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{"after": {"end": 538, "start": 0, "text": "En joignant les périodes contrôlées de ces essais et les essais d'extension en ouvert d’adalimumab terminés ou en cours avec une durée moyenne d'environ 3,3 ans incluant 6 427 patients et plus de 26 439 patient- années de traitement, le taux observé de cancers, autres que lymphomes et cancers de la peau non mélanomes est d'environ 8,5 pour 1 000 patient-années. Le taux observé de cancers de la peau non- mélanomes est d'environ 9,6 pour 1 000 patient-années et le taux de lymphomes observés est d'environ 1,3 pour 1 000 patient-années.", "truncated": false}, "after_length": 538, "after_sha256": "d55fdd2d3646a253b99baf79060e69b6ab26457700c4fa22a238d60c3435b3cc", "annex": "I", "before": {"end": 538, "start": 0, "text": "En joignant les périodes contrôlées de ces essais et les essais d'extension en ouvert d’adalimumab terminés ou en cours avec une durée moyenne d'environ 3,3 ans incluant 6 427 patients et plus de 26 439 patient- années de traitement, le taux observé de cancers, autres que lymphomes et cancers de la peau non mélanomes est d'environ 8,5 pour 1 000 patient-années. Le taux observé de cancers de la peau non- mélanomes est d'environ 9,6 pour 1 000 patient-années et le taux de lymphomes observés est d'environ 1,3 pour 1 000 patient-années.", "truncated": false}, "before_length": 538, "before_sha256": "d55fdd2d3646a253b99baf79060e69b6ab26457700c4fa22a238d60c3435b3cc", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00278b6dae2d63a768f38aed", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004212", "medicine_name": "Amgevita", "medicine_slug": "amgevita", "observed_at": "2026-10-12T13:39:47Z", "pipeline_version": "2.0.0", "presentation_label": "AMGEVITA 20 mg solution injectable en seringue préremplie AMGEVITA 40 mg solution injectable en seringue préremplie AMGEVITA 40 mg solution injectable en stylo prérempli", "presentation_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": "495de747483c4d23bf886e5c2174a036eaa23b3ee105284779c8eca84fa7417d", "source_snapshot_id": "source-49ac79fb98e8a5f00535ae35", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/amgevita-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 859}
{"after": {"end": 267, "start": 0, "text": "Cases of capillary leak syndrome have been reported with granulocyte colony-stimulating factor use. These have generally occurred in patients with advanced malignant diseases, sepsis, taking multiple chemotherapy medications or undergoing apheresis (see section 4.4).", "truncated": false}, "after_length": 267, "after_sha256": "5d255c0803b7f155468b0aab79786f1748be5fb5f4b79d49f8136c86cc20a220", "annex": "I", "before": {"end": 267, "start": 0, "text": "Cases of capillary leak syndrome have been reported with granulocyte colony-stimulating factor use. These have generally occurred in patients with advanced malignant diseases, sepsis, taking multiple chemotherapy medications or undergoing apheresis (see section 4.4).", "truncated": false}, "before_length": 267, "before_sha256": "5d255c0803b7f155468b0aab79786f1748be5fb5f4b79d49f8136c86cc20a220", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0036ccac65dab4bb0d8f0093", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000917", "medicine_name": "Zarzio", "medicine_slug": "zarzio", "observed_at": "2026-10-12T13:36:11Z", "pipeline_version": "2.0.0", "presentation_label": "Zarzio 30 MU/0.5 mL solution for injection or infusion in pre-filled syringe Zarzio 48 MU/0.5 mL solution for injection or infusion 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": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "51d80b39d33523efaa2f2e8b5daf45ee3bba97f334c746631ab8a9aebbe7ce22", "source_snapshot_id": "source-f8af93bde444dc30d01f0a12", "source_updated_at": "2026-06-05", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/zarzio-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 565}
{"after": {"end": 138, "start": 0, "text": "The safety and efficacy of Avtozma subcutaneous formulation in children with conditions other than sJIA or pJIA have not been established.", "truncated": false}, "after_length": 138, "after_sha256": "ec288e87fcf7164cd83153b5bf0c4d674f3e6db58ca71aa03b31e48693716aab", "annex": "I", "before": {"end": 138, "start": 0, "text": "The safety and efficacy of Avtozma subcutaneous formulation in children with conditions other than sJIA or pJIA have not been established.", "truncated": false}, "before_length": 138, "before_sha256": "ec288e87fcf7164cd83153b5bf0c4d674f3e6db58ca71aa03b31e48693716aab", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-003f1de50af0eb7fe2eaf0ae", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006196", "medicine_name": "Avtozma", "medicine_slug": "avtozma", "observed_at": "2026-10-12T19:08:15Z", "pipeline_version": "2.0.0", "presentation_label": "Avtozma 162 mg solution for injection in pre-filled pen.", "presentation_occurrence": 3, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "ba4e9a32d5db265220ea443856f682f3a2420f7a8beaf9b7631d5fb62e8f4ccc", "source_snapshot_id": "source-ba6ed4f3231b4e78449367be", "source_updated_at": "2025-09-24", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/avtozma-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 3056}
{"after": {"end": 577, "start": 0, "text": "Une étude de toxicité portant sur le développement embryo-fœtal et le développement périnatal a été réalisée chez des singes cynomologus à 0,30 et 100 mg/kg (9-17 singes/groupe) ; elle n’a pas révélé de signe de fœto-toxicité de l’adalimumab. Ni une étude du pouvoir carcinogène, ni une évaluation standard sur la fertilité et la toxicité post-natale n’ont été effectuées avec l’adalimumab en raison du manque de modèles appropriés pour un anticorps présentant une réactivité croisée limitée avec le TNF de rongeur et du développement d’anticorps neutralisants chez le rongeur.", "truncated": false}, "after_length": 577, "after_sha256": "2f35faec0ccb2b6c6a5318781d36541eb5252059d21f8eb0a0d418b0680254ea", "annex": "I", "before": {"end": 577, "start": 0, "text": "Une étude de toxicité portant sur le développement embryo-fœtal et le développement périnatal a été réalisée chez des singes cynomologus à 0,30 et 100 mg/kg (9-17 singes/groupe) ; elle n’a pas révélé de signe de fœto-toxicité de l’adalimumab. Ni une étude du pouvoir carcinogène, ni une évaluation standard sur la fertilité et la toxicité post-natale n’ont été effectuées avec l’adalimumab en raison du manque de modèles appropriés pour un anticorps présentant une réactivité croisée limitée avec le TNF de rongeur et du développement d’anticorps neutralisants chez le rongeur.", "truncated": false}, "before_length": 577, "before_sha256": "2f35faec0ccb2b6c6a5318781d36541eb5252059d21f8eb0a0d418b0680254ea", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-004194404590234dfa2b2149", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004212", "medicine_name": "Amgevita", "medicine_slug": "amgevita", "observed_at": "2026-10-12T13:39:47Z", "pipeline_version": "2.0.0", "presentation_label": "AMGEVITA 20 mg solution injectable en seringue préremplie AMGEVITA 40 mg solution injectable en seringue préremplie AMGEVITA 80 mg solution injectable en seringue préremplie AMGEVITA 40 mg solution injectable en stylo prérempli AMGEVITA 80 mg solution injectable en stylo prérempli", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.3", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "495de747483c4d23bf886e5c2174a036eaa23b3ee105284779c8eca84fa7417d", "source_snapshot_id": "source-49ac79fb98e8a5f00535ae35", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/amgevita-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 4759}
{"after": {"end": 1085, "start": 0, "text": "Les patients sous sildénafil toutes doses confondues ont obtenu une diminution statistiquement significative de leur PAPm et de la résistance vasculaire pulmonaire (RVP) par rapport aux patients sous placebo. Les effets sur la PAPm, exprimés en valeur moyenne ajustée par rapport à la valeur de l’effet dans le groupe placebo, ont été de –2,7 mmHg (p=0,04), de –3 mmHg (p=0,01) et de –5,1 mmHg (p<0,0001) avec respectivement 20 mg, 40 mg et 80 mg de sildénafil trois fois par jour. Les effets du traitement, corrigés par rapport au placebo, sur la RVP étaient respectivement de –178 dyne.sec/cm5 (p=0,0051), de –195 dyne.sec/cm5 (p=0,0017) et de –320 dyne.sec/cm5 (p<0,0001), avec respectivement 20 mg ,40 mg et 80 mg de sildénafil trois fois par jour. La diminution de la RVP à la 12ème semaine avec 20 mg ,40 mg et 80 mg de sildénafil trois fois par jour (11,2%, 12,9%, 23,3% par rapport à la valeur de base) a été proportionnellement plus importante que celle de la résistance vasculaire systémique (RVS) (7,2 %, 5,9%, 14,4%). L’effet du sildénafil sur la mortalité n’est pas connu.", "truncated": false}, "after_length": 1085, "after_sha256": "a475dc1376846e9e378320d3ba47512cb871e9088922000c083e10153adb7a37", "annex": "I", "before": {"end": 1085, "start": 0, "text": "Les patients sous sildénafil toutes doses confondues ont obtenu une diminution statistiquement significative de leur PAPm et de la résistance vasculaire pulmonaire (RVP) par rapport aux patients sous placebo. Les effets sur la PAPm, exprimés en valeur moyenne ajustée par rapport à la valeur de l’effet dans le groupe placebo, ont été de –2,7 mmHg (p=0,04), de –3 mmHg (p=0,01) et de –5,1 mmHg (p<0,0001) avec respectivement 20 mg, 40 mg et 80 mg de sildénafil trois fois par jour. Les effets du traitement, corrigés par rapport au placebo, sur la RVP étaient respectivement de –178 dyne.sec/cm5 (p=0,0051), de –195 dyne.sec/cm5 (p=0,0017) et de –320 dyne.sec/cm5 (p<0,0001), avec respectivement 20 mg ,40 mg et 80 mg de sildénafil trois fois par jour. La diminution de la RVP à la 12ème semaine avec 20 mg ,40 mg et 80 mg de sildénafil trois fois par jour (11,2%, 12,9%, 23,3% par rapport à la valeur de base) a été proportionnellement plus importante que celle de la résistance vasculaire systémique (RVS) (7,2 %, 5,9%, 14,4%). L’effet du sildénafil sur la mortalité n’est pas connu.", "truncated": false}, "before_length": 1085, "before_sha256": "a475dc1376846e9e378320d3ba47512cb871e9088922000c083e10153adb7a37", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0043218887bc62467c17977c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000638", "medicine_name": "Revatio", "medicine_slug": "revatio", "observed_at": "2026-10-12T19:08:54Z", "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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "6c76ebca3d160f6e6247735b08832aff244f11590a807346afa8ca96b68b6f4c", "source_snapshot_id": "source-5e60d5ca382f2c8103a43a9f", "source_updated_at": "2025-09-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/revatio-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 441}
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{"after": {"end": 382, "start": 0, "text": "Les patients des études HS-I et HS-II étaient éligibles à l'inclusion dans une étude d'extension en ouvert au cours de laquelle adalimumab 40 mg était administré toutes les semaines. L’exposition moyenne dans toute la population traitée par l’adalimumab a été de 762 jours. Tout au long des 3 études, les patients ont utilisé quotidiennement un antiseptique local sur leurs lésions.", "truncated": false}, "after_length": 382, "after_sha256": "30f8df1817deedb5bd672ea62ee8434a19cd4449c2ab51c4cd7aceb3fab737cc", "annex": "I", "before": {"end": 382, "start": 0, "text": "Les patients des études HS-I et HS-II étaient éligibles à l'inclusion dans une étude d'extension en ouvert au cours de laquelle adalimumab 40 mg était administré toutes les semaines. L’exposition moyenne dans toute la population traitée par l’adalimumab a été de 762 jours. Tout au long des 3 études, les patients ont utilisé quotidiennement un antiseptique local sur leurs lésions.", "truncated": false}, "before_length": 382, "before_sha256": "30f8df1817deedb5bd672ea62ee8434a19cd4449c2ab51c4cd7aceb3fab737cc", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-007db20e1997d78ba413d5c6", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004212", "medicine_name": "Amgevita", "medicine_slug": "amgevita", "observed_at": "2026-10-12T13:39:47Z", "pipeline_version": "2.0.0", "presentation_label": "AMGEVITA 20 mg solution injectable en seringue préremplie AMGEVITA 40 mg solution injectable en seringue préremplie AMGEVITA 80 mg solution injectable en seringue préremplie AMGEVITA 40 mg solution injectable en stylo prérempli AMGEVITA 80 mg solution injectable en stylo prérempli", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "495de747483c4d23bf886e5c2174a036eaa23b3ee105284779c8eca84fa7417d", "source_snapshot_id": "source-49ac79fb98e8a5f00535ae35", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/amgevita-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 4011}
{"after": {"end": 469, "start": 0, "text": "L’utilisation concomitante d’inhibiteurs puissants du CYP2C8 doit être évitée autant que possible. Si le patient doit recevoir un inhibiteur puissant du CYP2C8 de façon concomitante, la dose d’enzalutamide doit être réduite à 80 mg en une prise quotidienne. En cas d’arrêt de l’administration concomitante de l’inhibiteur puissant du CYP2C8, l’enzalutamide doit être repris à la dose utilisée avant l’instauration de l’inhibiteur puissant du CYP2C8 (voir rubrique 4.5).", "truncated": false}, "after_length": 469, "after_sha256": "d9c1a6fbc326f957a4ed229ad25dadfdca2b8d6e13384c99dcb4a0e14dbc2e64", "annex": "I", "before": {"end": 469, "start": 0, "text": "L’utilisation concomitante d’inhibiteurs puissants du CYP2C8 doit être évitée autant que possible. Si le patient doit recevoir un inhibiteur puissant du CYP2C8 de façon concomitante, la dose d’enzalutamide doit être réduite à 80 mg en une prise quotidienne. En cas d’arrêt de l’administration concomitante de l’inhibiteur puissant du CYP2C8, l’enzalutamide doit être repris à la dose utilisée avant l’instauration de l’inhibiteur puissant du CYP2C8 (voir rubrique 4.5).", "truncated": false}, "before_length": 469, "before_sha256": "d9c1a6fbc326f957a4ed229ad25dadfdca2b8d6e13384c99dcb4a0e14dbc2e64", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-008086c1f425191e1761be12", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002639", "medicine_name": "Xtandi", "medicine_slug": "xtandi", "observed_at": "2026-10-12T13:30:45Z", "pipeline_version": "2.0.0", "presentation_label": "Xtandi 40 mg, comprimé pelliculé Xtandi 80 mg, comprimé pelliculé", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "146d50d0de682089206c8c6edbc55f169388489efc96d97e9722ea592ba66301", "source_snapshot_id": "source-d2fba3c0f90382bddd977500", "source_updated_at": "2026-07-29", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xtandi-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1070}
{"after": {"end": 117, "start": 0, "text": "Tuberculose évolutive ou autres infections sévères telles que sepsis et infections opportunistes (voir rubrique 4.4).", "truncated": false}, "after_length": 117, "after_sha256": "94fd5cf013d2ed9f8a1a6b1ef695eaa7ec0f5cfe4a095ecb2446339fbbdb2554", "annex": "I", "before": {"end": 117, "start": 0, "text": "Tuberculose évolutive ou autres infections sévères telles que sepsis et infections opportunistes (voir rubrique 4.4).", "truncated": false}, "before_length": 117, "before_sha256": "94fd5cf013d2ed9f8a1a6b1ef695eaa7ec0f5cfe4a095ecb2446339fbbdb2554", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-008223bc4601b60a130a8740", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004212", "medicine_name": "Amgevita", "medicine_slug": "amgevita", "observed_at": "2026-10-12T13:39:47Z", "pipeline_version": "2.0.0", "presentation_label": "AMGEVITA 20 mg solution injectable en seringue préremplie AMGEVITA 40 mg solution injectable en seringue préremplie AMGEVITA 40 mg solution injectable en stylo prérempli", "presentation_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": "495de747483c4d23bf886e5c2174a036eaa23b3ee105284779c8eca84fa7417d", "source_snapshot_id": "source-49ac79fb98e8a5f00535ae35", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/amgevita-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 381}
{"after": {"end": 449, "start": 0, "text": "For patients who are initiating treatment, Eylea is administered with 1 injection per month for 3 consecutive doses. Injection intervals may then be extended up to every 4 months based on the physician’s judgement of visual and/or anatomic outcomes. Subsequently, the treatment intervals may be further extended up to 6 months, such as with a treatandextend dosing regimen, while maintaining stable visual and/or anatomic outcomes (see section 5.1).", "truncated": false}, "after_length": 449, "after_sha256": "58f4a17c58559d35f55900b3db3790a22e805e8a2381c674d141e5e3fa76f4ad", "annex": "I", "before": {"end": 449, "start": 0, "text": "For patients who are initiating treatment, Eylea is administered with 1 injection per month for 3 consecutive doses. Injection intervals may then be extended up to every 4 months based on the physician’s judgement of visual and/or anatomic outcomes. Subsequently, the treatment intervals may be further extended up to 6 months, such as with a treatandextend dosing regimen, while maintaining stable visual and/or anatomic outcomes (see section 5.1).", "truncated": false}, "before_length": 449, "before_sha256": "58f4a17c58559d35f55900b3db3790a22e805e8a2381c674d141e5e3fa76f4ad", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-008ae5fa324eda4c1044b223", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002392", "medicine_name": "Eylea", "medicine_slug": "eylea", "observed_at": "2026-10-12T13:53:22Z", "pipeline_version": "2.0.0", "presentation_label": "Eylea 114.3 mg/ml solution for injection Eylea 114.3 mg/ml solution for injection in prefilled syringe", "presentation_occurrence": 3, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "8ec9f7841188f4e35251feb5051d47572abbe281531b8bdaeb3e1668a767b648", "source_snapshot_id": "source-55765f484af9c246c4e50218", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/eylea-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2264}
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{"after": {"end": 1301, "start": 0, "text": "A randomised, doubleblind, placebocontrolled study was conducted in 278 patients with primary pulmonary hypertension, PAH associated with connective tissue disease, and PAH following surgical repair of congenital heart lesions. Patients were randomised to one of four treatment groups: placebo, sildenafil 20 mg, sildenafil 40 mg or sildenafil 80 mg, three times a day. Of the 278 patients randomised, 277 patients received at least 1 dose of study drug. The study population consisted of 68 (25 %) men and 209 (75 %) women with a mean age of 49 years (range: 18-81 years) and baseline 6minute walk test distance between 100 and 450 metres inclusive (mean: 344 metres). 175 patients (63 %) included were diagnosed with primary pulmonary hypertension, 84 (30 %) were diagnosed with PAH associated with connective tissue disease and 18 (7 %) of the patients were diagnosed with PAH following surgical repair of congenital heart lesions. Most patients were WHO Functional Class II (107/277, 39 %) or III (160/277, 58 %) with a mean baseline 6 minute walking distance of 378 meters and 326 meters respectively; fewer patients were Class I (1/277, 0.4 %) or IV (9/277, 3 %) at baseline. Patients with left ventricular ejection fraction < 45 % or left ventricular shortening fraction < 0.2 were not studied.", "truncated": false}, "after_length": 1301, "after_sha256": "9cc88647618c7b748d118e4782f6ae23e12f1c3e87434d326516be2ce6d35497", "annex": "I", "before": {"end": 1301, "start": 0, "text": "A randomised, doubleblind, placebocontrolled study was conducted in 278 patients with primary pulmonary hypertension, PAH associated with connective tissue disease, and PAH following surgical repair of congenital heart lesions. Patients were randomised to one of four treatment groups: placebo, sildenafil 20 mg, sildenafil 40 mg or sildenafil 80 mg, three times a day. Of the 278 patients randomised, 277 patients received at least 1 dose of study drug. The study population consisted of 68 (25 %) men and 209 (75 %) women with a mean age of 49 years (range: 18-81 years) and baseline 6minute walk test distance between 100 and 450 metres inclusive (mean: 344 metres). 175 patients (63 %) included were diagnosed with primary pulmonary hypertension, 84 (30 %) were diagnosed with PAH associated with connective tissue disease and 18 (7 %) of the patients were diagnosed with PAH following surgical repair of congenital heart lesions. Most patients were WHO Functional Class II (107/277, 39 %) or III (160/277, 58 %) with a mean baseline 6 minute walking distance of 378 meters and 326 meters respectively; fewer patients were Class I (1/277, 0.4 %) or IV (9/277, 3 %) at baseline. Patients with left ventricular ejection fraction < 45 % or left ventricular shortening fraction < 0.2 were not studied.", "truncated": false}, "before_length": 1301, "before_sha256": "9cc88647618c7b748d118e4782f6ae23e12f1c3e87434d326516be2ce6d35497", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0099f0eed9c1ebf2376132b7", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000638", "medicine_name": "Revatio", "medicine_slug": "revatio", "observed_at": "2026-10-12T19:08:51Z", "pipeline_version": "2.0.0", "presentation_label": "Revatio 10 mg/ml powder for oral suspension", "presentation_occurrence": 3, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "3fdd820dcc75acdfd3ef6e1aa7aef33b64b7a935f6f4f525ffdcfe55fe376bcc", "source_snapshot_id": "source-967e58a055aaa321d30c17b5", "source_updated_at": "2025-09-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/revatio-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1557}
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{"after": {"end": 791, "start": 0, "text": "Des cas généralement asymptomatiques de splénomégalie et des cas de rupture splénique ont été rapportés chez des patients et des donneurs sains suite à l’administration de filgrastim. Certains cas de rupture splénique ont été fatals. Par conséquent, une surveillance clinique du volume de la rate doit être instituée (par ex., examen clinique, échographie). Un diagnostic de rupture splénique devra être envisagé chez les donneurs sains et/ou chez les patients présentant une douleur au niveau de l’hypochondre gauche ou une douleur au sommet de l’épaule. Des réductions de la dose de filgrastim ont permis un ralentissement de l’évolution ou un arrêt de la splénomégalie chez les patients atteints de neutropénie chronique sévère et chez 3 % des patients, une splénectomie a été nécessaire.", "truncated": false}, "after_length": 791, "after_sha256": "6f771139b13cb2dc936fc6347640217e0fe29857eb351be59d031af471d25e6c", "annex": "I", "before": {"end": 791, "start": 0, "text": "Des cas généralement asymptomatiques de splénomégalie et des cas de rupture splénique ont été rapportés chez des patients et des donneurs sains suite à l’administration de filgrastim. Certains cas de rupture splénique ont été fatals. Par conséquent, une surveillance clinique du volume de la rate doit être instituée (par ex., examen clinique, échographie). Un diagnostic de rupture splénique devra être envisagé chez les donneurs sains et/ou chez les patients présentant une douleur au niveau de l’hypochondre gauche ou une douleur au sommet de l’épaule. Des réductions de la dose de filgrastim ont permis un ralentissement de l’évolution ou un arrêt de la splénomégalie chez les patients atteints de neutropénie chronique sévère et chez 3 % des patients, une splénectomie a été nécessaire.", "truncated": false}, "before_length": 791, "before_sha256": "6f771139b13cb2dc936fc6347640217e0fe29857eb351be59d031af471d25e6c", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00a480c7e8e68be95ab90113", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000917", "medicine_name": "Zarzio", "medicine_slug": "zarzio", "observed_at": "2026-10-12T13:36:13Z", "pipeline_version": "2.0.0", "presentation_label": "Zarzio 30 MU/0,5 mL solution injectable ou pour perfusion en seringue préremplie. Zarzio 48 MU/0,5 mL solution injectable ou pour perfusion 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": "968afffa2a72df6dda240602dfb44e50ec1ab7fb854d6d777ac92e19cd52fe6f", "source_snapshot_id": "source-bb736e6d90be96a990172ed5", "source_updated_at": "2026-06-05", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/zarzio-epar-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}
{"after": {"end": 522, "start": 0, "text": "La pharmacocinétique du tocilizumab chez les patients atteints d’ACG a été déterminée en utilisant un modèle pharmacocinétique de population à partir d’un ensemble de données d’analyse composées de 149 patients atteints d’ACG traités par 162 mg par voie sous-cutanée une fois par semaine ou 162 mg par voie sous-cutanée toutes les deux semaines. Le modèle développé avait la même structure que le modèle pharmacocinétique de population développé plus tôt basé sur les données des patients atteints de PR (voir Tableau 10).", "truncated": false}, "after_length": 522, "after_sha256": "16e9fd0009c41ee8f59d8bfa843d412cb15e8bd93a195afe4239fc1c1bc43e06", "annex": "I", "before": {"end": 522, "start": 0, "text": "La pharmacocinétique du tocilizumab chez les patients atteints d’ACG a été déterminée en utilisant un modèle pharmacocinétique de population à partir d’un ensemble de données d’analyse composées de 149 patients atteints d’ACG traités par 162 mg par voie sous-cutanée une fois par semaine ou 162 mg par voie sous-cutanée toutes les deux semaines. Le modèle développé avait la même structure que le modèle pharmacocinétique de population développé plus tôt basé sur les données des patients atteints de PR (voir Tableau 10).", "truncated": false}, "before_length": 522, "before_sha256": "16e9fd0009c41ee8f59d8bfa843d412cb15e8bd93a195afe4239fc1c1bc43e06", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00a5afac8fc30aac8b4827e6", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006196", "medicine_name": "Avtozma", "medicine_slug": "avtozma", "observed_at": "2026-10-12T19:08:25Z", "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": "af06c9bc155d0395dcc161183896ab3d1d2fb2ff66f287d3d066f9db43216f8c", "source_snapshot_id": "source-2d15c8bbc1703da693775086", "source_updated_at": "2025-09-24", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avtozma-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2816}
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{"after": {"end": 705, "start": 0, "text": "RA study III evaluated 619 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old, and who had an ineffective response to methotrexate at doses of 12.5 to 25 mg or have been intolerant to 10 mg of methotrexate every week. There were three groups in this study. The first received placebo injections every week for 52 weeks. The second received 20 mg of adalimumab every week for 52 weeks. The third group received 40 mg of adalimumab every other week with placebo injections on alternate weeks. Upon completion of the first 52 weeks, 457 patients enrolled in an open-label extension phase in which 40 mg of adalimumab/MTX was administered every other week up to 10 years.", "truncated": false}, "after_length": 705, "after_sha256": "0a887444ebc45e6e4328f331d0400a9062f87199837a0952e05de7985cc781e8", "annex": "I", "before": {"end": 705, "start": 0, "text": "RA study III evaluated 619 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old, and who had an ineffective response to methotrexate at doses of 12.5 to 25 mg or have been intolerant to 10 mg of methotrexate every week. There were three groups in this study. The first received placebo injections every week for 52 weeks. The second received 20 mg of adalimumab every week for 52 weeks. The third group received 40 mg of adalimumab every other week with placebo injections on alternate weeks. Upon completion of the first 52 weeks, 457 patients enrolled in an open-label extension phase in which 40 mg of adalimumab/MTX was administered every other week up to 10 years.", "truncated": false}, "before_length": 705, "before_sha256": "0a887444ebc45e6e4328f331d0400a9062f87199837a0952e05de7985cc781e8", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00b5c6e2ae273735ba541d49", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004212", "medicine_name": "Amgevita", "medicine_slug": "amgevita", "observed_at": "2026-10-12T13:39:38Z", "pipeline_version": "2.0.0", "presentation_label": "AMGEVITA 20 mg solution for injection in pre-filled syringe AMGEVITA 40 mg solution for injection in pre-filled syringe AMGEVITA 40 mg solution for injection in pre-filled pen", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "6f92419b049d4385c724668fa5eb4e806bffd72b3d39fb7c8cd44fa9594fe783", "source_snapshot_id": "source-813eb8c9e5f8c780c307d230", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/amgevita-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 962}
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{"after": {"end": 995, "start": 0, "text": "Des effets indésirables survenus sous traitement et des effets indésirables graves ont été rapportés chez respectivement 22 (75,9 %) et 7 (24,1 %) sujets du groupe de traitement NOi + sildénafil intraveineux, et chez respectivement 19 (63,3 %) et 2 (6,7 %) sujets du groupe NOi + placebo. Les effets indésirables apparus sous traitement le plus souvent rapportés dans le groupe de traitement NOi + sildénafil intraveineux étaient : hypotension (8 patients [27,6 %]), hypokaliémie (7 patients [24,1 %]), anémie (4 patients [13,8 %]), syndrome de sevrage (4 patients [13,8 %]) et bradycardie (3 patients [10,3 %]). Les effets indésirables apparus sous traitement le plus souvent rapportés dans le groupe de traitement NOi + placebo étaient : pneumothorax (4 patients [13,3 %]), anémie (3 patients [10,0 %]), œdème (3 patients [10,0 %]), hyperbilirubinémie (3 patients [10,0 %]), augmentation de la protéine C réactive (3 patients [10,0 %]) et hypotension (3 patients [10,0 %]) (voir rubrique 4.2).", "truncated": false}, "after_length": 995, "after_sha256": "1f5f86bb68c865be3ff5ad10832fd9d6d7dd904ec0ba7cfc24e73d741100a897", "annex": "I", "before": {"end": 995, "start": 0, "text": "Des effets indésirables survenus sous traitement et des effets indésirables graves ont été rapportés chez respectivement 22 (75,9 %) et 7 (24,1 %) sujets du groupe de traitement NOi + sildénafil intraveineux, et chez respectivement 19 (63,3 %) et 2 (6,7 %) sujets du groupe NOi + placebo. Les effets indésirables apparus sous traitement le plus souvent rapportés dans le groupe de traitement NOi + sildénafil intraveineux étaient : hypotension (8 patients [27,6 %]), hypokaliémie (7 patients [24,1 %]), anémie (4 patients [13,8 %]), syndrome de sevrage (4 patients [13,8 %]) et bradycardie (3 patients [10,3 %]). Les effets indésirables apparus sous traitement le plus souvent rapportés dans le groupe de traitement NOi + placebo étaient : pneumothorax (4 patients [13,3 %]), anémie (3 patients [10,0 %]), œdème (3 patients [10,0 %]), hyperbilirubinémie (3 patients [10,0 %]), augmentation de la protéine C réactive (3 patients [10,0 %]) et hypotension (3 patients [10,0 %]) (voir rubrique 4.2).", "truncated": false}, "before_length": 995, "before_sha256": "1f5f86bb68c865be3ff5ad10832fd9d6d7dd904ec0ba7cfc24e73d741100a897", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-014c6fae3805464ab655a9d5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000638", "medicine_name": "Revatio", "medicine_slug": "revatio", "observed_at": "2026-10-12T19:08:54Z", "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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "6c76ebca3d160f6e6247735b08832aff244f11590a807346afa8ca96b68b6f4c", "source_snapshot_id": "source-5e60d5ca382f2c8103a43a9f", "source_updated_at": "2025-09-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/revatio-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1736}
{"after": {"end": 143, "start": 0, "text": "Tableau 9. Moyenne prédictive ± écart type des paramètres pharmacocinétiques à l'état d'équilibre après administration sous-cutanée dans l’AJIp", "truncated": false}, "after_length": 143, "after_sha256": "76856bd68ac6d4590953da9f67a1472356805655eb4e81827f3b8a88bbbd9502", "annex": "I", "before": {"end": 143, "start": 0, "text": "Tableau 9. Moyenne prédictive ± écart type des paramètres pharmacocinétiques à l'état d'équilibre après administration sous-cutanée dans l’AJIp", "truncated": false}, "before_length": 143, "before_sha256": "76856bd68ac6d4590953da9f67a1472356805655eb4e81827f3b8a88bbbd9502", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01522f3af59f7aacec93fde1", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006196", "medicine_name": "Avtozma", "medicine_slug": "avtozma", "observed_at": "2026-10-12T19:08:25Z", "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": "af06c9bc155d0395dcc161183896ab3d1d2fb2ff66f287d3d066f9db43216f8c", "source_snapshot_id": "source-2d15c8bbc1703da693775086", "source_updated_at": "2025-09-24", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/avtozma-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2774}
{"after": {"end": 656, "start": 0, "text": "La sécurité et l’efficacité d’Eylea ont été évaluées dans une étude randomisée, multicentrique, en double insu, contrôlée versus comparateur actif, chez des patients atteints d’un œdème maculaire secondaire à une OBVR (VIBRANT), incluant des occlusions veineuses hémi-rétiniennes. Au total, 181 patients ont été traités puis évalués en terme d’efficacité (91 traités par Eylea). L’âge des patients était compris entre 42 et 94 ans, avec une moyenne de 65 ans. Dans l’étude menée dans l’OBVR, environ 58 % (53/91) des patients randomisés dans le groupe traité par Eylea étaient âgés de 65 ans ou plus, et environ 23 % (21/91) étaient âgés de 75 ans ou plus.", "truncated": false}, "after_length": 656, "after_sha256": "2c585825dbc23eb1a7ab98fc7ce46eba84a29c1575ebbfab2f105f2f5a6a0095", "annex": "I", "before": {"end": 656, "start": 0, "text": "La sécurité et l’efficacité d’Eylea ont été évaluées dans une étude randomisée, multicentrique, en double insu, contrôlée versus comparateur actif, chez des patients atteints d’un œdème maculaire secondaire à une OBVR (VIBRANT), incluant des occlusions veineuses hémi-rétiniennes. Au total, 181 patients ont été traités puis évalués en terme d’efficacité (91 traités par Eylea). L’âge des patients était compris entre 42 et 94 ans, avec une moyenne de 65 ans. Dans l’étude menée dans l’OBVR, environ 58 % (53/91) des patients randomisés dans le groupe traité par Eylea étaient âgés de 65 ans ou plus, et environ 23 % (21/91) étaient âgés de 75 ans ou plus.", "truncated": false}, "before_length": 656, "before_sha256": "2c585825dbc23eb1a7ab98fc7ce46eba84a29c1575ebbfab2f105f2f5a6a0095", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-015a91caa41613ad9efa1a28", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002392", "medicine_name": "Eylea", "medicine_slug": "eylea", "observed_at": "2026-10-12T13:53:34Z", "pipeline_version": "2.0.0", "presentation_label": "Eylea 40 mg/mL, solution injectable en flacon", "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": "03af134f054b3ca76ba18d4f6a4abf435a8c4a406ec9f00e730c3cd5cb244178", "source_snapshot_id": "source-014fa68ffdad12cbe954d7a0", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/eylea-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1976}
{"after": {"end": 188, "start": 0, "text": "Chaque flacon contient 30,1 mg d’aflibercept dans 0,263 mL de solution. Ceci fournit la quantité nécessaire de produit pour délivrer une seule dose de 0,07 mL contenant 8 mg d’aflibercept.", "truncated": false}, "after_length": 188, "after_sha256": "ad8a9bb99fcbf39670cd657fcdda2af31e0a8dac5283959e9c19bf7d1f1f95cd", "annex": "I", "before": {"end": 188, "start": 0, "text": "Chaque flacon contient 30,1 mg d’aflibercept dans 0,263 mL de solution. Ceci fournit la quantité nécessaire de produit pour délivrer une seule dose de 0,07 mL contenant 8 mg d’aflibercept.", "truncated": false}, "before_length": 188, "before_sha256": "ad8a9bb99fcbf39670cd657fcdda2af31e0a8dac5283959e9c19bf7d1f1f95cd", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-015d75d11106b3bce1f26e0b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002392", "medicine_name": "Eylea", "medicine_slug": "eylea", "observed_at": "2026-10-12T13:53:34Z", "pipeline_version": "2.0.0", "presentation_label": "Eylea 114,3 mg/mL, solution injectable Eylea 114,3 mg/mL, solution injectable en seringue préremplie", "presentation_occurrence": 3, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "2", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "03af134f054b3ca76ba18d4f6a4abf435a8c4a406ec9f00e730c3cd5cb244178", "source_snapshot_id": "source-014fa68ffdad12cbe954d7a0", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/eylea-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2497}
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{"after": {"end": 376, "start": 0, "text": "Special caution should be used when treating patients with high-dose chemotherapy because improved tumour outcome has not been demonstrated and intensified doses of chemotherapeutic agents may lead to increased toxicities including cardiac, pulmonary, neurologic, and dermatologic effects (please refer to the prescribing information of the specific chemotherapy agents used).", "truncated": false}, "after_length": 376, "after_sha256": "24012e30bb81dc44f8ca48d2ba960fdd99252d4818b5ef250c058f4b7f07ddcc", "annex": "I", "before": {"end": 376, "start": 0, "text": "Special caution should be used when treating patients with high-dose chemotherapy because improved tumour outcome has not been demonstrated and intensified doses of chemotherapeutic agents may lead to increased toxicities including cardiac, pulmonary, neurologic, and dermatologic effects (please refer to the prescribing information of the specific chemotherapy agents used).", "truncated": false}, "before_length": 376, "before_sha256": "24012e30bb81dc44f8ca48d2ba960fdd99252d4818b5ef250c058f4b7f07ddcc", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01830b81bfbae142ee18f5d7", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000917", "medicine_name": "Zarzio", "medicine_slug": "zarzio", "observed_at": "2026-10-12T13:36:11Z", "pipeline_version": "2.0.0", "presentation_label": "Zarzio 30 MU/0.5 mL solution for injection or infusion in pre-filled syringe Zarzio 48 MU/0.5 mL solution for injection or infusion 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": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "51d80b39d33523efaa2f2e8b5daf45ee3bba97f334c746631ab8a9aebbe7ce22", "source_snapshot_id": "source-f8af93bde444dc30d01f0a12", "source_updated_at": "2026-06-05", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/zarzio-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 261}
{"after": {"end": 505, "start": 0, "text": "The safety and efficacy of Eylea were assessed in a randomised, multi-centre, double-masked, sham-controlled study in treatment-naïve, Asian patients with myopic CNV. A total of 121 patients were treated and evaluable for efficacy (90 with Eylea). Patient ages ranged from 27 to 83 years with a mean of 58 years. In the myopic CNV study, approximately 36% (33/91) of the patients randomised to treatment with Eylea were 65 years of age or older, and approximately 10% (9/91) were 75 years of age or older.", "truncated": false}, "after_length": 505, "after_sha256": "558470e08915c4bbb0a0dbfca3a50bde12e1492b57939a47bbbb0e49c7c0c499", "annex": "I", "before": {"end": 505, "start": 0, "text": "The safety and efficacy of Eylea were assessed in a randomised, multi-centre, double-masked, sham-controlled study in treatment-naïve, Asian patients with myopic CNV. A total of 121 patients were treated and evaluable for efficacy (90 with Eylea). Patient ages ranged from 27 to 83 years with a mean of 58 years. In the myopic CNV study, approximately 36% (33/91) of the patients randomised to treatment with Eylea were 65 years of age or older, and approximately 10% (9/91) were 75 years of age or older.", "truncated": false}, "before_length": 505, "before_sha256": "558470e08915c4bbb0a0dbfca3a50bde12e1492b57939a47bbbb0e49c7c0c499", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-018486453539a96f3cb20e91", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002392", "medicine_name": "Eylea", "medicine_slug": "eylea", "observed_at": "2026-10-12T13:53:22Z", "pipeline_version": "2.0.0", "presentation_label": "Eylea 40 mg/mL 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": "8ec9f7841188f4e35251feb5051d47572abbe281531b8bdaeb3e1668a767b648", "source_snapshot_id": "source-55765f484af9c246c4e50218", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/eylea-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 889}
{"after": {"end": 625, "start": 0, "text": "Un autre critère secondaire clé d’efficacité évalué dans l’étude était la survie globale. Lors de l’analyse finale prédéfinie de la survie globale, réalisée après la survenue de 356 décès, une diminution statistiquement significative du risque de décès de 34 % a été démontrée dans le groupe randomisé pour recevoir l’enzalutamide par rapport au groupe randomisé pour recevoir le placebo (HR = 0,66 (IC à 95 % =[0,53 ; 0,81]), p < 0,0001). La durée médiane de la survie globale n’a été atteinte dans aucun des groupes de traitement. La durée médiane de suivi estimée pour tous les patients était de 44,6 mois (voir Figure 6).", "truncated": false}, "after_length": 625, "after_sha256": "0a2a501c5fa865fca8c0aa1244b086d2c3c1f3e439c4ce4c2864326130b4d3bd", "annex": "I", "before": {"end": 625, "start": 0, "text": "Un autre critère secondaire clé d’efficacité évalué dans l’étude était la survie globale. Lors de l’analyse finale prédéfinie de la survie globale, réalisée après la survenue de 356 décès, une diminution statistiquement significative du risque de décès de 34 % a été démontrée dans le groupe randomisé pour recevoir l’enzalutamide par rapport au groupe randomisé pour recevoir le placebo (HR = 0,66 (IC à 95 % =[0,53 ; 0,81]), p < 0,0001). La durée médiane de la survie globale n’a été atteinte dans aucun des groupes de traitement. La durée médiane de suivi estimée pour tous les patients était de 44,6 mois (voir Figure 6).", "truncated": false}, "before_length": 625, "before_sha256": "0a2a501c5fa865fca8c0aa1244b086d2c3c1f3e439c4ce4c2864326130b4d3bd", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01857f49752c44c0e6430154", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002639", "medicine_name": "Xtandi", "medicine_slug": "xtandi", "observed_at": "2026-10-12T13:30:45Z", "pipeline_version": "2.0.0", "presentation_label": "Xtandi 40 mg, comprimé pelliculé Xtandi 80 mg, comprimé pelliculé", "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": "146d50d0de682089206c8c6edbc55f169388489efc96d97e9722ea592ba66301", "source_snapshot_id": "source-d2fba3c0f90382bddd977500", "source_updated_at": "2026-07-29", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xtandi-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1622}
{"after": {"end": 985, "start": 0, "text": "La numération des polynucléaires neutrophiles (PNN) doit être étroitement surveillée, en particulier au cours des premières semaines du traitement par le filgrastim. Certains patients peuvent répondre très rapidement au traitement, avec dès le début une forte augmentation du taux de polynucléaires neutrophiles. Il est recommandé de surveiller le taux de PNN quotidiennement au cours des 2 à 3 premiers jours du traitement par le filgrastim. Par la suite, il est recommandé de doser le taux des PNN au moins deux fois par semaine pendant les deux premières semaines, puis une fois par semaine ou une semaine sur deux, durant la poursuite du traitement. Au cours de l’administration intermittente des doses de 30 MU/jour (300 microgrammes/jour) de filgrastim, on peut observer des fluctuations importantes du taux des PNN. Afin de déterminer le nadir du taux de PNN du patient, il est recommandé de procéder à une numération des PNN, immédiatement avant l’administration du filgrastim.", "truncated": false}, "after_length": 985, "after_sha256": "c0a8946d6cabeef8e71c54eee12898962963e9bcdc3777b59a52987848ddf927", "annex": "I", "before": {"end": 985, "start": 0, "text": "La numération des polynucléaires neutrophiles (PNN) doit être étroitement surveillée, en particulier au cours des premières semaines du traitement par le filgrastim. Certains patients peuvent répondre très rapidement au traitement, avec dès le début une forte augmentation du taux de polynucléaires neutrophiles. Il est recommandé de surveiller le taux de PNN quotidiennement au cours des 2 à 3 premiers jours du traitement par le filgrastim. Par la suite, il est recommandé de doser le taux des PNN au moins deux fois par semaine pendant les deux premières semaines, puis une fois par semaine ou une semaine sur deux, durant la poursuite du traitement. Au cours de l’administration intermittente des doses de 30 MU/jour (300 microgrammes/jour) de filgrastim, on peut observer des fluctuations importantes du taux des PNN. Afin de déterminer le nadir du taux de PNN du patient, il est recommandé de procéder à une numération des PNN, immédiatement avant l’administration du filgrastim.", "truncated": false}, "before_length": 985, "before_sha256": "c0a8946d6cabeef8e71c54eee12898962963e9bcdc3777b59a52987848ddf927", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-019104dbcbd32e7ba0cbe8d9", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000917", "medicine_name": "Zarzio", "medicine_slug": "zarzio", "observed_at": "2026-10-12T13:36:13Z", "pipeline_version": "2.0.0", "presentation_label": "Zarzio 30 MU/0,5 mL solution injectable ou pour perfusion en seringue préremplie. Zarzio 48 MU/0,5 mL solution injectable ou pour perfusion 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": "968afffa2a72df6dda240602dfb44e50ec1ab7fb854d6d777ac92e19cd52fe6f", "source_snapshot_id": "source-bb736e6d90be96a990172ed5", "source_updated_at": "2026-06-05", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/zarzio-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 350}
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{"after": {"end": 449, "start": 0, "text": "Since androgen deprivation treatment may prolong the QT interval, the concomitant use of Xtandi with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes such as class IA (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics, etc. should be carefully evaluated (see section 4.4).", "truncated": false}, "after_length": 449, "after_sha256": "11f377de72384653d305ef2daf09320c8e3dbd5faf3b7937dedccd4e33102601", "annex": "I", "before": {"end": 449, "start": 0, "text": "Since androgen deprivation treatment may prolong the QT interval, the concomitant use of Xtandi with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes such as class IA (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics, etc. should be carefully evaluated (see section 4.4).", "truncated": false}, "before_length": 449, "before_sha256": "11f377de72384653d305ef2daf09320c8e3dbd5faf3b7937dedccd4e33102601", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-02da162d25feb315e166225f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002639", "medicine_name": "Xtandi", "medicine_slug": "xtandi", "observed_at": "2026-10-12T13:30:37Z", "pipeline_version": "2.0.0", "presentation_label": "Xtandi - 40 mg soft capsules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "5ab28fb569f2fd21a2331b810ec038440ac438d84a6b8a346e430d7979fee559", "source_snapshot_id": "source-331c917f03e289e05c6dd9af", "source_updated_at": "2026-07-29", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/xtandi-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 195}
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{"after": {"end": 445, "start": 0, "text": "Serious adverse reactions were common (1-10 %) and not unexpected in the relapsed/refractory population. Those serious adverse reactions attributed to arsenic trioxide included APL differentiation syndrome (3), leucocytosis (3), prolonged QT interval (4, 1 with torsade de pointes), atrial fibrillation/atrial flutter (1), hyperglycaemia (2) and a variety of serious adverse reactions related to haemorrhage, infections, pain, diarrhoea, nausea.", "truncated": false}, "after_length": 445, "after_sha256": "e00ff501989a71fc88b2bf0a1e194eb003538d8070516e2b21aa0c732ee3774a", "annex": "I", "before": {"end": 445, "start": 0, "text": "Serious adverse reactions were common (1-10 %) and not unexpected in the relapsed/refractory population. Those serious adverse reactions attributed to arsenic trioxide included APL differentiation syndrome (3), leucocytosis (3), prolonged QT interval (4, 1 with torsade de pointes), atrial fibrillation/atrial flutter (1), hyperglycaemia (2) and a variety of serious adverse reactions related to haemorrhage, infections, pain, diarrhoea, nausea.", "truncated": false}, "before_length": 445, "before_sha256": "e00ff501989a71fc88b2bf0a1e194eb003538d8070516e2b21aa0c732ee3774a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-02efab9f08351153cb284ecd", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000388", "medicine_name": "Trisenox", "medicine_slug": "trisenox", "observed_at": "2026-10-12T19:02:27Z", "pipeline_version": "2.0.0", "presentation_label": "TRISENOX 1 mg/ml concentrate for solution for infusion TRISENOX 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": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "b5ada3476b5436cdde0bd6dbc7e49908b8720c4e91b27923152641fdd73a2d5c", "source_snapshot_id": "source-d86357b928da66e696014503", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/trisenox-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 205}
{"after": {"end": 789, "start": 0, "text": "When a single 100 mg dose of oral sildenafil was administered with erythromycin, a moderate CYP3A4 inhibitor, at steady state (500 mg twice daily for 5 days), there was a 182 % increase in sildenafil systemic exposure (AUC). For dose recommendations, see section 4.2. In healthy male volunteers, there was no evidence of an effect of azithromycin (500 mg daily for 3 days) on the AUC, Cmax, Tmax, elimination rate constant, or subsequent half-life of oral sildenafil or its principal circulating metabolite. No dose adjustment is required. Cimetidine (800 mg), a cytochrome P450 inhibitor and a non-specific CYP3A4 inhibitor, caused a 56 % increase in plasma sildenafil concentrations when co-administered with oral sildenafil (50 mg) to healthy volunteers. No dose adjustment is required.", "truncated": false}, "after_length": 789, "after_sha256": "e2fba0400d387a7a3cfdd1778fef26b16b84153d7fe6fdeaabf232d7b2e0b809", "annex": "I", "before": {"end": 789, "start": 0, "text": "When a single 100 mg dose of oral sildenafil was administered with erythromycin, a moderate CYP3A4 inhibitor, at steady state (500 mg twice daily for 5 days), there was a 182 % increase in sildenafil systemic exposure (AUC). For dose recommendations, see section 4.2. In healthy male volunteers, there was no evidence of an effect of azithromycin (500 mg daily for 3 days) on the AUC, Cmax, Tmax, elimination rate constant, or subsequent half-life of oral sildenafil or its principal circulating metabolite. No dose adjustment is required. Cimetidine (800 mg), a cytochrome P450 inhibitor and a non-specific CYP3A4 inhibitor, caused a 56 % increase in plasma sildenafil concentrations when co-administered with oral sildenafil (50 mg) to healthy volunteers. No dose adjustment is required.", "truncated": false}, "before_length": 789, "before_sha256": "e2fba0400d387a7a3cfdd1778fef26b16b84153d7fe6fdeaabf232d7b2e0b809", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0307ca96e21110dd72b17e7e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000638", "medicine_name": "Revatio", "medicine_slug": "revatio", "observed_at": "2026-10-12T19:08:51Z", "pipeline_version": "2.0.0", "presentation_label": "Revatio 0.8 mg/ml solution for injection", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "3fdd820dcc75acdfd3ef6e1aa7aef33b64b7a935f6f4f525ffdcfe55fe376bcc", "source_snapshot_id": "source-967e58a055aaa321d30c17b5", "source_updated_at": "2025-09-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/revatio-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 791}
{"after": {"end": 337, "start": 0, "text": "Prolonged erections and priapism have been reported with sildenafil in post-marketing experience. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result (see section 4.8).", "truncated": false}, "after_length": 337, "after_sha256": "238c9547683208e4ab5de229d4779dcd391a5cdbef7293fd4246d40976034699", "annex": "I", "before": {"end": 337, "start": 0, "text": "Prolonged erections and priapism have been reported with sildenafil in post-marketing experience. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result (see section 4.8).", "truncated": false}, "before_length": 337, "before_sha256": "238c9547683208e4ab5de229d4779dcd391a5cdbef7293fd4246d40976034699", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0307e6ce6d1c84a7991bab55", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000638", "medicine_name": "Revatio", "medicine_slug": "revatio", "observed_at": "2026-10-12T19:08:51Z", "pipeline_version": "2.0.0", "presentation_label": "Revatio 0.8 mg/ml solution for injection", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "3fdd820dcc75acdfd3ef6e1aa7aef33b64b7a935f6f4f525ffdcfe55fe376bcc", "source_snapshot_id": "source-967e58a055aaa321d30c17b5", "source_updated_at": "2025-09-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/revatio-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 734}
{"after": {"end": 416, "start": 0, "text": "La sécurité d’emploi et l’efficacité de l’utilisation concomitante de Xtandi et d’une chimiothérapie cytotoxique n’ont pas été établies. L’administration concomitante d’enzalutamide n’a pas d’effet cliniquement significatif sur la pharmacocinétique du docétaxel administré par voie intraveineuse (voir rubrique 4.5) ; cependant, une hausse de la fréquence de neutropénie induite par le docétaxel ne peut être exclue.", "truncated": false}, "after_length": 416, "after_sha256": "4c3523fbc265abfde74b8f84060534bbeaca75cc946a046f7f8149907ac8ae1a", "annex": "I", "before": {"end": 416, "start": 0, "text": "La sécurité d’emploi et l’efficacité de l’utilisation concomitante de Xtandi et d’une chimiothérapie cytotoxique n’ont pas été établies. L’administration concomitante d’enzalutamide n’a pas d’effet cliniquement significatif sur la pharmacocinétique du docétaxel administré par voie intraveineuse (voir rubrique 4.5) ; cependant, une hausse de la fréquence de neutropénie induite par le docétaxel ne peut être exclue.", "truncated": false}, "before_length": 416, "before_sha256": "4c3523fbc265abfde74b8f84060534bbeaca75cc946a046f7f8149907ac8ae1a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-031fc5b4313bb8cb1ff3148b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002639", "medicine_name": "Xtandi", "medicine_slug": "xtandi", "observed_at": "2026-10-12T13:30:45Z", "pipeline_version": "2.0.0", "presentation_label": "Xtandi 40 mg, comprimé pelliculé Xtandi 80 mg, comprimé pelliculé", "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": "146d50d0de682089206c8c6edbc55f169388489efc96d97e9722ea592ba66301", "source_snapshot_id": "source-d2fba3c0f90382bddd977500", "source_updated_at": "2026-07-29", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xtandi-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1117}
{"after": {"end": 236, "start": 0, "text": "There is insufficient experience with the use of topotecan in patients with severely impaired hepatic function (serum bilirubin 10 mg/dl) due to cirrhosis. Topotecan is not recommended to be used in this patient group (see section 4.4).", "truncated": false}, "after_length": 236, "after_sha256": "bd888b2a14aaa8a6e556525982593e3aef08786ce099188d5e28e5f1ccb192bc", "annex": "I", "before": {"end": 236, "start": 0, "text": "There is insufficient experience with the use of topotecan in patients with severely impaired hepatic function (serum bilirubin 10 mg/dl) due to cirrhosis. Topotecan is not recommended to be used in this patient group (see section 4.4).", "truncated": false}, "before_length": 236, "before_sha256": "bd888b2a14aaa8a6e556525982593e3aef08786ce099188d5e28e5f1ccb192bc", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0326f69a026b4992b65ec199", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000123", "medicine_name": "Hycamtin", "medicine_slug": "hycamtin", "observed_at": "2026-10-12T17:26:10Z", "pipeline_version": "2.0.0", "presentation_label": "HYCAMTIN 1 mg powder for concentrate for solution for infusion HYCAMTIN 4 mg powder for concentrate for solution for infusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "5c152141b53e2793fa084f4367d516f378805cad1930405e70758c7fdb02fb17", "source_snapshot_id": "source-6fe04bbf4adebecc8fc5931f", "source_updated_at": "2026-01-20", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/hycamtin-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 112}
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{"after": {"end": 304, "start": 0, "text": "La posologie recommandée d'AMGEVITA pour les patients atteints de spondylarthrite ankylosante, de spondyloarthrite axiale sans signes radiographiques de SA et pour les patients atteints de rhumatisme psoriasique est de 40 mg d'adalimumab en dose unique toutes les deux semaines, en injection souscutanée.", "truncated": false}, "after_length": 304, "after_sha256": "37c0458b4e917bdbdc3ff8488609cb5bb4efbbea4ea5a93ef889f08a47871884", "annex": "I", "before": {"end": 304, "start": 0, "text": "La posologie recommandée d'AMGEVITA pour les patients atteints de spondylarthrite ankylosante, de spondyloarthrite axiale sans signes radiographiques de SA et pour les patients atteints de rhumatisme psoriasique est de 40 mg d'adalimumab en dose unique toutes les deux semaines, en injection souscutanée.", "truncated": false}, "before_length": 304, "before_sha256": "37c0458b4e917bdbdc3ff8488609cb5bb4efbbea4ea5a93ef889f08a47871884", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-037382848d35abe96b3abb74", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004212", "medicine_name": "Amgevita", "medicine_slug": "amgevita", "observed_at": "2026-10-12T13:39:47Z", "pipeline_version": "2.0.0", "presentation_label": "AMGEVITA 20 mg solution injectable en seringue préremplie AMGEVITA 40 mg solution injectable en seringue préremplie AMGEVITA 80 mg solution injectable en seringue préremplie AMGEVITA 40 mg solution injectable en stylo prérempli AMGEVITA 80 mg solution injectable en stylo prérempli", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "495de747483c4d23bf886e5c2174a036eaa23b3ee105284779c8eca84fa7417d", "source_snapshot_id": "source-49ac79fb98e8a5f00535ae35", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/amgevita-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 2580}
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{"after": {"end": 848, "start": 0, "text": "Aucune étude n’a été réalisée avec l’enzalutamide chez des insuffisants rénaux. Les patients dont le taux de créatinine sérique était supérieur à 177 µmol/L (2 mg/dL) ont été exclus des études cliniques. Au vu d’une analyse pharmacocinétique de population, aucune adaptation posologique n’est nécessaire chez les patients dont la clairance de la créatinine calculée (ClCr) est supérieure ou égale à 30 mL/min (estimée au moyen de la formule de Cockcroft et Gault). L’enzalutamide n’a pas été évalué chez des patients atteints d’insuffisance rénale sévère (ClCr < 30 mL/min) ou d’une maladie rénale de stade terminal, et la prudence est recommandée lorsque ces patients sont traités. Il est peu probable que l’enzalutamide soit éliminé de façon significative lors d’une hémodialyse intermittente ou d’une dialyse péritonéale continue en ambulatoire.", "truncated": false}, "after_length": 848, "after_sha256": "42fa00dff5afadc1386196b25e351fa5ecb56b4c481c10128218a0cd7c090e24", "annex": "I", "before": {"end": 848, "start": 0, "text": "Aucune étude n’a été réalisée avec l’enzalutamide chez des insuffisants rénaux. Les patients dont le taux de créatinine sérique était supérieur à 177 µmol/L (2 mg/dL) ont été exclus des études cliniques. Au vu d’une analyse pharmacocinétique de population, aucune adaptation posologique n’est nécessaire chez les patients dont la clairance de la créatinine calculée (ClCr) est supérieure ou égale à 30 mL/min (estimée au moyen de la formule de Cockcroft et Gault). L’enzalutamide n’a pas été évalué chez des patients atteints d’insuffisance rénale sévère (ClCr < 30 mL/min) ou d’une maladie rénale de stade terminal, et la prudence est recommandée lorsque ces patients sont traités. Il est peu probable que l’enzalutamide soit éliminé de façon significative lors d’une hémodialyse intermittente ou d’une dialyse péritonéale continue en ambulatoire.", "truncated": false}, "before_length": 848, "before_sha256": "42fa00dff5afadc1386196b25e351fa5ecb56b4c481c10128218a0cd7c090e24", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-037c9834409ba62f56a09156", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002639", "medicine_name": "Xtandi", "medicine_slug": "xtandi", "observed_at": "2026-10-12T13:30:45Z", "pipeline_version": "2.0.0", "presentation_label": "Xtandi 40 mg, comprimé pelliculé Xtandi 80 mg, comprimé pelliculé", "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": "146d50d0de682089206c8c6edbc55f169388489efc96d97e9722ea592ba66301", "source_snapshot_id": "source-d2fba3c0f90382bddd977500", "source_updated_at": "2026-07-29", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xtandi-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1958}
{"after": {"end": 454, "start": 0, "text": "La buprénorphine est fortement métabolisée dans le foie et les taux plasmatiques de buprénorphine sont plus élevés chez les patients souffrant d'insuffisance hépatique. Le tableau 3 résume les résultats d'un essai clinique dans lequel l'exposition à la buprénorphine a été déterminée après l'administration d'un comprimé sublingual de buprénorphine/naloxone 2 0/0,5 mg à des sujets sains et à des sujets présentant divers degrés d'insuffisance hépatique.", "truncated": false}, "after_length": 454, "after_sha256": "77938719a1abe81f10d0a35628e9fdf63d488c841ea0e310e0ab25f7c8c8882c", "annex": "I", "before": {"end": 454, "start": 0, "text": "La buprénorphine est fortement métabolisée dans le foie et les taux plasmatiques de buprénorphine sont plus élevés chez les patients souffrant d'insuffisance hépatique. Le tableau 3 résume les résultats d'un essai clinique dans lequel l'exposition à la buprénorphine a été déterminée après l'administration d'un comprimé sublingual de buprénorphine/naloxone 2 0/0,5 mg à des sujets sains et à des sujets présentant divers degrés d'insuffisance hépatique.", "truncated": false}, "before_length": 454, "before_sha256": "77938719a1abe81f10d0a35628e9fdf63d488c841ea0e310e0ab25f7c8c8882c", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-038d566eb69e233cd61424c8", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006188", "medicine_name": "Buprenorphine Neuraxpharm", "medicine_slug": "buprenorphine-neuraxpharm", "observed_at": "2026-10-12T19:39:14Z", "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": "f83300398ca578b6c52fe73b15e336e19057f193df5dbaa62822f3b6d9ea8f46", "source_snapshot_id": "source-8fc14331f652f6a7e9217eb7", "source_updated_at": "2025-05-16", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/buprenorphine-neuraxpharm-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 480}
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{"after": {"end": 59, "start": 0, "text": "Chaque flacon de 6 mL contient 12 mg de trioxyde d’arsenic.", "truncated": false}, "after_length": 59, "after_sha256": "5c6a3169d8cdef2496c7215e9a68dad53c97a144f4d047e8b870be30a517cd7d", "annex": "I", "before": {"end": 59, "start": 0, "text": "Chaque flacon de 6 mL contient 12 mg de trioxyde d’arsenic.", "truncated": false}, "before_length": 59, "before_sha256": "5c6a3169d8cdef2496c7215e9a68dad53c97a144f4d047e8b870be30a517cd7d", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03b00a4dc342b9c1c027f684", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000388", "medicine_name": "Trisenox", "medicine_slug": "trisenox", "observed_at": "2026-10-12T19:02:30Z", "pipeline_version": "2.0.0", "presentation_label": "TRISENOX 1 mg/mL solution à diluer pour perfusion TRISENOX 2 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": "2", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "84d471b5142e7e1ef0a02035323924afb35918affe0d882315f04168b49b86d6", "source_snapshot_id": "source-e1ce1adb0d4bf10d339d6315", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/trisenox-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 44}
{"after": {"end": 346, "start": 0, "text": "Treatment may then be continued with a treat-and-extend regimen with gradually increased treatment intervals to maintain stable visual and/or anatomic outcomes, however there are insufficient data to conclude on the length of these intervals. If visual and/or anatomic outcomes deteriorate, the treatment interval should be shortened accordingly.", "truncated": false}, "after_length": 346, "after_sha256": "9f7a817f3def759e7aef9da74d78fdf57342af363048625149fee750c0b65038", "annex": "I", "before": {"end": 346, "start": 0, "text": "Treatment may then be continued with a treat-and-extend regimen with gradually increased treatment intervals to maintain stable visual and/or anatomic outcomes, however there are insufficient data to conclude on the length of these intervals. If visual and/or anatomic outcomes deteriorate, the treatment interval should be shortened accordingly.", "truncated": false}, "before_length": 346, "before_sha256": "9f7a817f3def759e7aef9da74d78fdf57342af363048625149fee750c0b65038", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03b10daf18190bbd743f3b0e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002392", "medicine_name": "Eylea", "medicine_slug": "eylea", "observed_at": "2026-10-12T13:53:22Z", "pipeline_version": "2.0.0", "presentation_label": "Eylea 40 mg/mL 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": "8ec9f7841188f4e35251feb5051d47572abbe281531b8bdaeb3e1668a767b648", "source_snapshot_id": "source-55765f484af9c246c4e50218", "source_updated_at": "2026-03-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/eylea-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 99}
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{"after": {"end": 445, "start": 0, "text": "5. Nettoyer le dessus du bouchon en élastomère et introduire une nouvelle seringue avec aiguille dans le flacon. Retourner le flacon et s’assurer que l’extrémité de l’aiguille se situe en dessous de la surface du liquide. Tirer le piston afin d’aspirer le volume de médicament correspondant à la dose appropriée, en veillant à expulser toute bulle d’air présente dans la seringue. Retirer la seringue avec aiguille du flacon et jeter l’aiguille.", "truncated": false}, "after_length": 445, "after_sha256": "a38338eb7b3685fa2a76779067cee5a92b4e8fa6de268d0d062a11afdce1770d", "annex": "I", "before": {"end": 445, "start": 0, "text": "5. Nettoyer le dessus du bouchon en élastomère et introduire une nouvelle seringue avec aiguille dans le flacon. Retourner le flacon et s’assurer que l’extrémité de l’aiguille se situe en dessous de la surface du liquide. Tirer le piston afin d’aspirer le volume de médicament correspondant à la dose appropriée, en veillant à expulser toute bulle d’air présente dans la seringue. Retirer la seringue avec aiguille du flacon et jeter l’aiguille.", "truncated": false}, "before_length": 445, "before_sha256": "a38338eb7b3685fa2a76779067cee5a92b4e8fa6de268d0d062a11afdce1770d", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0458dd7c56826df2b2e994a3", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004984", "medicine_name": "Azacitidine Mylan", "medicine_slug": "azacitidine-mylan", "observed_at": "2026-10-12T13:35:18Z", "pipeline_version": "2.0.0", "presentation_label": "Azacitidine Mylan 25 mg/mL poudre pour suspension injectable", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "8a23b15a1ee68b06c39713bce2cbde058eec479426bfc524dfa8d65f8d0f9265", "source_snapshot_id": "source-3f5e3d8a9ef30a41ad45c883", "source_updated_at": "2026-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/azacitidine-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": 678}
{"after": {"end": 55, "start": 0, "text": "Filgrastim pour la mobilisation des CSP, utilisé seul :", "truncated": false}, "after_length": 55, "after_sha256": "311a67a0f2ce34f202ac12262fe96280105c736256da0cdc645423fb84a2363d", "annex": "I", "before": {"end": 55, "start": 0, "text": "Filgrastim pour la mobilisation des CSP, utilisé seul :", "truncated": false}, "before_length": 55, "before_sha256": "311a67a0f2ce34f202ac12262fe96280105c736256da0cdc645423fb84a2363d", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-046badc4ade7b27b9e07e873", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000917", "medicine_name": "Zarzio", "medicine_slug": "zarzio", "observed_at": "2026-10-12T13:36:13Z", "pipeline_version": "2.0.0", "presentation_label": "Zarzio 30 MU/0,5 mL solution injectable ou pour perfusion en seringue préremplie. Zarzio 48 MU/0,5 mL solution injectable ou pour perfusion 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": "968afffa2a72df6dda240602dfb44e50ec1ab7fb854d6d777ac92e19cd52fe6f", "source_snapshot_id": "source-bb736e6d90be96a990172ed5", "source_updated_at": "2026-06-05", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/zarzio-epar-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": 566, "start": 0, "text": "In study PIPF-016, the decline of percent predicted FVC from Baseline at Week 52 of treatment was significantly reduced in patients receiving Esbriet (N=278) compared with patients receiving placebo (N=277; p<0.000001, rank ANCOVA). Treatment with Esbriet also significantly reduced the decline of percent predicted FVC from Baseline at Weeks 13 (p<0.000001), 26 (p<0.000001), and 39 (p=0.000002). At Week 52, a decline from Baseline in percent predicted FVC of ≥10% or death was seen in 17% of patients receiving Esbriet compared to 32% receiving placebo (Table 4).", "truncated": false}, "after_length": 566, "after_sha256": "8e03692e88931e618baf54979a6fddf2072e98e6fb295c80ec46187e754edcc3", "annex": "I", "before": {"end": 566, "start": 0, "text": "In study PIPF-016, the decline of percent predicted FVC from Baseline at Week 52 of treatment was significantly reduced in patients receiving Esbriet (N=278) compared with patients receiving placebo (N=277; p<0.000001, rank ANCOVA). Treatment with Esbriet also significantly reduced the decline of percent predicted FVC from Baseline at Weeks 13 (p<0.000001), 26 (p<0.000001), and 39 (p=0.000002). At Week 52, a decline from Baseline in percent predicted FVC of ≥10% or death was seen in 17% of patients receiving Esbriet compared to 32% receiving placebo (Table 4).", "truncated": false}, "before_length": 566, "before_sha256": "8e03692e88931e618baf54979a6fddf2072e98e6fb295c80ec46187e754edcc3", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-046f0a06321ccedd0b7d32f6", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002154", "medicine_name": "Esbriet", "medicine_slug": "esbriet", "observed_at": "2026-10-12T13:33:23Z", "pipeline_version": "2.0.0", "presentation_label": "Esbriet 267 mg film-coated tablets Esbriet 534 mg film-coated tablets Esbriet 801 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": "1c94f76794606f5da8bba59cce7aac025c02e0b7db8cbfb575d178ac07899bde", "source_snapshot_id": "source-215e5fbd703aae1bfb8b7f8b", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/esbriet-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 379}
{"after": {"end": 856, "start": 0, "text": "A total of 1717 asymptomatic or mildly symptomatic chemotherapy-naïve patients were randomised 1:1 to receive either enzalutamide orally at a dose of 160 mg once daily (N = 872) or placebo orally once daily (N = 845). Patients with visceral disease, patients with a history of mild to moderate heart failure (NYHA Class I or II), and patients taking medicinal products associated with lowering the seizure threshold were allowed. Patients with a previous history of seizure or a condition that might predispose to seizure and patients with moderate or severe pain from prostate cancer were excluded. Study treatment continued until disease progression (evidence of radiographic progression, a skeletal-related event, or clinical progression) and the initiation of either a cytotoxic chemotherapy or an investigational agent, or until unacceptable toxicity.", "truncated": false}, "after_length": 856, "after_sha256": "dae1a1a14f0a96e1db5d0f406040fe01248d141767b4c772097ceff684cd323a", "annex": "I", "before": {"end": 856, "start": 0, "text": "A total of 1717 asymptomatic or mildly symptomatic chemotherapy-naïve patients were randomised 1:1 to receive either enzalutamide orally at a dose of 160 mg once daily (N = 872) or placebo orally once daily (N = 845). Patients with visceral disease, patients with a history of mild to moderate heart failure (NYHA Class I or II), and patients taking medicinal products associated with lowering the seizure threshold were allowed. Patients with a previous history of seizure or a condition that might predispose to seizure and patients with moderate or severe pain from prostate cancer were excluded. Study treatment continued until disease progression (evidence of radiographic progression, a skeletal-related event, or clinical progression) and the initiation of either a cytotoxic chemotherapy or an investigational agent, or until unacceptable toxicity.", "truncated": false}, "before_length": 856, "before_sha256": "dae1a1a14f0a96e1db5d0f406040fe01248d141767b4c772097ceff684cd323a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-04914098962772476d2d973b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002639", "medicine_name": "Xtandi", "medicine_slug": "xtandi", "observed_at": "2026-10-12T13:30:37Z", "pipeline_version": "2.0.0", "presentation_label": "Xtandi 40 mg filmcoated tablets Xtandi 80 mg filmcoated tablets", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "5ab28fb569f2fd21a2331b810ec038440ac438d84a6b8a346e430d7979fee559", "source_snapshot_id": "source-331c917f03e289e05c6dd9af", "source_updated_at": "2026-07-29", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/xtandi-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1327}
{"after": {"end": 530, "start": 0, "text": "In volunteers with mild to moderate hepatic cirrhosis (Child-Pugh class A and B) sildenafil clearance was reduced, resulting in increases in AUC (85 %) and Cmax (47 %) compared to age-matched volunteers with no hepatic impairment. In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased by 154 % and 87 %, respectively in cirrhotic subjects compared to subjects with normal hepatic function. The pharmacokinetics of sildenafil in patients with severely impaired hepatic function have not been studied.", "truncated": false}, "after_length": 530, "after_sha256": "fd93cca2e5e910a18402bdc06b77b865998b0f57806bac8ec440afb663bba45a", "annex": "I", "before": {"end": 530, "start": 0, "text": "In volunteers with mild to moderate hepatic cirrhosis (Child-Pugh class A and B) sildenafil clearance was reduced, resulting in increases in AUC (85 %) and Cmax (47 %) compared to age-matched volunteers with no hepatic impairment. In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased by 154 % and 87 %, respectively in cirrhotic subjects compared to subjects with normal hepatic function. The pharmacokinetics of sildenafil in patients with severely impaired hepatic function have not been studied.", "truncated": false}, "before_length": 530, "before_sha256": "fd93cca2e5e910a18402bdc06b77b865998b0f57806bac8ec440afb663bba45a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-049b791324955e76fa035ab0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000638", "medicine_name": "Revatio", "medicine_slug": "revatio", "observed_at": "2026-10-12T19:08:51Z", "pipeline_version": "2.0.0", "presentation_label": "Revatio 0.8 mg/ml solution for injection", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "3fdd820dcc75acdfd3ef6e1aa7aef33b64b7a935f6f4f525ffdcfe55fe376bcc", "source_snapshot_id": "source-967e58a055aaa321d30c17b5", "source_updated_at": "2025-09-17", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/revatio-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1089}
{"after": {"end": 617, "start": 0, "text": "The effects of hepatic impairment on the pharmacokinetics of buprenorphine were evaluated in a single-dose postmarketing study. Since buprenorphine is extensively metabolized, plasma levels were found to be elevated for buprenorphine in patients with moderate and severe hepatic impairment. Patients should be monitored for signs and symptoms of toxicity or overdose caused by increased levels of buprenorphine. Buprenorphine should be used with caution in patients with moderate hepatic impairment. In patients with severe hepatic insufficiency the use of buprenorphine is contraindicated (See sections 4.3 and 5.2).", "truncated": false}, "after_length": 617, "after_sha256": "58689228e00ac056c6fdedd720edcb3a11d283a6fa2f516e8dc19fbf149b4a5d", "annex": "I", "before": {"end": 617, "start": 0, "text": "The effects of hepatic impairment on the pharmacokinetics of buprenorphine were evaluated in a single-dose postmarketing study. Since buprenorphine is extensively metabolized, plasma levels were found to be elevated for buprenorphine in patients with moderate and severe hepatic impairment. Patients should be monitored for signs and symptoms of toxicity or overdose caused by increased levels of buprenorphine. Buprenorphine should be used with caution in patients with moderate hepatic impairment. In patients with severe hepatic insufficiency the use of buprenorphine is contraindicated (See sections 4.3 and 5.2).", "truncated": false}, "before_length": 617, "before_sha256": "58689228e00ac056c6fdedd720edcb3a11d283a6fa2f516e8dc19fbf149b4a5d", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-04cd6ec2f7940a93a047ddc8", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006188", "medicine_name": "Buprenorphine Neuraxpharm", "medicine_slug": "buprenorphine-neuraxpharm", "observed_at": "2026-10-12T19:39:03Z", "pipeline_version": "2.0.0", "presentation_label": "Buprenorphine Neuraxpharm 0.4 mg sublingual films Buprenorphine Neuraxpharm 4 mg sublingual films Buprenorphine Neuraxpharm 6 mg sublingual films Buprenorphine Neuraxpharm 8 mg sublingual films", "presentation_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": "ba3471124a2eb32d4b294de55b522ed52fcd4916a236e260512b067d7985e7ae", "source_snapshot_id": "source-27e01c9d9f02ff9d6796fe48", "source_updated_at": "2025-05-16", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/buprenorphine-neuraxpharm-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 215}
{"after": {"end": 300, "start": 0, "text": "Most haematological adverse reactions were managed by routine monitoring of complete blood counts and delaying azacitidine administration in the next cycle, prophylactic antibiotics and/or growth factor support (e.g. GCSF) for neutropenia and transfusions for anaemia or thrombocytopenia as required.", "truncated": false}, "after_length": 300, "after_sha256": "9e35f30a2be0db64b71059bb47eecdaa2d9d9c0dae33a526dd2d9da4c6b1ca4c", "annex": "I", "before": {"end": 300, "start": 0, "text": "Most haematological adverse reactions were managed by routine monitoring of complete blood counts and delaying azacitidine administration in the next cycle, prophylactic antibiotics and/or growth factor support (e.g. GCSF) for neutropenia and transfusions for anaemia or thrombocytopenia as required.", "truncated": false}, "before_length": 300, "before_sha256": "9e35f30a2be0db64b71059bb47eecdaa2d9d9c0dae33a526dd2d9da4c6b1ca4c", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-04d663f868d735a7667e2f35", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004984", "medicine_name": "Azacitidine Mylan", "medicine_slug": "azacitidine-mylan", "observed_at": "2026-10-12T13:35:15Z", "pipeline_version": "2.0.0", "presentation_label": "Azacitidine Mylan 25 mg/mL powder for suspension for injection", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "2dab763f1da8ff3942467e20de6d30b5746ef6030def3da15b9994facca1adaf", "source_snapshot_id": "source-0c0faddb540a1c60c41a2ccb", "source_updated_at": "2026-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/azacitidine-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": 362}
{"after": {"end": 275, "start": 0, "text": "La buprénorphine peut provoquer une somnolence, en particulier lorsqu'il y a prise/administration concomitante avec de l’alcool ou avec des dépresseurs du système nerveux central (tels que benzodiazépines, tranquillisants, sédatifs ou hypnotiques) (voir rubriques 4.5 et 4.7)", "truncated": false}, "after_length": 275, "after_sha256": "1b742179dd3d2200c66da712edd3d224781ab6031263f53bf7d8d1dfb5adaecf", "annex": "I", "before": {"end": 275, "start": 0, "text": "La buprénorphine peut provoquer une somnolence, en particulier lorsqu'il y a prise/administration concomitante avec de l’alcool ou avec des dépresseurs du système nerveux central (tels que benzodiazépines, tranquillisants, sédatifs ou hypnotiques) (voir rubriques 4.5 et 4.7)", "truncated": false}, "before_length": 275, "before_sha256": "1b742179dd3d2200c66da712edd3d224781ab6031263f53bf7d8d1dfb5adaecf", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-04e2a4202e9913487a3222b8", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006188", "medicine_name": "Buprenorphine Neuraxpharm", "medicine_slug": "buprenorphine-neuraxpharm", "observed_at": "2026-10-12T19:39:14Z", "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": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "f83300398ca578b6c52fe73b15e336e19057f193df5dbaa62822f3b6d9ea8f46", "source_snapshot_id": "source-8fc14331f652f6a7e9217eb7", "source_updated_at": "2025-05-16", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/buprenorphine-neuraxpharm-epar-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": 100, "start": 0, "text": "Tout médicament non utilisé ou déchet doit être éliminé conformément à la réglementation en vigueur.", "truncated": false}, "after_length": 100, "after_sha256": "f9673871856e0b65a0aab1e2787b76a78aafb072fd8e972a82ee109179a0a58c", "annex": "I", "before": {"end": 100, "start": 0, "text": "Tout médicament non utilisé ou déchet doit être éliminé conformément à la réglementation en vigueur.", "truncated": false}, "before_length": 100, "before_sha256": "f9673871856e0b65a0aab1e2787b76a78aafb072fd8e972a82ee109179a0a58c", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-04eb7adb15b28abdad1c3298", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000917", "medicine_name": "Zarzio", "medicine_slug": "zarzio", "observed_at": "2026-10-12T13:36:13Z", "pipeline_version": "2.0.0", "presentation_label": "Zarzio 30 MU/0,5 mL solution injectable ou pour perfusion en seringue préremplie. Zarzio 48 MU/0,5 mL solution injectable ou pour perfusion en seringue préremplie.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "968afffa2a72df6dda240602dfb44e50ec1ab7fb854d6d777ac92e19cd52fe6f", "source_snapshot_id": "source-bb736e6d90be96a990172ed5", "source_updated_at": "2026-06-05", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/zarzio-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 791}
{"after": {"end": 91, "start": 0, "text": "TRISENOX is indicated for induction of remission, and consolidation in adult patients with:", "truncated": false}, "after_length": 91, "after_sha256": "153ff4867584d1f87a814da220b951c20f2b345f49bc85cd06cf982d64d8a6c6", "annex": "I", "before": {"end": 91, "start": 0, "text": "TRISENOX is indicated for induction of remission, and consolidation in adult patients with:", "truncated": false}, "before_length": 91, "before_sha256": "153ff4867584d1f87a814da220b951c20f2b345f49bc85cd06cf982d64d8a6c6", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-04fccd774d28eb2df0e299ae", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000388", "medicine_name": "Trisenox", "medicine_slug": "trisenox", "observed_at": "2026-10-12T19:02:27Z", "pipeline_version": "2.0.0", "presentation_label": "TRISENOX 1 mg/ml concentrate for solution for infusion TRISENOX 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": "4.1", "section_type": "indication", "source_provider": "European Medicines Agency", "source_sha256": "b5ada3476b5436cdde0bd6dbc7e49908b8720c4e91b27923152641fdd73a2d5c", "source_snapshot_id": "source-d86357b928da66e696014503", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/trisenox-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 54}
{"after": {"end": 188, "start": 0, "text": "Pour les 69 patients préalablement traités par chimiothérapie, la médiane de rPFS a été de 7,9 mois (IC à 95 % =[5,5 ; 10,8]). La réponse du PSA a été de 23,2 % (IC à 95 % =[13,9 ; 34,9]).", "truncated": false}, "after_length": 188, "after_sha256": "536f6c25fd9fe2ba76cfc1b8f418fe3f07f0d28ea4f6937c6f4e1b6ea5dfb7fc", "annex": "I", "before": {"end": 188, "start": 0, "text": "Pour les 69 patients préalablement traités par chimiothérapie, la médiane de rPFS a été de 7,9 mois (IC à 95 % =[5,5 ; 10,8]). La réponse du PSA a été de 23,2 % (IC à 95 % =[13,9 ; 34,9]).", "truncated": false}, "before_length": 188, "before_sha256": "536f6c25fd9fe2ba76cfc1b8f418fe3f07f0d28ea4f6937c6f4e1b6ea5dfb7fc", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-04fd80e6f2fdfcb9602f1b12", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002639", "medicine_name": "Xtandi", "medicine_slug": "xtandi", "observed_at": "2026-10-12T13:30:45Z", "pipeline_version": "2.0.0", "presentation_label": "Xtandi 40 mg, capsule molle", "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": "146d50d0de682089206c8c6edbc55f169388489efc96d97e9722ea592ba66301", "source_snapshot_id": "source-d2fba3c0f90382bddd977500", "source_updated_at": "2026-07-29", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xtandi-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 929}
{"after": {"end": 488, "start": 0, "text": "L’étude PROSPER a été menée chez 1401 patients atteints d’un CPRC non métastatique à haut risque asymptomatique continuant un traitement par suppression androgénique (TSA ; défini comme un analogue de la LHRH ou une orchidectomie bilatérale antérieure). Les patients devaient avoir un temps de doublement du PSA ≤ 10 mois, un taux de PSA ≥ 2 ng/mL et une confirmation de maladie non métastatique par la revue centralisée indépendante en aveugle (blinded independent central review, BICR).", "truncated": false}, "after_length": 488, "after_sha256": "1d2f993477315f499d16455438e0ebae503018e4beb1c7afe6df64500a784a41", "annex": "I", "before": {"end": 488, "start": 0, "text": "L’étude PROSPER a été menée chez 1401 patients atteints d’un CPRC non métastatique à haut risque asymptomatique continuant un traitement par suppression androgénique (TSA ; défini comme un analogue de la LHRH ou une orchidectomie bilatérale antérieure). Les patients devaient avoir un temps de doublement du PSA ≤ 10 mois, un taux de PSA ≥ 2 ng/mL et une confirmation de maladie non métastatique par la revue centralisée indépendante en aveugle (blinded independent central review, BICR).", "truncated": false}, "before_length": 488, "before_sha256": "1d2f993477315f499d16455438e0ebae503018e4beb1c7afe6df64500a784a41", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-051402fabf461f63e66cc0b9", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002639", "medicine_name": "Xtandi", "medicine_slug": "xtandi", "observed_at": "2026-10-12T13:30:45Z", "pipeline_version": "2.0.0", "presentation_label": "Xtandi 40 mg, capsule molle", "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": "146d50d0de682089206c8c6edbc55f169388489efc96d97e9722ea592ba66301", "source_snapshot_id": "source-d2fba3c0f90382bddd977500", "source_updated_at": "2026-07-29", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xtandi-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 643}
{"after": {"end": 1357, "start": 0, "text": "L’effet de l’insuffisance hépatique sur la pharmacocinétique de la buprénorphine a été évalué dans une étude réalisée après commercialisation. En raison de la métabolisation importante de la buprénorphine, on retrouve des taux plasmatiques de buprénorphine plus élevés chez les patients atteints d’insuffisance hépatique. L’exposition systémique est légèrement augmentée chez les sujets atteints d’une insuffisance hépatique légère et aucun ajustement de posologie n’est jugé nécessaire. Après administration d’une dose unique de 2 mg, l’exposition systémique totale est significativement augmentée chez les sujets atteints d’insuffisance hépatique modérée (1,6 fois) et sévère (2,8 fois) comparée aux sujets sains. Les patients doivent être surveillés afin d’éviter les signes et symptômes de toxicité ou de surdosage causés par des taux élevés de buprénorphine. La buprénorphine doit être utilisé avec précaution chez les patients atteints d’insuffisance hépatique modérée et une diminution de la dose initiale et de la dose d’entretien doit être envisagée. Compte tenu d’une exposition élevée chez les patients atteints d’insuffisance hépatique sévère et d’une possible accumulation après l’administration de doses répétées, la buprénorphine ne doit pas être utilisé chez les patients atteints d’insuffisance hépatique sévère (voir rubriques 4.3 et 5.2).", "truncated": false}, "after_length": 1357, "after_sha256": "41561dfcc13c66addeb7c8a860153b60fe2c9450a08346fbc2e2e84f04840162", "annex": "I", "before": {"end": 1357, "start": 0, "text": "L’effet de l’insuffisance hépatique sur la pharmacocinétique de la buprénorphine a été évalué dans une étude réalisée après commercialisation. En raison de la métabolisation importante de la buprénorphine, on retrouve des taux plasmatiques de buprénorphine plus élevés chez les patients atteints d’insuffisance hépatique. L’exposition systémique est légèrement augmentée chez les sujets atteints d’une insuffisance hépatique légère et aucun ajustement de posologie n’est jugé nécessaire. Après administration d’une dose unique de 2 mg, l’exposition systémique totale est significativement augmentée chez les sujets atteints d’insuffisance hépatique modérée (1,6 fois) et sévère (2,8 fois) comparée aux sujets sains. Les patients doivent être surveillés afin d’éviter les signes et symptômes de toxicité ou de surdosage causés par des taux élevés de buprénorphine. La buprénorphine doit être utilisé avec précaution chez les patients atteints d’insuffisance hépatique modérée et une diminution de la dose initiale et de la dose d’entretien doit être envisagée. Compte tenu d’une exposition élevée chez les patients atteints d’insuffisance hépatique sévère et d’une possible accumulation après l’administration de doses répétées, la buprénorphine ne doit pas être utilisé chez les patients atteints d’insuffisance hépatique sévère (voir rubriques 4.3 et 5.2).", "truncated": false}, "before_length": 1357, "before_sha256": "41561dfcc13c66addeb7c8a860153b60fe2c9450a08346fbc2e2e84f04840162", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-051cb6445a1f23f344cbd767", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006188", "medicine_name": "Buprenorphine Neuraxpharm", "medicine_slug": "buprenorphine-neuraxpharm", "observed_at": "2026-10-12T19:39:14Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "f83300398ca578b6c52fe73b15e336e19057f193df5dbaa62822f3b6d9ea8f46", "source_snapshot_id": "source-8fc14331f652f6a7e9217eb7", "source_updated_at": "2025-05-16", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/buprenorphine-neuraxpharm-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 123}
{"after": {"end": 272, "start": 0, "text": "Des études croisées randomisées, en double aveugle, à dose unique ou multiple, menées chez 204 volontaires sains ont montré que le profil pharmacocinétique de Zarzio est comparable à celui du produit de référence après administration par voie souscutanée ou intraveineuse.", "truncated": false}, "after_length": 272, "after_sha256": "97329eb11842afdba6ad7dc45d6d3859927ba05e40415294ded73b085309a1ca", "annex": "I", "before": {"end": 272, "start": 0, "text": "Des études croisées randomisées, en double aveugle, à dose unique ou multiple, menées chez 204 volontaires sains ont montré que le profil pharmacocinétique de Zarzio est comparable à celui du produit de référence après administration par voie souscutanée ou intraveineuse.", "truncated": false}, "before_length": 272, "before_sha256": "97329eb11842afdba6ad7dc45d6d3859927ba05e40415294ded73b085309a1ca", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-05258c4257b57b76424ecbcf", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000917", "medicine_name": "Zarzio", "medicine_slug": "zarzio", "observed_at": "2026-10-12T13:36:13Z", "pipeline_version": "2.0.0", "presentation_label": "Zarzio 30 MU/0,5 mL solution injectable ou pour perfusion en seringue préremplie. Zarzio 48 MU/0,5 mL solution injectable ou pour perfusion 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": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "968afffa2a72df6dda240602dfb44e50ec1ab7fb854d6d777ac92e19cd52fe6f", "source_snapshot_id": "source-bb736e6d90be96a990172ed5", "source_updated_at": "2026-06-05", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/zarzio-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 695}
{"after": {"end": 329, "start": 0, "text": "In view of limited safety and efficacy data in patients with secondary acute myelogenous leukaemia (AML), filgrastim should be administered with caution. The safety and efficacy of filgrastim administration in de novo AML patients aged < 55 years with good cytogenetics [t(8;21), t(15;17), and inv(16)] have not been established.", "truncated": false}, "after_length": 329, "after_sha256": "856d1461775e002d6ea9d4a9411cf58711d106d1b5171ae6908a76c9785f44d2", "annex": "I", "before": {"end": 329, "start": 0, "text": "In view of limited safety and efficacy data in patients with secondary acute myelogenous leukaemia (AML), filgrastim should be administered with caution. The safety and efficacy of filgrastim administration in de novo AML patients aged < 55 years with good cytogenetics [t(8;21), t(15;17), and inv(16)] have not been established.", "truncated": false}, "before_length": 329, "before_sha256": "856d1461775e002d6ea9d4a9411cf58711d106d1b5171ae6908a76c9785f44d2", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-052eea9140acb67a1d9f9a32", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000917", "medicine_name": "Zarzio", "medicine_slug": "zarzio", "observed_at": "2026-10-12T13:36:11Z", "pipeline_version": "2.0.0", "presentation_label": "Zarzio 30 MU/0.5 mL solution for injection or infusion in pre-filled syringe Zarzio 48 MU/0.5 mL solution for injection or infusion 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": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "51d80b39d33523efaa2f2e8b5daf45ee3bba97f334c746631ab8a9aebbe7ce22", "source_snapshot_id": "source-f8af93bde444dc30d01f0a12", "source_updated_at": "2026-06-05", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/zarzio-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 231}
{"after": {"end": 167, "start": 0, "text": "Tableau 1 : Effets indésirables observés dans une étude clinique pivot et/ou notifiés dans le cadre de la pharmacovigilance, présentés par classe de systèmes d’organes", "truncated": false}, "after_length": 167, "after_sha256": "cc094b89a6a17a20d9e1c206b78bc379da64554b98f4765fb663bb47e28e4c22", "annex": "I", "before": {"end": 167, "start": 0, "text": "Tableau 1 : Effets indésirables observés dans une étude clinique pivot et/ou notifiés dans le cadre de la pharmacovigilance, présentés par classe de systèmes d’organes", "truncated": false}, "before_length": 167, "before_sha256": "cc094b89a6a17a20d9e1c206b78bc379da64554b98f4765fb663bb47e28e4c22", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-05395841e38983ac7dfa9507", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006188", "medicine_name": "Buprenorphine Neuraxpharm", "medicine_slug": "buprenorphine-neuraxpharm", "observed_at": "2026-10-12T19:39:14Z", "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": "4.7", "section_type": "driving", "source_provider": "European Medicines Agency", "source_sha256": "f83300398ca578b6c52fe73b15e336e19057f193df5dbaa62822f3b6d9ea8f46", "source_snapshot_id": "source-8fc14331f652f6a7e9217eb7", "source_updated_at": "2025-05-16", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/buprenorphine-neuraxpharm-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 314}
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{"after": {"end": 181, "start": 0, "text": "Des cas de splénomégalie et de rupture splénique ont été observés à la suite de l’administration de filgrastim. Certains cas de rupture splénique ont été fatals (voir rubrique 4.4).", "truncated": false}, "after_length": 181, "after_sha256": "1eb2ecaacb583ef7754bc57021f1527eb4e53a61561bfce50d697b6815193e69", "annex": "I", "before": {"end": 181, "start": 0, "text": "Des cas de splénomégalie et de rupture splénique ont été observés à la suite de l’administration de filgrastim. Certains cas de rupture splénique ont été fatals (voir rubrique 4.4).", "truncated": false}, "before_length": 181, "before_sha256": "1eb2ecaacb583ef7754bc57021f1527eb4e53a61561bfce50d697b6815193e69", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-05afacd47d4c69fa447f9bd1", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000917", "medicine_name": "Zarzio", "medicine_slug": "zarzio", "observed_at": "2026-10-12T13:36:13Z", "pipeline_version": "2.0.0", "presentation_label": "Zarzio 30 MU/0,5 mL solution injectable ou pour perfusion en seringue préremplie. Zarzio 48 MU/0,5 mL solution injectable ou pour perfusion 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": "968afffa2a72df6dda240602dfb44e50ec1ab7fb854d6d777ac92e19cd52fe6f", "source_snapshot_id": "source-bb736e6d90be96a990172ed5", "source_updated_at": "2026-06-05", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/zarzio-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 560}
{"after": {"end": 588, "start": 0, "text": "Aucune étude spécifique concernant l’effet du sorafénib sur la cicatrisation des plaies n’a été effectuée. Chez les patients devant subir une intervention chirurgicale majeure, une interruption temporaire du sorafénib est recommandée à titre préventif. Il existe peu de données cliniques concernant le meilleur moment de ré-instauration du traitement après une intervention chirurgicale majeure. Par conséquent, la décision de reprendre le traitement par sorafénib après une intervention chirurgicale majeure doit reposer sur le constat clinique d’une cicatrisation appropriée des plaies.", "truncated": false}, "after_length": 588, "after_sha256": "4c3006a3e1fe93aa3a1f3f814141bd703c6a99f8d82b542702c9d55fa2c8415d", "annex": "I", "before": {"end": 588, "start": 0, "text": "Aucune étude spécifique concernant l’effet du sorafénib sur la cicatrisation des plaies n’a été effectuée. Chez les patients devant subir une intervention chirurgicale majeure, une interruption temporaire du sorafénib est recommandée à titre préventif. Il existe peu de données cliniques concernant le meilleur moment de ré-instauration du traitement après une intervention chirurgicale majeure. Par conséquent, la décision de reprendre le traitement par sorafénib après une intervention chirurgicale majeure doit reposer sur le constat clinique d’une cicatrisation appropriée des plaies.", "truncated": false}, "before_length": 588, "before_sha256": "4c3006a3e1fe93aa3a1f3f814141bd703c6a99f8d82b542702c9d55fa2c8415d", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-05b8259c8d2e134a49f383e0", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000690", "medicine_name": "Nexavar", "medicine_slug": "nexavar", "observed_at": "2026-10-12T19:46:57Z", "pipeline_version": "2.0.0", "presentation_label": "Nexavar 200 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": "453fff219cfe53ce95d40f8a77054887fe751af6807a8563eebfcfdb01b634d9", "source_snapshot_id": "source-b117901a8036012dde2ca350", "source_updated_at": "2025-03-28", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/nexavar-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 155}
{"after": {"end": 521, "start": 0, "text": "Lors d’un essai de non-infériorité multicentrique de phase III, comparant la trétinoïne (ou acide touttransrétinoïque (ATRA) associée à une chimiothérapie avec la trétinoïne associée au trioxyde d’arsenic chez des patients atteints de LPA à risque faible à intermédiaire nouvellement diagnostiquée (étude APL0406; voir également rubrique 5.1), des effets indésirables graves comprenant hépatotoxicité, thrombocytopénie, neutropénie et prolongation du QTc ont été observés chez des patients traités par trioxyde d'arsenic.", "truncated": false}, "after_length": 521, "after_sha256": "98c7b435e493a7599b1da5ba5783ebec4f5528516b0dfcf51e802f57a527396f", "annex": "I", "before": {"end": 521, "start": 0, "text": "Lors d’un essai de non-infériorité multicentrique de phase III, comparant la trétinoïne (ou acide touttransrétinoïque (ATRA) associée à une chimiothérapie avec la trétinoïne associée au trioxyde d’arsenic chez des patients atteints de LPA à risque faible à intermédiaire nouvellement diagnostiquée (étude APL0406; voir également rubrique 5.1), des effets indésirables graves comprenant hépatotoxicité, thrombocytopénie, neutropénie et prolongation du QTc ont été observés chez des patients traités par trioxyde d'arsenic.", "truncated": false}, "before_length": 521, "before_sha256": "98c7b435e493a7599b1da5ba5783ebec4f5528516b0dfcf51e802f57a527396f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-05bf8e05c16d611e6cdd2d13", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000388", "medicine_name": "Trisenox", "medicine_slug": "trisenox", "observed_at": "2026-10-12T19:02:30Z", "pipeline_version": "2.0.0", "presentation_label": "TRISENOX 1 mg/mL solution à diluer pour perfusion TRISENOX 2 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": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "84d471b5142e7e1ef0a02035323924afb35918affe0d882315f04168b49b86d6", "source_snapshot_id": "source-e1ce1adb0d4bf10d339d6315", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/trisenox-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 215}
{"after": {"end": 352, "start": 0, "text": "The safety profile of topotecan when given in combination with cisplatin in the cervical cancer clinical studies is consistent with that seen with topotecan monotherapy. The overall haematological toxicity is lower in patients treated with topotecan in combination with cisplatin compared to topotecan monotherapy, but higher than with cisplatin alone.", "truncated": false}, "after_length": 352, "after_sha256": "dba46848d483eab4f0e877bf7b4d1d79627bd99fa6e75bff5d560c3e6fbad0f1", "annex": "I", "before": {"end": 352, "start": 0, "text": "The safety profile of topotecan when given in combination with cisplatin in the cervical cancer clinical studies is consistent with that seen with topotecan monotherapy. The overall haematological toxicity is lower in patients treated with topotecan in combination with cisplatin compared to topotecan monotherapy, but higher than with cisplatin alone.", "truncated": false}, "before_length": 352, "before_sha256": "dba46848d483eab4f0e877bf7b4d1d79627bd99fa6e75bff5d560c3e6fbad0f1", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-05d81940d0b9cd536e6047a6", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000123", "medicine_name": "Hycamtin", "medicine_slug": "hycamtin", "observed_at": "2026-10-12T17:26:10Z", "pipeline_version": "2.0.0", "presentation_label": "HYCAMTIN 1 mg powder for concentrate for solution for infusion HYCAMTIN 4 mg powder for concentrate for solution for infusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "5c152141b53e2793fa084f4367d516f378805cad1930405e70758c7fdb02fb17", "source_snapshot_id": "source-6fe04bbf4adebecc8fc5931f", "source_updated_at": "2026-01-20", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/hycamtin-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 190}
{"after": {"end": 837, "start": 0, "text": "Concomitant use of buprenorphine and sedative medicinal products such as benzodiazepines, gabapentinoids or related medicinal products may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing with these sedative medicinal products should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe buprenorphine concomitantly with sedative medicinal products, the lowest effective dose of the sedative medicines should be used, and the duration of treatment should be as short as possible. The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their caregivers to be aware of these symptoms (see section 4.5).", "truncated": false}, "after_length": 837, "after_sha256": "2e8bcf475a225c4bef4178eaaa22f84a46648b82c213a13cfa3c3d37de32e466", "annex": "I", "before": {"end": 837, "start": 0, "text": "Concomitant use of buprenorphine and sedative medicinal products such as benzodiazepines, gabapentinoids or related medicinal products may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing with these sedative medicinal products should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe buprenorphine concomitantly with sedative medicinal products, the lowest effective dose of the sedative medicines should be used, and the duration of treatment should be as short as possible. The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their caregivers to be aware of these symptoms (see section 4.5).", "truncated": false}, "before_length": 837, "before_sha256": "2e8bcf475a225c4bef4178eaaa22f84a46648b82c213a13cfa3c3d37de32e466", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-05ef154fc2312e66c4b294cf", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006188", "medicine_name": "Buprenorphine Neuraxpharm", "medicine_slug": "buprenorphine-neuraxpharm", "observed_at": "2026-10-12T19:39:03Z", "pipeline_version": "2.0.0", "presentation_label": "Buprenorphine Neuraxpharm 0.4 mg sublingual films Buprenorphine Neuraxpharm 4 mg sublingual films Buprenorphine Neuraxpharm 6 mg sublingual films Buprenorphine Neuraxpharm 8 mg sublingual films", "presentation_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": "ba3471124a2eb32d4b294de55b522ed52fcd4916a236e260512b067d7985e7ae", "source_snapshot_id": "source-27e01c9d9f02ff9d6796fe48", "source_updated_at": "2025-05-16", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/buprenorphine-neuraxpharm-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 184}
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{"after": {"end": 222, "start": 0, "text": "Topotécan est contre-indiqué pendant l'allaitement (voir rubrique 4.3). En l'absence de données relatives au passage du topotécan dans le lait maternel humain, l'allaitement doit être interrompu dès le début du traitement.", "truncated": false}, "after_length": 222, "after_sha256": "5842dd607079c7b03b7162b0f48a90634fa08a278b330a8db47757dfb309931e", "annex": "I", "before": {"end": 222, "start": 0, "text": "Topotécan est contre-indiqué pendant l'allaitement (voir rubrique 4.3). En l'absence de données relatives au passage du topotécan dans le lait maternel humain, l'allaitement doit être interrompu dès le début du traitement.", "truncated": false}, "before_length": 222, "before_sha256": "5842dd607079c7b03b7162b0f48a90634fa08a278b330a8db47757dfb309931e", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-065dae9ff9595eb4e252ea6a", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000123", "medicine_name": "Hycamtin", "medicine_slug": "hycamtin", "observed_at": "2026-10-12T17:26:11Z", "pipeline_version": "2.0.0", "presentation_label": "HYCAMTIN 1 mg poudre pour solution à diluer pour perfusion HYCAMTIN 4 mg poudre pour solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.6", "section_type": "pregnancy", "source_provider": "European Medicines Agency", "source_sha256": "cc740ce34adc3137bbf79ea76fa7ba5cd9093619d96b5fb84f05b9163c07a229", "source_snapshot_id": "source-79c735b5dcac04ba6a20c112", "source_updated_at": "2026-01-20", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/hycamtin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 175}
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{"after": {"end": 53, "start": 0, "text": "Filgrastim should be given by subcutaneous injection.", "truncated": false}, "after_length": 53, "after_sha256": "1acd99f4a38c20b5ea55b245f37643ac1cb96fa05cfb2e8313a58e1725ea11e2", "annex": "I", "before": {"end": 53, "start": 0, "text": "Filgrastim should be given by subcutaneous injection.", "truncated": false}, "before_length": 53, "before_sha256": "1acd99f4a38c20b5ea55b245f37643ac1cb96fa05cfb2e8313a58e1725ea11e2", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0769d62366d51f4fe937f33f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000917", "medicine_name": "Zarzio", "medicine_slug": "zarzio", "observed_at": "2026-10-12T13:36:11Z", "pipeline_version": "2.0.0", "presentation_label": "Zarzio 30 MU/0.5 mL solution for injection or infusion in pre-filled syringe Zarzio 48 MU/0.5 mL solution for injection or infusion 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": "51d80b39d33523efaa2f2e8b5daf45ee3bba97f334c746631ab8a9aebbe7ce22", "source_snapshot_id": "source-f8af93bde444dc30d01f0a12", "source_updated_at": "2026-06-05", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/zarzio-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 120}
{"after": {"end": 46, "start": 0, "text": "Affections de la peau et du tissus sous-cutané", "truncated": false}, "after_length": 46, "after_sha256": "3deed88309682d8aa46f37c5f19de116877e4bb1b1dad138b75d9c0676bb9cf8", "annex": "I", "before": {"end": 46, "start": 0, "text": "Affections de la peau et du tissus sous-cutané", "truncated": false}, "before_length": 46, "before_sha256": "3deed88309682d8aa46f37c5f19de116877e4bb1b1dad138b75d9c0676bb9cf8", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0777608b433dc7afa9847c36", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000123", "medicine_name": "Hycamtin", "medicine_slug": "hycamtin", "observed_at": "2026-10-12T17:26:11Z", "pipeline_version": "2.0.0", "presentation_label": "HYCAMTIN 0,25 mg, gélules HYCAMTIN 1 mg, gélules", "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": "cc740ce34adc3137bbf79ea76fa7ba5cd9093619d96b5fb84f05b9163c07a229", "source_snapshot_id": "source-79c735b5dcac04ba6a20c112", "source_updated_at": "2026-01-20", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/hycamtin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 763}
{"after": {"end": 1500, "start": 0, "text": "The efficacy and safety of azacitidine were studied in an international, multicentre, controlled, openlabel, randomised, parallelgroup, Phase 3 comparative study (AZA PH GL 2003 CL 001) in adult patients with: intermediate2 and highrisk MDS according to the International Prognostic Scoring System (IPSS), refractory anaemia with excess blasts (RAEB), refractory anaemia with excess blasts in transformation (RAEBT) and modified chronic myelomonocytic leukaemia (mCMML) according to the French American British (FAB) classification system. RAEBT patients (2130% blasts) are now considered to be AML patients under the current WHO classification system. Azacitidine plus best supportive care (BSC) (n = 179) was compared to conventional care regimens (CCR). CCR consisted of BSC alone (n = 105), lowdose cytarabine plus BSC (n = 49) or standard induction chemotherapy plus BSC (n = 25). Patients were preselected by their physician to 1 of the 3 CCR prior to randomisation. Patients received this preselected regimen if not randomised to azacitidine. As part of the inclusion criteria, patients were required to have an Eastern Cooperative Oncology Group (ECOG) performance status of 02. Patients with secondary MDS were excluded from the study. The primary endpoint of the study was overall survival. Azacitidine was administered at a subcutaneous dose of 75 mg/m2 daily for 7 days, followed by a rest period of 21 days (28day treatment cycle) for a median of 9 cycles (range = 139) and a mean of 10.", "truncated": true}, "after_length": 1606, "after_sha256": "902d901fd659e14696dcd70298797c15cf81276915068a8790178970a8f2666f", "annex": "I", "before": {"end": 1500, "start": 0, "text": "The efficacy and safety of azacitidine were studied in an international, multicentre, controlled, openlabel, randomised, parallelgroup, Phase 3 comparative study (AZA PH GL 2003 CL 001) in adult patients with: intermediate2 and highrisk MDS according to the International Prognostic Scoring System (IPSS), refractory anaemia with excess blasts (RAEB), refractory anaemia with excess blasts in transformation (RAEBT) and modified chronic myelomonocytic leukaemia (mCMML) according to the French American British (FAB) classification system. RAEBT patients (2130% blasts) are now considered to be AML patients under the current WHO classification system. Azacitidine plus best supportive care (BSC) (n = 179) was compared to conventional care regimens (CCR). CCR consisted of BSC alone (n = 105), lowdose cytarabine plus BSC (n = 49) or standard induction chemotherapy plus BSC (n = 25). Patients were preselected by their physician to 1 of the 3 CCR prior to randomisation. Patients received this preselected regimen if not randomised to azacitidine. As part of the inclusion criteria, patients were required to have an Eastern Cooperative Oncology Group (ECOG) performance status of 02. Patients with secondary MDS were excluded from the study. The primary endpoint of the study was overall survival. Azacitidine was administered at a subcutaneous dose of 75 mg/m2 daily for 7 days, followed by a rest period of 21 days (28day treatment cycle) for a median of 9 cycles (range = 139) and a mean of 10.", "truncated": true}, "before_length": 1606, "before_sha256": "902d901fd659e14696dcd70298797c15cf81276915068a8790178970a8f2666f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-077a9405dd3eccc6f71c9c74", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004984", "medicine_name": "Azacitidine Mylan", "medicine_slug": "azacitidine-mylan", "observed_at": "2026-10-12T13:35:15Z", "pipeline_version": "2.0.0", "presentation_label": "Azacitidine Mylan 25 mg/mL powder for suspension for injection", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "2dab763f1da8ff3942467e20de6d30b5746ef6030def3da15b9994facca1adaf", "source_snapshot_id": "source-0c0faddb540a1c60c41a2ccb", "source_updated_at": "2026-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/azacitidine-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": 429}
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{"after": {"end": 172, "start": 0, "text": "Table 1 summarizes adverse reactions reported with a higher incidence in patients treated with buprenorphine (n=103) during a pivotal clinical study versus placebo (n=107).", "truncated": false}, "after_length": 172, "after_sha256": "a438800b807458a12a93f649fdd3b8c5f87d22e0fd6b4f43ca3aaae4d719fbce", "annex": "I", "before": {"end": 172, "start": 0, "text": "Table 1 summarizes adverse reactions reported with a higher incidence in patients treated with buprenorphine (n=103) during a pivotal clinical study versus placebo (n=107).", "truncated": false}, "before_length": 172, "before_sha256": "a438800b807458a12a93f649fdd3b8c5f87d22e0fd6b4f43ca3aaae4d719fbce", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-078e270890ac779716e81b9e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006188", "medicine_name": "Buprenorphine Neuraxpharm", "medicine_slug": "buprenorphine-neuraxpharm", "observed_at": "2026-10-12T19:39:03Z", "pipeline_version": "2.0.0", "presentation_label": "Buprenorphine Neuraxpharm 0.4 mg sublingual films Buprenorphine Neuraxpharm 4 mg sublingual films Buprenorphine Neuraxpharm 6 mg sublingual films Buprenorphine Neuraxpharm 8 mg sublingual films", "presentation_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": "ba3471124a2eb32d4b294de55b522ed52fcd4916a236e260512b067d7985e7ae", "source_snapshot_id": "source-27e01c9d9f02ff9d6796fe48", "source_updated_at": "2025-05-16", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/buprenorphine-neuraxpharm-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 299}
{"after": {"end": 1132, "start": 0, "text": "Treatment with arsenic trioxide has been associated with the development of hyperleucocytosis (≥ 10 x 103/μl) in some relapsed/refractory APL patients. There did not appear to be a relationship between baseline white blood cell (WBC) counts and development of hyperleucocytosis nor did there appear to be a correlation between baseline WBC count and peak WBC counts. Hyperleucocytosis was never treated with additional chemotherapy and resolved on continuation of TRISENOX. WBC counts during consolidation were not as high as during induction treatment and were < 10 x 103/μl, except in one patient who had a WBC count of 22 x 103/μl during consolidation. Twenty relapsed/refractory APL patients (50 %) experienced leucocytosis; however, in all these patients, the WBC count was declining or had normalized by the time of bone marrow remission and cytotoxic chemotherapy or leucopheresis was not required. In newly diagnosed patients with low to intermediate risk APL leucocytosis developed during induction therapy in 35 of 74 (47 %) patients (see section 4.8). However all cases were successfully managed with hydroxyurea therapy.", "truncated": false}, "after_length": 1132, "after_sha256": "b1e50cd9c6609a4ad14f9a5cd449ff1a9e15171eeb54bf3674a79cd9b1230df4", "annex": "I", "before": {"end": 1132, "start": 0, "text": "Treatment with arsenic trioxide has been associated with the development of hyperleucocytosis (≥ 10 x 103/μl) in some relapsed/refractory APL patients. There did not appear to be a relationship between baseline white blood cell (WBC) counts and development of hyperleucocytosis nor did there appear to be a correlation between baseline WBC count and peak WBC counts. Hyperleucocytosis was never treated with additional chemotherapy and resolved on continuation of TRISENOX. WBC counts during consolidation were not as high as during induction treatment and were < 10 x 103/μl, except in one patient who had a WBC count of 22 x 103/μl during consolidation. Twenty relapsed/refractory APL patients (50 %) experienced leucocytosis; however, in all these patients, the WBC count was declining or had normalized by the time of bone marrow remission and cytotoxic chemotherapy or leucopheresis was not required. In newly diagnosed patients with low to intermediate risk APL leucocytosis developed during induction therapy in 35 of 74 (47 %) patients (see section 4.8). However all cases were successfully managed with hydroxyurea therapy.", "truncated": false}, "before_length": 1132, "before_sha256": "b1e50cd9c6609a4ad14f9a5cd449ff1a9e15171eeb54bf3674a79cd9b1230df4", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-07ae52c17eb33ab1afc2d067", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000388", "medicine_name": "Trisenox", "medicine_slug": "trisenox", "observed_at": "2026-10-12T19:02:27Z", "pipeline_version": "2.0.0", "presentation_label": "TRISENOX 1 mg/ml concentrate for solution for infusion TRISENOX 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": "b5ada3476b5436cdde0bd6dbc7e49908b8720c4e91b27923152641fdd73a2d5c", "source_snapshot_id": "source-d86357b928da66e696014503", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/trisenox-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 144}
{"after": {"end": 501, "start": 0, "text": "Filgrastim may be given as a daily subcutaneous injection or as a daily intravenous infusion diluted in 5% glucose solution given over 30 minutes (see section 6.6). The subcutaneous route is preferred in most cases. There is some evidence from a study of single dose administration that intravenous dosing may shorten the duration of effect. The clinical relevance of this finding to multiple dose administration is not clear. The choice of route should depend on the individual clinical circumstance.", "truncated": false}, "after_length": 501, "after_sha256": "67f55af72db7ccfa10f018f3efd75cd79aa2eca28da838b70531b52428356229", "annex": "I", "before": {"end": 501, "start": 0, "text": "Filgrastim may be given as a daily subcutaneous injection or as a daily intravenous infusion diluted in 5% glucose solution given over 30 minutes (see section 6.6). The subcutaneous route is preferred in most cases. There is some evidence from a study of single dose administration that intravenous dosing may shorten the duration of effect. The clinical relevance of this finding to multiple dose administration is not clear. The choice of route should depend on the individual clinical circumstance.", "truncated": false}, "before_length": 501, "before_sha256": "67f55af72db7ccfa10f018f3efd75cd79aa2eca28da838b70531b52428356229", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-07b14b2ab2346c984cb533a3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000917", "medicine_name": "Zarzio", "medicine_slug": "zarzio", "observed_at": "2026-10-12T13:36:11Z", "pipeline_version": "2.0.0", "presentation_label": "Zarzio 30 MU/0.5 mL solution for injection or infusion in pre-filled syringe Zarzio 48 MU/0.5 mL solution for injection or infusion 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": "51d80b39d33523efaa2f2e8b5daf45ee3bba97f334c746631ab8a9aebbe7ce22", "source_snapshot_id": "source-f8af93bde444dc30d01f0a12", "source_updated_at": "2026-06-05", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/zarzio-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 83}
{"after": {"end": 487, "start": 0, "text": "La métabolisation représente moins de 10 % de l’élimination du topotécan. Un métabolite N-déméthylé, pour lequel une activité inférieure ou égale à la molécule mère a été montrée sur des modèles cellulaires, a été retrouvé dans les urines, le plasma et les fécès. Le rapport moyen des ASC métabolite/molécule mère était < 10 %, à la fois pour le topotécan total et le topotécan lactone. Un dérivé O-glucurono-conjugué du topotécan et du N-déméthyl-topotécan a été identifié dans l’urine.", "truncated": false}, "after_length": 487, "after_sha256": "fc824abe9ae9f8ab7beb96b243d73e3cfdd629a250aaa30eb27cdb426ca3fd33", "annex": "I", "before": {"end": 487, "start": 0, "text": "La métabolisation représente moins de 10 % de l’élimination du topotécan. Un métabolite N-déméthylé, pour lequel une activité inférieure ou égale à la molécule mère a été montrée sur des modèles cellulaires, a été retrouvé dans les urines, le plasma et les fécès. Le rapport moyen des ASC métabolite/molécule mère était < 10 %, à la fois pour le topotécan total et le topotécan lactone. Un dérivé O-glucurono-conjugué du topotécan et du N-déméthyl-topotécan a été identifié dans l’urine.", "truncated": false}, "before_length": 487, "before_sha256": "fc824abe9ae9f8ab7beb96b243d73e3cfdd629a250aaa30eb27cdb426ca3fd33", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-07c588d15075d04818471abf", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000123", "medicine_name": "Hycamtin", "medicine_slug": "hycamtin", "observed_at": "2026-10-12T17:26:11Z", "pipeline_version": "2.0.0", "presentation_label": "HYCAMTIN 1 mg poudre pour solution à diluer pour perfusion HYCAMTIN 4 mg poudre pour solution à diluer pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "cc740ce34adc3137bbf79ea76fa7ba5cd9093619d96b5fb84f05b9163c07a229", "source_snapshot_id": "source-79c735b5dcac04ba6a20c112", "source_updated_at": "2026-01-20", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/hycamtin-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 444}
{"after": {"end": 339, "start": 0, "text": "No dose adjustment is necessary in patients with mild renal impairment. Esbriet should be used with caution in patients with moderate (CrCl 30-50 ml/min) renal impairment. Esbriet therapy should not be used in patients with severe renal impairment (CrCl <30 ml/min) or end stage renal disease requiring dialysis (see sections 4.3 and 5.2).", "truncated": false}, "after_length": 339, "after_sha256": "a81d74da1a95b9729b721bcb68a52d1bccbeb3f7bba1f1dabec054750b850dbd", "annex": "I", "before": {"end": 339, "start": 0, "text": "No dose adjustment is necessary in patients with mild renal impairment. Esbriet should be used with caution in patients with moderate (CrCl 30-50 ml/min) renal impairment. Esbriet therapy should not be used in patients with severe renal impairment (CrCl <30 ml/min) or end stage renal disease requiring dialysis (see sections 4.3 and 5.2).", "truncated": false}, "before_length": 339, "before_sha256": "a81d74da1a95b9729b721bcb68a52d1bccbeb3f7bba1f1dabec054750b850dbd", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-07dc84a03bdd60f6ccfd6410", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002154", "medicine_name": "Esbriet", "medicine_slug": "esbriet", "observed_at": "2026-10-12T13:33:23Z", "pipeline_version": "2.0.0", "presentation_label": "Esbriet 267 mg film-coated tablets Esbriet 534 mg film-coated tablets Esbriet 801 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": "1c94f76794606f5da8bba59cce7aac025c02e0b7db8cbfb575d178ac07899bde", "source_snapshot_id": "source-215e5fbd703aae1bfb8b7f8b", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/esbriet-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 104}
{"after": {"end": 371, "start": 0, "text": "The steady-state concentrations of sorafenib administered at 400 mg twice daily were evaluated in DTC, RCC and HCC patients. The highest mean concentration was observed in DTC patients (approximately twice that observed in patients with RCC and HCC), though variability was high for all tumour types. The reason for the increased concentration in DTC patients is unknown.", "truncated": false}, "after_length": 371, "after_sha256": "72725939876d505d0065fa31621f7d11852ad66abe335d4918635e7181c7c75d", "annex": "I", "before": {"end": 371, "start": 0, "text": "The steady-state concentrations of sorafenib administered at 400 mg twice daily were evaluated in DTC, RCC and HCC patients. The highest mean concentration was observed in DTC patients (approximately twice that observed in patients with RCC and HCC), though variability was high for all tumour types. The reason for the increased concentration in DTC patients is unknown.", "truncated": false}, "before_length": 371, "before_sha256": "72725939876d505d0065fa31621f7d11852ad66abe335d4918635e7181c7c75d", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-07e4f72635692c028d118645", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000690", "medicine_name": "Nexavar", "medicine_slug": "nexavar", "observed_at": "2026-10-12T19:46:46Z", "pipeline_version": "2.0.0", "presentation_label": "Nexavar 200 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": "f674c06ce762276be6432e22856bfdc4bf30bfd2dddba754df81a1696f1fda82", "source_snapshot_id": "source-f1eb4a92e0b38587fb4bd033", "source_updated_at": "2025-03-28", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/nexavar-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 696}
{"after": {"end": 778, "start": 0, "text": "Une étude rétrospective européenne évaluant l’utilisation de GCSF à la suite d’une greffe de moelle osseuse allogénique chez des patients atteints de leucémie aiguë a indiqué un risque accru de GvH, de mortalité associée au traitement (MAT), ainsi que de mortalité, lorsque le GCSF était administré. Une étude internationale rétrospective distincte chez des patients atteints de leucémie aiguë myéloïde et de leucémie chronique myéloïde n’a montré aucun effet sur le risque de GvH, MAT et mortalité. Une métaanalyse d’études portant sur des allogreffes, incluant les résultats de 9 études prospectives randomisées, 8 études rétrospectives et 1 étude castémoins, n’a détecté aucun effet sur le risque de GvH aiguë, de GvH chronique ou de mortalité précoce associée au traitement.", "truncated": false}, "after_length": 778, "after_sha256": "faadbd9018858c4005f467a150ad676e72e0b51f7964fe7822bd3eab26bf3900", "annex": "I", "before": {"end": 778, "start": 0, "text": "Une étude rétrospective européenne évaluant l’utilisation de GCSF à la suite d’une greffe de moelle osseuse allogénique chez des patients atteints de leucémie aiguë a indiqué un risque accru de GvH, de mortalité associée au traitement (MAT), ainsi que de mortalité, lorsque le GCSF était administré. Une étude internationale rétrospective distincte chez des patients atteints de leucémie aiguë myéloïde et de leucémie chronique myéloïde n’a montré aucun effet sur le risque de GvH, MAT et mortalité. Une métaanalyse d’études portant sur des allogreffes, incluant les résultats de 9 études prospectives randomisées, 8 études rétrospectives et 1 étude castémoins, n’a détecté aucun effet sur le risque de GvH aiguë, de GvH chronique ou de mortalité précoce associée au traitement.", "truncated": false}, "before_length": 778, "before_sha256": "faadbd9018858c4005f467a150ad676e72e0b51f7964fe7822bd3eab26bf3900", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-07f003b9ff61bc015acf6cba", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000917", "medicine_name": "Zarzio", "medicine_slug": "zarzio", "observed_at": "2026-10-12T13:36:13Z", "pipeline_version": "2.0.0", "presentation_label": "Zarzio 30 MU/0,5 mL solution injectable ou pour perfusion en seringue préremplie. Zarzio 48 MU/0,5 mL solution injectable ou pour perfusion 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": "968afffa2a72df6dda240602dfb44e50ec1ab7fb854d6d777ac92e19cd52fe6f", "source_snapshot_id": "source-bb736e6d90be96a990172ed5", "source_updated_at": "2026-06-05", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/zarzio-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 627}
{"after": {"end": 591, "start": 0, "text": "La buprénorphine peut provoquer une dépression respiratoire sévère potentiellement mortelle chez les enfants et les personnes non dépendantes qui l’ingèrent accidentellement ou de manière délibérée. Les patients doivent être avertis de conserver les plaquettes enlieu sûr, de ne jamais sortir à l’avance les comprimés de la plaquette, de tenir les plaquettes hors de portée des enfants et des autres membres de la famille et de ne pas prendre ce médicament devant les enfants. Un service d’urgence doit être immédiatement contacté en cas d’ingestion accidentelle ou de suspicion d’ingestion.", "truncated": false}, "after_length": 591, "after_sha256": "2275ae95b7a9bbb967d14652f2611ded74ff48e8a8361f07bb150cd2f0dbe35d", "annex": "I", "before": {"end": 591, "start": 0, "text": "La buprénorphine peut provoquer une dépression respiratoire sévère potentiellement mortelle chez les enfants et les personnes non dépendantes qui l’ingèrent accidentellement ou de manière délibérée. Les patients doivent être avertis de conserver les plaquettes enlieu sûr, de ne jamais sortir à l’avance les comprimés de la plaquette, de tenir les plaquettes hors de portée des enfants et des autres membres de la famille et de ne pas prendre ce médicament devant les enfants. Un service d’urgence doit être immédiatement contacté en cas d’ingestion accidentelle ou de suspicion d’ingestion.", "truncated": false}, "before_length": 591, "before_sha256": "2275ae95b7a9bbb967d14652f2611ded74ff48e8a8361f07bb150cd2f0dbe35d", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-07f8c6a9422b87accafc4fd3", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006188", "medicine_name": "Buprenorphine Neuraxpharm", "medicine_slug": "buprenorphine-neuraxpharm", "observed_at": "2026-10-12T19:39:14Z", "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": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "f83300398ca578b6c52fe73b15e336e19057f193df5dbaa62822f3b6d9ea8f46", "source_snapshot_id": "source-8fc14331f652f6a7e9217eb7", "source_updated_at": "2025-05-16", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/buprenorphine-neuraxpharm-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 178}
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{"after": {"end": 512, "start": 0, "text": "Aucune différence globale de sécurité ou d’efficacité n’a été observée entre les sujets âgés de plus de 65 ans et les adultes plus jeunes (> 18 ans) recevant une chimiothérapie cytotoxique et l’expérience clinique n’a révélé aucune différence de réponse au traitement entre les patients âgés et les patients adultes plus jeunes. Les données disponibles ne sont pas suffisantes pour permettre d’évaluer l’utilisation du filgrastim chez les sujets gériatriques dans les autres indications approuvées du filgrastim.", "truncated": false}, "after_length": 512, "after_sha256": "ad580e1869217d440ed5d49b7424fd72dd823390b52ccee699cf982c07964969", "annex": "I", "before": {"end": 512, "start": 0, "text": "Aucune différence globale de sécurité ou d’efficacité n’a été observée entre les sujets âgés de plus de 65 ans et les adultes plus jeunes (> 18 ans) recevant une chimiothérapie cytotoxique et l’expérience clinique n’a révélé aucune différence de réponse au traitement entre les patients âgés et les patients adultes plus jeunes. Les données disponibles ne sont pas suffisantes pour permettre d’évaluer l’utilisation du filgrastim chez les sujets gériatriques dans les autres indications approuvées du filgrastim.", "truncated": false}, "before_length": 512, "before_sha256": "ad580e1869217d440ed5d49b7424fd72dd823390b52ccee699cf982c07964969", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-08360072dbc91e23801f0aa4", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000917", "medicine_name": "Zarzio", "medicine_slug": "zarzio", "observed_at": "2026-10-12T13:36:13Z", "pipeline_version": "2.0.0", "presentation_label": "Zarzio 30 MU/0,5 mL solution injectable ou pour perfusion en seringue préremplie. Zarzio 48 MU/0,5 mL solution injectable ou pour perfusion 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": "968afffa2a72df6dda240602dfb44e50ec1ab7fb854d6d777ac92e19cd52fe6f", "source_snapshot_id": "source-bb736e6d90be96a990172ed5", "source_updated_at": "2026-06-05", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/zarzio-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 596}
{"after": {"end": 953, "start": 0, "text": "Des cas de syndrome de différenciation (également connu sous le nom de syndrome de l’acide rétinoïque) ont été signalés chez des patients recevant de l’azacitidine injectable. Le syndrome de différenciation peut être mortel et les symptômes et les observations cliniques incluent une détresse respiratoire, des infiltrats pulmonaires, de la fièvre, une éruption cutanée, un œdème pulmonaire, un œdème périphérique, une prise de poids rapide, des épanchements pleuraux, des épanchements péricardiques, une hypotension et un dysfonctionnement rénal (voir rubrique 4.8). Un traitement par des corticostéroïdes IV à forte dose et une surveillance hémodynamique doivent être envisagés dès l’apparition des premiers symptômes ou signes évocateurs d’un syndrome de différenciation. L’arrêt temporaire du traitement par azacitidine injectable doit être envisagé jusqu’à disparition des symptômes et, en cas de reprise du traitement, la prudence est recommandée.", "truncated": false}, "after_length": 953, "after_sha256": "ab7709ee5fa50da634ab54fcf023ec479543a8c143b72af6edaacf94ef9cd5a2", "annex": "I", "before": {"end": 953, "start": 0, "text": "Des cas de syndrome de différenciation (également connu sous le nom de syndrome de l’acide rétinoïque) ont été signalés chez des patients recevant de l’azacitidine injectable. Le syndrome de différenciation peut être mortel et les symptômes et les observations cliniques incluent une détresse respiratoire, des infiltrats pulmonaires, de la fièvre, une éruption cutanée, un œdème pulmonaire, un œdème périphérique, une prise de poids rapide, des épanchements pleuraux, des épanchements péricardiques, une hypotension et un dysfonctionnement rénal (voir rubrique 4.8). Un traitement par des corticostéroïdes IV à forte dose et une surveillance hémodynamique doivent être envisagés dès l’apparition des premiers symptômes ou signes évocateurs d’un syndrome de différenciation. L’arrêt temporaire du traitement par azacitidine injectable doit être envisagé jusqu’à disparition des symptômes et, en cas de reprise du traitement, la prudence est recommandée.", "truncated": false}, "before_length": 953, "before_sha256": "ab7709ee5fa50da634ab54fcf023ec479543a8c143b72af6edaacf94ef9cd5a2", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-08577681abfe6e033456f445", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004984", "medicine_name": "Azacitidine Mylan", "medicine_slug": "azacitidine-mylan", "observed_at": "2026-10-12T13:35:18Z", "pipeline_version": "2.0.0", "presentation_label": "Azacitidine Mylan 25 mg/mL poudre pour suspension injectable", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "8a23b15a1ee68b06c39713bce2cbde058eec479426bfc524dfa8d65f8d0f9265", "source_snapshot_id": "source-3f5e3d8a9ef30a41ad45c883", "source_updated_at": "2026-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/azacitidine-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": 171}
{"after": {"end": 1500, "start": 0, "text": "Arsenic trioxide can cause QT interval prolongation and complete atrioventricular block. QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal. Previous treatment with anthracyclines may increase the risk of QT prolongation. The risk of torsade de pointes is related to the extent of QT prolongation, concomitant administration of QT prolonging medicinal products (such as class Ia and III antiarrythmics (e.g. quinidine, amiodarone, sotalol, dofetilide), antipsychotics (e.g. thioridazine), antidepressants (e.g. amitriptyline), some macrolides (e.g. erythromycin), some antihistamines (e.g. terfenadine and astemizole), some quinolone antibiotics (e.g. sparfloxacin), and other individual medicinal products known to increase QT interval (e.g. cisapride)), a history of torsade de pointes, pre-existing QT interval prolongation, congestive heart failure, administration of potassium-wasting diuretics, amphotericin B or other conditions that result in hypokalaemia or hypomagnesaemia. In clinical trials, in the relapsed/refractory setting, 40 % of patients treated with TRISENOX experienced at least one QT corrected (QTc) interval prolongation greater than 500 msec. Prolongation of the QTc was observed between 1 and 5 weeks after TRISENOX infusion, and then returned to baseline by the end of 8 weeks after TRISENOX infusion. One patient (receiving multiple, concomitant medicinal products, including amphotericin B) had asymptomatic torsade de pointe", "truncated": true}, "after_length": 1875, "after_sha256": "325c2560412b452047697824aa3b634eb4640374af71d21c163460da64f55e4a", "annex": "I", "before": {"end": 1500, "start": 0, "text": "Arsenic trioxide can cause QT interval prolongation and complete atrioventricular block. QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal. Previous treatment with anthracyclines may increase the risk of QT prolongation. The risk of torsade de pointes is related to the extent of QT prolongation, concomitant administration of QT prolonging medicinal products (such as class Ia and III antiarrythmics (e.g. quinidine, amiodarone, sotalol, dofetilide), antipsychotics (e.g. thioridazine), antidepressants (e.g. amitriptyline), some macrolides (e.g. erythromycin), some antihistamines (e.g. terfenadine and astemizole), some quinolone antibiotics (e.g. sparfloxacin), and other individual medicinal products known to increase QT interval (e.g. cisapride)), a history of torsade de pointes, pre-existing QT interval prolongation, congestive heart failure, administration of potassium-wasting diuretics, amphotericin B or other conditions that result in hypokalaemia or hypomagnesaemia. In clinical trials, in the relapsed/refractory setting, 40 % of patients treated with TRISENOX experienced at least one QT corrected (QTc) interval prolongation greater than 500 msec. Prolongation of the QTc was observed between 1 and 5 weeks after TRISENOX infusion, and then returned to baseline by the end of 8 weeks after TRISENOX infusion. One patient (receiving multiple, concomitant medicinal products, including amphotericin B) had asymptomatic torsade de pointe", "truncated": true}, "before_length": 1875, "before_sha256": "325c2560412b452047697824aa3b634eb4640374af71d21c163460da64f55e4a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-085aa1dd2801edf895c97402", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000388", "medicine_name": "Trisenox", "medicine_slug": "trisenox", "observed_at": "2026-10-12T19:02:27Z", "pipeline_version": "2.0.0", "presentation_label": "TRISENOX 1 mg/ml concentrate for solution for infusion TRISENOX 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": "b5ada3476b5436cdde0bd6dbc7e49908b8720c4e91b27923152641fdd73a2d5c", "source_snapshot_id": "source-d86357b928da66e696014503", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/trisenox-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 119}
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{"after": {"end": 297, "start": 0, "text": "Coadministration of medicinal products that act as potent inducers of both CYP1A2 and the other CYP isoenzymes involved in the metabolism of pirfenidone (e.g. rifampicin) may result in significant lowering of pirfenidone plasma levels. These medicinal products should be avoided whenever possible.", "truncated": false}, "after_length": 297, "after_sha256": "c9bd50ce8d0a9651f6dddb2e778fdf1f47c15ee4c589a04fda9f6f664bb557ca", "annex": "I", "before": {"end": 297, "start": 0, "text": "Coadministration of medicinal products that act as potent inducers of both CYP1A2 and the other CYP isoenzymes involved in the metabolism of pirfenidone (e.g. rifampicin) may result in significant lowering of pirfenidone plasma levels. These medicinal products should be avoided whenever possible.", "truncated": false}, "before_length": 297, "before_sha256": "c9bd50ce8d0a9651f6dddb2e778fdf1f47c15ee4c589a04fda9f6f664bb557ca", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-086292de4b9a8190c3e70cf2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002154", "medicine_name": "Esbriet", "medicine_slug": "esbriet", "observed_at": "2026-10-12T13:33:23Z", "pipeline_version": "2.0.0", "presentation_label": "Esbriet 267 mg film-coated tablets Esbriet 534 mg film-coated tablets Esbriet 801 mg film-coated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "1c94f76794606f5da8bba59cce7aac025c02e0b7db8cbfb575d178ac07899bde", "source_snapshot_id": "source-215e5fbd703aae1bfb8b7f8b", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/esbriet-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 200}
{"after": {"end": 255, "start": 0, "text": "In Study AZA-JMML-001, pharmacokinetic analysis was determined from 10 MDS and 18 JMML paediatric patients on Day 7 of Cycle 1 (see section 5.1). The median age (range) of the MDS patients was 13.3 (1.9-15) years and 2.1 (0.2-6.9) years for JMML patients.", "truncated": false}, "after_length": 255, "after_sha256": "43f931b207b9b8e5aaac524814f54c1bf62b8eb566aa81610940de32b4cf7c14", "annex": "I", "before": {"end": 255, "start": 0, "text": "In Study AZA-JMML-001, pharmacokinetic analysis was determined from 10 MDS and 18 JMML paediatric patients on Day 7 of Cycle 1 (see section 5.1). The median age (range) of the MDS patients was 13.3 (1.9-15) years and 2.1 (0.2-6.9) years for JMML patients.", "truncated": false}, "before_length": 255, "before_sha256": "43f931b207b9b8e5aaac524814f54c1bf62b8eb566aa81610940de32b4cf7c14", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-089109a59d296a043bdf903b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004984", "medicine_name": "Azacitidine Mylan", "medicine_slug": "azacitidine-mylan", "observed_at": "2026-10-12T13:35:15Z", "pipeline_version": "2.0.0", "presentation_label": "Azacitidine Mylan 25 mg/mL powder for suspension for injection", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "2dab763f1da8ff3942467e20de6d30b5746ef6030def3da15b9994facca1adaf", "source_snapshot_id": "source-0c0faddb540a1c60c41a2ccb", "source_updated_at": "2026-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/azacitidine-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": 528}
{"after": {"end": 538, "start": 0, "text": "Of the patients in the azacitidine group who were platelet transfusion dependent at baseline, 40.6% (95% CI = 30.9, 50.8) of these patients became platelet transfusion independent during the treatment period, compared with 29.3% of (95% CI = 19.7, 40.4) patients in the combined CCR groups. In patients who were platelet transfusion dependent at baseline and achieved transfusion independence on treatment, the median duration of platelet transfusion independence was 10.8 months in the azacitidine group and 19.2 months in the CCR group.", "truncated": false}, "after_length": 538, "after_sha256": "eb8b3bbabd5e116a340ed5743a008e6c1b026df5f69e1a0f3ace889308839c1e", "annex": "I", "before": {"end": 538, "start": 0, "text": "Of the patients in the azacitidine group who were platelet transfusion dependent at baseline, 40.6% (95% CI = 30.9, 50.8) of these patients became platelet transfusion independent during the treatment period, compared with 29.3% of (95% CI = 19.7, 40.4) patients in the combined CCR groups. In patients who were platelet transfusion dependent at baseline and achieved transfusion independence on treatment, the median duration of platelet transfusion independence was 10.8 months in the azacitidine group and 19.2 months in the CCR group.", "truncated": false}, "before_length": 538, "before_sha256": "eb8b3bbabd5e116a340ed5743a008e6c1b026df5f69e1a0f3ace889308839c1e", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0891cea095e647fe83658470", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004984", "medicine_name": "Azacitidine Mylan", "medicine_slug": "azacitidine-mylan", "observed_at": "2026-10-12T13:35:15Z", "pipeline_version": "2.0.0", "presentation_label": "Azacitidine Mylan 25 mg/mL powder for suspension for injection", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "2dab763f1da8ff3942467e20de6d30b5746ef6030def3da15b9994facca1adaf", "source_snapshot_id": "source-0c0faddb540a1c60c41a2ccb", "source_updated_at": "2026-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/azacitidine-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": 476}
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{"after": {"end": 701, "start": 0, "text": "The concomitant use of opioids with sedative medicinal products such as benzodiazepines (e.g. diazepam, temazepam, alprazolam), gabapentinoids (e.g. pregabalin, gabapentin) or related substances such as barbiturates (e.g. phenobarbital) or chloral hydrate increase the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. The doses and duration of concomitant use should be limited (see section 4.4). Patients should be warned that it is extremely dangerous to self-administer non-prescribed benzodiazepines while taking this product and should also be cautioned to use benzodiazepines concurrently whit this product only as prescribed (see section 4.4).", "truncated": false}, "after_length": 701, "after_sha256": "eaad45cdaf30c8602d8f33ea8706d5be8a66f2da3bcf345b7d844c197fde7234", "annex": "I", "before": {"end": 701, "start": 0, "text": "The concomitant use of opioids with sedative medicinal products such as benzodiazepines (e.g. diazepam, temazepam, alprazolam), gabapentinoids (e.g. pregabalin, gabapentin) or related substances such as barbiturates (e.g. phenobarbital) or chloral hydrate increase the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. The doses and duration of concomitant use should be limited (see section 4.4). Patients should be warned that it is extremely dangerous to self-administer non-prescribed benzodiazepines while taking this product and should also be cautioned to use benzodiazepines concurrently whit this product only as prescribed (see section 4.4).", "truncated": false}, "before_length": 701, "before_sha256": "eaad45cdaf30c8602d8f33ea8706d5be8a66f2da3bcf345b7d844c197fde7234", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-08a28b73b4d4d62c9a22ba71", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006188", "medicine_name": "Buprenorphine Neuraxpharm", "medicine_slug": "buprenorphine-neuraxpharm", "observed_at": "2026-10-12T19:39:03Z", "pipeline_version": "2.0.0", "presentation_label": "Buprenorphine Neuraxpharm 0.4 mg sublingual films Buprenorphine Neuraxpharm 4 mg sublingual films Buprenorphine Neuraxpharm 6 mg sublingual films Buprenorphine Neuraxpharm 8 mg sublingual films", "presentation_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": "ba3471124a2eb32d4b294de55b522ed52fcd4916a236e260512b067d7985e7ae", "source_snapshot_id": "source-27e01c9d9f02ff9d6796fe48", "source_updated_at": "2025-05-16", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/buprenorphine-neuraxpharm-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 252}
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{"after": {"end": 699, "start": 0, "text": "Les variations dans la composition corporelle ont été évaluées dans une sous-étude de SURMOUNT-1 en utilisant l’absorptiométrie biphotonique à rayons X (DEXA). Les résultats de l’évaluation par DEXA ont montré que le traitement par tirzépatide s'accompagnait d'une réduction plus importante de la masse grasse que de la masse maigre, conduisant à une amélioration de la composition corporelle par rapport au placebo après 72 semaines. De plus, cette réduction de masse grasse totale s’accompagnait d’une réduction de la graisse viscérale. Ces résultats suggèrent que la majeure partie de la perte de poids totale était attribuable à une réduction du tissu adipeux, notamment de la graisse viscérale.", "truncated": false}, "after_length": 699, "after_sha256": "6423becdbc8abfc5ffc5203319e83231be3f517c08d4fd100e75f4bf41063bf6", "annex": "I", "before": {"end": 699, "start": 0, "text": "Les variations dans la composition corporelle ont été évaluées dans une sous-étude de SURMOUNT-1 en utilisant l’absorptiométrie biphotonique à rayons X (DEXA). Les résultats de l’évaluation par DEXA ont montré que le traitement par tirzépatide s'accompagnait d'une réduction plus importante de la masse grasse que de la masse maigre, conduisant à une amélioration de la composition corporelle par rapport au placebo après 72 semaines. De plus, cette réduction de masse grasse totale s’accompagnait d’une réduction de la graisse viscérale. Ces résultats suggèrent que la majeure partie de la perte de poids totale était attribuable à une réduction du tissu adipeux, notamment de la graisse viscérale.", "truncated": false}, "before_length": 699, "before_sha256": "6423becdbc8abfc5ffc5203319e83231be3f517c08d4fd100e75f4bf41063bf6", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-093dd74cad58cb8a658f2443", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005620", "medicine_name": "Mounjaro", "medicine_slug": "mounjaro", "observed_at": "2026-10-12T13:28:06Z", "pipeline_version": "2.0.0", "presentation_label": "Mounjaro 2,5 mg solution injectable en stylo prérempli Mounjaro 5 mg solution injectable en stylo prérempli Mounjaro 7,5 mg solution injectable en stylo prérempli Mounjaro 10 mg solution injectable en stylo prérempli Mounjaro 12,5 mg solution injectable en stylo prérempli Mounjaro 15 mg solution inj", "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": "470db95d123b9f78106930042213a4fee5069aad9d085576ece30d2f5acffc35", "source_snapshot_id": "source-01b7f43e80477af34b4fefc8", "source_updated_at": "2026-08-28", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/mounjaro-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1966}
{"after": {"end": 551, "start": 0, "text": "Dans une étude clinique (MA29957) de Phase IIb de 52 semaines, multicentrique, randomisée, en double aveugle, contrôlée contre placebo conduite chez 89 patients présentant une FPI avec une insuffisance respiratoire sévère (DLCO < 40 %) et un haut risque d’hypertension pulmonaire de grade 3, et traités par Esbriet en monothérapie, la diminution de la CVF était similaire à celle observée chez des patients traités par Esbriet dans les analyses réalisées a posteriori dans les populations groupées des études de phase 3 PIPF-004, PIPF-006 et PIPF-016.", "truncated": false}, "after_length": 551, "after_sha256": "fb73a4f2cd243748a6fc5f5acf57cc753ea177721436954862ed13ef750e2503", "annex": "I", "before": {"end": 551, "start": 0, "text": "Dans une étude clinique (MA29957) de Phase IIb de 52 semaines, multicentrique, randomisée, en double aveugle, contrôlée contre placebo conduite chez 89 patients présentant une FPI avec une insuffisance respiratoire sévère (DLCO < 40 %) et un haut risque d’hypertension pulmonaire de grade 3, et traités par Esbriet en monothérapie, la diminution de la CVF était similaire à celle observée chez des patients traités par Esbriet dans les analyses réalisées a posteriori dans les populations groupées des études de phase 3 PIPF-004, PIPF-006 et PIPF-016.", "truncated": false}, "before_length": 551, "before_sha256": "fb73a4f2cd243748a6fc5f5acf57cc753ea177721436954862ed13ef750e2503", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-095b76c0538c44633402e03c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002154", "medicine_name": "Esbriet", "medicine_slug": "esbriet", "observed_at": "2026-10-12T13:33:24Z", "pipeline_version": "2.0.0", "presentation_label": "Esbriet 267 mg comprimés pelliculés Esbriet 534 mg comprimés pelliculés Esbriet 801 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": "2df13b23112defceb5fd947a2f85070f36906347957fd848cc53d6f2710df187", "source_snapshot_id": "source-cc371d7c2b53a38bdc313831", "source_updated_at": "2026-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/esbriet-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 409}
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{"after": {"end": 656, "start": 0, "text": "Dans une étude contrôlée versus placebo en double aveugle d’une durée de 72 semaines, 2 539 patients adultes en situation d’obésité (IMC ≥ 30 kg/m²), ou en surpoids (IMC ≥ 27 kg/m² et < 30 kg/m²) avec au moins une comorbidité liée au poids, ont été randomisés pour recevoir du tirzépatide 5 mg, 10 mg ou 15 mg une fois par semaine ou un placebo. Tous les patients ont été conseillés sur un régime hypocalorique et une augmentation de leur activité physique tout au long de l'essai. À l’inclusion, l’âge moyen des patients était de 45 ans, 67,5 % étaient des femmes, et 40,6 % des patients avaient un prédiabète. L’IMC moyen à l’inclusion était de 38 kg/m².", "truncated": false}, "after_length": 656, "after_sha256": "9c84b445fe51846d985144f68110cb5e6b7626dc8d3e9f45ce8dbc4501876f1e", "annex": "I", "before": {"end": 656, "start": 0, "text": "Dans une étude contrôlée versus placebo en double aveugle d’une durée de 72 semaines, 2 539 patients adultes en situation d’obésité (IMC ≥ 30 kg/m²), ou en surpoids (IMC ≥ 27 kg/m² et < 30 kg/m²) avec au moins une comorbidité liée au poids, ont été randomisés pour recevoir du tirzépatide 5 mg, 10 mg ou 15 mg une fois par semaine ou un placebo. Tous les patients ont été conseillés sur un régime hypocalorique et une augmentation de leur activité physique tout au long de l'essai. À l’inclusion, l’âge moyen des patients était de 45 ans, 67,5 % étaient des femmes, et 40,6 % des patients avaient un prédiabète. L’IMC moyen à l’inclusion était de 38 kg/m².", "truncated": false}, "before_length": 656, "before_sha256": "9c84b445fe51846d985144f68110cb5e6b7626dc8d3e9f45ce8dbc4501876f1e", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0b6722e65d33bae731136976", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005620", "medicine_name": "Mounjaro", "medicine_slug": "mounjaro", "observed_at": "2026-10-12T13:28:06Z", "pipeline_version": "2.0.0", "presentation_label": "Mounjaro 2,5 mg solution injectable en stylo prérempli Mounjaro 5 mg solution injectable en stylo prérempli Mounjaro 7,5 mg solution injectable en stylo prérempli Mounjaro 10 mg solution injectable en stylo prérempli Mounjaro 12,5 mg solution injectable en stylo prérempli Mounjaro 15 mg solution inj", "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": "470db95d123b9f78106930042213a4fee5069aad9d085576ece30d2f5acffc35", "source_snapshot_id": "source-01b7f43e80477af34b4fefc8", "source_updated_at": "2026-08-28", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/mounjaro-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1478}
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{"after": {"end": 660, "start": 0, "text": "Renal abnormalities ranging from elevated serum creatinine to renal failure and death were reported in patients treated with intravenous azacitidine in combination with other chemotherapeutic agents. In addition, renal tubular acidosis, defined as a fall in serum bicarbonate to < 20 mmol/L in association with an alkaline urine and hypokalaemia (serum potassium < 3 mmol/L) developed in 5 subjects with chronic myelogenous leukaemia (CML) treated with azacitidine and etoposide. If unexplained reductions in serum bicarbonate (< 20 mmol/L) or elevations of serum creatinine or BUN occur, the dose should be reduced or administration delayed (see section 4.2).", "truncated": false}, "after_length": 660, "after_sha256": "68222a2680909df73e7a9e9cfabae81d67fcd43ce57c67537a7b42ba46f7fbf4", "annex": "I", "before": {"end": 660, "start": 0, "text": "Renal abnormalities ranging from elevated serum creatinine to renal failure and death were reported in patients treated with intravenous azacitidine in combination with other chemotherapeutic agents. In addition, renal tubular acidosis, defined as a fall in serum bicarbonate to < 20 mmol/L in association with an alkaline urine and hypokalaemia (serum potassium < 3 mmol/L) developed in 5 subjects with chronic myelogenous leukaemia (CML) treated with azacitidine and etoposide. If unexplained reductions in serum bicarbonate (< 20 mmol/L) or elevations of serum creatinine or BUN occur, the dose should be reduced or administration delayed (see section 4.2).", "truncated": false}, "before_length": 660, "before_sha256": "68222a2680909df73e7a9e9cfabae81d67fcd43ce57c67537a7b42ba46f7fbf4", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0b9fe708991c7844d577d1ab", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004984", "medicine_name": "Azacitidine Mylan", "medicine_slug": "azacitidine-mylan", "observed_at": "2026-10-12T13:35:15Z", "pipeline_version": "2.0.0", "presentation_label": "Azacitidine Mylan 25 mg/mL powder for suspension for injection", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "2dab763f1da8ff3942467e20de6d30b5746ef6030def3da15b9994facca1adaf", "source_snapshot_id": "source-0c0faddb540a1c60c41a2ccb", "source_updated_at": "2026-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/azacitidine-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": 158}
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