at": "2026-10-12T17:26:40Z", "pipeline_version": "2.0.0", "presentation_label": "TRIZIVIR 300 mg/150 mg/300 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": "4.6", "section_type": "pregnancy", "source_provider": "European Medicines Agency", "source_sha256": "7b60528b5a9e0b2c4ab653d5cfe7aacd42662a265cb74e9eef5686e2d6eff4c8", "source_snapshot_id": "source-9ec91128981ab659e4649971", "source_updated_at": "2026-01-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/trizivir-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 490}
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{"after": {"end": 671, "start": 0, "text": "Hyperglycaemia (all grades) was reported in 9.4% of patients treated with ceritinib across the seven clinical studies; grade 3 or 4 events were reported in 5.4% of patients. These events required dose reduction or interruption in 1.4% of patients and led to discontinuation in 0.1% of patients. The risk of hyperglycaemia was higher in patients with diabetes mellitus and/or concurrent steroid use. Monitoring of fasting serum glucose is required prior to the start of ceritinib treatment and periodically thereafter as clinically indicated. Administration of antihyperglycaemic medicinal products should be initiated or optimised as indicated (see sections 4.2 and 4.4).", "truncated": false}, "after_length": 671, "after_sha256": "52590622654fc00e98da80e0dd90ebf1e9e9b8907cccb7e2a0419f1f14046993", "annex": "I", "before": {"end": 671, "start": 0, "text": "Hyperglycaemia (all grades) was reported in 9.4% of patients treated with ceritinib across the seven clinical studies; grade 3 or 4 events were reported in 5.4% of patients. These events required dose reduction or interruption in 1.4% of patients and led to discontinuation in 0.1% of patients. The risk of hyperglycaemia was higher in patients with diabetes mellitus and/or concurrent steroid use. Monitoring of fasting serum glucose is required prior to the start of ceritinib treatment and periodically thereafter as clinically indicated. Administration of antihyperglycaemic medicinal products should be initiated or optimised as indicated (see sections 4.2 and 4.4).", "truncated": false}, "before_length": 671, "before_sha256": "52590622654fc00e98da80e0dd90ebf1e9e9b8907cccb7e2a0419f1f14046993", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-02e9d8499ebe029a116269f6", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003819", "medicine_name": "Zykadia", "medicine_slug": "zykadia", "observed_at": "2026-10-12T19:15:39Z", "pipeline_version": "2.0.0", "presentation_label": "Zykadia 150 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": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "4b3fd6d33cd626bcea8e944733f8421f83e3a0eb26201f68753431159b4715d2", "source_snapshot_id": "source-a6e75dd529d9657c082cb659", "source_updated_at": "2025-08-26", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/zykadia-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1674}
{"after": {"end": 256, "start": 0, "text": "Umeclidinium was not genotoxic in a standard battery of studies and was not carcinogenic in lifetime inhalation studies in mice or rats at exposures 26 or 22-fold, times the human clinical exposure of umeclidinium 55 micrograms, based on AUC, respectively.", "truncated": false}, "after_length": 256, "after_sha256": "19e490432426b0ad4b372c468d5fe65a55752dc17a92b5f31734935afa4c38f7", "annex": "I", "before": {"end": 256, "start": 0, "text": "Umeclidinium was not genotoxic in a standard battery of studies and was not carcinogenic in lifetime inhalation studies in mice or rats at exposures 26 or 22-fold, times the human clinical exposure of umeclidinium 55 micrograms, based on AUC, respectively.", "truncated": false}, "before_length": 256, "before_sha256": "19e490432426b0ad4b372c468d5fe65a55752dc17a92b5f31734935afa4c38f7", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-02ed4ca8517166a4a40ec60d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002751", "medicine_name": "Anoro Ellipta (previously Anoro)", "medicine_slug": "anoro-ellipta-previously-anoro", "observed_at": "2026-10-12T19:17:37Z", "pipeline_version": "2.0.0", "presentation_label": "ANORO ELLIPTA 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": "5.3", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "7ebba8dd63bd37ec5d24ca7a9a63f2fcc64533b24cc9441412ad0beb523df07f", "source_snapshot_id": "source-14ffea35b90ed19d08622ffd", "source_updated_at": "2025-07-31", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/anoro-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": 532}
{"after": {"end": 278, "start": 0, "text": "Le céritinib et ses métabolites sont principalement excrétés dans les fèces. En moyenne, 68 % d’une dose de céritinib administrée par voie orale se retrouvent dans les fèces sous forme inchangée. Seulement 1,3 % de la dose administrée par voie orale se retrouve dans les urines.", "truncated": false}, "after_length": 278, "after_sha256": "17ebfe06246f5b8694e1677d344e9d6c85ab6351b433f592a8d91b8a35b2e6cf", "annex": "I", "before": {"end": 278, "start": 0, "text": "Le céritinib et ses métabolites sont principalement excrétés dans les fèces. En moyenne, 68 % d’une dose de céritinib administrée par voie orale se retrouvent dans les fèces sous forme inchangée. Seulement 1,3 % de la dose administrée par voie orale se retrouve dans les urines.", "truncated": false}, "before_length": 278, "before_sha256": "17ebfe06246f5b8694e1677d344e9d6c85ab6351b433f592a8d91b8a35b2e6cf", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-02f5ccd41a03fa0c4e981a0d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003819", "medicine_name": "Zykadia", "medicine_slug": "zykadia", "observed_at": "2026-10-12T19:15:42Z", "pipeline_version": "2.0.0", "presentation_label": "Zykadia 150 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": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "6b3aae395a85be44f16072cecfe58c284c9a0870255b00cbc21a8e89708a50ae", "source_snapshot_id": "source-ed9cf7f9565341980ec10144", "source_updated_at": "2025-08-26", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/zykadia-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2426}
{"after": {"end": 260, "start": 0, "text": "Patients should be made aware of the symptoms of cardiac arrhythmia (e.g. slow, rapid or irregular pulse, palpitations, shortness of breath, feeling lightheaded, fainting). Patients should be counselled to seek immediate medical advice if these symptoms occur.", "truncated": false}, "after_length": 260, "after_sha256": "e87f934703d1bad6b43b1a7764e7f3f136218b637fef6196ad8cb0636fc7b965", "annex": "I", "before": {"end": 260, "start": 0, "text": "Patients should be made aware of the symptoms of cardiac arrhythmia (e.g. slow, rapid or irregular pulse, palpitations, shortness of breath, feeling lightheaded, fainting). Patients should be counselled to seek immediate medical advice if these symptoms occur.", "truncated": false}, "before_length": 260, "before_sha256": "e87f934703d1bad6b43b1a7764e7f3f136218b637fef6196ad8cb0636fc7b965", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-02f5e30050357acae692ece4", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004443", "medicine_name": "Lacosamide Accord", "medicine_slug": "lacosamide-accord", "observed_at": "2026-10-12T19:37:18Z", "pipeline_version": "2.0.0", "presentation_label": "Treatment initiation pack (in adolescents and children weighing 50 kg or more and adults only) Lacosamide Accord 50 mg film-coated tablets Lacosamide Accord 100 mg film-coated tablets Lacosamide Accord 150 mg film-coated tablets Lacosamide Accord 200 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": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "9545e0873b112a71b2e986007eb48a83c9a8dbc1f9b46e449dc293355632f678", "source_snapshot_id": "source-d808ecdcc36d20bcbcc9522b", "source_updated_at": "2025-05-28", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/lacosamide-accord-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 972}
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{"after": {"end": 197, "start": 0, "text": "Tableau 5 Recommandations posologiques pendant le traitement par ruxolitinib pour les patients atteints de GvHD présentant une thrombopénie, une neutropénie ou une élévation de la bilirubine totale", "truncated": false}, "after_length": 197, "after_sha256": "9452e6e6a63f8f1e2b1f7582870649bc9c8498ccc613ec8eb25c072abf8def7f", "annex": "I", "before": {"end": 197, "start": 0, "text": "Tableau 5 Recommandations posologiques pendant le traitement par ruxolitinib pour les patients atteints de GvHD présentant une thrombopénie, une neutropénie ou une élévation de la bilirubine totale", "truncated": false}, "before_length": 197, "before_sha256": "9452e6e6a63f8f1e2b1f7582870649bc9c8498ccc613ec8eb25c072abf8def7f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03106474850e59dcfb269511", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002464", "medicine_name": "Jakavi", "medicine_slug": "jakavi", "observed_at": "2026-10-12T19:03:51Z", "pipeline_version": "2.0.0", "presentation_label": "Jakavi 5 mg, comprimé Jakavi 10 mg, comprimé Jakavi 15 mg, comprimé Jakavi 20 mg, comprimé", "presentation_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": "1d5244dc7298d3e9d7b666910018e6048ac8aba3eecdf6d0581d293bc93a0809", "source_snapshot_id": "source-8eeaa27a9b641ece4cddb943", "source_updated_at": "2025-11-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/jakavi-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 209}
{"after": {"end": 630, "start": 0, "text": "Les inhibiteurs puissants du CYP3A comprennent, de manière non exhaustive, le ritonavir, le cobicistat, le télaprevir, le lopinavir, l’itraconazole, le voriconazole, la clarithromycine, la télithromycine, le posaconazole, la néfazodone et le jus de pamplemousse. Si l’administration concomitante d’un inhibiteur puissant du CYP3A ne peut être évitée, les patients doivent être surveillés étroitement à la recherche d’effets indésirables. Pour les inhibiteurs puissants utilisés en courte durée, pendant 7 jours ou moins, envisager l’interruption du traitement par Cotellic pendant la durée du traitement par l’inhibiteur du CYP3A.", "truncated": false}, "after_length": 630, "after_sha256": "4552274eaf92cd84acded8ca8ee56fb9f0111812ae19fa5da97310a028bddf9c", "annex": "I", "before": {"end": 630, "start": 0, "text": "Les inhibiteurs puissants du CYP3A comprennent, de manière non exhaustive, le ritonavir, le cobicistat, le télaprevir, le lopinavir, l’itraconazole, le voriconazole, la clarithromycine, la télithromycine, le posaconazole, la néfazodone et le jus de pamplemousse. Si l’administration concomitante d’un inhibiteur puissant du CYP3A ne peut être évitée, les patients doivent être surveillés étroitement à la recherche d’effets indésirables. Pour les inhibiteurs puissants utilisés en courte durée, pendant 7 jours ou moins, envisager l’interruption du traitement par Cotellic pendant la durée du traitement par l’inhibiteur du CYP3A.", "truncated": false}, "before_length": 630, "before_sha256": "4552274eaf92cd84acded8ca8ee56fb9f0111812ae19fa5da97310a028bddf9c", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0318814a86e26834b8c10c75", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003960", "medicine_name": "Cotellic", "medicine_slug": "cotellic", "observed_at": "2026-10-12T19:30:48Z", "pipeline_version": "2.0.0", "presentation_label": "Cotellic 20 mg, comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "66e7b1cf7c3ee91ab58bcb8c7e50be3a43143695117ecffd7f1b81c2539743c7", "source_snapshot_id": "source-28a1371c0011b82ed12f2b58", "source_updated_at": "2025-06-24", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/cotellic-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 339}
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{"after": {"end": 907, "start": 0, "text": "Le ruxolitinib est principalement métabolisé par le CYP3A4 (> 50 %), avec une contribution additionnelle du CYP2C9. La molécule mère est l’entité prédominante dans le plasma humain et représente environ 60 % des substances apparentées en circulation. Deux métabolites actifs majeurs, représentant 25 % et 11 % de l’ASC de la molécule mère, sont présents dans le plasma. L’activité pharmacologique de ces métabolites sur les JAK est inférieure de 50 % à 20 % à celle de la molécule mère. Le total de tous les métabolites actifs contribue à hauteur de 18 % à la pharmacodynamie globale du ruxolitinib. Aux concentrations cliniquement pertinentes, le ruxolitinib n’inhibe pas les CYPIA2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 ou CYP3A4 et n’est pas un inducteur puissant du CYP1A2, CYP2B6 ou CYP3A4 selon les études in vitro. Les données in vitro indiquent que le ruxolitinib peut inhiber la P-gp et la BCRP.", "truncated": false}, "after_length": 907, "after_sha256": "f14cb4610217d20ad78aa213ab0ab3b088467885496c74acd7d2cc7aa64a8e68", "annex": "I", "before": {"end": 907, "start": 0, "text": "Le ruxolitinib est principalement métabolisé par le CYP3A4 (> 50 %), avec une contribution additionnelle du CYP2C9. La molécule mère est l’entité prédominante dans le plasma humain et représente environ 60 % des substances apparentées en circulation. Deux métabolites actifs majeurs, représentant 25 % et 11 % de l’ASC de la molécule mère, sont présents dans le plasma. L’activité pharmacologique de ces métabolites sur les JAK est inférieure de 50 % à 20 % à celle de la molécule mère. Le total de tous les métabolites actifs contribue à hauteur de 18 % à la pharmacodynamie globale du ruxolitinib. Aux concentrations cliniquement pertinentes, le ruxolitinib n’inhibe pas les CYPIA2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 ou CYP3A4 et n’est pas un inducteur puissant du CYP1A2, CYP2B6 ou CYP3A4 selon les études in vitro. Les données in vitro indiquent que le ruxolitinib peut inhiber la P-gp et la BCRP.", "truncated": false}, "before_length": 907, "before_sha256": "f14cb4610217d20ad78aa213ab0ab3b088467885496c74acd7d2cc7aa64a8e68", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-036b57c10d7cd071cead8c4d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002464", "medicine_name": "Jakavi", "medicine_slug": "jakavi", "observed_at": "2026-10-12T19:03:51Z", "pipeline_version": "2.0.0", "presentation_label": "Jakavi 5 mg, comprimé Jakavi 10 mg, comprimé Jakavi 15 mg, comprimé Jakavi 20 mg, comprimé", "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": "1d5244dc7298d3e9d7b666910018e6048ac8aba3eecdf6d0581d293bc93a0809", "source_snapshot_id": "source-8eeaa27a9b641ece4cddb943", "source_updated_at": "2025-11-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/jakavi-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1349}
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{"after": {"end": 400, "start": 0, "text": "La mutation M184V/I est survenue pour 2 isolats sur 19 (10,5 %) analysés, provenant de patients du groupe éfavirenz + emtricitabine + ténofovir disoproxil, et pour 10 isolats sur 29 (34,5 %) analysés provenant du groupe éfavirenz + lamivudine/zidovudine (p < 0,05, test exact de Fisher comparant le groupe emtricitabine + ténofovir disoproxil au groupe lamivudine/zidovudine parmi tous les patients).", "truncated": false}, "after_length": 400, "after_sha256": "89e6750c434e7f1ce8cdc35ca5bb7f81fe3247a2cafa6e14f6c52bb0608427a1", "annex": "I", "before": {"end": 400, "start": 0, "text": "La mutation M184V/I est survenue pour 2 isolats sur 19 (10,5 %) analysés, provenant de patients du groupe éfavirenz + emtricitabine + ténofovir disoproxil, et pour 10 isolats sur 29 (34,5 %) analysés provenant du groupe éfavirenz + lamivudine/zidovudine (p < 0,05, test exact de Fisher comparant le groupe emtricitabine + ténofovir disoproxil au groupe lamivudine/zidovudine parmi tous les patients).", "truncated": false}, "before_length": 400, "before_sha256": "89e6750c434e7f1ce8cdc35ca5bb7f81fe3247a2cafa6e14f6c52bb0608427a1", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03a2c47b802e8a0cc92437f2", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004240", "medicine_name": "Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan", "medicine_slug": "efavirenz-emtricitabine-tenofovir-disoproxil-mylan", "observed_at": "2026-10-12T13:35:36Z", "pipeline_version": "2.0.0", "presentation_label": "Éfavirenz/Emtricitabine/Ténofovir disoproxil Mylan 600 mg/200 mg/245 mg, comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "b05a93fb60d054704516fe125d3f487de5110d2f458193666c1071a32ca9a361", "source_snapshot_id": "source-a6bf09d6be60fa69e08ca140", "source_updated_at": "2026-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/efavirenz-emtricitabine-tenofovir-disoproxil-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": 1444}
{"after": {"end": 1134, "start": 0, "text": "Le nombre de patients présentant un des composants du critère du jugement principal décès cardiovasculaire (CV), infarctus du myocarde (IDM) ou accident vasculaire cérébral a été de 582 (9,3%) dans le groupe traité par clopidogrel et de 719 (11,4%) dans le groupe traité par le placebo, correspondant à une réduction du risque relatif (RRR) de 20% (IC à 95% : 10%-28%, p=0,00009) en faveur du groupe traité par le clopidogrel (RRR de 17% chez les patients traités de façon conservatrice, de 29% lorsqu’ils bénéficiaient d’une angioplastie coronaire avec ou sans pose de stent et de 10% lorsqu’ils bénéficiaient d’un pontage coronarien). De nouveaux événements cardiovasculaires (critère principal) ont été évités avec une réduction du risque relatif de 22% (IC : 8,6-33,4), 32% (IC : 12,8-46,4), 4% (IC : -26,9-26,7), 6% (IC : -33,5-34,3) et 14% (IC : -31,6-44,2) durant les intervalles respectifs suivants : 01 mois, 13 mois, 3–6 mois, 6–9 mois et 9–12 mois. Ainsi, au-delà de 3 mois de traitement, le bénéfice observé dans le groupe clopidogrel + AAS n’a pas augmenté alors que le risque hémorragique persistait (voir rubrique 4.4).", "truncated": false}, "after_length": 1134, "after_sha256": "0dd8ed8da5edff5cd60f8075e6f6643cfd2d71cbe8857ea46fda7947497d765c", "annex": "I", "before": {"end": 1134, "start": 0, "text": "Le nombre de patients présentant un des composants du critère du jugement principal décès cardiovasculaire (CV), infarctus du myocarde (IDM) ou accident vasculaire cérébral a été de 582 (9,3%) dans le groupe traité par clopidogrel et de 719 (11,4%) dans le groupe traité par le placebo, correspondant à une réduction du risque relatif (RRR) de 20% (IC à 95% : 10%-28%, p=0,00009) en faveur du groupe traité par le clopidogrel (RRR de 17% chez les patients traités de façon conservatrice, de 29% lorsqu’ils bénéficiaient d’une angioplastie coronaire avec ou sans pose de stent et de 10% lorsqu’ils bénéficiaient d’un pontage coronarien). De nouveaux événements cardiovasculaires (critère principal) ont été évités avec une réduction du risque relatif de 22% (IC : 8,6-33,4), 32% (IC : 12,8-46,4), 4% (IC : -26,9-26,7), 6% (IC : -33,5-34,3) et 14% (IC : -31,6-44,2) durant les intervalles respectifs suivants : 01 mois, 13 mois, 3–6 mois, 6–9 mois et 9–12 mois. Ainsi, au-delà de 3 mois de traitement, le bénéfice observé dans le groupe clopidogrel + AAS n’a pas augmenté alors que le risque hémorragique persistait (voir rubrique 4.4).", "truncated": false}, "before_length": 1134, "before_sha256": "0dd8ed8da5edff5cd60f8075e6f6643cfd2d71cbe8857ea46fda7947497d765c", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03a9c731b39c3584317c68aa", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/001136", "medicine_name": "Clopidogrel TAD", "medicine_slug": "clopidogrel-tad", "observed_at": "2026-10-12T19:41:00Z", "pipeline_version": "2.0.0", "presentation_label": "Clopidogrel TAD 75 mg comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "ee6ae8cacfb8b975d0540bc6fb939a17d6b2e929f257fdfe526eedfd3cbc837e", "source_snapshot_id": "source-aca2eb2a074bdefb15189a8a", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/clopidogrel-tad-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 394}
{"after": {"end": 478, "start": 0, "text": "Sur la base de l'analyse des données d'une étude clinique de non-infériorité en monothérapie comparant le lacosamide à la carbamazépine à libération prolongée (LP), les effets indésirables les plus fréquemment rapportés (≥ 10 %) avec le lacosamide ont été des céphalées et des sensations vertigineuses. Le taux d’arrêt de traitement en raison d'effets indésirables a été de 10,6 % pour les patients traités par lacosamide et 15,6% pour les patients traités par carbamazépine LP.", "truncated": false}, "after_length": 478, "after_sha256": "56176650c855ac0033f840f5b4ae5747576605adebf7ef3d5e1be506e2800c4b", "annex": "I", "before": {"end": 478, "start": 0, "text": "Sur la base de l'analyse des données d'une étude clinique de non-infériorité en monothérapie comparant le lacosamide à la carbamazépine à libération prolongée (LP), les effets indésirables les plus fréquemment rapportés (≥ 10 %) avec le lacosamide ont été des céphalées et des sensations vertigineuses. Le taux d’arrêt de traitement en raison d'effets indésirables a été de 10,6 % pour les patients traités par lacosamide et 15,6% pour les patients traités par carbamazépine LP.", "truncated": false}, "before_length": 478, "before_sha256": "56176650c855ac0033f840f5b4ae5747576605adebf7ef3d5e1be506e2800c4b", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03b077e0a03036cec1d38c20", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004443", "medicine_name": "Lacosamide Accord", "medicine_slug": "lacosamide-accord", "observed_at": "2026-10-12T19:37:29Z", "pipeline_version": "2.0.0", "presentation_label": "Lacosamide Accord 10 mg/mL solution pour perfusion", "presentation_occurrence": 3, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "cd3a95dc2f796cdb53458047b58cf6dec86ec7f028409ac05a0a03ff71e51db0", "source_snapshot_id": "source-2d34a37c349a23ae85f81df9", "source_updated_at": "2025-05-28", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/lacosamide-accord-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1977}
{"after": {"end": 77, "start": 0, "text": "Wait until ANC ³ 1,500 and platelets ³ 75,000; redose with no dose reduction.", "truncated": false}, "after_length": 77, "after_sha256": "31b6a8df83647002a49072bdb8fbded925c89c4908127ae13c09aa1867daa812", "annex": "I", "before": {"end": 77, "start": 0, "text": "Wait until ANC ³ 1,500 and platelets ³ 75,000; redose with no dose reduction.", "truncated": false}, "before_length": 77, "before_sha256": "31b6a8df83647002a49072bdb8fbded925c89c4908127ae13c09aa1867daa812", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03b0c866629061f474cf8c18", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000089", "medicine_name": "Caelyx pegylated liposomal", "medicine_slug": "caelyx-pegylated-liposomal", "observed_at": "2026-10-12T13:39:24Z", "pipeline_version": "2.0.0", "presentation_label": "Caelyx pegylated liposomal 2 mg/ml concentrate for solution for infusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "105b7194075dd91dfa9b4c53ccb8c5cafcef1398ea9d8e22cee320f1905e9896", "source_snapshot_id": "source-2b83429986b00509e2e9753d", "source_updated_at": "2026-04-24", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/caelyx-pegylated-liposomal-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 169}
{"after": {"end": 694, "start": 0, "text": "L’administration concomitante de céritinib et des substrats principalement métabolisés par le CYP3A ou des substrats du CYP3A connus pour avoir une marge thérapeutique étroite (alfuzosine, amiodarone, cisapride, ciclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quetiapine, quinidine, lovastatine, simvastatine, sildenafil, midazolam, triazolam, tacrolimus, alfentanil et sirolimus, par exemple) doit être évitée et des traitements alternatifs moins sensibles à l’inhibition du CYP3A doivent être utilisés si cela est possible. Si cela est inévitable, une réduction de dose des traitements concomitants substrats du CYP3A avec une marge thérapeutique étroite doit être envisagée.", "truncated": false}, "after_length": 694, "after_sha256": "0d650140236271fec42228b920a91c8354fac20cb7da1bda4d22b6fdc0f32513", "annex": "I", "before": {"end": 694, "start": 0, "text": "L’administration concomitante de céritinib et des substrats principalement métabolisés par le CYP3A ou des substrats du CYP3A connus pour avoir une marge thérapeutique étroite (alfuzosine, amiodarone, cisapride, ciclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quetiapine, quinidine, lovastatine, simvastatine, sildenafil, midazolam, triazolam, tacrolimus, alfentanil et sirolimus, par exemple) doit être évitée et des traitements alternatifs moins sensibles à l’inhibition du CYP3A doivent être utilisés si cela est possible. Si cela est inévitable, une réduction de dose des traitements concomitants substrats du CYP3A avec une marge thérapeutique étroite doit être envisagée.", "truncated": false}, "before_length": 694, "before_sha256": "0d650140236271fec42228b920a91c8354fac20cb7da1bda4d22b6fdc0f32513", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03be5ae10b0b47c753a61301", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003819", "medicine_name": "Zykadia", "medicine_slug": "zykadia", "observed_at": "2026-10-12T19:15:42Z", "pipeline_version": "2.0.0", "presentation_label": "Zykadia 150 mg gélules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "6b3aae395a85be44f16072cecfe58c284c9a0870255b00cbc21a8e89708a50ae", "source_snapshot_id": "source-ed9cf7f9565341980ec10144", "source_updated_at": "2025-08-26", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/zykadia-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 121}
{"after": {"end": 587, "start": 0, "text": "Patients VIH co-infectés par le VHB ou le VHC : Seul un nombre limité de patients étaient co-infectés par le VHB (n = 13) ou le VHC (n = 26) dans l’étude GS-01-934. Le profil des effets indésirables de l’éfavirenz, de l’emtricitabine et du ténofovir disoproxil chez les patients co-infectés par le VIH/VHB ou le VIH/VHC était comparable à celui observé chez les patients infectés par le VIH sans co-infection. Toutefois, comme attendu pour cette population de patients, les élévations des taux d’ASAT et d’ALAT ont été plus fréquentes que dans la population générale infectée par le VIH.", "truncated": false}, "after_length": 587, "after_sha256": "688aa74a0170fa0b23f2a80875ffee55d5185160708098f6b40d444a6eca14e3", "annex": "I", "before": {"end": 587, "start": 0, "text": "Patients VIH co-infectés par le VHB ou le VHC : Seul un nombre limité de patients étaient co-infectés par le VHB (n = 13) ou le VHC (n = 26) dans l’étude GS-01-934. Le profil des effets indésirables de l’éfavirenz, de l’emtricitabine et du ténofovir disoproxil chez les patients co-infectés par le VIH/VHB ou le VIH/VHC était comparable à celui observé chez les patients infectés par le VIH sans co-infection. Toutefois, comme attendu pour cette population de patients, les élévations des taux d’ASAT et d’ALAT ont été plus fréquentes que dans la population générale infectée par le VIH.", "truncated": false}, "before_length": 587, "before_sha256": "688aa74a0170fa0b23f2a80875ffee55d5185160708098f6b40d444a6eca14e3", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03c27dfac24b0eeb8e51f301", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004240", "medicine_name": "Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan", "medicine_slug": "efavirenz-emtricitabine-tenofovir-disoproxil-mylan", "observed_at": "2026-10-12T13:35:36Z", "pipeline_version": "2.0.0", "presentation_label": "Éfavirenz/Emtricitabine/Ténofovir disoproxil Mylan 600 mg/200 mg/245 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": "b05a93fb60d054704516fe125d3f487de5110d2f458193666c1071a32ca9a361", "source_snapshot_id": "source-a6bf09d6be60fa69e08ca140", "source_updated_at": "2026-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/efavirenz-emtricitabine-tenofovir-disoproxil-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": 1392}
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{"after": {"end": 253, "start": 0, "text": "Prior to initiating or continuing therapy with Jakavi, the benefits and risks for the individual patient should be considered, particularly in patients with cardiovascular risk factors (see also section 4.4 “Major adverse cardiovascular events (MACE)”).", "truncated": false}, "after_length": 253, "after_sha256": "c183c769434e785ecef32361e127e80eeb8902d6189a0394a269f6566bb10016", "annex": "I", "before": {"end": 253, "start": 0, "text": "Prior to initiating or continuing therapy with Jakavi, the benefits and risks for the individual patient should be considered, particularly in patients with cardiovascular risk factors (see also section 4.4 “Major adverse cardiovascular events (MACE)”).", "truncated": false}, "before_length": 253, "before_sha256": "c183c769434e785ecef32361e127e80eeb8902d6189a0394a269f6566bb10016", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03cfa5180da924030e76e774", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002464", "medicine_name": "Jakavi", "medicine_slug": "jakavi", "observed_at": "2026-10-12T19:03:48Z", "pipeline_version": "2.0.0", "presentation_label": "Jakavi 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": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "61869ebfe2680776654fa74d3c8410b0979ca573d1bd47d9bd6bc38201c69007", "source_snapshot_id": "source-c6766690c7b668e9ed97ac25", "source_updated_at": "2025-11-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/jakavi-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1718}
{"after": {"end": 98, "start": 0, "text": "Réduire Jakavi d’un niveau de dose. Reprendre au niveau de dose initial si le NAN est > 1 000/mm3.", "truncated": false}, "after_length": 98, "after_sha256": "905d502aa6d164b133bc9b5a7980a0342b7e62b1c4ce91a3a9416739f072a09b", "annex": "I", "before": {"end": 98, "start": 0, "text": "Réduire Jakavi d’un niveau de dose. Reprendre au niveau de dose initial si le NAN est > 1 000/mm3.", "truncated": false}, "before_length": 98, "before_sha256": "905d502aa6d164b133bc9b5a7980a0342b7e62b1c4ce91a3a9416739f072a09b", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03d222bfe48bde56e9410f6b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002464", "medicine_name": "Jakavi", "medicine_slug": "jakavi", "observed_at": "2026-10-12T19:03:51Z", "pipeline_version": "2.0.0", "presentation_label": "Jakavi 5 mg, comprimé Jakavi 10 mg, comprimé Jakavi 15 mg, comprimé Jakavi 20 mg, comprimé", "presentation_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": "1d5244dc7298d3e9d7b666910018e6048ac8aba3eecdf6d0581d293bc93a0809", "source_snapshot_id": "source-8eeaa27a9b641ece4cddb943", "source_updated_at": "2025-11-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/jakavi-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 218}
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{"after": {"end": 471, "start": 0, "text": "Des élévations importantes des taux d’alanine aminotransférase et de bilirubine ont été observées chez des patients traités par le pomalidomide (voir rubrique 4.8). Des cas d’hépatite nécessitant l’arrêt du traitement par le pomalidomide ont également été rapportés. Il est recommandé de contrôler régulièrement les paramètres de la fonction hépatique pendant les six premiers mois de traitement par le pomalidomide, puis, ensuite, selon les données cliniques du patient.", "truncated": false}, "after_length": 471, "after_sha256": "636357793a9ebd69108e61b66dd7ec688cdc166ea6bced385d8922ac4604418d", "annex": "I", "before": {"end": 471, "start": 0, "text": "Des élévations importantes des taux d’alanine aminotransférase et de bilirubine ont été observées chez des patients traités par le pomalidomide (voir rubrique 4.8). Des cas d’hépatite nécessitant l’arrêt du traitement par le pomalidomide ont également été rapportés. Il est recommandé de contrôler régulièrement les paramètres de la fonction hépatique pendant les six premiers mois de traitement par le pomalidomide, puis, ensuite, selon les données cliniques du patient.", "truncated": false}, "before_length": 471, "before_sha256": "636357793a9ebd69108e61b66dd7ec688cdc166ea6bced385d8922ac4604418d", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-04bccce655b479a43ea0a6db", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002682", "medicine_name": "Imnovid (previously Pomalidomide Celgene)", "medicine_slug": "imnovid-previously-pomalidomide-celgene", "observed_at": "2026-10-12T17:29:04Z", "pipeline_version": "2.0.0", "presentation_label": "Imnovid 1 mg gélules Imnovid 2 mg gélules Imnovid 3 mg gélules Imnovid 4 mg gélules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "5583cc334bc038ccc5a55a97f36d59c566b5938a3732fd08845b50e84358a414", "source_snapshot_id": "source-4e152dde578b80a63ee2fcd5", "source_updated_at": "2025-12-05", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/imnovid-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 589}
{"after": {"end": 260, "start": 0, "text": "Due to the limited clinical data in patients ≥75 years old with STEMI PCI, and increased risk of bleeding, the use of clopidogrel 600 mg loading dose should be considered only after an individual assessment of the bleeding risk of the patient by the physician.", "truncated": false}, "after_length": 260, "after_sha256": "7baa056e940d28cdcfcfaebd4cf795a2a740b474598d24fd12d4d78880b66ed4", "annex": "I", "before": {"end": 260, "start": 0, "text": "Due to the limited clinical data in patients ≥75 years old with STEMI PCI, and increased risk of bleeding, the use of clopidogrel 600 mg loading dose should be considered only after an individual assessment of the bleeding risk of the patient by the physician.", "truncated": false}, "before_length": 260, "before_sha256": "7baa056e940d28cdcfcfaebd4cf795a2a740b474598d24fd12d4d78880b66ed4", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-04bf5403a87758c6f8478cfb", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001136", "medicine_name": "Clopidogrel TAD", "medicine_slug": "clopidogrel-tad", "observed_at": "2026-10-12T19:40:49Z", "pipeline_version": "2.0.0", "presentation_label": "Clopidogrel TAD 75 mg film-coated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "f688cd18a108dfe948012d5534bb0d48e1142e08f8c4090f92bcc1b7fb75e3f9", "source_snapshot_id": "source-b81b59fb1db742037cab80d6", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/clopidogrel-tad-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 137}
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{"after": {"end": 260, "start": 0, "text": "The primary evidence of efficacy was based on objective response rates. Tumours were required to be measurable in at least one site of disease, and response characterisation based on Southwestern Oncology Group (SWOG) criteria. Results are provided in Table 6.", "truncated": false}, "after_length": 260, "after_sha256": "fd04c647629f31f8b49b5b4fdbb401737569c0d07f90a0511deb19eaa0d70ac7", "annex": "I", "before": {"end": 260, "start": 0, "text": "The primary evidence of efficacy was based on objective response rates. Tumours were required to be measurable in at least one site of disease, and response characterisation based on Southwestern Oncology Group (SWOG) criteria. Results are provided in Table 6.", "truncated": false}, "before_length": 260, "before_sha256": "fd04c647629f31f8b49b5b4fdbb401737569c0d07f90a0511deb19eaa0d70ac7", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-05e7778a4ed1aefee7708d26", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000406", "medicine_name": "Glivec", "medicine_slug": "glivec", "observed_at": "2026-10-12T19:03:38Z", "pipeline_version": "2.0.0", "presentation_label": "Glivec 100 mg film-coated tablets Glivec 400 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": "95c79dedfc53e396fad5a311bbe8a6df4004476bbd633a148be93f027da818fe", "source_snapshot_id": "source-39d14defaaa30dc741c01dfc", "source_updated_at": "2025-11-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/glivec-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 987}
{"after": {"end": 382, "start": 0, "text": "In repeat dose studies conducted in animals, the toxicity profile of Caelyx pegylated liposomal appears very similar to that reported in humans who receive longterm infusions of standard doxorubicin hydrochloride. With Caelyx pegylated liposomal, the encapsulation of doxorubicin hydrochloride in pegylated liposomes results in these effects having a differing strength, as follows.", "truncated": false}, "after_length": 382, "after_sha256": "9ed218dd6714c9824f2dfe7ad0f148d9732fd88d27f5ee402bf9fdd604d7f7cf", "annex": "I", "before": {"end": 382, "start": 0, "text": "In repeat dose studies conducted in animals, the toxicity profile of Caelyx pegylated liposomal appears very similar to that reported in humans who receive longterm infusions of standard doxorubicin hydrochloride. With Caelyx pegylated liposomal, the encapsulation of doxorubicin hydrochloride in pegylated liposomes results in these effects having a differing strength, as follows.", "truncated": false}, "before_length": 382, "before_sha256": "9ed218dd6714c9824f2dfe7ad0f148d9732fd88d27f5ee402bf9fdd604d7f7cf", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-05f0605d7679ba1f87472346", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000089", "medicine_name": "Caelyx pegylated liposomal", "medicine_slug": "caelyx-pegylated-liposomal", "observed_at": "2026-10-12T13:39:24Z", "pipeline_version": "2.0.0", "presentation_label": "Caelyx pegylated liposomal 2 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": "5.3", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "105b7194075dd91dfa9b4c53ccb8c5cafcef1398ea9d8e22cee320f1905e9896", "source_snapshot_id": "source-2b83429986b00509e2e9753d", "source_updated_at": "2026-04-24", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/caelyx-pegylated-liposomal-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 936}
{"after": {"end": 735, "start": 0, "text": "L’imatinib augmente la valeur moyenne de la Cmax et l’ASC de la simvastatine (substrat du CYP3A4), respectivement 2 fois et 3,5 fois, indiquant ainsi une inhibition du CYP3A4 par l’imatinib. Glivec doit donc être associé avec prudence à des substrats du CYP3A4 dont l’index thérapeutique est étroit (par exemple : ciclosporine, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfénadine, bortézomib, docétaxel et quinidine). Par ailleurs, Glivec peut augmenter la concentration plasmatique d’autres médicaments métabolisés par le CYP3A4 (par exemple triazolo-benzodiazépines, inhibiteurs calciques de type dihydropyridine, certains inhibiteurs de l’HMG-CoA réductase, c’est à dire les statines, etc.).", "truncated": false}, "after_length": 735, "after_sha256": "03840283b1d7f5e96b5d8ffbb96cee513b1d8ce9d5109c1ddcf5c15f8b5d6753", "annex": "I", "before": {"end": 735, "start": 0, "text": "L’imatinib augmente la valeur moyenne de la Cmax et l’ASC de la simvastatine (substrat du CYP3A4), respectivement 2 fois et 3,5 fois, indiquant ainsi une inhibition du CYP3A4 par l’imatinib. Glivec doit donc être associé avec prudence à des substrats du CYP3A4 dont l’index thérapeutique est étroit (par exemple : ciclosporine, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfénadine, bortézomib, docétaxel et quinidine). Par ailleurs, Glivec peut augmenter la concentration plasmatique d’autres médicaments métabolisés par le CYP3A4 (par exemple triazolo-benzodiazépines, inhibiteurs calciques de type dihydropyridine, certains inhibiteurs de l’HMG-CoA réductase, c’est à dire les statines, etc.).", "truncated": false}, "before_length": 735, "before_sha256": "03840283b1d7f5e96b5d8ffbb96cee513b1d8ce9d5109c1ddcf5c15f8b5d6753", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-05f5e0f7a77f8dfb6583dab0", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000406", "medicine_name": "Glivec", "medicine_slug": "glivec", "observed_at": "2026-10-12T19:03:41Z", "pipeline_version": "2.0.0", "presentation_label": "Glivec 100 mg comprimés pelliculés Glivec 400 mg comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "0a7399d86623c6528f9f7bdca262048f57cb0f2cb325b4cb64a1012d75b5d47a", "source_snapshot_id": "source-9b05d28fe88db964e63adf77", "source_updated_at": "2025-11-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/glivec-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 324}
{"after": {"end": 800, "start": 0, "text": "Patients with a creatinine clearance between 30 and 49 mL/min receiving Trizivir may experience a 1.6-to 3.3-fold higher lamivudine exposure (AUC) than patients with a creatinine clearance ≥50 mL/min. There are no safety data from randomized, controlled trials comparing Trizivir to the individual components in patients with a creatinine clearance between 30 and 49 mL/min who received dose-adjusted lamivudine. In the original lamivudine registrational trials in combination with zidovudine, higher lamivudine exposures were associated with higher rates of haematologic toxicities (neutropenia and anaemia), although discontinuations due to neutropenia or anaemia each occurred in <1% of subjects. Other lamivudine-related adverse events (such as gastro-intestinal and hepatic disorders) may occur.", "truncated": false}, "after_length": 800, "after_sha256": "b886400d173adb3b6dfab092a3b0101355b471095793e7d68a7d15ebf7a3405a", "annex": "I", "before": {"end": 800, "start": 0, "text": "Patients with a creatinine clearance between 30 and 49 mL/min receiving Trizivir may experience a 1.6-to 3.3-fold higher lamivudine exposure (AUC) than patients with a creatinine clearance ≥50 mL/min. There are no safety data from randomized, controlled trials comparing Trizivir to the individual components in patients with a creatinine clearance between 30 and 49 mL/min who received dose-adjusted lamivudine. In the original lamivudine registrational trials in combination with zidovudine, higher lamivudine exposures were associated with higher rates of haematologic toxicities (neutropenia and anaemia), although discontinuations due to neutropenia or anaemia each occurred in <1% of subjects. Other lamivudine-related adverse events (such as gastro-intestinal and hepatic disorders) may occur.", "truncated": false}, "before_length": 800, "before_sha256": "b886400d173adb3b6dfab092a3b0101355b471095793e7d68a7d15ebf7a3405a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-05fa0dc1a6d406cb5b26a433", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000338", "medicine_name": "Trizivir", "medicine_slug": "trizivir", "observed_at": "2026-10-12T17:26:40Z", "pipeline_version": "2.0.0", "presentation_label": "TRIZIVIR 300 mg/150 mg/300 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": "7b60528b5a9e0b2c4ab653d5cfe7aacd42662a265cb74e9eef5686e2d6eff4c8", "source_snapshot_id": "source-9ec91128981ab659e4649971", "source_updated_at": "2026-01-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/trizivir-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 204}
{"after": {"end": 121, "start": 0, "text": "Aucun effet génotoxique, ni carcinogène n’a été observé lors des tests standards réalisés avec la duloxétine chez le rat.", "truncated": false}, "after_length": 121, "after_sha256": "4c4a2b989dd70a062d65f3aabc371c7ac75080b454a6f3a6a46da4ec65a814af", "annex": "I", "before": {"end": 121, "start": 0, "text": "Aucun effet génotoxique, ni carcinogène n’a été observé lors des tests standards réalisés avec la duloxétine chez le rat.", "truncated": false}, "before_length": 121, "before_sha256": "4c4a2b989dd70a062d65f3aabc371c7ac75080b454a6f3a6a46da4ec65a814af", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0600db92ed2a4b6e2d784b5c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003981", "medicine_name": "Duloxetine Viatris (previously Duloxetine Mylan)", "medicine_slug": "duloxetine-viatris-previously-duloxetine-mylan", "observed_at": "2026-10-12T19:05:31Z", "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": "5.3", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a3fcd41b075d15c850a0f367ebb6f0d92da2955806b88a6247a9bf6368228bcd", "source_snapshot_id": "source-9ec61c9d1156351893a29ca4", "source_updated_at": "2025-10-15", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/duloxetine-viatris-previously-duloxetine-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": 684}
{"after": {"end": 232, "start": 0, "text": "There was no efficacy benefit of continuing DAPT beyond 21 days. A time-course distribution of major ischemic events and major hemorrhages by treatment assignment was done to analyze the impact of the short-term time-course of DAPT.", "truncated": false}, "after_length": 232, "after_sha256": "d395054d3cb6858be2e7f481681422bea397dd653790c2457d3cc21e0d414e63", "annex": "I", "before": {"end": 232, "start": 0, "text": "There was no efficacy benefit of continuing DAPT beyond 21 days. A time-course distribution of major ischemic events and major hemorrhages by treatment assignment was done to analyze the impact of the short-term time-course of DAPT.", "truncated": false}, "before_length": 232, "before_sha256": "d395054d3cb6858be2e7f481681422bea397dd653790c2457d3cc21e0d414e63", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0613299006fb4c660eba800f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001136", "medicine_name": "Clopidogrel TAD", "medicine_slug": "clopidogrel-tad", "observed_at": "2026-10-12T19:40:49Z", "pipeline_version": "2.0.0", "presentation_label": "Clopidogrel TAD 75 mg film-coated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "f688cd18a108dfe948012d5534bb0d48e1142e08f8c4090f92bcc1b7fb75e3f9", "source_snapshot_id": "source-b81b59fb1db742037cab80d6", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/clopidogrel-tad-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 475}
{"after": {"end": 626, "start": 0, "text": "Dans l’étude I, le tocilizumab a été administré par voie intraveineuse toutes les quatre semaines en monothérapie. Au cours des études II, III et V, le tocilizumab a été administré par voie intraveineuse toutes les quatre semaines en association avec le MTX et comparé à l’association d’un placebo et du MTX. Dans l’étude IV, le tocilizumab a été administré par voie intraveineuse toutes les 4 semaines en association avec un autre DMARD et comparé à un placebo associé à un autre DMARD. Le critère de jugement principal de chacune des cinq études était la proportion de patients atteignant une réponse ACR 20 à la semaine 24.", "truncated": false}, "after_length": 626, "after_sha256": "50d2cbd60068911c31fe26672317d1137c843cac780834fe831ceeed503215bc", "annex": "I", "before": {"end": 626, "start": 0, "text": "Dans l’étude I, le tocilizumab a été administré par voie intraveineuse toutes les quatre semaines en monothérapie. Au cours des études II, III et V, le tocilizumab a été administré par voie intraveineuse toutes les quatre semaines en association avec le MTX et comparé à l’association d’un placebo et du MTX. Dans l’étude IV, le tocilizumab a été administré par voie intraveineuse toutes les 4 semaines en association avec un autre DMARD et comparé à un placebo associé à un autre DMARD. Le critère de jugement principal de chacune des cinq études était la proportion de patients atteignant une réponse ACR 20 à la semaine 24.", "truncated": false}, "before_length": 626, "before_sha256": "50d2cbd60068911c31fe26672317d1137c843cac780834fe831ceeed503215bc", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0619df0984c2d532c531bbfd", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005984", "medicine_name": "Tocilizumab STADA (previously Tofidence)", "medicine_slug": "tocilizumab-stada-previously-tofidence", "observed_at": "2026-10-12T17:26:06Z", "pipeline_version": "2.0.0", "presentation_label": "Tocilizumab STADA 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "e85a34cd8f287b1fcc1b295d47151ff1cdd43b6c5d781d465ebb56ee155cdbe3", "source_snapshot_id": "source-8116ef89b641d9a73d218c68", "source_updated_at": "2026-01-20", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/tocilizumab-stada-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 836}
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{"after": {"end": 763, "start": 0, "text": "L’étude a atteint son critère principal en démontrant une amélioration statistiquement significative de la SSP évaluée par le CRIA avec une réduction du risque estimée à 51% dans le bras du céritinib par rapport au bras de la chimiothérapie (voir Tableau 4 et Figure 3). Le bénéfice obtenu en termes de SSP dans le bras de céritinib était similaire dans les divers sous-groupes définis en fonction de l’âge, du genre, de l’ethnie, du statut tabagique, du statut de performance ECOG, et de la présence de métastases cérébrales ou de la réponse préalable au crizotinib. Le bénéfice en termes de SSP était par ailleurs confirmé par l’évaluation de l’investigateur local, et par l’analyse du taux de réponse objective (TRO) et du taux de contrôle de la maladie (TCM).", "truncated": false}, "after_length": 763, "after_sha256": "0699a9fe7b167b8ce99642cdaf4ce3e66b32cca7f86ff03e4818abdcc8935dfb", "annex": "I", "before": {"end": 763, "start": 0, "text": "L’étude a atteint son critère principal en démontrant une amélioration statistiquement significative de la SSP évaluée par le CRIA avec une réduction du risque estimée à 51% dans le bras du céritinib par rapport au bras de la chimiothérapie (voir Tableau 4 et Figure 3). Le bénéfice obtenu en termes de SSP dans le bras de céritinib était similaire dans les divers sous-groupes définis en fonction de l’âge, du genre, de l’ethnie, du statut tabagique, du statut de performance ECOG, et de la présence de métastases cérébrales ou de la réponse préalable au crizotinib. Le bénéfice en termes de SSP était par ailleurs confirmé par l’évaluation de l’investigateur local, et par l’analyse du taux de réponse objective (TRO) et du taux de contrôle de la maladie (TCM).", "truncated": false}, "before_length": 763, "before_sha256": "0699a9fe7b167b8ce99642cdaf4ce3e66b32cca7f86ff03e4818abdcc8935dfb", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-07108d87ad72871bcd9286ef", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003819", "medicine_name": "Zykadia", "medicine_slug": "zykadia", "observed_at": "2026-10-12T19:15:42Z", "pipeline_version": "2.0.0", "presentation_label": "Zykadia 150 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "6b3aae395a85be44f16072cecfe58c284c9a0870255b00cbc21a8e89708a50ae", "source_snapshot_id": "source-ed9cf7f9565341980ec10144", "source_updated_at": "2025-08-26", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/zykadia-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1996}
{"after": {"end": 346, "start": 0, "text": "L’utilisation d’éfavirenz/emtricitabine/ténofovir disoproxil doit être évitée en cas d’utilisation concomitante ou récente d’un médicament néphrotoxique. Certains exemples incluent, entre autres, les aminosides, l’amphotéricine B, le foscarnet, le ganciclovir, la pentamidine, la vancomycine, le cidofovir ou l’interleukine­2 (voir rubrique 4.4).", "truncated": false}, "after_length": 346, "after_sha256": "55600922d9a42767aea1650329e04a537c582cf478d981cbe89071dcbc094bd7", "annex": "I", "before": {"end": 346, "start": 0, "text": "L’utilisation d’éfavirenz/emtricitabine/ténofovir disoproxil doit être évitée en cas d’utilisation concomitante ou récente d’un médicament néphrotoxique. Certains exemples incluent, entre autres, les aminosides, l’amphotéricine B, le foscarnet, le ganciclovir, la pentamidine, la vancomycine, le cidofovir ou l’interleukine­2 (voir rubrique 4.4).", "truncated": false}, "before_length": 346, "before_sha256": "55600922d9a42767aea1650329e04a537c582cf478d981cbe89071dcbc094bd7", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-07213e5b28763c3d649c5cc7", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004240", "medicine_name": "Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan", "medicine_slug": "efavirenz-emtricitabine-tenofovir-disoproxil-mylan", "observed_at": "2026-10-12T13:35:36Z", "pipeline_version": "2.0.0", "presentation_label": "Éfavirenz/Emtricitabine/Ténofovir disoproxil Mylan 600 mg/200 mg/245 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": "4.3", "section_type": "contraindication", "source_provider": "European Medicines Agency", "source_sha256": "b05a93fb60d054704516fe125d3f487de5110d2f458193666c1071a32ca9a361", "source_snapshot_id": "source-a6bf09d6be60fa69e08ca140", "source_updated_at": "2026-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/efavirenz-emtricitabine-tenofovir-disoproxil-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": 299}
{"after": {"end": 676, "start": 0, "text": "Les caractéristiques de la population des patients préalablement non traités atteints d’un CBNPC ALK positif, localement avancé ou métastatique, dans les deux bras 450 mg avec prise de nourriture (N=73) et 750 mg à jeun (N=74) étaient respectivement les suivantes : un âge moyen de 54,3 et 51,3 ans, âge inférieur à 65 ans (78,1 % et 83,8 %), femmes (56,2 % et 47,3 %), caucasiens (49,3 % et 54,1 %), asiatiques (39,7 % et 35,1 %), anciens fumeurs ou n’avaient jamais fumé (90,4 % et 95,9 %), indice de performance Organisation Mondiale de la Santé (OMS) à 0 ou 1 (91,7 % et 91,9 %), histologie d’adénocarcinome (98,6 % et 93,2 %%) et métastases cérébrales (32,9 % et 28,4 %).", "truncated": false}, "after_length": 676, "after_sha256": "0ef198bf3952fefda7770f2d66bedbea16e9e4ab44ac272e52b9ac0e0c15eeed", "annex": "I", "before": {"end": 676, "start": 0, "text": "Les caractéristiques de la population des patients préalablement non traités atteints d’un CBNPC ALK positif, localement avancé ou métastatique, dans les deux bras 450 mg avec prise de nourriture (N=73) et 750 mg à jeun (N=74) étaient respectivement les suivantes : un âge moyen de 54,3 et 51,3 ans, âge inférieur à 65 ans (78,1 % et 83,8 %), femmes (56,2 % et 47,3 %), caucasiens (49,3 % et 54,1 %), asiatiques (39,7 % et 35,1 %), anciens fumeurs ou n’avaient jamais fumé (90,4 % et 95,9 %), indice de performance Organisation Mondiale de la Santé (OMS) à 0 ou 1 (91,7 % et 91,9 %), histologie d’adénocarcinome (98,6 % et 93,2 %%) et métastases cérébrales (32,9 % et 28,4 %).", "truncated": false}, "before_length": 676, "before_sha256": "0ef198bf3952fefda7770f2d66bedbea16e9e4ab44ac272e52b9ac0e0c15eeed", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-07223651f09bdc3d217fe94e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003819", "medicine_name": "Zykadia", "medicine_slug": "zykadia", "observed_at": "2026-10-12T19:15:42Z", "pipeline_version": "2.0.0", "presentation_label": "Zykadia 150 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "6b3aae395a85be44f16072cecfe58c284c9a0870255b00cbc21a8e89708a50ae", "source_snapshot_id": "source-ed9cf7f9565341980ec10144", "source_updated_at": "2025-08-26", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/zykadia-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2290}
{"after": {"end": 331, "start": 0, "text": "Jakavi est indiqué dans le traitement de la splénomégalie ou des symptômes liés à la maladie chez l’adulte atteint de myélofibrose primitive (appelée également myélofibrose chronique idiopathique), de myélofibrose secondaire à la maladie de Vaquez (polycythémie vraie) ou de myélofibrose secondaire à la thrombocytémie essentielle.", "truncated": false}, "after_length": 331, "after_sha256": "b093422a0d3f369c2eb4de07e69e2b5b19afb0ad70aeebff866b22dc46a61b34", "annex": "I", "before": {"end": 331, "start": 0, "text": "Jakavi est indiqué dans le traitement de la splénomégalie ou des symptômes liés à la maladie chez l’adulte atteint de myélofibrose primitive (appelée également myélofibrose chronique idiopathique), de myélofibrose secondaire à la maladie de Vaquez (polycythémie vraie) ou de myélofibrose secondaire à la thrombocytémie essentielle.", "truncated": false}, "before_length": 331, "before_sha256": "b093422a0d3f369c2eb4de07e69e2b5b19afb0ad70aeebff866b22dc46a61b34", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-072892a875ca2350efad95a0", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002464", "medicine_name": "Jakavi", "medicine_slug": "jakavi", "observed_at": "2026-10-12T19:03:51Z", "pipeline_version": "2.0.0", "presentation_label": "Jakavi 5 mg, comprimé Jakavi 10 mg, comprimé Jakavi 15 mg, comprimé Jakavi 20 mg, comprimé", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.1", "section_type": "indication", "source_provider": "European Medicines Agency", "source_sha256": "1d5244dc7298d3e9d7b666910018e6048ac8aba3eecdf6d0581d293bc93a0809", "source_snapshot_id": "source-8eeaa27a9b641ece4cddb943", "source_updated_at": "2025-11-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/jakavi-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 82}
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{"after": {"end": 410, "start": 0, "text": "L’administration concomitante d’éfavirenz/emtricitabine/ ténofovir disoproxil avec sofosbuvir/velpatasvir ou sofosbuvir/velpatasvir/ voxilaprévir pourrait diminuer la concentration plasmatique de velpatasvir et de voxilaprévir. La co-administration d’éfavirenz/emtricitabine/ ténofovir disoproxil avec sofosbuvir/velpatasvir ou de sofosbuvir/velpatasvir/ voxilaprévir n’est pas recommandée (voir rubrique 4.4).", "truncated": false}, "after_length": 410, "after_sha256": "acb14735ef883baae83644fec0fae480021cfd4454277f1bea14d3b1cec9a310", "annex": "I", "before": {"end": 410, "start": 0, "text": "L’administration concomitante d’éfavirenz/emtricitabine/ ténofovir disoproxil avec sofosbuvir/velpatasvir ou sofosbuvir/velpatasvir/ voxilaprévir pourrait diminuer la concentration plasmatique de velpatasvir et de voxilaprévir. La co-administration d’éfavirenz/emtricitabine/ ténofovir disoproxil avec sofosbuvir/velpatasvir ou de sofosbuvir/velpatasvir/ voxilaprévir n’est pas recommandée (voir rubrique 4.4).", "truncated": false}, "before_length": 410, "before_sha256": "acb14735ef883baae83644fec0fae480021cfd4454277f1bea14d3b1cec9a310", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-08cb52fb0207a8ffd86603cc", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004240", "medicine_name": "Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan", "medicine_slug": "efavirenz-emtricitabine-tenofovir-disoproxil-mylan", "observed_at": "2026-10-12T13:35:36Z", "pipeline_version": "2.0.0", "presentation_label": "Éfavirenz/Emtricitabine/Ténofovir disoproxil Mylan 600 mg/200 mg/245 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": "4.3", "section_type": "contraindication", "source_provider": "European Medicines Agency", "source_sha256": "b05a93fb60d054704516fe125d3f487de5110d2f458193666c1071a32ca9a361", "source_snapshot_id": "source-a6bf09d6be60fa69e08ca140", "source_updated_at": "2026-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/efavirenz-emtricitabine-tenofovir-disoproxil-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": 610}
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{"after": {"end": 951, "start": 0, "text": "Éfavirenz/emtricitabine/ténofovir disoproxil ne doit pas être administré aux patients présentant une insuffisance hépatique sévère (voir rubrique 4.3) et n’est pas recommandé chez les patients présentant une insuffisance hépatique modérée. Dans une étude avec une dose unique d’éfavirenz, la demi-vie de l’éfavirenz était deux fois plus importante chez le seul patient étudié qui présentait une insuffisance hépatique sévère (Child-Pugh-Turcotte, classe C), ce qui indique la possibilité d’une accumulation bien supérieure. Une étude avec prises répétées d’éfavirenz n’a montré aucun effet significatif sur la pharmacocinétique de l’éfavirenz chez les patients présentant une maladie hépatique légère (Child-Pugh-Turcotte, classe A) par rapport au groupe témoin. Les données n’étaient pas suffisantes pour déterminer si l’insuffisance hépatique modérée ou sévère (Child-Pugh-Turcotte, classe B ou C) a un effet sur la pharmacocinétique de l’éfavirenz.", "truncated": false}, "after_length": 951, "after_sha256": "54216e556c012d624355e76a76d20a8f50182788c88972c779bbfb85e58cc37c", "annex": "I", "before": {"end": 951, "start": 0, "text": "Éfavirenz/emtricitabine/ténofovir disoproxil ne doit pas être administré aux patients présentant une insuffisance hépatique sévère (voir rubrique 4.3) et n’est pas recommandé chez les patients présentant une insuffisance hépatique modérée. Dans une étude avec une dose unique d’éfavirenz, la demi-vie de l’éfavirenz était deux fois plus importante chez le seul patient étudié qui présentait une insuffisance hépatique sévère (Child-Pugh-Turcotte, classe C), ce qui indique la possibilité d’une accumulation bien supérieure. Une étude avec prises répétées d’éfavirenz n’a montré aucun effet significatif sur la pharmacocinétique de l’éfavirenz chez les patients présentant une maladie hépatique légère (Child-Pugh-Turcotte, classe A) par rapport au groupe témoin. Les données n’étaient pas suffisantes pour déterminer si l’insuffisance hépatique modérée ou sévère (Child-Pugh-Turcotte, classe B ou C) a un effet sur la pharmacocinétique de l’éfavirenz.", "truncated": false}, "before_length": 951, "before_sha256": "54216e556c012d624355e76a76d20a8f50182788c88972c779bbfb85e58cc37c", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-090b6724585d002da2eebc44", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004240", "medicine_name": "Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan", "medicine_slug": "efavirenz-emtricitabine-tenofovir-disoproxil-mylan", "observed_at": "2026-10-12T13:35:36Z", "pipeline_version": "2.0.0", "presentation_label": "Éfavirenz/Emtricitabine/Ténofovir disoproxil Mylan 600 mg/200 mg/245 mg, comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "b05a93fb60d054704516fe125d3f487de5110d2f458193666c1071a32ca9a361", "source_snapshot_id": "source-a6bf09d6be60fa69e08ca140", "source_updated_at": "2026-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/efavirenz-emtricitabine-tenofovir-disoproxil-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": 1787}
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{"after": {"end": 267, "start": 0, "text": "Clinically significant effects were not seen on blood pressure, heart rate, blood glucose, and blood potassium levels. Co-administration with ketoconazole did not increase the elimination half-life of salmeterol or increase salmeterol accumulation with repeat dosing.", "truncated": false}, "after_length": 267, "after_sha256": "b14a1b22b4d9e260f655e021778436d19825c454f69fb37f7a1ea45241048ddf", "annex": "I", "before": {"end": 267, "start": 0, "text": "Clinically significant effects were not seen on blood pressure, heart rate, blood glucose, and blood potassium levels. Co-administration with ketoconazole did not increase the elimination half-life of salmeterol or increase salmeterol accumulation with repeat dosing.", "truncated": false}, "before_length": 267, "before_sha256": "b14a1b22b4d9e260f655e021778436d19825c454f69fb37f7a1ea45241048ddf", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-09a852c23ee4d570ac863bf0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004881", "medicine_name": "Seffalair Spiromax", "medicine_slug": "seffalair-spiromax", "observed_at": "2026-10-12T17:28:07Z", "pipeline_version": "2.0.0", "presentation_label": "Seffalair Spiromax 12.75 micrograms/100 micrograms inhalation powder Seffalair Spiromax 12.75 micrograms/202 micrograms inhalation powder", "presentation_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": "7eff81949b3d672e4e4d45be072c05d86664a74a9352fa76df2a19e6260c69b3", "source_snapshot_id": "source-a7a56afe8c7c3d12f12413ba", "source_updated_at": "2025-12-16", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/seffalair-spiromax-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 208}
{"after": {"end": 549, "start": 0, "text": "La pharmacocinétique de la duloxétine est modifiée en cas d’atteinte hépatique modérée (Classe B de Child Pugh). Par rapport aux sujets sains, la clairance plasmatique apparente de la duloxétine était inférieure de 79%, la demi-vie terminale apparente était 2,3 fois plus longue et l’aire sous la courbe était 3,7 fois plus importante chez les patients atteints d’insuffisance hépatique modérée. La pharmacocinétique de la duloxétine et de ses métabolites n’a pas été étudiée chez les patients présentant une insuffisance hépatique légère ou sévère.", "truncated": false}, "after_length": 549, "after_sha256": "4cef1e0bdc9a218ea641db8af91a68d2e28ac94318611b9d42a2272f69fcbea7", "annex": "I", "before": {"end": 549, "start": 0, "text": "La pharmacocinétique de la duloxétine est modifiée en cas d’atteinte hépatique modérée (Classe B de Child Pugh). Par rapport aux sujets sains, la clairance plasmatique apparente de la duloxétine était inférieure de 79%, la demi-vie terminale apparente était 2,3 fois plus longue et l’aire sous la courbe était 3,7 fois plus importante chez les patients atteints d’insuffisance hépatique modérée. La pharmacocinétique de la duloxétine et de ses métabolites n’a pas été étudiée chez les patients présentant une insuffisance hépatique légère ou sévère.", "truncated": false}, "before_length": 549, "before_sha256": "4cef1e0bdc9a218ea641db8af91a68d2e28ac94318611b9d42a2272f69fcbea7", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-09aa91edb626b2e364540872", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003981", "medicine_name": "Duloxetine Viatris (previously Duloxetine Mylan)", "medicine_slug": "duloxetine-viatris-previously-duloxetine-mylan", "observed_at": "2026-10-12T19:05:31Z", "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": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a3fcd41b075d15c850a0f367ebb6f0d92da2955806b88a6247a9bf6368228bcd", "source_snapshot_id": "source-9ec61c9d1156351893a29ca4", "source_updated_at": "2025-10-15", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/duloxetine-viatris-previously-duloxetine-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": 674}
{"after": {"end": 551, "start": 0, "text": "Dans une étude clinique conduite chez des volontaires sains, l’administration concomitante de cimétidine, inhibiteur du transport des cations organiques considéré comme contribuant à l’élimination rénale du glycopyrronium, a augmenté de 22 % l’exposition totale (ASC) au glycopyrronium et diminué de 23 % la clairance rénale. Au vu de ces résultats, il n’est pas attendu d’interaction cliniquement significative en cas d’administration concomitante du glycopyrronium avec la cimétidine ou avec d’autres inhibiteurs du transport des cations organiques.", "truncated": false}, "after_length": 551, "after_sha256": "487a69b1628d58febbf3ed63c3e8943336bdb14afd565a5e1738fafebc36dac7", "annex": "I", "before": {"end": 551, "start": 0, "text": "Dans une étude clinique conduite chez des volontaires sains, l’administration concomitante de cimétidine, inhibiteur du transport des cations organiques considéré comme contribuant à l’élimination rénale du glycopyrronium, a augmenté de 22 % l’exposition totale (ASC) au glycopyrronium et diminué de 23 % la clairance rénale. Au vu de ces résultats, il n’est pas attendu d’interaction cliniquement significative en cas d’administration concomitante du glycopyrronium avec la cimétidine ou avec d’autres inhibiteurs du transport des cations organiques.", "truncated": false}, "before_length": 551, "before_sha256": "487a69b1628d58febbf3ed63c3e8943336bdb14afd565a5e1738fafebc36dac7", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-09cee067f1e904b7db7da20e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002679", "medicine_name": "Ultibro Breezhaler", "medicine_slug": "ultibro-breezhaler", "observed_at": "2026-10-12T19:22:58Z", "pipeline_version": "2.0.0", "presentation_label": "Ultibro Breezhaler 85 microgrammes/43 microgrammes poudre pour inhalation en gélules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "7a8e17b6e96d132586ba251b55a8df6963d974237bd2c26e711f797281eae3e2", "source_snapshot_id": "source-f7b68dcb050a536d8586dbbc", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/ultibro-breezhaler-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 183}
{"after": {"end": 209, "start": 0, "text": "Les études chez l’animal ont montré une toxicité sur la reproduction pour des taux d’exposition systémiques (Aires Sous la Courbe) de duloxétine inférieurs à l’exposition clinique maximale (voir rubrique 5.3).", "truncated": false}, "after_length": 209, "after_sha256": "69eaed30055685163fbbbe28dc2209490e7517cb7c4b7c5354c6c6c62b9a120a", "annex": "I", "before": {"end": 209, "start": 0, "text": "Les études chez l’animal ont montré une toxicité sur la reproduction pour des taux d’exposition systémiques (Aires Sous la Courbe) de duloxétine inférieurs à l’exposition clinique maximale (voir rubrique 5.3).", "truncated": false}, "before_length": 209, "before_sha256": "69eaed30055685163fbbbe28dc2209490e7517cb7c4b7c5354c6c6c62b9a120a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-09d1210b66154909d6723445", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003981", "medicine_name": "Duloxetine Viatris (previously Duloxetine Mylan)", "medicine_slug": "duloxetine-viatris-previously-duloxetine-mylan", "observed_at": "2026-10-12T19:05:31Z", "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": "4.6", "section_type": "pregnancy", "source_provider": "European Medicines Agency", "source_sha256": "a3fcd41b075d15c850a0f367ebb6f0d92da2955806b88a6247a9bf6368228bcd", "source_snapshot_id": "source-9ec61c9d1156351893a29ca4", "source_updated_at": "2025-10-15", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/duloxetine-viatris-previously-duloxetine-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": 290}
{"after": {"end": 540, "start": 0, "text": "BCR-ABL tyrosine kinase inhibitors (TKIs) have been associated with thrombotic microangiopathy (TMA), including individual case reports for Glivec (see section 4.8). If laboratory or clinical findings associated with TMA occur in a patient receiving Glivec, treatment should be discontinued and thorough evaluation for TMA, including ADAMTS13 activity and anti-ADAMTS13-antibody determination, should be completed. If anti-ADAMTS13-antibody is elevated in conjunction with low ADAMTS13 activity, treatment with Glivec should not be resumed.", "truncated": false}, "after_length": 540, "after_sha256": "e7482b9cf97a042baaaa8fd8f8eb72ac2d9db3b97c23e83a4ba9a03d1de8c05a", "annex": "I", "before": {"end": 540, "start": 0, "text": "BCR-ABL tyrosine kinase inhibitors (TKIs) have been associated with thrombotic microangiopathy (TMA), including individual case reports for Glivec (see section 4.8). If laboratory or clinical findings associated with TMA occur in a patient receiving Glivec, treatment should be discontinued and thorough evaluation for TMA, including ADAMTS13 activity and anti-ADAMTS13-antibody determination, should be completed. If anti-ADAMTS13-antibody is elevated in conjunction with low ADAMTS13 activity, treatment with Glivec should not be resumed.", "truncated": false}, "before_length": 540, "before_sha256": "e7482b9cf97a042baaaa8fd8f8eb72ac2d9db3b97c23e83a4ba9a03d1de8c05a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-09d1b0c7b6704a2cb29e8f19", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000406", "medicine_name": "Glivec", "medicine_slug": "glivec", "observed_at": "2026-10-12T19:03:38Z", "pipeline_version": "2.0.0", "presentation_label": "Glivec 100 mg film-coated tablets Glivec 400 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": "95c79dedfc53e396fad5a311bbe8a6df4004476bbd633a148be93f027da818fe", "source_snapshot_id": "source-39d14defaaa30dc741c01dfc", "source_updated_at": "2025-11-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/glivec-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 298}
{"after": {"end": 371, "start": 0, "text": "La sécurité et l’efficacité de Cegfila n’ont pas été étudiées chez les patients atteints de syndrome myélodysplasique, de leucémie myéloïde chronique ou de LAM secondaire ; par conséquent, Cegfila ne doit pas être utilisé chez ces patients. Il importe de bien différencier le diagnostic d’une transformation blastique d’une leucémie myéloïde chronique de celui d’une LAM.", "truncated": false}, "after_length": 371, "after_sha256": "caf5945b3732d08faeee9a4549f3417d0e9ec55e2d6a06cd5480fb848bec9178", "annex": "I", "before": {"end": 371, "start": 0, "text": "La sécurité et l’efficacité de Cegfila n’ont pas été étudiées chez les patients atteints de syndrome myélodysplasique, de leucémie myéloïde chronique ou de LAM secondaire ; par conséquent, Cegfila ne doit pas être utilisé chez ces patients. Il importe de bien différencier le diagnostic d’une transformation blastique d’une leucémie myéloïde chronique de celui d’une LAM.", "truncated": false}, "before_length": 371, "before_sha256": "caf5945b3732d08faeee9a4549f3417d0e9ec55e2d6a06cd5480fb848bec9178", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-09d349e1c13420edb100e9a9", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005312", "medicine_name": "Cegfila (previously Pegfilgrastim Mundipharma)", "medicine_slug": "cegfila-previously-pegfilgrastim-mundipharma", "observed_at": "2026-10-12T13:47:32Z", "pipeline_version": "2.0.0", "presentation_label": "Cegfila 6 mg solution injectable en seringue préremplie.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "c817faef7d8a8650791b2eccc0afc9d687d22a4e3719cd73f9304a216d33baa6", "source_snapshot_id": "source-18665792536f9c0be526f0f6", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/cegfila-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 101}
{"after": {"end": 416, "start": 0, "text": "Pharmacokinetic data has been obtained for abacavir, lamivudine and zidovudine separately. Limited data in patients with cirrhosis suggest that accumulation of zidovudine may occur in patients with hepatic impairment because of decreased glucuronidation. Data obtained in patients with moderate to severe hepatic impairment show that lamivudine pharmacokinetics are not significantly affected by hepatic dysfunction.", "truncated": false}, "after_length": 416, "after_sha256": "082106b5a246a19eb8887326b340f44e48a4510b94f3930dc642619fe2daff47", "annex": "I", "before": {"end": 416, "start": 0, "text": "Pharmacokinetic data has been obtained for abacavir, lamivudine and zidovudine separately. Limited data in patients with cirrhosis suggest that accumulation of zidovudine may occur in patients with hepatic impairment because of decreased glucuronidation. Data obtained in patients with moderate to severe hepatic impairment show that lamivudine pharmacokinetics are not significantly affected by hepatic dysfunction.", "truncated": false}, "before_length": 416, "before_sha256": "082106b5a246a19eb8887326b340f44e48a4510b94f3930dc642619fe2daff47", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-09e1bc8f3d2122174a79b1d2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000338", "medicine_name": "Trizivir", "medicine_slug": "trizivir", "observed_at": "2026-10-12T17:26:40Z", "pipeline_version": "2.0.0", "presentation_label": "TRIZIVIR 300 mg/150 mg/300 mg film-coated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "7b60528b5a9e0b2c4ab653d5cfe7aacd42662a265cb74e9eef5686e2d6eff4c8", "source_snapshot_id": "source-9ec91128981ab659e4649971", "source_updated_at": "2026-01-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/trizivir-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 852}
{"after": {"end": 389, "start": 0, "text": "La sécurité et l’efficacité de Seffalair Spiromax ont été évaluées chez 3 004 patients atteints d’asthme. Le programme de développement comprenait 2 essais confirmatoires d’une durée de 12 semaines, une étude de 26 semaines évaluant la sécurité et 3 études de recherche de dose. L’efficacité de Seffalair Spiromax est fondée principalement sur les essais confirmatoires décrits ci-dessous.", "truncated": false}, "after_length": 389, "after_sha256": "497529d769ace582809cd74713d01b7e34fd91f40d4f58bb71942badecbe3d5a", "annex": "I", "before": {"end": 389, "start": 0, "text": "La sécurité et l’efficacité de Seffalair Spiromax ont été évaluées chez 3 004 patients atteints d’asthme. Le programme de développement comprenait 2 essais confirmatoires d’une durée de 12 semaines, une étude de 26 semaines évaluant la sécurité et 3 études de recherche de dose. L’efficacité de Seffalair Spiromax est fondée principalement sur les essais confirmatoires décrits ci-dessous.", "truncated": false}, "before_length": 389, "before_sha256": "497529d769ace582809cd74713d01b7e34fd91f40d4f58bb71942badecbe3d5a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0a21aef0588f3002128fbaba", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004881", "medicine_name": "Seffalair Spiromax", "medicine_slug": "seffalair-spiromax", "observed_at": "2026-10-12T17:28:11Z", "pipeline_version": "2.0.0", "presentation_label": "Seffalair Spiromax 12,75 microgrammes/100 microgrammes poudre pour inhalation Seffalair Spiromax 12,75 microgrammes/202 microgrammes poudre pour inhalation", "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": "b400d80be8345a8bf3225fb16f1b348532237af04c82caaf20ff6e0cd46993e8", "source_snapshot_id": "source-87ebc6ce7e018f0368638099", "source_updated_at": "2025-12-16", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/seffalair-spiromax-epar-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": 365, "start": 0, "text": "As with other serotonergic medicinal products, discontinuation symptoms may occur in the neonate after maternal duloxetine use near term. Discontinuation symptoms seen with duloxetine may include hypotonia, tremor, jitteriness, feeding difficulty, respiratory distress and seizures. The majority of cases have occurred either at birth or within a few days of birth.", "truncated": false}, "after_length": 365, "after_sha256": "76bd0ee826d95a00775fbca44d19dd240e80bf5f26ff9a41d6be0cf0a998c9d3", "annex": "I", "before": {"end": 365, "start": 0, "text": "As with other serotonergic medicinal products, discontinuation symptoms may occur in the neonate after maternal duloxetine use near term. Discontinuation symptoms seen with duloxetine may include hypotonia, tremor, jitteriness, feeding difficulty, respiratory distress and seizures. The majority of cases have occurred either at birth or within a few days of birth.", "truncated": false}, "before_length": 365, "before_sha256": "76bd0ee826d95a00775fbca44d19dd240e80bf5f26ff9a41d6be0cf0a998c9d3", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0a2d6cbbe61527dccaf8f846", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003981", "medicine_name": "Duloxetine Viatris (previously Duloxetine Mylan)", "medicine_slug": "duloxetine-viatris-previously-duloxetine-mylan", "observed_at": "2026-10-12T19:05:27Z", "pipeline_version": "2.0.0", "presentation_label": "Duloxetine Viatris 30 mg hard gastroresistant capsules Duloxetine Viatris 60 mg hard gastro-resistant 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": "4.6", "section_type": "pregnancy", "source_provider": "European Medicines Agency", "source_sha256": "367855ac0546054cc8272bc29520f2bf88d4319351112d47f14d7122f468db47", "source_snapshot_id": "source-013d20105a4b3b4c74c2d78b", "source_updated_at": "2025-10-15", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/duloxetine-viatris-previously-duloxetine-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": 301}
{"after": {"end": 195, "start": 0, "text": "When administered to pregnant rats, cobimetinib caused embryolethality and foetal malformations of the great vessels and skull at systemic exposures similar to human exposure at recommended dose.", "truncated": false}, "after_length": 195, "after_sha256": "f9bf67baf6fdf9a85057bfd407914118594c26957c2e5ee83d228b3f66448acc", "annex": "I", "before": {"end": 195, "start": 0, "text": "When administered to pregnant rats, cobimetinib caused embryolethality and foetal malformations of the great vessels and skull at systemic exposures similar to human exposure at recommended dose.", "truncated": false}, "before_length": 195, "before_sha256": "f9bf67baf6fdf9a85057bfd407914118594c26957c2e5ee83d228b3f66448acc", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0a3aea01e5975afee8725849", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003960", "medicine_name": "Cotellic", "medicine_slug": "cotellic", "observed_at": "2026-10-12T19:30:44Z", "pipeline_version": "2.0.0", "presentation_label": "Cotellic 20 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": "5.3", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "5b62f129f593b5079a0f5e9a47f83933bb019af62d7cc40ee07a9334d281bcf3", "source_snapshot_id": "source-0d296868a063a7fb7eaa3145", "source_updated_at": "2025-06-24", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/cotellic-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 854}
{"after": {"end": 269, "start": 0, "text": "Le pegfilgrastim n’a pas affecté la performance de reproduction ou la fertilité chez les rats mâles et femelles recevant des doses hebdomadaires cumulées environ 6 à 9 fois supérieures à la dose humaine recommandée (basée sur la surface corporelle) (voir rubrique 5.3).", "truncated": false}, "after_length": 269, "after_sha256": "3c8b3e5869d88c1b2c875382c4d0a5fcf55b3e6c26aa3c1fb94e9ea5884d03f3", "annex": "I", "before": {"end": 269, "start": 0, "text": "Le pegfilgrastim n’a pas affecté la performance de reproduction ou la fertilité chez les rats mâles et femelles recevant des doses hebdomadaires cumulées environ 6 à 9 fois supérieures à la dose humaine recommandée (basée sur la surface corporelle) (voir rubrique 5.3).", "truncated": false}, "before_length": 269, "before_sha256": "3c8b3e5869d88c1b2c875382c4d0a5fcf55b3e6c26aa3c1fb94e9ea5884d03f3", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0a457ee0cc1071298fa4c826", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005312", "medicine_name": "Cegfila (previously Pegfilgrastim Mundipharma)", "medicine_slug": "cegfila-previously-pegfilgrastim-mundipharma", "observed_at": "2026-10-12T13:47:32Z", "pipeline_version": "2.0.0", "presentation_label": "Cegfila 6 mg solution injectable en seringue préremplie.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.6", "section_type": "pregnancy", "source_provider": "European Medicines Agency", "source_sha256": "c817faef7d8a8650791b2eccc0afc9d687d22a4e3719cd73f9304a216d33baa6", "source_snapshot_id": "source-18665792536f9c0be526f0f6", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/cegfila-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 192}
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{"after": {"end": 397, "start": 0, "text": "As with other medicinal products with similar pharmacological action (antidepressants), isolated cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation. Concerning risk factors for suicidality in depression, see above. Physicians should encourage patients to report any distressing thoughts or feelings at any time.", "truncated": false}, "after_length": 397, "after_sha256": "f15cf282c67cd2828ab752a212e5b36145273bb30488fc9499bbb08b221df489", "annex": "I", "before": {"end": 397, "start": 0, "text": "As with other medicinal products with similar pharmacological action (antidepressants), isolated cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation. Concerning risk factors for suicidality in depression, see above. Physicians should encourage patients to report any distressing thoughts or feelings at any time.", "truncated": false}, "before_length": 397, "before_sha256": "f15cf282c67cd2828ab752a212e5b36145273bb30488fc9499bbb08b221df489", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0a54c55edd0fb79a4c0cbb58", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003981", "medicine_name": "Duloxetine Viatris (previously Duloxetine Mylan)", "medicine_slug": "duloxetine-viatris-previously-duloxetine-mylan", "observed_at": "2026-10-12T19:05:27Z", "pipeline_version": "2.0.0", "presentation_label": "Duloxetine Viatris 30 mg hard gastroresistant capsules Duloxetine Viatris 60 mg hard gastro-resistant 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": "367855ac0546054cc8272bc29520f2bf88d4319351112d47f14d7122f468db47", "source_snapshot_id": "source-013d20105a4b3b4c74c2d78b", "source_updated_at": "2025-10-15", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/duloxetine-viatris-previously-duloxetine-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": 197}
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{"after": {"end": 888, "start": 0, "text": "Les substances inhibant l’activité de l’isoenzyme CYP3A4 du cytochrome P450 (par exemple : inhibiteurs de protéase tels qu’indinavir, lopinavir/ritonavir, ritonavir, saquinavir, télaprévir, nelfinavir, bocéprévir ; antifongiques azolés tels que kétoconazole, itraconazole, posaconazole, voriconazole ; certains macrolides tels qu’érythromycine, clarithromycine et télithromycine) pourraient diminuer le métabolisme d’imatinib et donc augmenter les concentrations plasmatiques de l’imatinib. Une augmentation significative de l’exposition systémique à l’imatinib (la valeur moyenne de la Cmax et de l’ASC (Aire sous la courbe) ont respectivement été augmentées de 26% et 40%) a été observée chez des volontaires sains lors de l’administration d’une dose unique de kétoconazole (un inhibiteur du CYP3A4). La prudence est requise lorsque Glivec est administré avec des inhibiteurs du CYP3A4.", "truncated": false}, "after_length": 888, "after_sha256": "250e8752779e189385439fb9a31a9c8d4a45eb1659035b94e06b195ea15cfbfb", "annex": "I", "before": {"end": 888, "start": 0, "text": "Les substances inhibant l’activité de l’isoenzyme CYP3A4 du cytochrome P450 (par exemple : inhibiteurs de protéase tels qu’indinavir, lopinavir/ritonavir, ritonavir, saquinavir, télaprévir, nelfinavir, bocéprévir ; antifongiques azolés tels que kétoconazole, itraconazole, posaconazole, voriconazole ; certains macrolides tels qu’érythromycine, clarithromycine et télithromycine) pourraient diminuer le métabolisme d’imatinib et donc augmenter les concentrations plasmatiques de l’imatinib. Une augmentation significative de l’exposition systémique à l’imatinib (la valeur moyenne de la Cmax et de l’ASC (Aire sous la courbe) ont respectivement été augmentées de 26% et 40%) a été observée chez des volontaires sains lors de l’administration d’une dose unique de kétoconazole (un inhibiteur du CYP3A4). La prudence est requise lorsque Glivec est administré avec des inhibiteurs du CYP3A4.", "truncated": false}, "before_length": 888, "before_sha256": "250e8752779e189385439fb9a31a9c8d4a45eb1659035b94e06b195ea15cfbfb", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0a5a10ba125d0b2e57ea9889", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000406", "medicine_name": "Glivec", "medicine_slug": "glivec", "observed_at": "2026-10-12T19:03:41Z", "pipeline_version": "2.0.0", "presentation_label": "Glivec 100 mg comprimés pelliculés Glivec 400 mg comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "0a7399d86623c6528f9f7bdca262048f57cb0f2cb325b4cb64a1012d75b5d47a", "source_snapshot_id": "source-9b05d28fe88db964e63adf77", "source_updated_at": "2025-11-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/glivec-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 316}
{"after": {"end": 302, "start": 0, "text": "Grade 2 (intolerable) or Grade ≥3 photosensitivity: Cotellic and vemurafenib should be interrupted until resolution to Grade ≤1. Treatment can be restarted with no change in Cotellic dose. Vemurafenib dosing should be reduced as clinically appropriate, please refer to its SmPC for further information.", "truncated": false}, "after_length": 302, "after_sha256": "c74dced3458687090e965c1d13dd0ca3988555a1cf5bb9c39c5d0fdc1cde58a5", "annex": "I", "before": {"end": 302, "start": 0, "text": "Grade 2 (intolerable) or Grade ≥3 photosensitivity: Cotellic and vemurafenib should be interrupted until resolution to Grade ≤1. Treatment can be restarted with no change in Cotellic dose. Vemurafenib dosing should be reduced as clinically appropriate, please refer to its SmPC for further information.", "truncated": false}, "before_length": 302, "before_sha256": "c74dced3458687090e965c1d13dd0ca3988555a1cf5bb9c39c5d0fdc1cde58a5", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0a7363c7999475b56e5cb0a5", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003960", "medicine_name": "Cotellic", "medicine_slug": "cotellic", "observed_at": "2026-10-12T19:30:44Z", "pipeline_version": "2.0.0", "presentation_label": "Cotellic 20 mg film-coated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "5b62f129f593b5079a0f5e9a47f83933bb019af62d7cc40ee07a9334d281bcf3", "source_snapshot_id": "source-0d296868a063a7fb7eaa3145", "source_updated_at": "2025-06-24", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/cotellic-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 214}
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{"after": {"end": 1377, "start": 0, "text": "A crossover study in 40 healthy subjects, 10 each in the four CYP2C19 metaboliser groups (ultrarapid, extensive, intermediate and poor), evaluated pharmacokinetic and antiplatelet responses using 300 mg followed by 75 mg/day and 600 mg followed by 150 mg/day, each for a total of 5 days (steady state). No substantial differences in active metabolite exposure and mean inhibition of platelet aggregation (IPA) were observed between ultrarapid, extensive and intermediate metabolisers. In poor metabolisers, active metabolite exposure was decreased by 6371% compared to extensive metabolisers. After the 300 mg/75 mg dose regimen, antiplatelet responses were decreased in the poor metabolisers with mean IPA (5 μM ADP) of 24% (24 hours) and 37% (Day 5) as compared to IPA of 39% (24 hours) and 58% (Day 5) in the extensive metabolisers and 37% (24 hours) and 60% (Day 5) in the intermediate metabolisers. When poor metabolisers received the 600 mg/150 mg regimen, active metabolite exposure was greater than with the 300 mg/75 mg regimen. In addition, IPA was 32% (24 hours) and 61% (Day 5), which were greater than in the poor metabolisers receiving the 300 mg/75 mg regimen, and were similar to the other CYP2C19 metaboliser groups receiving the 300 mg/75 mg regimen. An appropriate dose regimen for this patient population has not been established in clinical outcome trials.", "truncated": false}, "after_length": 1377, "after_sha256": "cb6aded00b149febe11364b0600f60bc8b911c2e0325466f46b62cf32dff9922", "annex": "I", "before": {"end": 1377, "start": 0, "text": "A crossover study in 40 healthy subjects, 10 each in the four CYP2C19 metaboliser groups (ultrarapid, extensive, intermediate and poor), evaluated pharmacokinetic and antiplatelet responses using 300 mg followed by 75 mg/day and 600 mg followed by 150 mg/day, each for a total of 5 days (steady state). No substantial differences in active metabolite exposure and mean inhibition of platelet aggregation (IPA) were observed between ultrarapid, extensive and intermediate metabolisers. In poor metabolisers, active metabolite exposure was decreased by 6371% compared to extensive metabolisers. After the 300 mg/75 mg dose regimen, antiplatelet responses were decreased in the poor metabolisers with mean IPA (5 μM ADP) of 24% (24 hours) and 37% (Day 5) as compared to IPA of 39% (24 hours) and 58% (Day 5) in the extensive metabolisers and 37% (24 hours) and 60% (Day 5) in the intermediate metabolisers. When poor metabolisers received the 600 mg/150 mg regimen, active metabolite exposure was greater than with the 300 mg/75 mg regimen. In addition, IPA was 32% (24 hours) and 61% (Day 5), which were greater than in the poor metabolisers receiving the 300 mg/75 mg regimen, and were similar to the other CYP2C19 metaboliser groups receiving the 300 mg/75 mg regimen. An appropriate dose regimen for this patient population has not been established in clinical outcome trials.", "truncated": false}, "before_length": 1377, "before_sha256": "cb6aded00b149febe11364b0600f60bc8b911c2e0325466f46b62cf32dff9922", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0ad8df97cce3df4fa77e7868", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001136", "medicine_name": "Clopidogrel TAD", "medicine_slug": "clopidogrel-tad", "observed_at": "2026-10-12T19:40:49Z", "pipeline_version": "2.0.0", "presentation_label": "Clopidogrel TAD 75 mg film-coated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "f688cd18a108dfe948012d5534bb0d48e1142e08f8c4090f92bcc1b7fb75e3f9", "source_snapshot_id": "source-b81b59fb1db742037cab80d6", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/clopidogrel-tad-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 568}
{"after": {"end": 739, "start": 0, "text": "Duloxetine Viatris should not be used in the treatment of children and adolescents under the age of 18 years. Suiciderelated behaviours (suicide attempts and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger), were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo. If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms (see section 5.1). In addition, longterm safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking (see section 4.8).", "truncated": false}, "after_length": 739, "after_sha256": "5cd6dc8d73c03fde9c8b302087a5f782ffee31dc513ac503239e18a1fbbb6e54", "annex": "I", "before": {"end": 739, "start": 0, "text": "Duloxetine Viatris should not be used in the treatment of children and adolescents under the age of 18 years. Suiciderelated behaviours (suicide attempts and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger), were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo. If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms (see section 5.1). In addition, longterm safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking (see section 4.8).", "truncated": false}, "before_length": 739, "before_sha256": "5cd6dc8d73c03fde9c8b302087a5f782ffee31dc513ac503239e18a1fbbb6e54", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0afda388f395689f1668ade9", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003981", "medicine_name": "Duloxetine Viatris (previously Duloxetine Mylan)", "medicine_slug": "duloxetine-viatris-previously-duloxetine-mylan", "observed_at": "2026-10-12T19:05:27Z", "pipeline_version": "2.0.0", "presentation_label": "Duloxetine Viatris 30 mg hard gastroresistant capsules Duloxetine Viatris 60 mg hard gastro-resistant 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": "367855ac0546054cc8272bc29520f2bf88d4319351112d47f14d7122f468db47", "source_snapshot_id": "source-013d20105a4b3b4c74c2d78b", "source_updated_at": "2025-10-15", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/duloxetine-viatris-previously-duloxetine-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": 201}
{"after": {"end": 133, "start": 0, "text": "Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.", "truncated": false}, "after_length": 133, "after_sha256": "eabdb61a543e11ee016c5c43ada549964199ddf9e287a2eb3256e15d4a87fe4a", "annex": "I", "before": {"end": 133, "start": 0, "text": "Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.", "truncated": false}, "before_length": 133, "before_sha256": "eabdb61a543e11ee016c5c43ada549964199ddf9e287a2eb3256e15d4a87fe4a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0b022dd578c7673afc462463", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002751", "medicine_name": "Anoro Ellipta (previously Anoro)", "medicine_slug": "anoro-ellipta-previously-anoro", "observed_at": "2026-10-12T19:17:37Z", "pipeline_version": "2.0.0", "presentation_label": "ANORO ELLIPTA 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": "10", "section_type": "administrative", "source_provider": "European Medicines Agency", "source_sha256": "7ebba8dd63bd37ec5d24ca7a9a63f2fcc64533b24cc9441412ad0beb523df07f", "source_snapshot_id": "source-14ffea35b90ed19d08622ffd", "source_updated_at": "2025-07-31", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/anoro-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": 611}
{"after": {"end": 519, "start": 0, "text": "Aucune adaptation posologique n’est recommandée chez les patients présentant une insuffisance hépatique. Les patients présentant une insuffisance hépatique sévère peuvent avoir des concentrations plasmatiques en cobimetinib libre augmentées par rapport aux patients ayant une fonction hépatique normale (voir rubrique 5.2). Des anomalies du bilan hépatique peuvent apparaître avec Cotellic, la prudence est de rigueur chez les patients présentant une insuffisance hépatique quel qu’en soit le degré (voir rubrique 4.4).", "truncated": false}, "after_length": 519, "after_sha256": "14bb724418442353f4119c94772d60b50144dd5bdd77bb77d4b572d81b52b345", "annex": "I", "before": {"end": 519, "start": 0, "text": "Aucune adaptation posologique n’est recommandée chez les patients présentant une insuffisance hépatique. Les patients présentant une insuffisance hépatique sévère peuvent avoir des concentrations plasmatiques en cobimetinib libre augmentées par rapport aux patients ayant une fonction hépatique normale (voir rubrique 5.2). Des anomalies du bilan hépatique peuvent apparaître avec Cotellic, la prudence est de rigueur chez les patients présentant une insuffisance hépatique quel qu’en soit le degré (voir rubrique 4.4).", "truncated": false}, "before_length": 519, "before_sha256": "14bb724418442353f4119c94772d60b50144dd5bdd77bb77d4b572d81b52b345", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0b0d20d42461e35e74aeb8e5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003960", "medicine_name": "Cotellic", "medicine_slug": "cotellic", "observed_at": "2026-10-12T19:30:48Z", "pipeline_version": "2.0.0", "presentation_label": "Cotellic 20 mg, comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "66e7b1cf7c3ee91ab58bcb8c7e50be3a43143695117ecffd7f1b81c2539743c7", "source_snapshot_id": "source-28a1371c0011b82ed12f2b58", "source_updated_at": "2025-06-24", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/cotellic-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 243}
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{"after": {"end": 161, "start": 0, "text": "Si un contrôle adéquat de l’hypertension ne peut être obtenu avec une prise en charge médicale optimale, interrompre définitivement le traitement par lorlatinib.", "truncated": false}, "after_length": 161, "after_sha256": "db275d8199aff2b6c773dd6005490fd65cd6c8514bd1bb2b88ac56e1c74f9942", "annex": "I", "before": {"end": 161, "start": 0, "text": "Si un contrôle adéquat de l’hypertension ne peut être obtenu avec une prise en charge médicale optimale, interrompre définitivement le traitement par lorlatinib.", "truncated": false}, "before_length": 161, "before_sha256": "db275d8199aff2b6c773dd6005490fd65cd6c8514bd1bb2b88ac56e1c74f9942", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0c985e147b91e429abf1df14", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004646", "medicine_name": "Lorviqua", "medicine_slug": "lorviqua", "observed_at": "2026-10-12T13:40:21Z", "pipeline_version": "2.0.0", "presentation_label": "Lorviqua 25 mg, comprimés pelliculés Lorviqua 100 mg, comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "60dc172f08ea3d561119e0d5bda985db037f78b0a16e1e39ca300b1f129588f1", "source_snapshot_id": "source-d3dc2424089c088062be259f", "source_updated_at": "2026-04-15", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/lorviqua-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 208}
{"after": {"end": 52, "start": 0, "text": "Clopidogrel in combination with ASA is indicated in:", "truncated": false}, "after_length": 52, "after_sha256": "ccce2c310a3d6908a2aa0e1ff3d69d8f4c0022bc0fd937bb0566570c17dc96e6", "annex": "I", "before": {"end": 52, "start": 0, "text": "Clopidogrel in combination with ASA is indicated in:", "truncated": false}, "before_length": 52, "before_sha256": "ccce2c310a3d6908a2aa0e1ff3d69d8f4c0022bc0fd937bb0566570c17dc96e6", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0ccd9e03a682892b89318d37", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001136", "medicine_name": "Clopidogrel TAD", "medicine_slug": "clopidogrel-tad", "observed_at": "2026-10-12T19:40:49Z", "pipeline_version": "2.0.0", "presentation_label": "Clopidogrel TAD 75 mg film-coated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.1", "section_type": "indication", "source_provider": "European Medicines Agency", "source_sha256": "f688cd18a108dfe948012d5534bb0d48e1142e08f8c4090f92bcc1b7fb75e3f9", "source_snapshot_id": "source-b81b59fb1db742037cab80d6", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/clopidogrel-tad-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 62}
{"after": {"end": 536, "start": 0, "text": "Aucun ajustement posologique n'est nécessaire pour les patients présentant une fonction rénale normale et une insuffisance rénale légère ou modérée [débit de filtration glomérulaire estimé (DFGe) absolu : ≥ 30 ml/min]. Il est recommandé aux patients présentant une insuffisance rénale sévère (DFGe absolu < 30 ml/min) de prendre une dose réduite de lorlatinib, par exemple une dose initiale de 75 mg à prendre quotidiennement par voie orale (voir rubrique 5.2). Aucune information n’est disponible chez les patients sous dialyse rénale.", "truncated": false}, "after_length": 536, "after_sha256": "fbb66acb19570bc0670339281a272c0281026223159beb0d6ce36c34c4e196aa", "annex": "I", "before": {"end": 536, "start": 0, "text": "Aucun ajustement posologique n'est nécessaire pour les patients présentant une fonction rénale normale et une insuffisance rénale légère ou modérée [débit de filtration glomérulaire estimé (DFGe) absolu : ≥ 30 ml/min]. Il est recommandé aux patients présentant une insuffisance rénale sévère (DFGe absolu < 30 ml/min) de prendre une dose réduite de lorlatinib, par exemple une dose initiale de 75 mg à prendre quotidiennement par voie orale (voir rubrique 5.2). Aucune information n’est disponible chez les patients sous dialyse rénale.", "truncated": false}, "before_length": 536, "before_sha256": "fbb66acb19570bc0670339281a272c0281026223159beb0d6ce36c34c4e196aa", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0cd6aa10f6e7baf34e7fb29a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004646", "medicine_name": "Lorviqua", "medicine_slug": "lorviqua", "observed_at": "2026-10-12T13:40:21Z", "pipeline_version": "2.0.0", "presentation_label": "Lorviqua 25 mg, comprimés pelliculés Lorviqua 100 mg, comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "60dc172f08ea3d561119e0d5bda985db037f78b0a16e1e39ca300b1f129588f1", "source_snapshot_id": "source-d3dc2424089c088062be259f", "source_updated_at": "2026-04-15", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/lorviqua-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 245}
{"after": {"end": 1072, "start": 0, "text": "Les résultats obtenus sur des populations de patients présentant des caractéristiques différentes (tel qu‘angor instable ou IDM sans onde Q, niveau de risque faible à élevé, diabète, nécessité d’une revascularisation, âge, sexe, etc…) ont été cohérents avec les résultats de l’analyse principale. En particulier, dans une analyse post-hoc portant sur 2 172 patients (soit 17 % de la population totale de l’étude CURE) ayant bénéficié d’une pose de stent (Stent-CURE), les données ont montré une réduction significative du risque relatif de 26,2% en faveur du clopidogrel comparé au placebo sur le critère de jugement principal (décès CV, IDM, accident vasculaire cérébral), ainsi qu’une réduction significative du risque relatif de 23,9% sur le co-critère de jugement principal (décès CV, IDM, accident vasculaire cérébral ou ischémie réfractaire). Par ailleurs, le profil de tolérance du clopidogrel dans ce sous-groupe de patients n’a pas soulevé de problème particulier. Ainsi, les résultats de ce sous-groupe sont cohérents avec les résultats de l’ensemble de l’étude.", "truncated": false}, "after_length": 1072, "after_sha256": "1d1fe02275a0f79b621a135a65105e32b21d4f0f8960ce61aaf0362265765a1e", "annex": "I", "before": {"end": 1072, "start": 0, "text": "Les résultats obtenus sur des populations de patients présentant des caractéristiques différentes (tel qu‘angor instable ou IDM sans onde Q, niveau de risque faible à élevé, diabète, nécessité d’une revascularisation, âge, sexe, etc…) ont été cohérents avec les résultats de l’analyse principale. En particulier, dans une analyse post-hoc portant sur 2 172 patients (soit 17 % de la population totale de l’étude CURE) ayant bénéficié d’une pose de stent (Stent-CURE), les données ont montré une réduction significative du risque relatif de 26,2% en faveur du clopidogrel comparé au placebo sur le critère de jugement principal (décès CV, IDM, accident vasculaire cérébral), ainsi qu’une réduction significative du risque relatif de 23,9% sur le co-critère de jugement principal (décès CV, IDM, accident vasculaire cérébral ou ischémie réfractaire). Par ailleurs, le profil de tolérance du clopidogrel dans ce sous-groupe de patients n’a pas soulevé de problème particulier. Ainsi, les résultats de ce sous-groupe sont cohérents avec les résultats de l’ensemble de l’étude.", "truncated": false}, "before_length": 1072, "before_sha256": "1d1fe02275a0f79b621a135a65105e32b21d4f0f8960ce61aaf0362265765a1e", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0ce02a635be7375eca2c89f3", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/001136", "medicine_name": "Clopidogrel TAD", "medicine_slug": "clopidogrel-tad", "observed_at": "2026-10-12T19:41:00Z", "pipeline_version": "2.0.0", "presentation_label": "Clopidogrel TAD 75 mg comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "ee6ae8cacfb8b975d0540bc6fb939a17d6b2e929f257fdfe526eedfd3cbc837e", "source_snapshot_id": "source-aca2eb2a074bdefb15189a8a", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/clopidogrel-tad-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 401}
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{"after": {"end": 280, "start": 0, "text": "In vitro, le clopidogrel et son principal métabolite circulant (inactif) se lient de façon réversible aux protéines plasmatiques humaines (taux de liaison respectifs de 98% et de 94%). Cette liaison aux protéines n'est pas saturable in vitro sur une large gamme de concentrations.", "truncated": false}, "after_length": 280, "after_sha256": "16dd6d928c77441292bf643b937aa1ea9977aa87c368ff4b4ff5a8cd0953c93b", "annex": "I", "before": {"end": 280, "start": 0, "text": "In vitro, le clopidogrel et son principal métabolite circulant (inactif) se lient de façon réversible aux protéines plasmatiques humaines (taux de liaison respectifs de 98% et de 94%). Cette liaison aux protéines n'est pas saturable in vitro sur une large gamme de concentrations.", "truncated": false}, "before_length": 280, "before_sha256": "16dd6d928c77441292bf643b937aa1ea9977aa87c368ff4b4ff5a8cd0953c93b", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0d6ad5810d5ddc21485b310b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/001136", "medicine_name": "Clopidogrel TAD", "medicine_slug": "clopidogrel-tad", "observed_at": "2026-10-12T19:41:00Z", "pipeline_version": "2.0.0", "presentation_label": "Clopidogrel TAD 75 mg comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "ee6ae8cacfb8b975d0540bc6fb939a17d6b2e929f257fdfe526eedfd3cbc837e", "source_snapshot_id": "source-aca2eb2a074bdefb15189a8a", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/clopidogrel-tad-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 558}
{"after": {"end": 313, "start": 0, "text": "L’augmentation de l’activité hématopoïétique de la moelle osseuse en réponse à un traitement par facteurs de croissance a été associée à des variations transitoires observables de la scintigraphie osseuse. Celles-ci doivent être prises en compte lors de l’interprétation des résultats de la scintigraphie osseuse.", "truncated": false}, "after_length": 313, "after_sha256": "984a200a9c80925839e3fde965bf763c34a1823f120243e76300f9fe019adc90", "annex": "I", "before": {"end": 313, "start": 0, "text": "L’augmentation de l’activité hématopoïétique de la moelle osseuse en réponse à un traitement par facteurs de croissance a été associée à des variations transitoires observables de la scintigraphie osseuse. Celles-ci doivent être prises en compte lors de l’interprétation des résultats de la scintigraphie osseuse.", "truncated": false}, "before_length": 313, "before_sha256": "984a200a9c80925839e3fde965bf763c34a1823f120243e76300f9fe019adc90", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0d7dd924c20fc2b8c373ef6c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005312", "medicine_name": "Cegfila (previously Pegfilgrastim Mundipharma)", "medicine_slug": "cegfila-previously-pegfilgrastim-mundipharma", "observed_at": "2026-10-12T13:47:32Z", "pipeline_version": "2.0.0", "presentation_label": "Cegfila 6 mg solution injectable en seringue préremplie.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "c817faef7d8a8650791b2eccc0afc9d687d22a4e3719cd73f9304a216d33baa6", "source_snapshot_id": "source-18665792536f9c0be526f0f6", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/cegfila-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 160}
{"after": {"end": 113, "start": 0, "text": "Il doit être conseillé aux patients d’utiliser Seffalair Spiromax tous les jours, même en l’absence de symptômes.", "truncated": false}, "after_length": 113, "after_sha256": "7f3b3361ab8c451818d71c635fcc31fd14c5d5785b0e51d1bfd919d214394a14", "annex": "I", "before": {"end": 113, "start": 0, "text": "Il doit être conseillé aux patients d’utiliser Seffalair Spiromax tous les jours, même en l’absence de symptômes.", "truncated": false}, "before_length": 113, "before_sha256": "7f3b3361ab8c451818d71c635fcc31fd14c5d5785b0e51d1bfd919d214394a14", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0db0acf1b1f1a5179f8f7e70", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004881", "medicine_name": "Seffalair Spiromax", "medicine_slug": "seffalair-spiromax", "observed_at": "2026-10-12T17:28:11Z", "pipeline_version": "2.0.0", "presentation_label": "Seffalair Spiromax 12,75 microgrammes/100 microgrammes poudre pour inhalation Seffalair Spiromax 12,75 microgrammes/202 microgrammes poudre pour inhalation", "presentation_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": "b400d80be8345a8bf3225fb16f1b348532237af04c82caaf20ff6e0cd46993e8", "source_snapshot_id": "source-87ebc6ce7e018f0368638099", "source_updated_at": "2025-12-16", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/seffalair-spiromax-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 60}
{"after": {"end": 299, "start": 0, "text": "There is no data to support the use of dual antiplatelet therapy in patients for whom treatment with carotid endarterectomy or intravascular thrombectomy is indicated, or in patients planned for thrombolysis or anticoagulant therapy. Dual antiplatelet therapy is not recommended in these situations.", "truncated": false}, "after_length": 299, "after_sha256": "78a6d35ead9381f2334db8b404db017be61788813ef2b80af2e6b794009063b4", "annex": "I", "before": {"end": 299, "start": 0, "text": "There is no data to support the use of dual antiplatelet therapy in patients for whom treatment with carotid endarterectomy or intravascular thrombectomy is indicated, or in patients planned for thrombolysis or anticoagulant therapy. Dual antiplatelet therapy is not recommended in these situations.", "truncated": false}, "before_length": 299, "before_sha256": "78a6d35ead9381f2334db8b404db017be61788813ef2b80af2e6b794009063b4", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0dd1d6e2a412fcbe9673babb", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/001136", "medicine_name": "Clopidogrel TAD", "medicine_slug": "clopidogrel-tad", "observed_at": "2026-10-12T19:40:49Z", "pipeline_version": "2.0.0", "presentation_label": "Clopidogrel TAD 75 mg film-coated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "f688cd18a108dfe948012d5534bb0d48e1142e08f8c4090f92bcc1b7fb75e3f9", "source_snapshot_id": "source-b81b59fb1db742037cab80d6", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/clopidogrel-tad-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 153}
{"after": {"end": 630, "start": 0, "text": "832 patients (22,1%) ont présenté un des composants du critère principal d’efficacité (AVC, IDM, embolie systémique en dehors du SNC ou décès d’origine vasculaire) dans le groupe clopidogrel + AAS versus 924 patients (24,4%) dans le groupe placebo + AAS (soit une réduction du risque relatif de 11,1% ; IC95% : 2,4-19,1% ; p=0,013). Cette différence est principalement due à une diminution importante du nombre d’AVC. 296 patients (7,8%) dans le groupe clopidogrel + AAS ont présenté un AVC versus 408 patients (10,8%) dans le groupe placebo + AAS (soit une réduction du risque relatif de 28,4% ; IC95% : 16,8%-38,3% ; p=0,00001).", "truncated": false}, "after_length": 630, "after_sha256": "1954639bac671a59a8f1d1852ab4d9b497406cd8667e4d2ab61972e572cb88a9", "annex": "I", "before": {"end": 630, "start": 0, "text": "832 patients (22,1%) ont présenté un des composants du critère principal d’efficacité (AVC, IDM, embolie systémique en dehors du SNC ou décès d’origine vasculaire) dans le groupe clopidogrel + AAS versus 924 patients (24,4%) dans le groupe placebo + AAS (soit une réduction du risque relatif de 11,1% ; IC95% : 2,4-19,1% ; p=0,013). Cette différence est principalement due à une diminution importante du nombre d’AVC. 296 patients (7,8%) dans le groupe clopidogrel + AAS ont présenté un AVC versus 408 patients (10,8%) dans le groupe placebo + AAS (soit une réduction du risque relatif de 28,4% ; IC95% : 16,8%-38,3% ; p=0,00001).", "truncated": false}, "before_length": 630, "before_sha256": "1954639bac671a59a8f1d1852ab4d9b497406cd8667e4d2ab61972e572cb88a9", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0deea0e461ec3a429beae1cb", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/001136", "medicine_name": "Clopidogrel TAD", "medicine_slug": "clopidogrel-tad", "observed_at": "2026-10-12T19:41:00Z", "pipeline_version": "2.0.0", "presentation_label": "Clopidogrel TAD 75 mg comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "ee6ae8cacfb8b975d0540bc6fb939a17d6b2e929f257fdfe526eedfd3cbc837e", "source_snapshot_id": "source-aca2eb2a074bdefb15189a8a", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/clopidogrel-tad-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 534}
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{"after": {"end": 523, "start": 0, "text": "L’utilisation concomitante d’inhibiteurs puissants du CYP3A pendant le traitement par Cotellic doit être évitée. La prudence est de rigueur en cas d’administration concomitante d’un inhibiteur modéré du CYP3A avec Cotellic. Si l’administration concomitante d’un inhibiteur modéré ou puissant du CYP3A ne peut être évitée, les patients doivent être surveillés étroitement à la recherche d’effets indésirables et des adaptations posologiques doivent être appliquées si cliniquement indiqué (voir Tableau 1 à la rubrique 4.2).", "truncated": false}, "after_length": 523, "after_sha256": "501505b32fa2fa9beab6e071df3f3e22d9ec7120c853c01453462a566fdf2f99", "annex": "I", "before": {"end": 523, "start": 0, "text": "L’utilisation concomitante d’inhibiteurs puissants du CYP3A pendant le traitement par Cotellic doit être évitée. La prudence est de rigueur en cas d’administration concomitante d’un inhibiteur modéré du CYP3A avec Cotellic. Si l’administration concomitante d’un inhibiteur modéré ou puissant du CYP3A ne peut être évitée, les patients doivent être surveillés étroitement à la recherche d’effets indésirables et des adaptations posologiques doivent être appliquées si cliniquement indiqué (voir Tableau 1 à la rubrique 4.2).", "truncated": false}, "before_length": 523, "before_sha256": "501505b32fa2fa9beab6e071df3f3e22d9ec7120c853c01453462a566fdf2f99", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0e56baf360cddb6860c27c9e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003960", "medicine_name": "Cotellic", "medicine_slug": "cotellic", "observed_at": "2026-10-12T19:30:48Z", "pipeline_version": "2.0.0", "presentation_label": "Cotellic 20 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": "66e7b1cf7c3ee91ab58bcb8c7e50be3a43143695117ecffd7f1b81c2539743c7", "source_snapshot_id": "source-28a1371c0011b82ed12f2b58", "source_updated_at": "2025-06-24", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/cotellic-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 316}
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{"after": {"end": 951, "start": 0, "text": "The effect of umeclidinium/vilanterol on the QT interval was evaluated in a placebo and active (moxifloxacin) controlled QT study involving once daily administration of umeclidinium/vilanterol 113/22 micrograms or 500/100 micrograms (pre-dispensed dose with umeclidinium at eight times the recommended dose and vilanterol at four times the recommended dose) for 10 days in 103 healthy volunteers. The maximum mean difference in prolongations of QT interval (corrected using the Fridericia method, QTcF) from placebo after baseline-correction was 4.3 (90% CI=2.2 to 6.4) milliseconds seen 10 minutes after administration with umeclidinium/vilanterol 113/22 micrograms and 8.2 (90% CI=6.2 to 10.2) milliseconds seen 30 minutes after administration with umeclidinium/vilanterol 500/100 micrograms. Therefore, no clinically relevant pro-arrhythmic potential related to QT-interval prolongations was observed with umeclidinium/vilanterol 113/22 micrograms.", "truncated": false}, "after_length": 951, "after_sha256": "8df8ed263dc6014f169a9df2f70de62f03bee0f5f93d32613156c1648d07fe12", "annex": "I", "before": {"end": 951, "start": 0, "text": "The effect of umeclidinium/vilanterol on the QT interval was evaluated in a placebo and active (moxifloxacin) controlled QT study involving once daily administration of umeclidinium/vilanterol 113/22 micrograms or 500/100 micrograms (pre-dispensed dose with umeclidinium at eight times the recommended dose and vilanterol at four times the recommended dose) for 10 days in 103 healthy volunteers. The maximum mean difference in prolongations of QT interval (corrected using the Fridericia method, QTcF) from placebo after baseline-correction was 4.3 (90% CI=2.2 to 6.4) milliseconds seen 10 minutes after administration with umeclidinium/vilanterol 113/22 micrograms and 8.2 (90% CI=6.2 to 10.2) milliseconds seen 30 minutes after administration with umeclidinium/vilanterol 500/100 micrograms. Therefore, no clinically relevant pro-arrhythmic potential related to QT-interval prolongations was observed with umeclidinium/vilanterol 113/22 micrograms.", "truncated": false}, "before_length": 951, "before_sha256": "8df8ed263dc6014f169a9df2f70de62f03bee0f5f93d32613156c1648d07fe12", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0fd26fe6e8923a699cd6c2c5", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002751", "medicine_name": "Anoro Ellipta (previously Anoro)", "medicine_slug": "anoro-ellipta-previously-anoro", "observed_at": "2026-10-12T19:17:37Z", "pipeline_version": "2.0.0", "presentation_label": "ANORO ELLIPTA 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "7ebba8dd63bd37ec5d24ca7a9a63f2fcc64533b24cc9441412ad0beb523df07f", "source_snapshot_id": "source-14ffea35b90ed19d08622ffd", "source_updated_at": "2025-07-31", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/anoro-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": 339}
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{"after": {"end": 927, "start": 0, "text": "Syndrome coronaire aigu sans sus-décalage du segment ST (angor instable ou infarctus du myocarde sans onde Q) : le traitement par clopidogrel doit être initié par une dose de charge unique de 300 mg ou 600 mg. Une dose de charge de 600 mg peut être envisagée chez les patients âgés de moins de 75 ans lorsqu'une intervention coronarienne percutanée est prévue (voir rubrique 4.4). Le traitement par le clopidogrel doit être poursuivi à la dose de 75 mg une fois par jour (en association à l’acide acétylsalicylique (AAS) à la dose quotidienne de 75 mg à 325 mg). Les doses les plus élevées d’AAS ayant été associées à un risque plus élevé de saignement, il est recommandé de ne pas dépasser une dose d’AAS de 100 mg/j. La durée optimale du traitement n’a pas été formellement établie. Les données de l’essai clinique supportent son utilisation jusqu’à 12 mois et le bénéfice maximum a été constaté à 3 mois (voir rubrique 5.1).", "truncated": false}, "after_length": 927, "after_sha256": "f7d0973e3373d0e48e04fbeada49f1ab93c1f592e3aef31d3ef2783691d0d612", "annex": "I", "before": {"end": 927, "start": 0, "text": "Syndrome coronaire aigu sans sus-décalage du segment ST (angor instable ou infarctus du myocarde sans onde Q) : le traitement par clopidogrel doit être initié par une dose de charge unique de 300 mg ou 600 mg. Une dose de charge de 600 mg peut être envisagée chez les patients âgés de moins de 75 ans lorsqu'une intervention coronarienne percutanée est prévue (voir rubrique 4.4). Le traitement par le clopidogrel doit être poursuivi à la dose de 75 mg une fois par jour (en association à l’acide acétylsalicylique (AAS) à la dose quotidienne de 75 mg à 325 mg). Les doses les plus élevées d’AAS ayant été associées à un risque plus élevé de saignement, il est recommandé de ne pas dépasser une dose d’AAS de 100 mg/j. La durée optimale du traitement n’a pas été formellement établie. Les données de l’essai clinique supportent son utilisation jusqu’à 12 mois et le bénéfice maximum a été constaté à 3 mois (voir rubrique 5.1).", "truncated": false}, "before_length": 927, "before_sha256": "f7d0973e3373d0e48e04fbeada49f1ab93c1f592e3aef31d3ef2783691d0d612", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-102aa9ea04cbd75ad712013e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/001136", "medicine_name": "Clopidogrel TAD", "medicine_slug": "clopidogrel-tad", "observed_at": "2026-10-12T19:41:00Z", "pipeline_version": "2.0.0", "presentation_label": "Clopidogrel TAD 75 mg comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "ee6ae8cacfb8b975d0540bc6fb939a17d6b2e929f257fdfe526eedfd3cbc837e", "source_snapshot_id": "source-aca2eb2a074bdefb15189a8a", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/clopidogrel-tad-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 77}
{"after": {"end": 194, "start": 0, "text": "Les réductions de l'incidence de nouvelles fractures vertébrales, de la hanche et non vertébrales par denosumab sur 3 ans ont été cohérentes quel que soit le risque fracturaire initial à 10 ans.", "truncated": false}, "after_length": 194, "after_sha256": "f7fb9bd29b409c7b085bad1c2a096e92e3daa288fe83f21e379f1510646f4e91", "annex": "I", "before": {"end": 194, "start": 0, "text": "Les réductions de l'incidence de nouvelles fractures vertébrales, de la hanche et non vertébrales par denosumab sur 3 ans ont été cohérentes quel que soit le risque fracturaire initial à 10 ans.", "truncated": false}, "before_length": 194, "before_sha256": "f7fb9bd29b409c7b085bad1c2a096e92e3daa288fe83f21e379f1510646f4e91", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-10365edcf17535cd6b8c181c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005964", "medicine_name": "Jubbonti", "medicine_slug": "jubbonti", "observed_at": "2026-10-12T19:08:30Z", "pipeline_version": "2.0.0", "presentation_label": "Jubbonti 60 mg solution injectable en seringue préremplie", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "df6b97acc2d782b761f939572b7292740dd9eb14cd692875fb83dea28bac754d", "source_snapshot_id": "source-7d90e140ea04fe82f7b1c281", "source_updated_at": "2025-09-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/jubbonti-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 427}
{"after": {"end": 88, "start": 0, "text": "No dose adjustment is recommended in patients with hepatic impairment (see section 5.2).", "truncated": false}, "after_length": 88, "after_sha256": "64d295aeb5bd64fa69d5369c9c9bb7fa0a7c3972a56b9c4ed491f7b1306a2a3f", "annex": "I", "before": {"end": 88, "start": 0, "text": "No dose adjustment is recommended in patients with hepatic impairment (see section 5.2).", "truncated": false}, "before_length": 88, "before_sha256": "64d295aeb5bd64fa69d5369c9c9bb7fa0a7c3972a56b9c4ed491f7b1306a2a3f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-10483619441614fa044831f9", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003960", "medicine_name": "Cotellic", "medicine_slug": "cotellic", "observed_at": "2026-10-12T19:30:44Z", "pipeline_version": "2.0.0", "presentation_label": "Cotellic 20 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": "5b62f129f593b5079a0f5e9a47f83933bb019af62d7cc40ee07a9334d281bcf3", "source_snapshot_id": "source-0d296868a063a7fb7eaa3145", "source_updated_at": "2025-06-24", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/cotellic-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 616}
{"after": {"end": 1500, "start": 0, "text": "Six doses de propionate de fluticasone allant de 16 µg à 434 µg (exprimées en doses émises) administrées deux fois par jour à l’aide d’un inhalateur de poudre sèche multidose et un comparateur en ouvert à base de propionate de fluticasone en poudre sèche (100 µg ou 250 µg) ont été évalués dans 2 essais randomisés, en double aveugle, contrôlés contre placebo, menés sur 12 semaines. L’étude 201 a été menée chez des patients dont l’asthme n’était pas contrôlé à l’inclusion et qui avaient été traités précédemment par un β2-agoniste de courte durée d’action utilisé seul ou en association avec un traitement de l’asthme sans corticoïde. Les patients traités par corticostéroïde inhalé (CSI) à faible dose pouvaient être inclus après une période de sevrage de 2 semaines minimum. L’étude 202 a été menée chez des patients dont l’asthme n’était pas contrôlé à l’inclusion et qui avaient été traités précédemment par un CSI à forte dose associé ou non à un bêta-agoniste de longue durée d’action (LABA). Les doses émises de propionate de fluticasone Spiromax (16, 28, 59, 118, 225 et 434 µg) utilisées dans l’étude 201 et l’étude 202 sont différentes des doses émises des comparateurs (fluticasone en poudre pour inhalation) et des produits expérimentaux de phase 3 qui ont servi de base pour définir la dose émise figurant sur l’étiquetage du produit (113 et 232 µg pour le propionate de fluticasone). Les variations des doses entre les phases 2 et 3 résultent de l’optimisation du procédé de fabricat", "truncated": true}, "after_length": 1504, "after_sha256": "0ed1f1937c78b852ffd9a391846c0d04d106d77077b09307e5f7dbe9ba5171de", "annex": "I", "before": {"end": 1500, "start": 0, "text": "Six doses de propionate de fluticasone allant de 16 µg à 434 µg (exprimées en doses émises) administrées deux fois par jour à l’aide d’un inhalateur de poudre sèche multidose et un comparateur en ouvert à base de propionate de fluticasone en poudre sèche (100 µg ou 250 µg) ont été évalués dans 2 essais randomisés, en double aveugle, contrôlés contre placebo, menés sur 12 semaines. L’étude 201 a été menée chez des patients dont l’asthme n’était pas contrôlé à l’inclusion et qui avaient été traités précédemment par un β2-agoniste de courte durée d’action utilisé seul ou en association avec un traitement de l’asthme sans corticoïde. Les patients traités par corticostéroïde inhalé (CSI) à faible dose pouvaient être inclus après une période de sevrage de 2 semaines minimum. L’étude 202 a été menée chez des patients dont l’asthme n’était pas contrôlé à l’inclusion et qui avaient été traités précédemment par un CSI à forte dose associé ou non à un bêta-agoniste de longue durée d’action (LABA). Les doses émises de propionate de fluticasone Spiromax (16, 28, 59, 118, 225 et 434 µg) utilisées dans l’étude 201 et l’étude 202 sont différentes des doses émises des comparateurs (fluticasone en poudre pour inhalation) et des produits expérimentaux de phase 3 qui ont servi de base pour définir la dose émise figurant sur l’étiquetage du produit (113 et 232 µg pour le propionate de fluticasone). 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{"after": {"end": 111, "start": 0, "text": "Le traitement par Cegfila doit être instauré et supervisé par un spécialiste en oncologie et/ou en hématologie.", "truncated": false}, "after_length": 111, "after_sha256": "1d5b813203df8c84805e4b296138cdecd3948518c724d8ea5b0b76e9fc9e0dae", "annex": "I", "before": {"end": 111, "start": 0, "text": "Le traitement par Cegfila doit être instauré et supervisé par un spécialiste en oncologie et/ou en hématologie.", "truncated": false}, "before_length": 111, "before_sha256": "1d5b813203df8c84805e4b296138cdecd3948518c724d8ea5b0b76e9fc9e0dae", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-106824b1bd2528e6e1acb8e6", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005312", "medicine_name": "Cegfila (previously Pegfilgrastim Mundipharma)", "medicine_slug": "cegfila-previously-pegfilgrastim-mundipharma", "observed_at": "2026-10-12T13:47:32Z", "pipeline_version": "2.0.0", "presentation_label": "Cegfila 6 mg solution injectable en seringue préremplie.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "c817faef7d8a8650791b2eccc0afc9d687d22a4e3719cd73f9304a216d33baa6", "source_snapshot_id": "source-18665792536f9c0be526f0f6", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/cegfila-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 67}
{"after": {"end": 792, "start": 0, "text": "L’uméclidinium est un substrat du cytochrome P450 2D6 (CYP2D6). La pharmacocinétique de l’uméclidinium à l’état d’équilibre a été évaluée chez des volontaires sains déficients en CYP2D6 (métaboliseurs lents). Aucun effet n'a été observé sur l’ASC ou la Cmax de l’uméclidinium administré à une dose 8 fois plus élevée. Une augmentation de l’ASC de l’uméclidinium d'un facteur de l'ordre de 1,3 a été observée à une dose 16 fois plus élevée, sans effet sur la Cmax. Ces résultats permettent de conclure qu’aucune interaction cliniquement significative n’est attendue lorsque l’association uméclidinium/vilantérol est administrée de façon concomitante avec des inhibiteurs du CYP2D6 ou lorsqu’elle est administrée à des patients génétiquement déficients en activité CYP2D6 (métaboliseurs lents).", "truncated": false}, "after_length": 792, "after_sha256": "c570daa1ab7e0aa498220c7f519d882355c8350600d8fac558d686d372ffc3fc", "annex": "I", "before": {"end": 792, "start": 0, "text": "L’uméclidinium est un substrat du cytochrome P450 2D6 (CYP2D6). La pharmacocinétique de l’uméclidinium à l’état d’équilibre a été évaluée chez des volontaires sains déficients en CYP2D6 (métaboliseurs lents). Aucun effet n'a été observé sur l’ASC ou la Cmax de l’uméclidinium administré à une dose 8 fois plus élevée. Une augmentation de l’ASC de l’uméclidinium d'un facteur de l'ordre de 1,3 a été observée à une dose 16 fois plus élevée, sans effet sur la Cmax. Ces résultats permettent de conclure qu’aucune interaction cliniquement significative n’est attendue lorsque l’association uméclidinium/vilantérol est administrée de façon concomitante avec des inhibiteurs du CYP2D6 ou lorsqu’elle est administrée à des patients génétiquement déficients en activité CYP2D6 (métaboliseurs lents).", "truncated": false}, "before_length": 792, "before_sha256": "c570daa1ab7e0aa498220c7f519d882355c8350600d8fac558d686d372ffc3fc", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-10757f41737360a7b3a46629", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002751", "medicine_name": "Anoro Ellipta (previously Anoro)", "medicine_slug": "anoro-ellipta-previously-anoro", "observed_at": "2026-10-12T19:18:50Z", "pipeline_version": "2.0.0", "presentation_label": "ANORO ELLIPTA 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": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "83b2fe4c87629e48ee1aefad7454d0f6f254155b73f5f2830247cafb022942ad", "source_snapshot_id": "source-0377a0f374da46618f13df9c", "source_updated_at": "2025-07-31", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/anoro-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": 164}
{"after": {"end": 880, "start": 0, "text": "In a placebo-controlled, double blind study in patients with breast cancer the effect of pegfilgrastim on the incidence of febrile neutropenia was evaluated following administration of a chemotherapy regimen associated with a febrile neutropenia rate of 10-20 % (docetaxel 100 mg/m2 every 3 weeks for 4 cycles). Nine hundred and twenty eight patients were randomised to receive either a single dose of pegfilgrastim or placebo approximately 24 hours (Day 2) after chemotherapy in each cycle. The incidence of febrile neutropenia was lower for patients randomised to receive pegfilgrastim compared with placebo (1 % versus 17 %, p < 0.001). The incidence of hospitalisations and IV anti-infective use associated with a clinical diagnosis of febrile neutropenia was lower in the pegfilgrastim group compared with placebo (1 % versus 14 %, p < 0.001; and 2 % versus 10 %, p < 0.001).", "truncated": false}, "after_length": 880, "after_sha256": "099d022cac72b546f0b3a79a482293188535bdc730ce6d44ea4fcbbc6f6bbc88", "annex": "I", "before": {"end": 880, "start": 0, "text": "In a placebo-controlled, double blind study in patients with breast cancer the effect of pegfilgrastim on the incidence of febrile neutropenia was evaluated following administration of a chemotherapy regimen associated with a febrile neutropenia rate of 10-20 % (docetaxel 100 mg/m2 every 3 weeks for 4 cycles). Nine hundred and twenty eight patients were randomised to receive either a single dose of pegfilgrastim or placebo approximately 24 hours (Day 2) after chemotherapy in each cycle. The incidence of febrile neutropenia was lower for patients randomised to receive pegfilgrastim compared with placebo (1 % versus 17 %, p < 0.001). The incidence of hospitalisations and IV anti-infective use associated with a clinical diagnosis of febrile neutropenia was lower in the pegfilgrastim group compared with placebo (1 % versus 14 %, p < 0.001; and 2 % versus 10 %, p < 0.001).", "truncated": false}, "before_length": 880, "before_sha256": "099d022cac72b546f0b3a79a482293188535bdc730ce6d44ea4fcbbc6f6bbc88", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-10da9cab8f91cff745bd9b51", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005312", "medicine_name": "Cegfila (previously Pegfilgrastim Mundipharma)", "medicine_slug": "cegfila-previously-pegfilgrastim-mundipharma", "observed_at": "2026-10-12T13:47:30Z", "pipeline_version": "2.0.0", "presentation_label": "Cegfila 6 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": "dd41c573f3407f6620feeeb91d402c4e6ca914261a9adb23330819e3f620071e", "source_snapshot_id": "source-878eb702fff3865e274eac51", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/cegfila-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 389}
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{"after": {"end": 172, "start": 0, "text": "Jubbonti est un médicament biosimilaire. Des informations détaillées sont disponibles sur le site internet de l’Agence européenne des médicaments https://www.ema.europa.eu.", "truncated": false}, "after_length": 172, "after_sha256": "065889237855aed5229196d9aa21aff392813fc8d80395dd94375033a7a26d9c", "annex": "I", "before": {"end": 172, "start": 0, "text": "Jubbonti est un médicament biosimilaire. Des informations détaillées sont disponibles sur le site internet de l’Agence européenne des médicaments https://www.ema.europa.eu.", "truncated": false}, "before_length": 172, "before_sha256": "065889237855aed5229196d9aa21aff392813fc8d80395dd94375033a7a26d9c", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-11361db44bd37ffe9b2adfa7", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005964", "medicine_name": "Jubbonti", "medicine_slug": "jubbonti", "observed_at": "2026-10-12T19:08:30Z", "pipeline_version": "2.0.0", "presentation_label": "Jubbonti 60 mg solution injectable en seringue préremplie", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "df6b97acc2d782b761f939572b7292740dd9eb14cd692875fb83dea28bac754d", "source_snapshot_id": "source-7d90e140ea04fe82f7b1c281", "source_updated_at": "2025-09-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/jubbonti-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 322}
{"after": {"end": 661, "start": 0, "text": "Efficacy and safety of denosumab administered once every 6 months for 3 years were investigated in postmenopausal women (7 808 women aged 60 – 91 years, of which 23.6% had prevalent vertebral fractures) with baseline bone mineral density (BMD) T-scores at the lumbar spine or total hip between 2.5 and 4.0 and a mean absolute 10year fracture probability of 18.60% (deciles: 7.9 – 32.4%) for major osteoporotic fracture and 7.22% (deciles: 1.4 – 14.9%) for hip fracture. Women with other diseases or on therapies that may affect bone were excluded from this study. Women received calcium (at least 1 000 mg) and vitamin D (at least 400 IU) supplementation daily.", "truncated": false}, "after_length": 661, "after_sha256": "1bf5a18867aac8d648c40af36b0e9a21bbedd3c4f76384b8289422832e6433a4", "annex": "I", "before": {"end": 661, "start": 0, "text": "Efficacy and safety of denosumab administered once every 6 months for 3 years were investigated in postmenopausal women (7 808 women aged 60 – 91 years, of which 23.6% had prevalent vertebral fractures) with baseline bone mineral density (BMD) T-scores at the lumbar spine or total hip between 2.5 and 4.0 and a mean absolute 10year fracture probability of 18.60% (deciles: 7.9 – 32.4%) for major osteoporotic fracture and 7.22% (deciles: 1.4 – 14.9%) for hip fracture. Women with other diseases or on therapies that may affect bone were excluded from this study. Women received calcium (at least 1 000 mg) and vitamin D (at least 400 IU) supplementation daily.", "truncated": false}, "before_length": 661, "before_sha256": "1bf5a18867aac8d648c40af36b0e9a21bbedd3c4f76384b8289422832e6433a4", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-1139eddbe08827e0d4a4cbfe", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005964", "medicine_name": "Jubbonti", "medicine_slug": "jubbonti", "observed_at": "2026-10-12T19:08:27Z", "pipeline_version": "2.0.0", "presentation_label": "Jubbonti 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": "c8be583e8c4bc4f050847900363e5111e9dde378657ef91ec2c8445d34a6fb78", "source_snapshot_id": "source-340a83fc9d44bbc138a92bb2", "source_updated_at": "2025-09-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/jubbonti-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 346}
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{"after": {"end": 241, "start": 0, "text": "Jubbonti ne doit pas être utilisé chez les patients pédiatriques (âgés de moins de 18 ans). Des cas d’hypercalcémie grave ont été rapportés. Certains cas observés au cours d’études cliniques ont été compliqués par des lésions rénales aiguës.", "truncated": false}, "after_length": 241, "after_sha256": "0dcf0f3d3ee54096d929b250610ab88164128fcdcad434019743547565fe1bd6", "annex": "I", "before": {"end": 241, "start": 0, "text": "Jubbonti ne doit pas être utilisé chez les patients pédiatriques (âgés de moins de 18 ans). Des cas d’hypercalcémie grave ont été rapportés. Certains cas observés au cours d’études cliniques ont été compliqués par des lésions rénales aiguës.", "truncated": false}, "before_length": 241, "before_sha256": "0dcf0f3d3ee54096d929b250610ab88164128fcdcad434019743547565fe1bd6", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-117e80973ecae747971a51f5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005964", "medicine_name": "Jubbonti", "medicine_slug": "jubbonti", "observed_at": "2026-10-12T19:08:30Z", "pipeline_version": "2.0.0", "presentation_label": "Jubbonti 60 mg solution injectable en seringue préremplie", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "df6b97acc2d782b761f939572b7292740dd9eb14cd692875fb83dea28bac754d", "source_snapshot_id": "source-7d90e140ea04fe82f7b1c281", "source_updated_at": "2025-09-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/jubbonti-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 159}
{"after": {"end": 361, "start": 0, "text": "La prise en charge des patients qui développent une ONM doit être mise en place en collaboration étroite entre le médecin traitant et un dentiste ou chirurgien stomatologiste ayant l’expertise des ONM. Une interruption temporaire du traitement doit être envisagée jusqu’au rétablissement complet de l’ONM et si possible jusqu’au contrôle des facteurs de risque.", "truncated": false}, "after_length": 361, "after_sha256": "092e742ef6b9884b76fbcae6a8182b6a5328ccf673fe75726560031b1de1eff5", "annex": "I", "before": {"end": 361, "start": 0, "text": "La prise en charge des patients qui développent une ONM doit être mise en place en collaboration étroite entre le médecin traitant et un dentiste ou chirurgien stomatologiste ayant l’expertise des ONM. Une interruption temporaire du traitement doit être envisagée jusqu’au rétablissement complet de l’ONM et si possible jusqu’au contrôle des facteurs de risque.", "truncated": false}, "before_length": 361, "before_sha256": "092e742ef6b9884b76fbcae6a8182b6a5328ccf673fe75726560031b1de1eff5", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-11b5a78077a0deb1a073f7a2", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005964", "medicine_name": "Jubbonti", "medicine_slug": "jubbonti", "observed_at": "2026-10-12T19:08:30Z", "pipeline_version": "2.0.0", "presentation_label": "Jubbonti 60 mg solution injectable en seringue préremplie", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "df6b97acc2d782b761f939572b7292740dd9eb14cd692875fb83dea28bac754d", "source_snapshot_id": "source-7d90e140ea04fe82f7b1c281", "source_updated_at": "2025-09-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/jubbonti-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 141}
{"after": {"end": 217, "start": 0, "text": "Following inhalation of Ultibro Breezhaler, the absolute bioavailability of indacaterol has been estimated to range from 61 to 85% of the delivered dose, and that of glycopyrronium was about 47% of the delivered dose.", "truncated": false}, "after_length": 217, "after_sha256": "6e1ab2e3c22ca14cdb25bbcb74217ff93c96f964a18f4a9fccff620d747dd571", "annex": "I", "before": {"end": 217, "start": 0, "text": "Following inhalation of Ultibro Breezhaler, the absolute bioavailability of indacaterol has been estimated to range from 61 to 85% of the delivered dose, and that of glycopyrronium was about 47% of the delivered dose.", "truncated": false}, "before_length": 217, "before_sha256": "6e1ab2e3c22ca14cdb25bbcb74217ff93c96f964a18f4a9fccff620d747dd571", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-12189d90203beae3a9ee2c04", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002679", "medicine_name": "Ultibro Breezhaler", "medicine_slug": "ultibro-breezhaler", "observed_at": "2026-10-12T19:22:54Z", "pipeline_version": "2.0.0", "presentation_label": "Ultibro Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "1534af9e5e3a20baf83a63b142c8f06cb96a21d3d33ab5c9ae9334dd02433392", "source_snapshot_id": "source-f1d16a06ac4c68f0e5ff9294", "source_updated_at": "2025-07-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/ultibro-breezhaler-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 458}
{"after": {"end": 651, "start": 0, "text": "Il est important d’identifier les patients présentant des facteurs de risque d’hypocalcémie. Avant l’instauration du traitement, toute hypocalcémie doit être corrigée par un apport adapté de calcium et de vitamine D. Une surveillance clinique du taux de calcium est recommandée avant chaque administration, et, chez les patients prédisposés à l'hypocalcémie, au cours des deux semaines suivant la dose initiale. Si des symptômes d’hypocalcémie sont suspectés chez un patient au cours du traitement (voir rubrique 4.8 pour les symptômes) le taux de calcium doit être mesuré. Les patients doivent être encouragés à signaler tout symptôme d’hypocalcémie.", "truncated": false}, "after_length": 651, "after_sha256": "f1e873a1d40022b0ee6e814567b1c280e7a6f10a7d1c3991c8be12bd54f0303b", "annex": "I", "before": {"end": 651, "start": 0, "text": "Il est important d’identifier les patients présentant des facteurs de risque d’hypocalcémie. Avant l’instauration du traitement, toute hypocalcémie doit être corrigée par un apport adapté de calcium et de vitamine D. Une surveillance clinique du taux de calcium est recommandée avant chaque administration, et, chez les patients prédisposés à l'hypocalcémie, au cours des deux semaines suivant la dose initiale. Si des symptômes d’hypocalcémie sont suspectés chez un patient au cours du traitement (voir rubrique 4.8 pour les symptômes) le taux de calcium doit être mesuré. Les patients doivent être encouragés à signaler tout symptôme d’hypocalcémie.", "truncated": false}, "before_length": 651, "before_sha256": "f1e873a1d40022b0ee6e814567b1c280e7a6f10a7d1c3991c8be12bd54f0303b", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-122473235797b99421224f16", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005964", "medicine_name": "Jubbonti", "medicine_slug": "jubbonti", "observed_at": "2026-10-12T19:08:30Z", "pipeline_version": "2.0.0", "presentation_label": "Jubbonti 60 mg solution injectable en seringue préremplie", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "df6b97acc2d782b761f939572b7292740dd9eb14cd692875fb83dea28bac754d", "source_snapshot_id": "source-7d90e140ea04fe82f7b1c281", "source_updated_at": "2025-09-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/jubbonti-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 115}
{"after": {"end": 106, "start": 0, "text": "L’étude ACTIVE-W a démontré qu’un traitement par AVK est plus efficace que l’association clopidogrel +AAS.", "truncated": false}, "after_length": 106, "after_sha256": "3a3c5117e75dcd5df68d7ca48d45a8bf5aae74b840a46aef073388f03cb642e6", "annex": "I", "before": {"end": 106, "start": 0, "text": "L’étude ACTIVE-W a démontré qu’un traitement par AVK est plus efficace que l’association clopidogrel +AAS.", "truncated": false}, "before_length": 106, "before_sha256": "3a3c5117e75dcd5df68d7ca48d45a8bf5aae74b840a46aef073388f03cb642e6", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-12428e1af1af007bda6ed49c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/001136", "medicine_name": "Clopidogrel TAD", "medicine_slug": "clopidogrel-tad", "observed_at": "2026-10-12T19:41:00Z", "pipeline_version": "2.0.0", "presentation_label": "Clopidogrel TAD 75 mg comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "ee6ae8cacfb8b975d0540bc6fb939a17d6b2e929f257fdfe526eedfd3cbc837e", "source_snapshot_id": "source-aca2eb2a074bdefb15189a8a", "source_updated_at": "2025-05-13", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/clopidogrel-tad-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 522}
{"after": {"end": 311, "start": 0, "text": "No clinically relevant effects of hypokalaemia were observed in clinical studies with umeclidinium/vilanterol at the recommended therapeutic dose. Caution should be exercised when umeclidinium/vilanterol is used with other medicinal products that also have the potential to cause hypokalaemia (see section 4.5).", "truncated": false}, "after_length": 311, "after_sha256": "bbc57cb4568fb159288734f4efce17976d2983fce59c85882c9a9c47f49d9e5d", "annex": "I", "before": {"end": 311, "start": 0, "text": "No clinically relevant effects of hypokalaemia were observed in clinical studies with umeclidinium/vilanterol at the recommended therapeutic dose. Caution should be exercised when umeclidinium/vilanterol is used with other medicinal products that also have the potential to cause hypokalaemia (see section 4.5).", "truncated": false}, "before_length": 311, "before_sha256": "bbc57cb4568fb159288734f4efce17976d2983fce59c85882c9a9c47f49d9e5d", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-12702ee0ece1111bdc5a1262", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002751", "medicine_name": "Anoro Ellipta (previously Anoro)", "medicine_slug": "anoro-ellipta-previously-anoro", "observed_at": "2026-10-12T19:17:37Z", "pipeline_version": "2.0.0", "presentation_label": "ANORO ELLIPTA 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": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "7ebba8dd63bd37ec5d24ca7a9a63f2fcc64533b24cc9441412ad0beb523df07f", "source_snapshot_id": "source-14ffea35b90ed19d08622ffd", "source_updated_at": "2025-07-31", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/anoro-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": 157}
{"after": {"end": 270, "start": 0, "text": "Figure 1 : Analyse principale de la spirométrie en série : évolution moyenne du VEMS (L) entre l’inclusion et la semaine 12 selon le moment de la mesure et le groupe de traitement dans l’étude 1 (population globale ; sous-groupe avec des mesures spirométriques en série)", "truncated": false}, "after_length": 270, "after_sha256": "98d4e64f5cf0e2d5dd5e1e6102edafe65f3c8627f16583b8d8f2826055869e58", "annex": "I", "before": {"end": 270, "start": 0, "text": "Figure 1 : Analyse principale de la spirométrie en série : évolution moyenne du VEMS (L) entre l’inclusion et la semaine 12 selon le moment de la mesure et le groupe de traitement dans l’étude 1 (population globale ; sous-groupe avec des mesures spirométriques en série)", "truncated": false}, "before_length": 270, "before_sha256": "98d4e64f5cf0e2d5dd5e1e6102edafe65f3c8627f16583b8d8f2826055869e58", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-13090175272282b5cb87e9b6", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004881", "medicine_name": "Seffalair Spiromax", "medicine_slug": "seffalair-spiromax", "observed_at": "2026-10-12T17:28:11Z", "pipeline_version": "2.0.0", "presentation_label": "Seffalair Spiromax 12,75 microgrammes/100 microgrammes poudre pour inhalation Seffalair Spiromax 12,75 microgrammes/202 microgrammes poudre pour inhalation", "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": "b400d80be8345a8bf3225fb16f1b348532237af04c82caaf20ff6e0cd46993e8", "source_snapshot_id": "source-87ebc6ce7e018f0368638099", "source_updated_at": "2025-12-16", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/seffalair-spiromax-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 523}
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{"after": {"end": 1148, "start": 0, "text": "L’effet de l’association uméclidinium/vilantérol sur l’intervalle QT a été évalué dans une étude spécifique portant sur l’intervalle QT, contrôlée contre placebo et traitement actif (moxifloxacine) utilisant une administration quotidienne de l’association uméclidinium/vilantérol 113/22 microgrammes ou 500/100 microgrammes (soit huit fois la dose recommandée avec l’uméclidinium et quatre fois la dose recommandée avec le vilantérol , exprimée en dose unitaire) pendant 10 jours chez 103 volontaires sains. La différence moyenne maximale par rapport au placebo de l’allongement de l’intervalle QT corrigé (méthode de Fridericia, QTcF), ajustée sur la valeur à l'inclusion était de 4,3 [IC 90 % : 2,2 ; 6,4] millisecondes 10 minutes après administration de la dose de 113/22 microgrammes d’uméclidinium/vilantérol, et de 8,2 [IC 90 % : 6,2 ; 10,2] millisecondes 30 minutes après administration de la dose de 500/100 microgrammes d’uméclidinium/vilantérol. Par conséquent, aucun potentiel pro-arythmique cliniquement significatif lié à un allongement de l’intervalle QT n’a été observé avec la dose de 113/22 microgrammes d’uméclidinium/ vilantérol.", "truncated": false}, "after_length": 1148, "after_sha256": "eb15c6050f2dd338c22b17d4eeda5ecef69671fe4b2a507e6e167056fcdf9fb0", "annex": "I", "before": {"end": 1148, "start": 0, "text": "L’effet de l’association uméclidinium/vilantérol sur l’intervalle QT a été évalué dans une étude spécifique portant sur l’intervalle QT, contrôlée contre placebo et traitement actif (moxifloxacine) utilisant une administration quotidienne de l’association uméclidinium/vilantérol 113/22 microgrammes ou 500/100 microgrammes (soit huit fois la dose recommandée avec l’uméclidinium et quatre fois la dose recommandée avec le vilantérol , exprimée en dose unitaire) pendant 10 jours chez 103 volontaires sains. La différence moyenne maximale par rapport au placebo de l’allongement de l’intervalle QT corrigé (méthode de Fridericia, QTcF), ajustée sur la valeur à l'inclusion était de 4,3 [IC 90 % : 2,2 ; 6,4] millisecondes 10 minutes après administration de la dose de 113/22 microgrammes d’uméclidinium/vilantérol, et de 8,2 [IC 90 % : 6,2 ; 10,2] millisecondes 30 minutes après administration de la dose de 500/100 microgrammes d’uméclidinium/vilantérol. Par conséquent, aucun potentiel pro-arythmique cliniquement significatif lié à un allongement de l’intervalle QT n’a été observé avec la dose de 113/22 microgrammes d’uméclidinium/ vilantérol.", "truncated": false}, "before_length": 1148, "before_sha256": "eb15c6050f2dd338c22b17d4eeda5ecef69671fe4b2a507e6e167056fcdf9fb0", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-1391a7444c3fcf16f95171c6", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002751", "medicine_name": "Anoro Ellipta (previously Anoro)", "medicine_slug": "anoro-ellipta-previously-anoro", "observed_at": "2026-10-12T19:18:50Z", "pipeline_version": "2.0.0", "presentation_label": "ANORO ELLIPTA 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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "83b2fe4c87629e48ee1aefad7454d0f6f254155b73f5f2830247cafb022942ad", "source_snapshot_id": "source-0377a0f374da46618f13df9c", "source_updated_at": "2025-07-31", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/anoro-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": 318}
{"after": {"end": 458, "start": 0, "text": "Fracture incidence was evaluated as a safety endpoint but efficacy in fracture prevention cannot be estimated due to high number of discontinuations and open-label design. The cumulative incidence of new vertebral and non-vertebral fractures were approximately 6.8% and 13.1% respectively, in patients who remained on denosumab treatment for 10 years (n = 1 278). Patients who did not complete the study for any reason had higher on-treatment fracture rates.", "truncated": false}, "after_length": 458, "after_sha256": "fa6c0b9adb6a12c360bcc45124250108a78cf17f6febdd5be49918ecbadb0070", "annex": "I", "before": {"end": 458, "start": 0, "text": "Fracture incidence was evaluated as a safety endpoint but efficacy in fracture prevention cannot be estimated due to high number of discontinuations and open-label design. The cumulative incidence of new vertebral and non-vertebral fractures were approximately 6.8% and 13.1% respectively, in patients who remained on denosumab treatment for 10 years (n = 1 278). Patients who did not complete the study for any reason had higher on-treatment fracture rates.", "truncated": false}, "before_length": 458, "before_sha256": "fa6c0b9adb6a12c360bcc45124250108a78cf17f6febdd5be49918ecbadb0070", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-1397f3c764a3c07846abcf8d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005964", "medicine_name": "Jubbonti", "medicine_slug": "jubbonti", "observed_at": "2026-10-12T19:08:27Z", "pipeline_version": "2.0.0", "presentation_label": "Jubbonti 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": "c8be583e8c4bc4f050847900363e5111e9dde378657ef91ec2c8445d34a6fb78", "source_snapshot_id": "source-340a83fc9d44bbc138a92bb2", "source_updated_at": "2025-09-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/jubbonti-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 452}
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{"after": {"end": 361, "start": 0, "text": "The optimal total duration of antiresorptive treatment for osteoporosis (including both denosumab and bisphosphonates) has not been established. The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of denosumab on an individual patient basis, particularly after 5 or more years of use (see section 4.4).", "truncated": false}, "after_length": 361, "after_sha256": "9b951eb11fc7d4f3963ff054a9011743e1a1df95ba789cc1cc47cb7230a256c1", "annex": "I", "before": {"end": 361, "start": 0, "text": "The optimal total duration of antiresorptive treatment for osteoporosis (including both denosumab and bisphosphonates) has not been established. The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of denosumab on an individual patient basis, particularly after 5 or more years of use (see section 4.4).", "truncated": false}, "before_length": 361, "before_sha256": "9b951eb11fc7d4f3963ff054a9011743e1a1df95ba789cc1cc47cb7230a256c1", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-17947627b381647d6b66ba0c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005964", "medicine_name": "Jubbonti", "medicine_slug": "jubbonti", "observed_at": "2026-10-12T19:08:27Z", "pipeline_version": "2.0.0", "presentation_label": "Jubbonti 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": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "c8be583e8c4bc4f050847900363e5111e9dde378657ef91ec2c8445d34a6fb78", "source_snapshot_id": "source-340a83fc9d44bbc138a92bb2", "source_updated_at": "2025-09-19", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/jubbonti-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 73}
{"after": {"end": 482, "start": 0, "text": "Interstitial lung disease (ILD), which may have an acute onset, has been observed in patients receiving pegylated liposomal doxorubicin, including fatal cases (see section 4.8). If patients experience worsening of respiratory symptoms such as dyspnoea, dry cough, and fever, Caelyx pegylated liposomal should be interrupted and the patient should be promptly investigated. If ILD is confirmed, Caelyx pegylated liposomal should be discontinued and the patient treated appropriately.", "truncated": false}, "after_length": 482, "after_sha256": "a1027513f9112dab98859a6a44cd6a787189157999f5f2331c04d25d138c0167", "annex": "I", "before": {"end": 482, "start": 0, "text": "Interstitial lung disease (ILD), which may have an acute onset, has been observed in patients receiving pegylated liposomal doxorubicin, including fatal cases (see section 4.8). If patients experience worsening of respiratory symptoms such as dyspnoea, dry cough, and fever, Caelyx pegylated liposomal should be interrupted and the patient should be promptly investigated. If ILD is confirmed, Caelyx pegylated liposomal should be discontinued and the patient treated appropriately.", "truncated": false}, "before_length": 482, "before_sha256": "a1027513f9112dab98859a6a44cd6a787189157999f5f2331c04d25d138c0167", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-17c7f34c26a2c639896d8142", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000089", "medicine_name": "Caelyx pegylated liposomal", "medicine_slug": "caelyx-pegylated-liposomal", "observed_at": "2026-10-12T13:39:24Z", "pipeline_version": "2.0.0", "presentation_label": "Caelyx pegylated liposomal 2 mg/ml concentrate for solution for infusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "105b7194075dd91dfa9b4c53ccb8c5cafcef1398ea9d8e22cee320f1905e9896", "source_snapshot_id": "source-2b83429986b00509e2e9753d", "source_updated_at": "2026-04-24", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/caelyx-pegylated-liposomal-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 281}
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