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{"after": {"end": 186, "start": 0, "text": "Once Simponi has been stored at room temperature, it should not be returned to refrigerated storage. Simponi must be discarded if not used within the 30 days of room temperature storage.", "truncated": false}, "after_length": 186, "after_sha256": "2891bf926e41555556a670a4ec45a1eeeb35161f5340e18eb5ead3ef0be9722f", "annex": "I", "before": {"end": 186, "start": 0, "text": "Once Simponi has been stored at room temperature, it should not be returned to refrigerated storage. Simponi must be discarded if not used within the 30 days of room temperature storage.", "truncated": false}, "before_length": 186, "before_sha256": "2891bf926e41555556a670a4ec45a1eeeb35161f5340e18eb5ead3ef0be9722f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0025614f8f0d7ec9c291e44f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000992", "medicine_name": "Simponi", "medicine_slug": "simponi", "observed_at": "2026-10-12T19:02:32Z", "pipeline_version": "2.0.0", "presentation_label": "Simponi 50 mg solution for injection in prefilled pen. Simponi 50 mg solution for injection in prefilled syringe", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.4", "section_type": "storage", "source_provider": "European Medicines Agency", "source_sha256": "1a1239651c23a86bc841f47c86336103ad978e9ff64d9205b83e310c257e18bc", "source_snapshot_id": "source-3a7a8db98719dd67a2a12fab", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/simponi-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": 2399}
{"after": {"end": 527, "start": 0, "text": "No clinically relevant interaction of co-administered chemotherapy on bevacizumab pharmacokinetics was observed based on the results of population pharmacokinetic analyses. There were neither statistically significant nor clinically relevant differences in bevacizumab clearance in patients receiving bevacizumab monotherapy compared to patients receiving bevacizumab in combination with interferon alfa-2a, erlotinib or chemotherapies (IFL, 5-FU/LV, carboplatin/paclitaxel, capecitabine, doxorubicin or cisplatin/gemcitabine).", "truncated": false}, "after_length": 527, "after_sha256": "3f9907b515d9fa0791af9a28a426d32d2e7c2828a9e7511df31613440c85b0a5", "annex": "I", "before": {"end": 527, "start": 0, "text": "No clinically relevant interaction of co-administered chemotherapy on bevacizumab pharmacokinetics was observed based on the results of population pharmacokinetic analyses. There were neither statistically significant nor clinically relevant differences in bevacizumab clearance in patients receiving bevacizumab monotherapy compared to patients receiving bevacizumab in combination with interferon alfa-2a, erlotinib or chemotherapies (IFL, 5-FU/LV, carboplatin/paclitaxel, capecitabine, doxorubicin or cisplatin/gemcitabine).", "truncated": false}, "before_length": 527, "before_sha256": "3f9907b515d9fa0791af9a28a426d32d2e7c2828a9e7511df31613440c85b0a5", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0025dff49136c208bb81907e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005106", "medicine_name": "Aybintio", "medicine_slug": "aybintio", "observed_at": "2026-10-12T13:27:42Z", "pipeline_version": "2.0.0", "presentation_label": "Aybintio 25 mg/ml concentrate for solution for infusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "fba935554f03156639cf5f78cbde9b08cd3489bf366e599397ae71b670ba5459", "source_snapshot_id": "source-ba46e119957a3ca29a915015", "source_updated_at": "2026-09-11", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/aybintio-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": 285}
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{"after": {"end": 417, "start": 0, "text": "Due to its inhibition of TNF, golimumab administered during pregnancy could affect normal immune responses in the newborn. Studies in animals do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). The available clinical experience is limited. Golimumab should only be used during pregnancy if clearly needed.", "truncated": false}, "after_length": 417, "after_sha256": "afd30a577212c1a39971f2f41e8ab568c684b3038f7b011deb740c64595793a4", "annex": "I", "before": {"end": 417, "start": 0, "text": "Due to its inhibition of TNF, golimumab administered during pregnancy could affect normal immune responses in the newborn. Studies in animals do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). The available clinical experience is limited. Golimumab should only be used during pregnancy if clearly needed.", "truncated": false}, "before_length": 417, "before_sha256": "afd30a577212c1a39971f2f41e8ab568c684b3038f7b011deb740c64595793a4", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-002f85f6a0a02f16410f38b0", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000992", "medicine_name": "Simponi", "medicine_slug": "simponi", "observed_at": "2026-10-12T19:02:32Z", "pipeline_version": "2.0.0", "presentation_label": "Simponi 100 mg solution for injection in prefilled pen. Simponi 100 mg solution for injection in prefilled syringe", "presentation_occurrence": 4, "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": "1a1239651c23a86bc841f47c86336103ad978e9ff64d9205b83e310c257e18bc", "source_snapshot_id": "source-3a7a8db98719dd67a2a12fab", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/simponi-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": 3915}
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{"after": {"end": 721, "start": 0, "text": "3 Oedema/fluid retention has been associated with the use of ERAs including macitentan. In SERAPHIN, a long-term double-blind study in patients with PAH, the incidence of oedema AEs in the macitentan 10 mg and placebo treatment groups was 21.9% and 20.5%, respectively. In a double-blind study in adult patients with idiopathic pulmonary fibrosis, the incidence of peripheral oedema AEs in the macitentan and placebo treatment groups was 11.8% and 6.8%, respectively. In two double-blind clinical studies in adult patients with digital ulcers associated with systemic sclerosis, the incidences of peripheral oedema AEs ranged from 13.4% to 16.1% in the macitentan 10 mg groups and from 6.2% to 4.5% in the placebo groups.", "truncated": false}, "after_length": 721, "after_sha256": "971708f2aed208dd610360fa9344af6f16d8a4a36bf6198bebde7e59348c5faf", "annex": "I", "before": {"end": 721, "start": 0, "text": "3 Oedema/fluid retention has been associated with the use of ERAs including macitentan. In SERAPHIN, a long-term double-blind study in patients with PAH, the incidence of oedema AEs in the macitentan 10 mg and placebo treatment groups was 21.9% and 20.5%, respectively. In a double-blind study in adult patients with idiopathic pulmonary fibrosis, the incidence of peripheral oedema AEs in the macitentan and placebo treatment groups was 11.8% and 6.8%, respectively. In two double-blind clinical studies in adult patients with digital ulcers associated with systemic sclerosis, the incidences of peripheral oedema AEs ranged from 13.4% to 16.1% in the macitentan 10 mg groups and from 6.2% to 4.5% in the placebo groups.", "truncated": false}, "before_length": 721, "before_sha256": "971708f2aed208dd610360fa9344af6f16d8a4a36bf6198bebde7e59348c5faf", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-007267a2b930072766afbf8e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002697", "medicine_name": "Opsumit", "medicine_slug": "opsumit", "observed_at": "2026-10-12T13:39:34Z", "pipeline_version": "2.0.0", "presentation_label": "Opsumit 10 mg film-coated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "494af21fb5dc7c276172dddb7e206a3394382d7c59311813bde021d616f2ec59", "source_snapshot_id": "source-820cf6001aa1d241fbd68a85", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/opsumit-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": 287}
{"after": {"end": 501, "start": 0, "text": "Le critère principal d’efficacité de l’étude a été la survie globale, définie entre le temps de la randomisation et celui du décès quelle que soit sa cause. 829 patients ont été randomisés (292 sous FOLFOX-4, 293 sous bevacizumab + FOLFOX-4 et 244 sous bevacizumab en monothérapie). L’ajout de bevacizumab à FOLFOX-4 a prolongé la survie de manière significative. Une augmentation significative de la survie sans progression et du taux de réponse objective ont également été observés (voir Tableau 8).", "truncated": false}, "after_length": 501, "after_sha256": "cfa3ad5c577213eca35b2b5686fdf8253875c60a1b9c2ac566d5f2ce51a74932", "annex": "I", "before": {"end": 501, "start": 0, "text": "Le critère principal d’efficacité de l’étude a été la survie globale, définie entre le temps de la randomisation et celui du décès quelle que soit sa cause. 829 patients ont été randomisés (292 sous FOLFOX-4, 293 sous bevacizumab + FOLFOX-4 et 244 sous bevacizumab en monothérapie). L’ajout de bevacizumab à FOLFOX-4 a prolongé la survie de manière significative. Une augmentation significative de la survie sans progression et du taux de réponse objective ont également été observés (voir Tableau 8).", "truncated": false}, "before_length": 501, "before_sha256": "cfa3ad5c577213eca35b2b5686fdf8253875c60a1b9c2ac566d5f2ce51a74932", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0079f535579e00000a1f3eca", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005286", "medicine_name": "Alymsys", "medicine_slug": "alymsys", "observed_at": "2026-10-12T19:02:07Z", "pipeline_version": "2.0.0", "presentation_label": "Alymsys 25 mg/mL solution à diluer pour perfusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8fef19b3e09caee6abcedaa762e16d4b3139843cc8ce41d68d572a4c2413df8b", "source_snapshot_id": "source-031f90cd07def6d808f3a292", "source_updated_at": "2026-02-06", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/alymsys-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": 1157}
{"after": {"end": 274, "start": 0, "text": "Renal thrombotic microangiopathy with or without concomitant sunitinib use, and hyaline occlusive glomerular microangiopathy which may be clinically manifested as proteinuria (not known) . For further information on proteinuria see section 4.4 and Proteinuria in section 4.8", "truncated": false}, "after_length": 274, "after_sha256": "b8054236bec94ac682751a840ff1a281c9ca4e5113876cd52af0a2c4c3f9bd4f", "annex": "I", "before": {"end": 274, "start": 0, "text": "Renal thrombotic microangiopathy with or without concomitant sunitinib use, and hyaline occlusive glomerular microangiopathy which may be clinically manifested as proteinuria (not known) . For further information on proteinuria see section 4.4 and Proteinuria in section 4.8", "truncated": false}, "before_length": 274, "before_sha256": "b8054236bec94ac682751a840ff1a281c9ca4e5113876cd52af0a2c4c3f9bd4f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-007e097aa421b2f5e55eb209", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005286", "medicine_name": "Alymsys", "medicine_slug": "alymsys", "observed_at": "2026-10-12T19:02:06Z", "pipeline_version": "2.0.0", "presentation_label": "Alymsys 25 mg/mL concentrate for solution for infusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "5bb6b472d886d4b44238eb3be4943592bb93672ef59e2424935ca8190fe65c5d", "source_snapshot_id": "source-6897a05da7751ed6781e8850", "source_updated_at": "2026-02-06", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/alymsys-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 836}
{"after": {"end": 772, "start": 0, "text": "At week 24 improvements in parameters of peripheral activity characteristic of psoriatic arthritis (e.g. number of swollen joints, number of painful/tender joints, dactylitis and enthesitis) were seen in the Simponitreated patients. Simponi treatment resulted in significant improvement in physical function as assessed by HAQ DI, as well as significant improvements in healthrelated quality of life as measured by the physical and mental component summary scores of the SF36. Among patients who remained on the Simponi treatment to which they were randomised at study start, DAS28 and HAQ DI responses were maintained through week 104. Among patients remaining in the study and treated with Simponi, DAS28 and HAQ DI responses were similar from week 104 through week 256.", "truncated": false}, "after_length": 772, "after_sha256": "e20ce86a2ea3df04a45fa32c4eb1e0638637249d9bc33218027c38b95b96f62d", "annex": "I", "before": {"end": 772, "start": 0, "text": "At week 24 improvements in parameters of peripheral activity characteristic of psoriatic arthritis (e.g. number of swollen joints, number of painful/tender joints, dactylitis and enthesitis) were seen in the Simponitreated patients. Simponi treatment resulted in significant improvement in physical function as assessed by HAQ DI, as well as significant improvements in healthrelated quality of life as measured by the physical and mental component summary scores of the SF36. Among patients who remained on the Simponi treatment to which they were randomised at study start, DAS28 and HAQ DI responses were maintained through week 104. Among patients remaining in the study and treated with Simponi, DAS28 and HAQ DI responses were similar from week 104 through week 256.", "truncated": false}, "before_length": 772, "before_sha256": "e20ce86a2ea3df04a45fa32c4eb1e0638637249d9bc33218027c38b95b96f62d", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0087838e2e627149b4701eb4", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000992", "medicine_name": "Simponi", "medicine_slug": "simponi", "observed_at": "2026-10-12T19:02:32Z", "pipeline_version": "2.0.0", "presentation_label": "Simponi 100 mg solution for injection in prefilled pen", "presentation_occurrence": 5, "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": "1a1239651c23a86bc841f47c86336103ad978e9ff64d9205b83e310c257e18bc", "source_snapshot_id": "source-3a7a8db98719dd67a2a12fab", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/simponi-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": 5518}
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{"after": {"end": 690, "start": 0, "text": "Dans l’étude Einstein Extension (voir tableau 9), le rivaroxaban a été supérieur au placebo pour les critères principaux et secondaires d’efficacité. Concernant le critère principal de tolérance (événements hémorragiques majeurs), une incidence numériquement plus élevée non significative a été observée chez les patients traités par le rivaroxaban à 20 mg en une seule prise par jour en comparaison au placebo. Concernant le critère secondaire de tolérance (événements hémorragiques majeurs ou saignements non majeurs cliniquement pertinents), les taux ont été plus élevés chez les patients traités par le rivaroxaban à 20 mg en une seule prise par jour que chez les patients sous placebo.", "truncated": false}, "after_length": 690, "after_sha256": "a5b4ee218fb35d4a9093ab7728daa9105752f2ca911554bbbb875b20f3fe043b", "annex": "I", "before": {"end": 690, "start": 0, "text": "Dans l’étude Einstein Extension (voir tableau 9), le rivaroxaban a été supérieur au placebo pour les critères principaux et secondaires d’efficacité. Concernant le critère principal de tolérance (événements hémorragiques majeurs), une incidence numériquement plus élevée non significative a été observée chez les patients traités par le rivaroxaban à 20 mg en une seule prise par jour en comparaison au placebo. Concernant le critère secondaire de tolérance (événements hémorragiques majeurs ou saignements non majeurs cliniquement pertinents), les taux ont été plus élevés chez les patients traités par le rivaroxaban à 20 mg en une seule prise par jour que chez les patients sous placebo.", "truncated": false}, "before_length": 690, "before_sha256": "a5b4ee218fb35d4a9093ab7728daa9105752f2ca911554bbbb875b20f3fe043b", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00b465933dfaba9d64910bf5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005600", "medicine_name": "Rivaroxaban Viatris (previously Rivaroxaban Mylan)", "medicine_slug": "rivaroxaban-viatris-previously-rivaroxaban-mylan", "observed_at": "2026-10-12T19:37:08Z", "pipeline_version": "2.0.0", "presentation_label": "Rivaroxaban Viatris 20 mg comprimé pelliculé", "presentation_occurrence": 4, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "0a259647b297ee400ee98db938921b80900e015ef366694c6fbdf31e9b54f8bf", "source_snapshot_id": "source-6734c149d0cfab550c98319c", "source_updated_at": "2025-06-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/rivaroxaban-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": 4200}
{"after": {"end": 329, "start": 0, "text": "Les effets indésirables de classe des antibiotiques comprennent la colite pseudomembraneuse et la prolifération de microorganismes non sensibles, y compris de champignons (voir rubrique 4.4). Lors des essais cliniques, une diarrhée liée au traitement est survenue chez 0,7 % des patients; tous les cas étaient de sévérité légère.", "truncated": false}, "after_length": 329, "after_sha256": "efe0b87585677a8eccbe192f6bcec298a7ee2afb84c794f142515d06509aef72", "annex": "I", "before": {"end": 329, "start": 0, "text": "Les effets indésirables de classe des antibiotiques comprennent la colite pseudomembraneuse et la prolifération de microorganismes non sensibles, y compris de champignons (voir rubrique 4.4). Lors des essais cliniques, une diarrhée liée au traitement est survenue chez 0,7 % des patients; tous les cas étaient de sévérité légère.", "truncated": false}, "before_length": 329, "before_sha256": "efe0b87585677a8eccbe192f6bcec298a7ee2afb84c794f142515d06509aef72", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00b53a039122fbe344616f08", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004237", "medicine_name": "Xerava", "medicine_slug": "xerava", "observed_at": "2026-10-12T19:02:12Z", "pipeline_version": "2.0.0", "presentation_label": "Xerava 50 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": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "263d3ee147b0360b9af7a2f8482dad0491caf07a9cbd85e97930e37ff272c34a", "source_snapshot_id": "source-4ad843ef8e3dd9f86ed13b08", "source_updated_at": "2026-02-06", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xerava-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 245}
{"after": {"end": 428, "start": 0, "text": "L’objectif principal d’amélioration de la SSP a été atteint. Les patientes ayant reçu du bevacizumab à la dose de 7,5 mg/kg toutes les 3 semaines en association à la chimiothérapie et ayant continué à recevoir du bevacizumab seul pendant 18 cycles au maximum, ont eu une amélioration de la SSP statistiquement significative comparée aux patientes traitées par chimiothérapie seule (carboplatine et paclitaxel) en première ligne.", "truncated": false}, "after_length": 428, "after_sha256": "a28fcd178e6f634c8aefb50532899232d0bfe37579c7111d8a8cf5c8d8efe170", "annex": "I", "before": {"end": 428, "start": 0, "text": "L’objectif principal d’amélioration de la SSP a été atteint. Les patientes ayant reçu du bevacizumab à la dose de 7,5 mg/kg toutes les 3 semaines en association à la chimiothérapie et ayant continué à recevoir du bevacizumab seul pendant 18 cycles au maximum, ont eu une amélioration de la SSP statistiquement significative comparée aux patientes traitées par chimiothérapie seule (carboplatine et paclitaxel) en première ligne.", "truncated": false}, "before_length": 428, "before_sha256": "a28fcd178e6f634c8aefb50532899232d0bfe37579c7111d8a8cf5c8d8efe170", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00b68b9856d80b7b5d4fef54", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005106", "medicine_name": "Aybintio", "medicine_slug": "aybintio", "observed_at": "2026-10-12T13:27:44Z", "pipeline_version": "2.0.0", "presentation_label": "Aybintio 25 mg/ml solution à diluer pour perfusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "4a45f4a7b4e7df4dbc475a3f92ce3f16543120b39806a2fc6e5399c3925ecba4", "source_snapshot_id": "source-70a38464ff06de59375a15c3", "source_updated_at": "2026-09-11", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/aybintio-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": 1854}
{"after": {"end": 592, "start": 0, "text": "Une augmentation de l’incidence des neutropénies sévères, des neutropénies fébriles ou des infections avec ou sans neutropénie sévère (dont certaines fatales) a été observée chez des patients recevant une chimiothérapie myélotoxique associée à bevacizumab, comparé à ceux recevant une chimiothérapie seule. Cela a principalement été observé en association aux dérivés du platine ou aux chimiothérapies à base de taxane dans le CBNPC, le cancer du sein métastatique, et en association avec le paclitaxel et le topotécan dans le cancer du col de l’utérus persistant, en rechute ou métastatique.", "truncated": false}, "after_length": 592, "after_sha256": "5086adab27da66c2711b6286210ffc21712dd5bbe295393dac35ed7efd346cc2", "annex": "I", "before": {"end": 592, "start": 0, "text": "Une augmentation de l’incidence des neutropénies sévères, des neutropénies fébriles ou des infections avec ou sans neutropénie sévère (dont certaines fatales) a été observée chez des patients recevant une chimiothérapie myélotoxique associée à bevacizumab, comparé à ceux recevant une chimiothérapie seule. Cela a principalement été observé en association aux dérivés du platine ou aux chimiothérapies à base de taxane dans le CBNPC, le cancer du sein métastatique, et en association avec le paclitaxel et le topotécan dans le cancer du col de l’utérus persistant, en rechute ou métastatique.", "truncated": false}, "before_length": 592, "before_sha256": "5086adab27da66c2711b6286210ffc21712dd5bbe295393dac35ed7efd346cc2", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00c122ccd5e2cad31afb96aa", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005286", "medicine_name": "Alymsys", "medicine_slug": "alymsys", "observed_at": "2026-10-12T19:02:07Z", "pipeline_version": "2.0.0", "presentation_label": "Alymsys 25 mg/mL solution à diluer pour perfusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "8fef19b3e09caee6abcedaa762e16d4b3139843cc8ce41d68d572a4c2413df8b", "source_snapshot_id": "source-031f90cd07def6d808f3a292", "source_updated_at": "2026-02-06", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/alymsys-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": 274}
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{"after": {"end": 297, "start": 0, "text": "Le posaconazole est actif in vitro contre les micro-organismes suivants : les espèces Aspergillus (Aspergillus fumigatus, A. flavus, A. terreus, A. nidulans, A. niger, A. ustus), Candida species (Candida albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis, C. dubliniensis, C. famata,", "truncated": false}, "after_length": 297, "after_sha256": "00603a4b84855e61bd5ca00b340312e5d835bba94c3babfacf242764f1098224", "annex": "I", "before": {"end": 297, "start": 0, "text": "Le posaconazole est actif in vitro contre les micro-organismes suivants : les espèces Aspergillus (Aspergillus fumigatus, A. flavus, A. terreus, A. nidulans, A. niger, A. ustus), Candida species (Candida albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis, C. dubliniensis, C. famata,", "truncated": false}, "before_length": 297, "before_sha256": "00603a4b84855e61bd5ca00b340312e5d835bba94c3babfacf242764f1098224", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00c774a276f2c972b8293ff2", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005005", "medicine_name": "Posaconazole Accord", "medicine_slug": "posaconazole-accord", "observed_at": "2026-10-12T19:44:30Z", "pipeline_version": "2.0.0", "presentation_label": "Posaconazole Accord 100 mg comprimés gastro-résistants", "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": "307cc53ed0048509787bc0b73f2040c678b1df3cc6f8e722f513a205cc3e6baa", "source_snapshot_id": "source-b5de155abfc26fe489dd1b33", "source_updated_at": "2025-05-06", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/posaconazole-accord-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 417}
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{"after": {"end": 908, "start": 0, "text": "The pharmacokinetic/pharmacodynamic (PK/PD) relationship between rivaroxaban plasma concentration and several PD endpoints (factor Xa inhibition, PT, aPTT, Heptest) has been evaluated after administration of a wide range of doses (5 – 30 mg twice a day). The relationship between rivaroxaban concentration and factor Xa activity was best described by an Emax model. For PT, the linear intercept model generally described the data better. Depending on the different PT reagents used, the slope differed considerably. When Neoplastin PT was used, baseline PT was about 13 s and the slope was around 3 to 4 s/(100 mcg/l). The results of the PK/PD analyses in Phase II and III were consistent with the data established in healthy subjects. In patients, baseline factor Xa and PT were influenced by the surgery resulting in a difference in the concentration-PT slope between the day post-surgery and steady state.", "truncated": false}, "after_length": 908, "after_sha256": "9ae6773972ceeb660144561d5443420d478f33384e340a4398a8e5e61cfb1bae", "annex": "I", "before": {"end": 908, "start": 0, "text": "The pharmacokinetic/pharmacodynamic (PK/PD) relationship between rivaroxaban plasma concentration and several PD endpoints (factor Xa inhibition, PT, aPTT, Heptest) has been evaluated after administration of a wide range of doses (5 – 30 mg twice a day). The relationship between rivaroxaban concentration and factor Xa activity was best described by an Emax model. For PT, the linear intercept model generally described the data better. Depending on the different PT reagents used, the slope differed considerably. When Neoplastin PT was used, baseline PT was about 13 s and the slope was around 3 to 4 s/(100 mcg/l). The results of the PK/PD analyses in Phase II and III were consistent with the data established in healthy subjects. In patients, baseline factor Xa and PT were influenced by the surgery resulting in a difference in the concentration-PT slope between the day post-surgery and steady state.", "truncated": false}, "before_length": 908, "before_sha256": "9ae6773972ceeb660144561d5443420d478f33384e340a4398a8e5e61cfb1bae", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00f4855cce4c0db324ef433a", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005600", "medicine_name": "Rivaroxaban Viatris (previously Rivaroxaban Mylan)", "medicine_slug": "rivaroxaban-viatris-previously-rivaroxaban-mylan", "observed_at": "2026-10-12T19:36:56Z", "pipeline_version": "2.0.0", "presentation_label": "Rivaroxaban Viatris 10 mg film-coated tablets", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "23e12930e87dfb1e4ff35978713886b95f3ffda265129f4e22fc85df9f4aff16", "source_snapshot_id": "source-c96321ac7577e21fc0d40119", "source_updated_at": "2025-06-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/rivaroxaban-viatris-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": 2169}
{"after": {"end": 670, "start": 0, "text": "Après administration intraveineuse, les volumes de distribution de l’emtricitabine et du ténofovir à l’état d’équilibre sont estimés à environ 1,4 L/kg et 800 mL/kg. Après administration orale d’emtricitabine ou de ténofovir disoproxil, l’emtricitabine et le ténofovir diffusent largement dans la plupart des tissus. La liaison in vitro de l’emtricitabine aux protéines plasmatiques humaines a été inférieure à 4 % et indépendante de la concentration sur l’intervalle 0,02200 µg/mL. La liaison in vitro du ténofovir aux protéines plasmatiques ou sériques a été inférieure à 0,7 et 7,2 % respectivement, dans l’intervalle de concentrations compris entre 0,01 et 25 µg/mL.", "truncated": false}, "after_length": 670, "after_sha256": "8f35dcde27b3c2ce79cb1e6261d6a3460b095b039e73be7718c238d04e54a692", "annex": "I", "before": {"end": 670, "start": 0, "text": "Après administration intraveineuse, les volumes de distribution de l’emtricitabine et du ténofovir à l’état d’équilibre sont estimés à environ 1,4 L/kg et 800 mL/kg. Après administration orale d’emtricitabine ou de ténofovir disoproxil, l’emtricitabine et le ténofovir diffusent largement dans la plupart des tissus. La liaison in vitro de l’emtricitabine aux protéines plasmatiques humaines a été inférieure à 4 % et indépendante de la concentration sur l’intervalle 0,02200 µg/mL. La liaison in vitro du ténofovir aux protéines plasmatiques ou sériques a été inférieure à 0,7 et 7,2 % respectivement, dans l’intervalle de concentrations compris entre 0,01 et 25 µg/mL.", "truncated": false}, "before_length": 670, "before_sha256": "8f35dcde27b3c2ce79cb1e6261d6a3460b095b039e73be7718c238d04e54a692", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00f4d41a5bb53646894c8801", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004050", "medicine_name": "Emtricitabine/Tenofovir disoproxil Mylan", "medicine_slug": "emtricitabine-tenofovir-disoproxil-mylan", "observed_at": "2026-10-12T13:35:51Z", "pipeline_version": "2.0.0", "presentation_label": "Emtricitabine/Ténofovir disoproxil Mylan 200 mg/245 mg comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "7a5a04d549250cb67ad770d743021a0458cbd7895ad18a20df3607fc5facb642", "source_snapshot_id": "source-3391e5c4d8af438fa2e3720e", "source_updated_at": "2026-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/emtricitabine-tenofovir-disoproxil-mylan-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1498}
{"after": {"end": 246, "start": 0, "text": "In the presence of strong CYP3A4 inducers reduced efficacy of macitentan could occur. The combination of macitentan with strong CYP3A4 inducers (e.g., rifampicin, St. John’s wort, carbamazepine, and phenytoin) should be avoided (see section 4.5).", "truncated": false}, "after_length": 246, "after_sha256": "af98ab2609c702537d8d8a0a5db59d54bd299ad60eaa08801004d1c4780dedb6", "annex": "I", "before": {"end": 246, "start": 0, "text": "In the presence of strong CYP3A4 inducers reduced efficacy of macitentan could occur. The combination of macitentan with strong CYP3A4 inducers (e.g., rifampicin, St. John’s wort, carbamazepine, and phenytoin) should be avoided (see section 4.5).", "truncated": false}, "before_length": 246, "before_sha256": "af98ab2609c702537d8d8a0a5db59d54bd299ad60eaa08801004d1c4780dedb6", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00fc368665fbdee0969930a4", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002697", "medicine_name": "Opsumit", "medicine_slug": "opsumit", "observed_at": "2026-10-12T13:39:34Z", "pipeline_version": "2.0.0", "presentation_label": "Opsumit 2.5 mg dispersible tablets", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "494af21fb5dc7c276172dddb7e206a3394382d7c59311813bde021d616f2ec59", "source_snapshot_id": "source-820cf6001aa1d241fbd68a85", "source_updated_at": "2026-04-23", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/opsumit-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": 751}
{"after": {"end": 178, "start": 0, "text": "Probabilité de survie sans progressionCensuréMois de randomisationN° de patients à risqueProbabilité de survie sans progressionCensuréMois de randomisationN° de patients à risque", "truncated": false}, "after_length": 178, "after_sha256": "5da51162422f3ecf7731c2448abbffe522cee2331d14e79e11544333034398e7", "annex": "I", "before": {"end": 178, "start": 0, "text": "Probabilité de survie sans progressionCensuréMois de randomisationN° de patients à risqueProbabilité de survie sans progressionCensuréMois de randomisationN° de patients à risque", "truncated": false}, "before_length": 178, "before_sha256": "5da51162422f3ecf7731c2448abbffe522cee2331d14e79e11544333034398e7", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00fcbdd85250ef6bc9aed58f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004978", "medicine_name": "Brukinsa", "medicine_slug": "brukinsa", "observed_at": "2026-10-12T13:27:26Z", "pipeline_version": "2.0.0", "presentation_label": "BRUKINSA 80 mg gélules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "efec7bab67f8714aa0fdd45569bd6351972f18b19a073cffc0c53d347ad4ce72", "source_snapshot_id": "source-7d6ee877ee45091e559446f5", "source_updated_at": "2026-10-07", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/brukinsa-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": 979}
{"after": {"end": 369, "start": 0, "text": "Necrotising fasciitis, including fatal cases, has rarely been reported in patients treated with bevacizumab. This condition is usually secondary to wound healing complications, gastrointestinal perforation or fistula formation. Alymsys therapy should be discontinued in patients who develop necrotising fasciitis, and appropriate treatment should be promptly initiated.", "truncated": false}, "after_length": 369, "after_sha256": "723775e7e7e75badd65d6a12a91aa15656556d2ad3410787b4aeca6d4f1740be", "annex": "I", "before": {"end": 369, "start": 0, "text": "Necrotising fasciitis, including fatal cases, has rarely been reported in patients treated with bevacizumab. This condition is usually secondary to wound healing complications, gastrointestinal perforation or fistula formation. Alymsys therapy should be discontinued in patients who develop necrotising fasciitis, and appropriate treatment should be promptly initiated.", "truncated": false}, "before_length": 369, "before_sha256": "723775e7e7e75badd65d6a12a91aa15656556d2ad3410787b4aeca6d4f1740be", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00ff856b5bf90957a4bc9e06", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005286", "medicine_name": "Alymsys", "medicine_slug": "alymsys", "observed_at": "2026-10-12T19:02:06Z", "pipeline_version": "2.0.0", "presentation_label": "Alymsys 25 mg/mL concentrate for solution for infusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "5bb6b472d886d4b44238eb3be4943592bb93672ef59e2424935ca8190fe65c5d", "source_snapshot_id": "source-6897a05da7751ed6781e8850", "source_updated_at": "2026-02-06", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/alymsys-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 204}
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{"after": {"end": 1500, "start": 0, "text": "Pendant les périodes contrôlées des essais pivots chez l’adulte avec l’adalimumab d’une durée d’au moins 12 semaines chez des patients atteints de polyarthrite rhumatoïde active modérée à sévère, de spondylarthrite ankylosante, de spondyloarthrite axiale sans signes radiographiques de SA, de rhumatisme psoriasique, de psoriasis, d’hidrosadénite suppurée, de la maladie de Crohn, de rectocolite hémorragique et d’uvéite, un taux (intervalle de confiance à 95 %) de cancers autres que lymphomes ou cancers de la peau non mélanomes, de 6,8 (4,4 – 10,5) pour 1 000 patientsannée parmi les 5 291 patients traités par adalimumab, a été observé versus un taux de 6,3 (3,4 – 11,8) pour 1 000 patientsannée parmi les 3 444 patients du groupe contrôle (la durée moyenne du traitement était de 4,0 mois pour les patients traités par adalimumab et de 3,8 mois pour les patients du groupe contrôle). Le taux (intervalle de confiance à 95 %) de cancers de la peau non mélanomes était de 8,8 (6,0 – 13,0) pour 1 000 patientsannée parmi les patients traités par adalimumab et de 3,2 (1,3 – 7,6) pour 1 000 patientsannée parmi les patients du groupe contrôle. Dans ces cancers de la peau, des carcinomes spino-cellulaires sont survenus à des taux (intervalle de confiance à 95 %) de 2,7 (1,4 – 5,4) pour 1 000 patientsannée parmi les patients traités par adalimumab et 0,6 (0,1 – 4,5) pour 1 000 patientsannée parmi les patients du groupe contrôle. Le taux (intervalle de confiance à 95 %) de lymphomes était de 0,7", "truncated": true}, "after_length": 1662, "after_sha256": "04af3f9edaa882182d8680bb2a9698936360d242619035aa764287c7f619bdaa", "annex": "I", "before": {"end": 1500, "start": 0, "text": "Pendant les périodes contrôlées des essais pivots chez l’adulte avec l’adalimumab d’une durée d’au moins 12 semaines chez des patients atteints de polyarthrite rhumatoïde active modérée à sévère, de spondylarthrite ankylosante, de spondyloarthrite axiale sans signes radiographiques de SA, de rhumatisme psoriasique, de psoriasis, d’hidrosadénite suppurée, de la maladie de Crohn, de rectocolite hémorragique et d’uvéite, un taux (intervalle de confiance à 95 %) de cancers autres que lymphomes ou cancers de la peau non mélanomes, de 6,8 (4,4 – 10,5) pour 1 000 patientsannée parmi les 5 291 patients traités par adalimumab, a été observé versus un taux de 6,3 (3,4 – 11,8) pour 1 000 patientsannée parmi les 3 444 patients du groupe contrôle (la durée moyenne du traitement était de 4,0 mois pour les patients traités par adalimumab et de 3,8 mois pour les patients du groupe contrôle). Le taux (intervalle de confiance à 95 %) de cancers de la peau non mélanomes était de 8,8 (6,0 – 13,0) pour 1 000 patientsannée parmi les patients traités par adalimumab et de 3,2 (1,3 – 7,6) pour 1 000 patientsannée parmi les patients du groupe contrôle. Dans ces cancers de la peau, des carcinomes spino-cellulaires sont survenus à des taux (intervalle de confiance à 95 %) de 2,7 (1,4 – 5,4) pour 1 000 patientsannée parmi les patients traités par adalimumab et 0,6 (0,1 – 4,5) pour 1 000 patientsannée parmi les patients du groupe contrôle. Le taux (intervalle de confiance à 95 %) de lymphomes était de 0,7", "truncated": true}, "before_length": 1662, "before_sha256": "04af3f9edaa882182d8680bb2a9698936360d242619035aa764287c7f619bdaa", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-012c328f8bea7bd2c29167c8", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004879", "medicine_name": "Amsparity", "medicine_slug": "amsparity", "observed_at": "2026-10-12T19:15:12Z", "pipeline_version": "2.0.0", "presentation_label": "Amsparity 40 mg/0,8 ml, solution injectable", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "24d0cc9d1a51b9be434880981aaadecfd5acfad769bf26ba5172cf74b57f6266", "source_snapshot_id": "source-ff374e236a5e5c8d097f6178", "source_updated_at": "2025-09-05", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/amsparity-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": 2561}
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{"after": {"end": 866, "start": 0, "text": "Les données épidémiologiques disponibles concernant le risque de malformation après exposition aux IEC lors du 1er trimestre de la grossesse ne permettent pas de conclure. Cependant une petite augmentation du risque de malformation congénitale ne peut être exclue. Il n’existe pas d’études épidémiologiques disponibles concernant l’utilisation des ARAII au 1er trimestre de la grossesse, cependant un risque similaire aux IEC pourrait exister pour cette classe. A moins que le traitement avec un ARAII soit considéré comme essentiel, il est recommandé de modifier le traitement antihypertenseur chez les patientes qui envisagent une grossesse pour un médicament ayant un profil de sécurité établi pendant la grossesse. En cas de diagnostic de grossesse, le traitement par un ARAII doit être arrêté immédiatement et si nécessaire un traitement alternatif sera débuté.", "truncated": false}, "after_length": 866, "after_sha256": "c3617238c6a5544de0a4548d8aa3119d0a96f565e909dbe4babc88ff28b0018c", "annex": "I", "before": {"end": 866, "start": 0, "text": "Les données épidémiologiques disponibles concernant le risque de malformation après exposition aux IEC lors du 1er trimestre de la grossesse ne permettent pas de conclure. Cependant une petite augmentation du risque de malformation congénitale ne peut être exclue. Il n’existe pas d’études épidémiologiques disponibles concernant l’utilisation des ARAII au 1er trimestre de la grossesse, cependant un risque similaire aux IEC pourrait exister pour cette classe. A moins que le traitement avec un ARAII soit considéré comme essentiel, il est recommandé de modifier le traitement antihypertenseur chez les patientes qui envisagent une grossesse pour un médicament ayant un profil de sécurité établi pendant la grossesse. En cas de diagnostic de grossesse, le traitement par un ARAII doit être arrêté immédiatement et si nécessaire un traitement alternatif sera débuté.", "truncated": false}, "before_length": 866, "before_sha256": "c3617238c6a5544de0a4548d8aa3119d0a96f565e909dbe4babc88ff28b0018c", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-012efe5a6fbf510d99b53605", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000141", "medicine_name": "Aprovel", "medicine_slug": "aprovel", "observed_at": "2026-10-12T17:26:17Z", "pipeline_version": "2.0.0", "presentation_label": "Aprovel 150 mg comprimés pelliculés.", "presentation_occurrence": 5, "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": "8bb8b2b3057f8f9a8fac8321a222a7c020fa068739f1494a85cf638bf4f41b88", "source_snapshot_id": "source-47a3bd7fbf930750d7ef7891", "source_updated_at": "2026-01-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/aprovel-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": 1824}
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{"after": {"end": 1193, "start": 0, "text": "Trial E2100 was an open-label, randomised, active controlled, multicentre clinical trial evaluating bevacizumab in combination with paclitaxel for locally recurrent or metastatic breast cancer in patients who had not previously received chemotherapy for locally recurrent and metastatic disease. Patients were randomised to paclitaxel alone (90 mg/m2 intravenously over 1 hour once weekly for three out of four weeks) or in combination with bevacizumab (10 mg/kg intravenous infusion every two weeks). Prior hormonal therapy for the treatment of metastatic disease was allowed. Adjuvant taxane therapy was allowed only if it was completed at least 12 months prior to trial entry. Of the 722 patients in the trial, the majority of patients had HER2negative disease (90%), with a small number of patients with unknown (8%) or confirmed HER2positive status (2%), who had previously been treated with or were considered unsuitable for trastuzumab therapy. Furthermore, 65% of patients had received adjuvant chemotherapy including 19% prior taxanes and 49% prior anthracyclines. Patients with central nervous system metastases, including previously treated or resected brain lesions, were excluded.", "truncated": false}, "after_length": 1193, "after_sha256": "3811a9e770045dc70657badb8fed4fd142cabab371051867126897e382b41f90", "annex": "I", "before": {"end": 1193, "start": 0, "text": "Trial E2100 was an open-label, randomised, active controlled, multicentre clinical trial evaluating bevacizumab in combination with paclitaxel for locally recurrent or metastatic breast cancer in patients who had not previously received chemotherapy for locally recurrent and metastatic disease. Patients were randomised to paclitaxel alone (90 mg/m2 intravenously over 1 hour once weekly for three out of four weeks) or in combination with bevacizumab (10 mg/kg intravenous infusion every two weeks). Prior hormonal therapy for the treatment of metastatic disease was allowed. Adjuvant taxane therapy was allowed only if it was completed at least 12 months prior to trial entry. Of the 722 patients in the trial, the majority of patients had HER2negative disease (90%), with a small number of patients with unknown (8%) or confirmed HER2positive status (2%), who had previously been treated with or were considered unsuitable for trastuzumab therapy. Furthermore, 65% of patients had received adjuvant chemotherapy including 19% prior taxanes and 49% prior anthracyclines. Patients with central nervous system metastases, including previously treated or resected brain lesions, were excluded.", "truncated": false}, "before_length": 1193, "before_sha256": "3811a9e770045dc70657badb8fed4fd142cabab371051867126897e382b41f90", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0136e9bc775fd61d6bf1815c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005106", "medicine_name": "Aybintio", "medicine_slug": "aybintio", "observed_at": "2026-10-12T13:27:42Z", "pipeline_version": "2.0.0", "presentation_label": "Aybintio 25 mg/ml concentrate for solution for infusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "fba935554f03156639cf5f78cbde9b08cd3489bf366e599397ae71b670ba5459", "source_snapshot_id": "source-ba46e119957a3ca29a915015", "source_updated_at": "2026-09-11", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/aybintio-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": 1284}
{"after": {"end": 343, "start": 0, "text": "Toujeo can be used in adolescents and children from the age of 6 years based on the same principles as for adult patients (see sections 5.1and 5.2). When switching basal insulin to Toujeo, dose reduction of basal and bolus insulin needs to be considered on an individual basis, in order to minimise the risk of hypoglycaemia (see section 4.4).", "truncated": false}, "after_length": 343, "after_sha256": "5df098327c893cf97b22a44ed18c9d8fabc5287d607b43bf07668343a706d990", "annex": "I", "before": {"end": 343, "start": 0, "text": "Toujeo can be used in adolescents and children from the age of 6 years based on the same principles as for adult patients (see sections 5.1and 5.2). When switching basal insulin to Toujeo, dose reduction of basal and bolus insulin needs to be considered on an individual basis, in order to minimise the risk of hypoglycaemia (see section 4.4).", "truncated": false}, "before_length": 343, "before_sha256": "5df098327c893cf97b22a44ed18c9d8fabc5287d607b43bf07668343a706d990", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0137759df11879fc84e0d1e2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000309", "medicine_name": "Toujeo (previously Optisulin)", "medicine_slug": "toujeo-previously-optisulin", "observed_at": "2026-10-12T19:30:06Z", "pipeline_version": "2.0.0", "presentation_label": "Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen Toujeo 300 units/ml DoubleStar, solution for injection in a 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": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "958e68d317ead1784b761df53174f59803bbabb77bcf31c3603b908121943aff", "source_snapshot_id": "source-469265d9b6d6251540ddde37", "source_updated_at": "2025-07-09", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/toujeo-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": 136}
{"after": {"end": 488, "start": 0, "text": "Care is to be taken if patients are treated concomitantly with medicinal products affecting haemostasis such as non-steroidal anti-inflammatory medicinal products (NSAIDs), acetylsalicylic acid (ASA) and platelet aggregation inhibitors or selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs). For patients at risk of ulcerative gastrointestinal disease an appropriate prophylactic treatment may be considered (see sections 4.5 and 5.1).", "truncated": false}, "after_length": 488, "after_sha256": "9d01a8eae1839f1f2bf2409a7316770a1e18d23b78565b73597ccb69b7803a84", "annex": "I", "before": {"end": 488, "start": 0, "text": "Care is to be taken if patients are treated concomitantly with medicinal products affecting haemostasis such as non-steroidal anti-inflammatory medicinal products (NSAIDs), acetylsalicylic acid (ASA) and platelet aggregation inhibitors or selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs). For patients at risk of ulcerative gastrointestinal disease an appropriate prophylactic treatment may be considered (see sections 4.5 and 5.1).", "truncated": false}, "before_length": 488, "before_sha256": "9d01a8eae1839f1f2bf2409a7316770a1e18d23b78565b73597ccb69b7803a84", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01414bea27663cc1df71cd8e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005600", "medicine_name": "Rivaroxaban Viatris (previously Rivaroxaban Mylan)", "medicine_slug": "rivaroxaban-viatris-previously-rivaroxaban-mylan", "observed_at": "2026-10-12T19:36:56Z", "pipeline_version": "2.0.0", "presentation_label": "Rivaroxaban Viatris 2.5 mg film-coated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "23e12930e87dfb1e4ff35978713886b95f3ffda265129f4e22fc85df9f4aff16", "source_snapshot_id": "source-c96321ac7577e21fc0d40119", "source_updated_at": "2025-06-04", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/rivaroxaban-viatris-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": 181}
{"after": {"end": 191, "start": 0, "text": "Aucune interaction pharmacocinétique ou pharmacodynamique cliniquement significative n’a été observée lors de l’administration concomitante de rivaroxaban et d’acide acétylsalicylique 500 mg.", "truncated": false}, "after_length": 191, "after_sha256": "f5a9a1b3ee89104aa5194680142a60370067749d6a650bf24a287549727f6ee8", "annex": "I", "before": {"end": 191, "start": 0, "text": "Aucune interaction pharmacocinétique ou pharmacodynamique cliniquement significative n’a été observée lors de l’administration concomitante de rivaroxaban et d’acide acétylsalicylique 500 mg.", "truncated": false}, "before_length": 191, "before_sha256": "f5a9a1b3ee89104aa5194680142a60370067749d6a650bf24a287549727f6ee8", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-015111b2382464acf02886b5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005600", "medicine_name": "Rivaroxaban Viatris (previously Rivaroxaban Mylan)", "medicine_slug": "rivaroxaban-viatris-previously-rivaroxaban-mylan", "observed_at": "2026-10-12T19:37:08Z", "pipeline_version": "2.0.0", "presentation_label": "Rivaroxaban Viatris 15 mg comprimé pelliculé", "presentation_occurrence": 3, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "0a259647b297ee400ee98db938921b80900e015ef366694c6fbdf31e9b54f8bf", "source_snapshot_id": "source-6734c149d0cfab550c98319c", "source_updated_at": "2025-06-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/rivaroxaban-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": 2376}
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{"after": {"end": 394, "start": 0, "text": "Les effets indésirables suivants ont été rapportés au cours des études cliniques versus placebo dans lesquelles 1965 patients ont reçu de l’irbésartan. Chez les patients hypertendus diabétiques ayant une insuffisance rénale chronique et une protéinurie patente, les effets indésirables marqués d’une (*) ont été rapportés en plus chez plus de 2% des patients et en excès par rapport au placebo.", "truncated": false}, "after_length": 394, "after_sha256": "dc6c9e6346b1a09ed8ac305c6a4f849311521bb94971cfbfd4afdf987fd1479b", "annex": "I", "before": {"end": 394, "start": 0, "text": "Les effets indésirables suivants ont été rapportés au cours des études cliniques versus placebo dans lesquelles 1965 patients ont reçu de l’irbésartan. Chez les patients hypertendus diabétiques ayant une insuffisance rénale chronique et une protéinurie patente, les effets indésirables marqués d’une (*) ont été rapportés en plus chez plus de 2% des patients et en excès par rapport au placebo.", "truncated": false}, "before_length": 394, "before_sha256": "dc6c9e6346b1a09ed8ac305c6a4f849311521bb94971cfbfd4afdf987fd1479b", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-018ab415b8802e5e63913f54", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000141", "medicine_name": "Aprovel", "medicine_slug": "aprovel", "observed_at": "2026-10-12T17:26:17Z", "pipeline_version": "2.0.0", "presentation_label": "Aprovel 150 mg comprimés pelliculés.", "presentation_occurrence": 5, "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": "8bb8b2b3057f8f9a8fac8321a222a7c020fa068739f1494a85cf638bf4f41b88", "source_snapshot_id": "source-47a3bd7fbf930750d7ef7891", "source_updated_at": "2026-01-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/aprovel-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": 1853}
{"after": {"end": 474, "start": 0, "text": "Asfotase alfa contains a catalytic domain of tissue non-specific alkaline phosphatase. Administration of asfotase alfa will interfere with routine measurement of serum alkaline phosphatase by hospital laboratories resulting in serum alkaline phosphatase activity measurements of several thousand units per litre. Asfotase alfa activity results must not be interpreted as the same measure as serum alkaline phosphatase activity owing to differences in enzyme characteristics.", "truncated": false}, "after_length": 474, "after_sha256": "744a42b6594d5d6898f547d6a4cec3214378391ef97646e5d54863a800329569", "annex": "I", "before": {"end": 474, "start": 0, "text": "Asfotase alfa contains a catalytic domain of tissue non-specific alkaline phosphatase. Administration of asfotase alfa will interfere with routine measurement of serum alkaline phosphatase by hospital laboratories resulting in serum alkaline phosphatase activity measurements of several thousand units per litre. Asfotase alfa activity results must not be interpreted as the same measure as serum alkaline phosphatase activity owing to differences in enzyme characteristics.", "truncated": false}, "before_length": 474, "before_sha256": "744a42b6594d5d6898f547d6a4cec3214378391ef97646e5d54863a800329569", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-018bb8cf1d7e8e7d57975e78", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003794", "medicine_name": "Strensiq", "medicine_slug": "strensiq", "observed_at": "2026-10-12T13:49:10Z", "pipeline_version": "2.0.0", "presentation_label": "Strensiq 40 mg/ml solution for injection Strensiq 100 mg/ml solution for injection", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "1bb7c73286f57e11c88682980aa6f9ee26ad231f7581e9da57e308f067ba93fb", "source_snapshot_id": "source-f9cee1a032291fa10f55a891", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/strensiq-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": 354}
{"after": {"end": 392, "start": 0, "text": "In patients not previously treated with tocilizumab, initiation is not recommended in patients with an ANC below 2 × 109/L. Caution should be exercised when considering initiation of treatment in patients with a low platelet count (i.e. platelet count below 100 × 103/µL). In patients who develop an ANC < 0.5 × 109/L or a platelet count < 50 × 103/µL, continued treatment is not recommended.", "truncated": false}, "after_length": 392, "after_sha256": "cf234c90b0e4fa81fac6ffe8f31204cf65bee9a26ea83820e9c3d7a5664992c6", "annex": "I", "before": {"end": 392, "start": 0, "text": "In patients not previously treated with tocilizumab, initiation is not recommended in patients with an ANC below 2 × 109/L. Caution should be exercised when considering initiation of treatment in patients with a low platelet count (i.e. platelet count below 100 × 103/µL). In patients who develop an ANC < 0.5 × 109/L or a platelet count < 50 × 103/µL, continued treatment is not recommended.", "truncated": false}, "before_length": 392, "before_sha256": "cf234c90b0e4fa81fac6ffe8f31204cf65bee9a26ea83820e9c3d7a5664992c6", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0190011c6ce2afc933b69cab", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000955", "medicine_name": "RoActemra", "medicine_slug": "roactemra", "observed_at": "2026-10-12T13:41:18Z", "pipeline_version": "2.0.0", "presentation_label": "RoActemra 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": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "cf4a91213ae92233c428a558204a83d1068aed134fdda1b1071732f361531aa2", "source_snapshot_id": "source-c502f5a07564cf8070079339", "source_updated_at": "2026-04-01", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/roactemra-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": 3275}
{"after": {"end": 226, "start": 0, "text": "Les données disponibles laissent supposer que la réponse clinique est habituellement obtenue en 12 semaines de traitement. La poursuite du traitement devra être reconsidérée chez un patient n’ayant pas répondu dans ces délais.", "truncated": false}, "after_length": 226, "after_sha256": "5999401e2fc8c31719ae7f16db66fb5300a3af5ba10ae00b4c7d6dd6122fd3b7", "annex": "I", "before": {"end": 226, "start": 0, "text": "Les données disponibles laissent supposer que la réponse clinique est habituellement obtenue en 12 semaines de traitement. La poursuite du traitement devra être reconsidérée chez un patient n’ayant pas répondu dans ces délais.", "truncated": false}, "before_length": 226, "before_sha256": "5999401e2fc8c31719ae7f16db66fb5300a3af5ba10ae00b4c7d6dd6122fd3b7", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0190421ae2abfa202a5ea1e0", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004879", "medicine_name": "Amsparity", "medicine_slug": "amsparity", "observed_at": "2026-10-12T19:15:12Z", "pipeline_version": "2.0.0", "presentation_label": "Amsparity 40 mg, solution injectable en seringue préremplie Amsparity 40 mg, solution injectable en stylo prérempli", "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": "24d0cc9d1a51b9be434880981aaadecfd5acfad769bf26ba5172cf74b57f6266", "source_snapshot_id": "source-ff374e236a5e5c8d097f6178", "source_updated_at": "2025-09-05", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/amsparity-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": 3963}
{"after": {"end": 277, "start": 0, "text": "Une hémorragie associée à la tumeur (y compris des cas d’hémorragies du système nerveux central (SNC) chez des patients atteints de métastases du SNC) a également été observée dans de rares cas, dans d’autres types de tumeurs et dans d’autres localisations (voir rubrique 4.4).", "truncated": false}, "after_length": 277, "after_sha256": "81e355b3e8ac82f00901f911d56d5b96ce4b19d9f41a28ebb33eba64becba310", "annex": "I", "before": {"end": 277, "start": 0, "text": "Une hémorragie associée à la tumeur (y compris des cas d’hémorragies du système nerveux central (SNC) chez des patients atteints de métastases du SNC) a également été observée dans de rares cas, dans d’autres types de tumeurs et dans d’autres localisations (voir rubrique 4.4).", "truncated": false}, "before_length": 277, "before_sha256": "81e355b3e8ac82f00901f911d56d5b96ce4b19d9f41a28ebb33eba64becba310", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0190d22dadb944cb03bab600", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005286", "medicine_name": "Alymsys", "medicine_slug": "alymsys", "observed_at": "2026-10-12T19:02:07Z", "pipeline_version": "2.0.0", "presentation_label": "Alymsys 25 mg/mL solution à diluer pour perfusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "8fef19b3e09caee6abcedaa762e16d4b3139843cc8ce41d68d572a4c2413df8b", "source_snapshot_id": "source-031f90cd07def6d808f3a292", "source_updated_at": "2026-02-06", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/alymsys-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": 753}
{"after": {"end": 164, "start": 0, "text": "L’incidence des infections graves a été de 0,04 par patientannée dans le groupe adalimumab et de 0,03 par patientannée dans le groupe placebo et le groupe contrôle.", "truncated": false}, "after_length": 164, "after_sha256": "5c901caa3384bd19ebbf2043604c5f2de3d662fa096dbefaa66a258287a39be0", "annex": "I", "before": {"end": 164, "start": 0, "text": "L’incidence des infections graves a été de 0,04 par patientannée dans le groupe adalimumab et de 0,03 par patientannée dans le groupe placebo et le groupe contrôle.", "truncated": false}, "before_length": 164, "before_sha256": "5c901caa3384bd19ebbf2043604c5f2de3d662fa096dbefaa66a258287a39be0", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-019125f00e36242bd2da1048", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004879", "medicine_name": "Amsparity", "medicine_slug": "amsparity", "observed_at": "2026-10-12T19:15:12Z", "pipeline_version": "2.0.0", "presentation_label": "Amsparity 40 mg/0,8 ml, solution injectable", "presentation_occurrence": 2, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "24d0cc9d1a51b9be434880981aaadecfd5acfad769bf26ba5172cf74b57f6266", "source_snapshot_id": "source-ff374e236a5e5c8d097f6178", "source_updated_at": "2025-09-05", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/amsparity-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": 2553}
{"after": {"end": 583, "start": 0, "text": "Une étude multicentrique, ouverte, randomisée (PIONEER AF-PCI) a été menée chez 2 124 patients atteints de fibrillation atriale non valvulaire qui ont bénéficié d’une ICP avec pose de stent pour le traitement d’une maladie athérosclérotique primitive afin de comparer la sécurité de deux schémas thérapeutiques du rivaroxaban et un schéma thérapeutique d’un AVK. Les patients ont été randomisés selon un rapport 1:1:1 pour une durée de traitement globale de 12 mois. Les patients ayant un antécédent d’accident vasculaire cérébral ou d’accident ischémique transitoire ont été exclus.", "truncated": false}, "after_length": 583, "after_sha256": "3b1190901da5f69f7084108ac2b9aa9a4d7aa980d0d06e29bd138e896910b5f7", "annex": "I", "before": {"end": 583, "start": 0, "text": "Une étude multicentrique, ouverte, randomisée (PIONEER AF-PCI) a été menée chez 2 124 patients atteints de fibrillation atriale non valvulaire qui ont bénéficié d’une ICP avec pose de stent pour le traitement d’une maladie athérosclérotique primitive afin de comparer la sécurité de deux schémas thérapeutiques du rivaroxaban et un schéma thérapeutique d’un AVK. Les patients ont été randomisés selon un rapport 1:1:1 pour une durée de traitement globale de 12 mois. Les patients ayant un antécédent d’accident vasculaire cérébral ou d’accident ischémique transitoire ont été exclus.", "truncated": false}, "before_length": 583, "before_sha256": "3b1190901da5f69f7084108ac2b9aa9a4d7aa980d0d06e29bd138e896910b5f7", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01921d35d46a3d7018133918", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005600", "medicine_name": "Rivaroxaban Viatris (previously Rivaroxaban Mylan)", "medicine_slug": "rivaroxaban-viatris-previously-rivaroxaban-mylan", "observed_at": "2026-10-12T19:37:08Z", "pipeline_version": "2.0.0", "presentation_label": "Rivaroxaban Viatris 20 mg comprimé pelliculé", "presentation_occurrence": 4, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "0a259647b297ee400ee98db938921b80900e015ef366694c6fbdf31e9b54f8bf", "source_snapshot_id": "source-6734c149d0cfab550c98319c", "source_updated_at": "2025-06-04", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/rivaroxaban-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": 4053}
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{"after": {"end": 105, "start": 0, "text": "Tableau 25. Résultats d’efficacité de l’étude GOG0240 en fonction de l’ajout du bevacizumab au traitement", "truncated": false}, "after_length": 105, "after_sha256": "209d57fd4b95c60744cbf63c403eb7d6f3a694dc5a843428632192b18101a377", "annex": "I", "before": {"end": 105, "start": 0, "text": "Tableau 25. Résultats d’efficacité de l’étude GOG0240 en fonction de l’ajout du bevacizumab au traitement", "truncated": false}, "before_length": 105, "before_sha256": "209d57fd4b95c60744cbf63c403eb7d6f3a694dc5a843428632192b18101a377", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01b6aed933a603e14b0929cd", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005106", "medicine_name": "Aybintio", "medicine_slug": "aybintio", "observed_at": "2026-10-12T13:27:44Z", "pipeline_version": "2.0.0", "presentation_label": "Aybintio 25 mg/ml solution à diluer pour perfusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "4a45f4a7b4e7df4dbc475a3f92ce3f16543120b39806a2fc6e5399c3925ecba4", "source_snapshot_id": "source-70a38464ff06de59375a15c3", "source_updated_at": "2026-09-11", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/aybintio-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": 2250}
{"after": {"end": 609, "start": 0, "text": "Chez les porteurs du VHB qui nécessitent un traitement par Amsparity, il faut surveiller attentivement les signes et les symptômes d’infection active par le VHB tout au long du traitement et pendant plusieurs mois après son arrêt. Il n’y a pas de données disponibles suffisantes concernant le traitement de patients porteurs du VHB traités par antiviral associé à antagoniste du TNF pour prévenir une réactivation du VHB. Chez les patients qui développent une réactivation du VHB, Amsparity doit être arrêté et un traitement antiviral efficace ainsi qu’un traitement de support approprié doivent être initiés.", "truncated": false}, "after_length": 609, "after_sha256": "c507b1f20ebfa2c70c105ab773fdadb1e28b5b0d9e5adba3db9bc1e205af76a2", "annex": "I", "before": {"end": 609, "start": 0, "text": "Chez les porteurs du VHB qui nécessitent un traitement par Amsparity, il faut surveiller attentivement les signes et les symptômes d’infection active par le VHB tout au long du traitement et pendant plusieurs mois après son arrêt. Il n’y a pas de données disponibles suffisantes concernant le traitement de patients porteurs du VHB traités par antiviral associé à antagoniste du TNF pour prévenir une réactivation du VHB. Chez les patients qui développent une réactivation du VHB, Amsparity doit être arrêté et un traitement antiviral efficace ainsi qu’un traitement de support approprié doivent être initiés.", "truncated": false}, "before_length": 609, "before_sha256": "c507b1f20ebfa2c70c105ab773fdadb1e28b5b0d9e5adba3db9bc1e205af76a2", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01b830f24d54e41c5158e741", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004879", "medicine_name": "Amsparity", "medicine_slug": "amsparity", "observed_at": "2026-10-12T19:15:12Z", "pipeline_version": "2.0.0", "presentation_label": "Amsparity 40 mg, solution injectable en seringue préremplie Amsparity 40 mg, solution injectable en stylo prérempli", "presentation_occurrence": 3, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "24d0cc9d1a51b9be434880981aaadecfd5acfad769bf26ba5172cf74b57f6266", "source_snapshot_id": "source-ff374e236a5e5c8d097f6178", "source_updated_at": "2025-09-05", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/amsparity-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": 4281}
{"after": {"end": 551, "start": 0, "text": "Adalimumab significantly delayed the time to treatment failure, as compared to placebo (see Figure 2, P < 0.0001 from log rank test). The median time to treatment failure was 24.1 weeks for subjects treated with placebo, whereas the median time to treatment failure was not estimable for subjects treated with adalimumab because less than onehalf of these subjects experienced treatment failure. Adalimumab significantly decreased the risk of treatment failure by 75% relative to placebo, as shown by the hazard ratio (HR = 0.25 [95% CI: 0.12, 0.49]).", "truncated": false}, "after_length": 551, "after_sha256": "e840e5540c61c32d8d1c03148111b7105ab5f5868f436ce6e67836448857293a", "annex": "I", "before": {"end": 551, "start": 0, "text": "Adalimumab significantly delayed the time to treatment failure, as compared to placebo (see Figure 2, P < 0.0001 from log rank test). The median time to treatment failure was 24.1 weeks for subjects treated with placebo, whereas the median time to treatment failure was not estimable for subjects treated with adalimumab because less than onehalf of these subjects experienced treatment failure. Adalimumab significantly decreased the risk of treatment failure by 75% relative to placebo, as shown by the hazard ratio (HR = 0.25 [95% CI: 0.12, 0.49]).", "truncated": false}, "before_length": 551, "before_sha256": "e840e5540c61c32d8d1c03148111b7105ab5f5868f436ce6e67836448857293a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01b97e3d03c5703995d4d05e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004879", "medicine_name": "Amsparity", "medicine_slug": "amsparity", "observed_at": "2026-10-12T19:15:08Z", "pipeline_version": "2.0.0", "presentation_label": "Amsparity 20 mg solution for injection in prefilled 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": "ba2d2bebd7522cef09c6d189150f085d43e6510c2f227c0b5975c26e7bd9abd1", "source_snapshot_id": "source-26ece7d1cb806d3ad8238dc7", "source_updated_at": "2025-09-05", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/amsparity-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": 1688}
{"after": {"end": 561, "start": 0, "text": "Le critère principal d’efficacité de l’étude était la survie globale. L’association du bevacizumab + IFL a conduit à une augmentation statistiquement significative de la survie globale, de la survie sans progression et du taux de réponse globale (voir tableau 4). Le bénéfice clinique, évalué par la survie globale, a été constaté dans toutes les sous-populations de patients prédéfinies en fonction de l’âge, du sexe, de l’indice de performance, de la localisation de la tumeur primitive, du nombre d’organes atteints et de la durée de la maladie métastatique.", "truncated": false}, "after_length": 561, "after_sha256": "7b7144e4778ba1a95134c843fc55b8936ceaefb7cad3ec3c087bd588779d6105", "annex": "I", "before": {"end": 561, "start": 0, "text": "Le critère principal d’efficacité de l’étude était la survie globale. L’association du bevacizumab + IFL a conduit à une augmentation statistiquement significative de la survie globale, de la survie sans progression et du taux de réponse globale (voir tableau 4). Le bénéfice clinique, évalué par la survie globale, a été constaté dans toutes les sous-populations de patients prédéfinies en fonction de l’âge, du sexe, de l’indice de performance, de la localisation de la tumeur primitive, du nombre d’organes atteints et de la durée de la maladie métastatique.", "truncated": false}, "before_length": 561, "before_sha256": "7b7144e4778ba1a95134c843fc55b8936ceaefb7cad3ec3c087bd588779d6105", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01ba0f8b2c172bdf24d1eea2", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005286", "medicine_name": "Alymsys", "medicine_slug": "alymsys", "observed_at": "2026-10-12T19:02:07Z", "pipeline_version": "2.0.0", "presentation_label": "Alymsys 25 mg/mL solution à diluer pour perfusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8fef19b3e09caee6abcedaa762e16d4b3139843cc8ce41d68d572a4c2413df8b", "source_snapshot_id": "source-031f90cd07def6d808f3a292", "source_updated_at": "2026-02-06", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/alymsys-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": 910}
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{"after": {"end": 169, "start": 0, "text": "§ Hypothesis testing for the noninferiority of ORR at the interim analysis is based on the first 415 randomized patients only with a 1-sided significance level of 0.005.", "truncated": false}, "after_length": 169, "after_sha256": "af3852b955ddf622637326ab6742f63a95355c2ea4b9ca07341053f30cef58e6", "annex": "I", "before": {"end": 169, "start": 0, "text": "§ Hypothesis testing for the noninferiority of ORR at the interim analysis is based on the first 415 randomized patients only with a 1-sided significance level of 0.005.", "truncated": false}, "before_length": 169, "before_sha256": "af3852b955ddf622637326ab6742f63a95355c2ea4b9ca07341053f30cef58e6", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01cc258ad7b33b26e92422b8", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004978", "medicine_name": "Brukinsa", "medicine_slug": "brukinsa", "observed_at": "2026-10-12T13:27:22Z", "pipeline_version": "2.0.0", "presentation_label": "BRUKINSA 80 mg hard capsules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "2171ac5e589cf9527d9bc5ab2958997e970517f090a8425dfa56f9f4d9e6e96c", "source_snapshot_id": "source-93035c199195b0e5ecae337e", "source_updated_at": "2026-10-07", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/brukinsa-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": 954}
{"after": {"end": 688, "start": 0, "text": "Dans la population en intention de traiter (ITT) (tous les sujets qui ont reçu au moins une dose du médicament à l’étude), 288 patients ont reçu le posaconazole et 287 patients ont reçu le voriconazole. L’analyse sur l'ensemble des données disponibles (full analysis set (FAS)) prend en compte le sous-groupe de tous les sujets en intention de traiter (ITT) qui ont été classés par un arbitrage indépendant comme ayant des aspergilloses invasives prouvées ou probables : 163 sujets pour le posaconazole et 171 sujets pour le voriconazole. La mortalité toutes causes confondues et la réponse clinique globale de ces deux populations sont respectivement présentées dans les Tableaux 3 et 4.", "truncated": false}, "after_length": 688, "after_sha256": "0a612440895f8300169eef4fe894cc84d2f92e9147fcad8ae116a7f8981a7703", "annex": "I", "before": {"end": 688, "start": 0, "text": "Dans la population en intention de traiter (ITT) (tous les sujets qui ont reçu au moins une dose du médicament à l’étude), 288 patients ont reçu le posaconazole et 287 patients ont reçu le voriconazole. L’analyse sur l'ensemble des données disponibles (full analysis set (FAS)) prend en compte le sous-groupe de tous les sujets en intention de traiter (ITT) qui ont été classés par un arbitrage indépendant comme ayant des aspergilloses invasives prouvées ou probables : 163 sujets pour le posaconazole et 171 sujets pour le voriconazole. La mortalité toutes causes confondues et la réponse clinique globale de ces deux populations sont respectivement présentées dans les Tableaux 3 et 4.", "truncated": false}, "before_length": 688, "before_sha256": "0a612440895f8300169eef4fe894cc84d2f92e9147fcad8ae116a7f8981a7703", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01cde002efeca3a501aec459", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005005", "medicine_name": "Posaconazole Accord", "medicine_slug": "posaconazole-accord", "observed_at": "2026-10-12T19:44:30Z", "pipeline_version": "2.0.0", "presentation_label": "Posaconazole Accord 100 mg comprimés gastro-résistants", "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": "307cc53ed0048509787bc0b73f2040c678b1df3cc6f8e722f513a205cc3e6baa", "source_snapshot_id": "source-b5de155abfc26fe489dd1b33", "source_updated_at": "2025-05-06", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/posaconazole-accord-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 452}
{"after": {"end": 512, "start": 0, "text": "Diurétiques et autres antihypertenseurs : d’autres agents antihypertenseurs peuvent augmenter les effets hypotenseurs de l’irbésartan. Cependant Aprovel a été associé sans problème à d’autres antihypertenseurs tels que des bêtabloquants, des antagonistes calciques à longue durée d’action et des diurétiques thiazidiques. Un traitement antérieur par des diurétiques à une dose élevée peut provoquer une hypovolémie et un risque d’hypotension lorsqu’un traitement par Aprovel est mis en route (voir rubrique 4.4).", "truncated": false}, "after_length": 512, "after_sha256": "26ef30fff631569fdf4509bc68c8b01c5f57cb4258fbdebcc294ea59797bc5cb", "annex": "I", "before": {"end": 512, "start": 0, "text": "Diurétiques et autres antihypertenseurs : d’autres agents antihypertenseurs peuvent augmenter les effets hypotenseurs de l’irbésartan. Cependant Aprovel a été associé sans problème à d’autres antihypertenseurs tels que des bêtabloquants, des antagonistes calciques à longue durée d’action et des diurétiques thiazidiques. Un traitement antérieur par des diurétiques à une dose élevée peut provoquer une hypovolémie et un risque d’hypotension lorsqu’un traitement par Aprovel est mis en route (voir rubrique 4.4).", "truncated": false}, "before_length": 512, "before_sha256": "26ef30fff631569fdf4509bc68c8b01c5f57cb4258fbdebcc294ea59797bc5cb", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01d96fe215d57a679e6ebd33", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000141", "medicine_name": "Aprovel", "medicine_slug": "aprovel", "observed_at": "2026-10-12T17:26:17Z", "pipeline_version": "2.0.0", "presentation_label": "Aprovel 75 mg comprimés.", "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": "8bb8b2b3057f8f9a8fac8321a222a7c020fa068739f1494a85cf638bf4f41b88", "source_snapshot_id": "source-47a3bd7fbf930750d7ef7891", "source_updated_at": "2026-01-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/aprovel-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": 140}
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{"after": {"end": 852, "start": 0, "text": "Général : chez les patients dont la tonicité vasculaire et la fonction rénale dépendent de façon prédominante de l’activité du système rénine-angiotensine-aldostérone (par exemple les patients présentant une insuffisance cardiaque congestive sévère ou une maladie rénale sous-jacente, y compris une sténose des artères rénales), le traitement par inhibiteurs de l’enzyme de conversion ou antagonistes des récepteurs de l’angiotensineII agissant sur ce système a été associé à une hypotension aiguë, une azotémie, une oligurie ou, rarement, à une insuffisance rénale aiguë. Comme avec n’importe quels agents antihypertenseurs, une baisse brutale de la pression artérielle chez des patients porteurs d’une cardiopathie ischémique ou d’une maladie cardiovasculaire ischémique pourrait entraîner un infarctus du myocarde ou un accident vasculaire cérébral.", "truncated": false}, "after_length": 852, "after_sha256": "a40cf98c2be1007f4fcdff39e6e36ac193126462b7db95866740360629c73cb9", "annex": "I", "before": {"end": 852, "start": 0, "text": "Général : chez les patients dont la tonicité vasculaire et la fonction rénale dépendent de façon prédominante de l’activité du système rénine-angiotensine-aldostérone (par exemple les patients présentant une insuffisance cardiaque congestive sévère ou une maladie rénale sous-jacente, y compris une sténose des artères rénales), le traitement par inhibiteurs de l’enzyme de conversion ou antagonistes des récepteurs de l’angiotensineII agissant sur ce système a été associé à une hypotension aiguë, une azotémie, une oligurie ou, rarement, à une insuffisance rénale aiguë. Comme avec n’importe quels agents antihypertenseurs, une baisse brutale de la pression artérielle chez des patients porteurs d’une cardiopathie ischémique ou d’une maladie cardiovasculaire ischémique pourrait entraîner un infarctus du myocarde ou un accident vasculaire cérébral.", "truncated": false}, "before_length": 852, "before_sha256": "a40cf98c2be1007f4fcdff39e6e36ac193126462b7db95866740360629c73cb9", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0226bba432db04fa482be226", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000141", "medicine_name": "Aprovel", "medicine_slug": "aprovel", "observed_at": "2026-10-12T17:26:17Z", "pipeline_version": "2.0.0", "presentation_label": "Aprovel 150 mg comprimés pelliculés.", "presentation_occurrence": 5, "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": "8bb8b2b3057f8f9a8fac8321a222a7c020fa068739f1494a85cf638bf4f41b88", "source_snapshot_id": "source-47a3bd7fbf930750d7ef7891", "source_updated_at": "2026-01-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/aprovel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1787}
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{"after": {"end": 731, "start": 0, "text": "Lors d’une étude clinique exploratoire, les patients atteints d’asthme persistant sévère ont reçu une dose de charge de golimumab (150 % de la dose de traitement attribuée) par voie souscutanée à la semaine 0 suivie d’une dose de golimumab 200 mg, de golimumab 100 mg ou de golimumab 50 mg toutes les 4 semaines par voie souscutanée jusqu’à la semaine 52. Huit tumeurs malignes dans le groupe de traitement golimumab combiné (n = 230) ont été rapportées et aucune dans le groupe placebo (n = 79). Un lymphome a été rapporté chez 1 patient, un cancer de la peau autre que le mélanome chez 2 patients et d’autres tumeurs malignes chez 5 patients. Aucun groupement spécifique selon un type quelconque de tumeur maligne n’a été défini.", "truncated": false}, "after_length": 731, "after_sha256": "d9feb0467500b140b6ea216fd407bc53400e0990b805eb15a5b82ab32caf2548", "annex": "I", "before": {"end": 731, "start": 0, "text": "Lors d’une étude clinique exploratoire, les patients atteints d’asthme persistant sévère ont reçu une dose de charge de golimumab (150 % de la dose de traitement attribuée) par voie souscutanée à la semaine 0 suivie d’une dose de golimumab 200 mg, de golimumab 100 mg ou de golimumab 50 mg toutes les 4 semaines par voie souscutanée jusqu’à la semaine 52. Huit tumeurs malignes dans le groupe de traitement golimumab combiné (n = 230) ont été rapportées et aucune dans le groupe placebo (n = 79). Un lymphome a été rapporté chez 1 patient, un cancer de la peau autre que le mélanome chez 2 patients et d’autres tumeurs malignes chez 5 patients. Aucun groupement spécifique selon un type quelconque de tumeur maligne n’a été défini.", "truncated": false}, "before_length": 731, "before_sha256": "d9feb0467500b140b6ea216fd407bc53400e0990b805eb15a5b82ab32caf2548", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-02318ebd2fc209ce542eff65", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000992", "medicine_name": "Simponi", "medicine_slug": "simponi", "observed_at": "2026-10-12T19:02:36Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "359338f13851566c1b5a50785093846e9e52980167d40c4e41d57c7d5eda0080", "source_snapshot_id": "source-5a963b257532afbfd4ca477b", "source_updated_at": "2026-01-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/simponi-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": 5296}
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{"after": {"end": 92, "start": 0, "text": "For persistent increases in this range, interrupt tocilizumab until ALT/AST have normalised.", "truncated": false}, "after_length": 92, "after_sha256": "8f3c4f8eb452134da8a384c41df1ec211a6ab0bf60a787f44a3b36099d89dbcc", "annex": "I", "before": {"end": 92, "start": 0, "text": "For persistent increases in this range, interrupt tocilizumab until ALT/AST have normalised.", "truncated": false}, "before_length": 92, "before_sha256": "8f3c4f8eb452134da8a384c41df1ec211a6ab0bf60a787f44a3b36099d89dbcc", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0248ff29595f56dc2b10a6b1", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000955", "medicine_name": "RoActemra", "medicine_slug": "roactemra", "observed_at": "2026-10-12T13:41:18Z", "pipeline_version": "2.0.0", "presentation_label": "RoActemra 20 mg/mL concentrate for solution for infusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "cf4a91213ae92233c428a558204a83d1068aed134fdda1b1071732f361531aa2", "source_snapshot_id": "source-c502f5a07564cf8070079339", "source_updated_at": "2026-04-01", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/roactemra-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": 188}
{"after": {"end": 373, "start": 0, "text": "La tolérance et l’efficacité à la posologie recommandée (5 mg/kg de poids corporel toutes les deux semaines) dans le cancer colorectal métastatique ont été évaluées dans trois études cliniques randomisées, contrôlées, associant le bevacizumab à une chimiothérapie de première ligne à base de fluoropyrimidine. Bevacizumab était associé à deux protocoles de chimiothérapie :", "truncated": false}, "after_length": 373, "after_sha256": "274f383fdb01d33b0649ea213b5d30e56420ba4fc7e5fc8224aab75ae0c6cded", "annex": "I", "before": {"end": 373, "start": 0, "text": "La tolérance et l’efficacité à la posologie recommandée (5 mg/kg de poids corporel toutes les deux semaines) dans le cancer colorectal métastatique ont été évaluées dans trois études cliniques randomisées, contrôlées, associant le bevacizumab à une chimiothérapie de première ligne à base de fluoropyrimidine. Bevacizumab était associé à deux protocoles de chimiothérapie :", "truncated": false}, "before_length": 373, "before_sha256": "274f383fdb01d33b0649ea213b5d30e56420ba4fc7e5fc8224aab75ae0c6cded", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-024e68bd0e2bf73452706034", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005286", "medicine_name": "Alymsys", "medicine_slug": "alymsys", "observed_at": "2026-10-12T19:02:07Z", "pipeline_version": "2.0.0", "presentation_label": "Alymsys 25 mg/mL solution à diluer pour perfusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8fef19b3e09caee6abcedaa762e16d4b3139843cc8ce41d68d572a4c2413df8b", "source_snapshot_id": "source-031f90cd07def6d808f3a292", "source_updated_at": "2026-02-06", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/alymsys-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": 894}
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{"after": {"end": 860, "start": 0, "text": "Une augmentation de l’incidence d’ICC a été observée dans un essai clinique chez des patients atteints d’un lymphome diffus à grandes cellules B recevant du bevacizumab en association à une dose cumulative de doxorubicine supérieure à 300 mg/m2. Cette étude clinique de phase III comparait l’association rituximab/cyclophosphamide/doxorubicine/vincristine/prednisone (R-CHOP) avec bevacizumab à R-CHOP sans bevacizumab. Alors que l’incidence d’ICC était, dans les deux bras, au-dessus de celle observée précédemment pour le traitement par doxorubicine, le taux était supérieur dans le bras R-CHOP plus bevacizumab. Ces résultats suggèrent qu’un suivi clinique rapproché comprenant des évaluations cardiaques appropriées doit être considéré chez des patients exposés à des doses cumulées de doxorubicine supérieures à 300 mg/m2, lorsque associée au bevacizumab.", "truncated": false}, "after_length": 860, "after_sha256": "fc5494aea2f9b29f090c03c7d9943b82e0bfd454370d8c2850eccbc468c37a61", "annex": "I", "before": {"end": 860, "start": 0, "text": "Une augmentation de l’incidence d’ICC a été observée dans un essai clinique chez des patients atteints d’un lymphome diffus à grandes cellules B recevant du bevacizumab en association à une dose cumulative de doxorubicine supérieure à 300 mg/m2. Cette étude clinique de phase III comparait l’association rituximab/cyclophosphamide/doxorubicine/vincristine/prednisone (R-CHOP) avec bevacizumab à R-CHOP sans bevacizumab. Alors que l’incidence d’ICC était, dans les deux bras, au-dessus de celle observée précédemment pour le traitement par doxorubicine, le taux était supérieur dans le bras R-CHOP plus bevacizumab. Ces résultats suggèrent qu’un suivi clinique rapproché comprenant des évaluations cardiaques appropriées doit être considéré chez des patients exposés à des doses cumulées de doxorubicine supérieures à 300 mg/m2, lorsque associée au bevacizumab.", "truncated": false}, "before_length": 860, "before_sha256": "fc5494aea2f9b29f090c03c7d9943b82e0bfd454370d8c2850eccbc468c37a61", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-024ebf0281b2a75f6e5d259c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004728", "medicine_name": "Mvasi", "medicine_slug": "mvasi", "observed_at": "2026-10-12T19:05:25Z", "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": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "a52e278712552c88d687c789c8c0efa23c11f88e02e6d8914d109160079d55b7", "source_snapshot_id": "source-96f65d891051b574197708bc", "source_updated_at": "2025-10-16", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/mvasi-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": 878}
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{"after": {"end": 1385, "start": 0, "text": "Pegcetacoplan est administré en perfusion souscutanée et progressivement absorbé dans la circulation générale, avec un Tmax médian compris entre 108 et 144 heures (4,5 à 6,0 jours) après administration d’une dose souscutanée unique chez des volontaires sains. Lors de l’administration de 1 080 mg deux fois par semaine chez des patients atteints d’HPN, les concentrations sériques ont atteint l’état d’équilibre 4 à 6 semaines environ après la première dose. Chez les patients ayant déjà reçu un inhibiteur du complément (étude APL2302), la moyenne géométrique (%CV) des concentrations sériques à l’état d’équilibre a été comprise entre 655 (18,6 %) et 706 (15,1 %) µg/mL chez les patients traités pendant 16 semaines. Chez les patients ayant continué à recevoir pegcetacoplan jusqu’à la semaine 48 (n = 22), les concentrations à l’état d’équilibre étaient de 623 µg/mL (39,7 %), ce qui indique que les concentrations thérapeutiques de pegcetacoplan se sont maintenues durablement jusqu’à la semaine 48. Chez les patients n’ayant pas reçu précédemment d’inhibiteur du complément (étude APL2308), la moyenne géométrique (%CV) des concentrations sériques à l’état d’équilibre à la semaine 26 a été de 744 µg/mL (25,5 %) avec le traitement administré deux fois par semaine. La biodisponibilité d’une dose souscutanée de pegcetacoplan est estimée à 76 % d’après l’analyse PK de population.", "truncated": false}, "after_length": 1385, "after_sha256": "54063ead7417e30e3975f5c3cfa29961a76027c72ebf8c2f927b06e244eb3835", "annex": "I", "before": {"end": 1385, "start": 0, "text": "Pegcetacoplan est administré en perfusion souscutanée et progressivement absorbé dans la circulation générale, avec un Tmax médian compris entre 108 et 144 heures (4,5 à 6,0 jours) après administration d’une dose souscutanée unique chez des volontaires sains. Lors de l’administration de 1 080 mg deux fois par semaine chez des patients atteints d’HPN, les concentrations sériques ont atteint l’état d’équilibre 4 à 6 semaines environ après la première dose. Chez les patients ayant déjà reçu un inhibiteur du complément (étude APL2302), la moyenne géométrique (%CV) des concentrations sériques à l’état d’équilibre a été comprise entre 655 (18,6 %) et 706 (15,1 %) µg/mL chez les patients traités pendant 16 semaines. Chez les patients ayant continué à recevoir pegcetacoplan jusqu’à la semaine 48 (n = 22), les concentrations à l’état d’équilibre étaient de 623 µg/mL (39,7 %), ce qui indique que les concentrations thérapeutiques de pegcetacoplan se sont maintenues durablement jusqu’à la semaine 48. Chez les patients n’ayant pas reçu précédemment d’inhibiteur du complément (étude APL2308), la moyenne géométrique (%CV) des concentrations sériques à l’état d’équilibre à la semaine 26 a été de 744 µg/mL (25,5 %) avec le traitement administré deux fois par semaine. La biodisponibilité d’une dose souscutanée de pegcetacoplan est estimée à 76 % d’après l’analyse PK de population.", "truncated": false}, "before_length": 1385, "before_sha256": "54063ead7417e30e3975f5c3cfa29961a76027c72ebf8c2f927b06e244eb3835", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-02f3af0988bd096d14da520d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005553", "medicine_name": "Aspaveli", "medicine_slug": "aspaveli", "observed_at": "2026-10-12T19:03:46Z", "pipeline_version": "2.0.0", "presentation_label": "ASPAVELI 1 080 mg solution pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "86f4a87b61227842d3e9445141875f8d32664723dce946b7cdbb8f13dd93512e", "source_snapshot_id": "source-1f0c69f5bea684bae12db8c2", "source_updated_at": "2025-11-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/aspaveli-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": 660}
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{"after": {"end": 315, "start": 0, "text": "Le profil de tolérance de tocilizumab par voie sous-cutanée a été étudié chez 51 patients pédiatriques (âgés de 1 à 17 ans) atteints d’une AJIs. En général, le type d’effets indésirables observés chez les patients atteints d’AJIs a été similaire à celui observé chez les patients atteints de PR (voir rubrique 4.8).", "truncated": false}, "after_length": 315, "after_sha256": "43c07891411ac34703e028171a0b5c6dd7d78d02366b33f1f78f6e8c823ae3ce", "annex": "I", "before": {"end": 315, "start": 0, "text": "Le profil de tolérance de tocilizumab par voie sous-cutanée a été étudié chez 51 patients pédiatriques (âgés de 1 à 17 ans) atteints d’une AJIs. En général, le type d’effets indésirables observés chez les patients atteints d’AJIs a été similaire à celui observé chez les patients atteints de PR (voir rubrique 4.8).", "truncated": false}, "before_length": 315, "before_sha256": "43c07891411ac34703e028171a0b5c6dd7d78d02366b33f1f78f6e8c823ae3ce", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0307317ca9d5ee381d2a88b7", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000955", "medicine_name": "RoActemra", "medicine_slug": "roactemra", "observed_at": "2026-10-12T13:42:39Z", "pipeline_version": "2.0.0", "presentation_label": "RoActemra 162 mg solution injectable en stylo prérempli.", "presentation_occurrence": 3, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "72afdc53bbcc6479ec5acd0b7d60ba3c37dbb0d17876de3458e30d98dddaf154", "source_snapshot_id": "source-6de14ff57b8ce7397893a636", "source_updated_at": "2026-04-01", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/roactemra-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": 3716}
{"after": {"end": 787, "start": 0, "text": "Hypersensitivity reactions including signs and symptoms consistent with anaphylaxis have been reported in patients treated with asfotase alfa (see section 4.8). These symptoms included difficulty breathing, choking sensation, periorbital edema, and dizziness. The reactions have occurred within minutes after subcutaneous administration of asfotase alfa and can occur in patients on treatment for more than 1 year. Other hypersensitivity reactions included vomiting, nausea, fever, headache, flushing, irritability, chills, skin erythema, rash, pruritus, and oral hypoaesthesia. If these reactions occur, immediate discontinuation of treatment is recommended and appropriate medical treatment should be initiated. The current medical standards for emergency treatment should be observed.", "truncated": false}, "after_length": 787, "after_sha256": "8bd52f8e3c84b15721cf466a3512b689bb4eae872cdf400b4867cd759e5b096c", "annex": "I", "before": {"end": 787, "start": 0, "text": "Hypersensitivity reactions including signs and symptoms consistent with anaphylaxis have been reported in patients treated with asfotase alfa (see section 4.8). These symptoms included difficulty breathing, choking sensation, periorbital edema, and dizziness. The reactions have occurred within minutes after subcutaneous administration of asfotase alfa and can occur in patients on treatment for more than 1 year. Other hypersensitivity reactions included vomiting, nausea, fever, headache, flushing, irritability, chills, skin erythema, rash, pruritus, and oral hypoaesthesia. If these reactions occur, immediate discontinuation of treatment is recommended and appropriate medical treatment should be initiated. The current medical standards for emergency treatment should be observed.", "truncated": false}, "before_length": 787, "before_sha256": "8bd52f8e3c84b15721cf466a3512b689bb4eae872cdf400b4867cd759e5b096c", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0310491a9d4bc97ffeb3d160", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003794", "medicine_name": "Strensiq", "medicine_slug": "strensiq", "observed_at": "2026-10-12T13:49:10Z", "pipeline_version": "2.0.0", "presentation_label": "Strensiq 40 mg/ml solution for injection Strensiq 100 mg/ml solution for injection", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "1bb7c73286f57e11c88682980aa6f9ee26ad231f7581e9da57e308f067ba93fb", "source_snapshot_id": "source-f9cee1a032291fa10f55a891", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/strensiq-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": 313}
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{"after": {"end": 631, "start": 0, "text": "There is no information on the safety profile of bevacizumab in patients with congenital bleeding diathesis, acquired coagulopathy or in patients receiving full dose of anticoagulants for the treatment of thromboembolism prior to starting bevacizumab treatment, as such patients were excluded from clinical trials. Therefore, caution should be exercised before initiating therapy in these patients. However, patients who developed venous thrombosis while receiving therapy did not appear to have an increased rate of grade 3 or above bleeding when treated with a full dose of warfarin and bevacizumab concomitantly (NCI-CTCAE v.3).", "truncated": false}, "after_length": 631, "after_sha256": "61d8e265cf877baa1c18f69bd12d9a5e8375a1a28854f5815e96c28b0c1e147a", "annex": "I", "before": {"end": 631, "start": 0, "text": "There is no information on the safety profile of bevacizumab in patients with congenital bleeding diathesis, acquired coagulopathy or in patients receiving full dose of anticoagulants for the treatment of thromboembolism prior to starting bevacizumab treatment, as such patients were excluded from clinical trials. Therefore, caution should be exercised before initiating therapy in these patients. However, patients who developed venous thrombosis while receiving therapy did not appear to have an increased rate of grade 3 or above bleeding when treated with a full dose of warfarin and bevacizumab concomitantly (NCI-CTCAE v.3).", "truncated": false}, "before_length": 631, "before_sha256": "61d8e265cf877baa1c18f69bd12d9a5e8375a1a28854f5815e96c28b0c1e147a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-038c32322236b1b5c2ae5e6d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004728", "medicine_name": "Mvasi", "medicine_slug": "mvasi", "observed_at": "2026-10-12T19:05:22Z", "pipeline_version": "2.0.0", "presentation_label": "MVASI 25 mg/mL concentrate for solution for infusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "a37a7026b3fe5f943bf2dfae1da40e8922cb9100634f93bc6a182245d68b91bd", "source_snapshot_id": "source-3ab1af890e3622bfbf594b39", "source_updated_at": "2025-10-16", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/mvasi-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": 242}
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{"after": {"end": 530, "start": 0, "text": "For patients who stayed on their randomised therapy, the mean (±SD) adalimumab trough concentrations at Week 52 were 9.5 ± 5.6 µg/ml for the Standard Dose group and 3.5 ± 2.2 µg/ml for the Low Dose group. The mean trough concentrations were maintained in patients who continued to receive adalimumab treatment eow for 52 weeks. For patients who dose escalated from eow to weekly regimen, the mean (±SD) serum concentrations of adalimumab at Week 52 were 15.3 ± 11.4 μg/ml (40/20 mg, weekly) and 6.7 ± 3.5 μg/ml (20/10 mg, weekly).", "truncated": false}, "after_length": 530, "after_sha256": "27c1e5b942a9fb289013a453ccf9a6f9d14b7e7f07cf85ad3a1644dafb74d54a", "annex": "I", "before": {"end": 530, "start": 0, "text": "For patients who stayed on their randomised therapy, the mean (±SD) adalimumab trough concentrations at Week 52 were 9.5 ± 5.6 µg/ml for the Standard Dose group and 3.5 ± 2.2 µg/ml for the Low Dose group. The mean trough concentrations were maintained in patients who continued to receive adalimumab treatment eow for 52 weeks. For patients who dose escalated from eow to weekly regimen, the mean (±SD) serum concentrations of adalimumab at Week 52 were 15.3 ± 11.4 μg/ml (40/20 mg, weekly) and 6.7 ± 3.5 μg/ml (20/10 mg, weekly).", "truncated": false}, "before_length": 530, "before_sha256": "27c1e5b942a9fb289013a453ccf9a6f9d14b7e7f07cf85ad3a1644dafb74d54a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-038fe16d33214aee723d85c2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004879", "medicine_name": "Amsparity", "medicine_slug": "amsparity", "observed_at": "2026-10-12T19:15:08Z", "pipeline_version": "2.0.0", "presentation_label": "Amsparity 20 mg solution for injection in prefilled 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": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "ba2d2bebd7522cef09c6d189150f085d43e6510c2f227c0b5975c26e7bd9abd1", "source_snapshot_id": "source-26ece7d1cb806d3ad8238dc7", "source_updated_at": "2025-09-05", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/amsparity-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": 1708}
{"after": {"end": 482, "start": 0, "text": "Hypertension artérielle rénovasculaire : il existe un risque accru d’hypotension sévère et d’insuffisance rénale lorsque des patients présentant une sténose bilatérale de l’artère rénale ou une sténose artérielle rénale sur rein fonctionnel unique, reçoivent des médicaments qui agissent sur le système rénine-angiotensine-aldostérone. Bien que cela n’ait pas été documenté avec Aprovel, un phénomène similaire est à prévoir avec les antagonistes des récepteurs de l’angiotensineII.", "truncated": false}, "after_length": 482, "after_sha256": "81e4743c58edc7dcb42483584eb1b734bca531cd632cbab476234a04e3173b03", "annex": "I", "before": {"end": 482, "start": 0, "text": "Hypertension artérielle rénovasculaire : il existe un risque accru d’hypotension sévère et d’insuffisance rénale lorsque des patients présentant une sténose bilatérale de l’artère rénale ou une sténose artérielle rénale sur rein fonctionnel unique, reçoivent des médicaments qui agissent sur le système rénine-angiotensine-aldostérone. Bien que cela n’ait pas été documenté avec Aprovel, un phénomène similaire est à prévoir avec les antagonistes des récepteurs de l’angiotensineII.", "truncated": false}, "before_length": 482, "before_sha256": "81e4743c58edc7dcb42483584eb1b734bca531cd632cbab476234a04e3173b03", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03939b9590848c051d98b165", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000141", "medicine_name": "Aprovel", "medicine_slug": "aprovel", "observed_at": "2026-10-12T17:26:17Z", "pipeline_version": "2.0.0", "presentation_label": "Aprovel 75 mg comprimés.", "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": "8bb8b2b3057f8f9a8fac8321a222a7c020fa068739f1494a85cf638bf4f41b88", "source_snapshot_id": "source-47a3bd7fbf930750d7ef7891", "source_updated_at": "2026-01-19", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/aprovel-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 103}
{"after": {"end": 275, "start": 0, "text": "Addition of bevacizumab to RT/T did not demonstrate clinical benefit in study BO25041 in 60 evaluable children patients with newly diagnosed supratentorial or infratentorial cerebellar or peduncular high-grade glioma (HGG) (see section 4.2 for information on paediatric use).", "truncated": false}, "after_length": 275, "after_sha256": "ea74ed0b40b2fe725372a51733e36fe59cbc36f7a9ebcc59f690f7f989969206", "annex": "I", "before": {"end": 275, "start": 0, "text": "Addition of bevacizumab to RT/T did not demonstrate clinical benefit in study BO25041 in 60 evaluable children patients with newly diagnosed supratentorial or infratentorial cerebellar or peduncular high-grade glioma (HGG) (see section 4.2 for information on paediatric use).", "truncated": false}, "before_length": 275, "before_sha256": "ea74ed0b40b2fe725372a51733e36fe59cbc36f7a9ebcc59f690f7f989969206", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03a0142fe24db57472ffef52", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005106", "medicine_name": "Aybintio", "medicine_slug": "aybintio", "observed_at": "2026-10-12T13:27:42Z", "pipeline_version": "2.0.0", "presentation_label": "Aybintio 25 mg/ml concentrate for solution for infusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "fba935554f03156639cf5f78cbde9b08cd3489bf366e599397ae71b670ba5459", "source_snapshot_id": "source-ba46e119957a3ca29a915015", "source_updated_at": "2026-09-11", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/aybintio-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": 2326}
{"after": {"end": 588, "start": 0, "text": "In Cohort 1 (MYD88MUT), the median age was 70 years (range, 38 to 90 years), with 71% and 60% of patients treated with ibrutinib and zanubrutinib respectively being >65 years old. 33% of patients in the zanubrutinib arm and 22% in the ibrutinib were >75 years. 67% were male, and 91% were Caucasian. At study entry, 44% of patients in the ibrutinib arm and 46% of patients in the zanubrutinib arm had an International Prognostic Scoring System (IPSS) high. One hundred and sixty-four patients had relapsed or refractory disease; the median number of prior therapies was 1 (range, 1 to 8).", "truncated": false}, "after_length": 588, "after_sha256": "f097990676cc644cae53bb7cdc202f21701d6bc3f69108fb97b2da37c5597e5b", "annex": "I", "before": {"end": 588, "start": 0, "text": "In Cohort 1 (MYD88MUT), the median age was 70 years (range, 38 to 90 years), with 71% and 60% of patients treated with ibrutinib and zanubrutinib respectively being >65 years old. 33% of patients in the zanubrutinib arm and 22% in the ibrutinib were >75 years. 67% were male, and 91% were Caucasian. At study entry, 44% of patients in the ibrutinib arm and 46% of patients in the zanubrutinib arm had an International Prognostic Scoring System (IPSS) high. One hundred and sixty-four patients had relapsed or refractory disease; the median number of prior therapies was 1 (range, 1 to 8).", "truncated": false}, "before_length": 588, "before_sha256": "f097990676cc644cae53bb7cdc202f21701d6bc3f69108fb97b2da37c5597e5b", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03b7ddcbe783d27127e383a9", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004978", "medicine_name": "Brukinsa", "medicine_slug": "brukinsa", "observed_at": "2026-10-12T13:27:22Z", "pipeline_version": "2.0.0", "presentation_label": "BRUKINSA 80 mg hard capsules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "2171ac5e589cf9527d9bc5ab2958997e970517f090a8425dfa56f9f4d9e6e96c", "source_snapshot_id": "source-93035c199195b0e5ecae337e", "source_updated_at": "2026-10-07", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/brukinsa-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": 699}
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{"after": {"end": 155, "start": 0, "text": "Tableau 4. Pourcentages de patients présentant des réponses ACR à la semaine 16 dans les études PALACE 1, PALACE 2 et PALACE 3 et dans les études combinées", "truncated": false}, "after_length": 155, "after_sha256": "b948c9ca02b4bfab89334dbe1e9c4d6fa2d8fde14a44b0a8d0ba05fbda766210", "annex": "I", "before": {"end": 155, "start": 0, "text": "Tableau 4. Pourcentages de patients présentant des réponses ACR à la semaine 16 dans les études PALACE 1, PALACE 2 et PALACE 3 et dans les études combinées", "truncated": false}, "before_length": 155, "before_sha256": "b948c9ca02b4bfab89334dbe1e9c4d6fa2d8fde14a44b0a8d0ba05fbda766210", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03d2247f92f4bc08ed5a4009", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006208", "medicine_name": "Apremilast Accord", "medicine_slug": "apremilast-accord", "observed_at": "2026-10-12T13:35:31Z", "pipeline_version": "2.0.0", "presentation_label": "Apremilast Accord 10 mg comprimés pelliculés Apremilast Accord 20 mg comprimés pelliculés Apremilast Accord 30 mg comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "08c4d3196305b7b0fc9dde2eeb1d81d1bf001562592b1e281d192d8b8fd880b4", "source_snapshot_id": "source-11b725ad337f36a7ee1e46c0", "source_updated_at": "2026-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/apremilast-accord-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 476}
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{"after": {"end": 1090, "start": 0, "text": "Dans les études de fertilité conduites chez le rat mâle, l’administration d’eravacycline à des doses représentant environ 5 fois l’exposition clinique (basée sur l’AUC) a entraîné une réduction significative du nombre de gestations. Cette baisse a été réversible après 70 jours sans traitement (10 semaines), équivalant à un cycle spermatogenèse chez le rat. Des anomalies des organes reproducteurs mâles ont également été observées chez le rat au cours des études de toxicité répétée conduites pendant14 jours ou 13 semaines, et ce à des expositions représentant plus de 10 ou 5 fois l’exposition en clinique basée sur l’AUC. Ces anomalies consistaient en une dégénérescence des tubes séminifères, une oligospermie, la présence de débris cellulaires dans les épididymes, une rétention de spermatides dans les tubes séminifères, une augmentation de la rétention de spermatides dans les cellules de Sertoli et une vacuolisation des cellules de Sertoli avec une diminution du nombre de spermatozoïdes. Aucun effet indésirable n’a été observé sur l’accouplement ou la fertilité chez les rates.", "truncated": false}, "after_length": 1090, "after_sha256": "b5a14fa11a2a28eca8ad2ed747ae7ee366c84b0cbc929eb3c58db89fd00e5f6e", "annex": "I", "before": {"end": 1090, "start": 0, "text": "Dans les études de fertilité conduites chez le rat mâle, l’administration d’eravacycline à des doses représentant environ 5 fois l’exposition clinique (basée sur l’AUC) a entraîné une réduction significative du nombre de gestations. Cette baisse a été réversible après 70 jours sans traitement (10 semaines), équivalant à un cycle spermatogenèse chez le rat. Des anomalies des organes reproducteurs mâles ont également été observées chez le rat au cours des études de toxicité répétée conduites pendant14 jours ou 13 semaines, et ce à des expositions représentant plus de 10 ou 5 fois l’exposition en clinique basée sur l’AUC. Ces anomalies consistaient en une dégénérescence des tubes séminifères, une oligospermie, la présence de débris cellulaires dans les épididymes, une rétention de spermatides dans les tubes séminifères, une augmentation de la rétention de spermatides dans les cellules de Sertoli et une vacuolisation des cellules de Sertoli avec une diminution du nombre de spermatozoïdes. Aucun effet indésirable n’a été observé sur l’accouplement ou la fertilité chez les rates.", "truncated": false}, "before_length": 1090, "before_sha256": "b5a14fa11a2a28eca8ad2ed747ae7ee366c84b0cbc929eb3c58db89fd00e5f6e", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-03d9be83c1bcddfe7ae18a3c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004237", "medicine_name": "Xerava", "medicine_slug": "xerava", "observed_at": "2026-10-12T19:02:12Z", "pipeline_version": "2.0.0", "presentation_label": "Xerava 50 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": "5.3", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "263d3ee147b0360b9af7a2f8482dad0491caf07a9cbd85e97930e37ff272c34a", "source_snapshot_id": "source-4ad843ef8e3dd9f86ed13b08", "source_updated_at": "2026-02-06", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/xerava-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": 423}
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{"after": {"end": 487, "start": 0, "text": "Aucune interaction cliniquement pertinente du bevacizumab n’a été observée sur la pharmacocinétique de l’interféron alfa-2a, de l’erlotinib (et son métabolite actif OSI-420) ou d’autres chimiothérapies: irinotécan (et son métabolite actif SN38), capécitabine, oxaliplatine (déterminée d’après la mesure du platine libre et total) ou cisplatine, lors de leur co-administration. Les conclusions sur l’impact du bevacizumab sur la pharmacocinétique de la gemcitabine ne peuvent être tirées.", "truncated": false}, "after_length": 487, "after_sha256": "3799c71372b64bad698fa7f22f040d9e516baee3f08a5c50c6c1110e2d0ef7dd", "annex": "I", "before": {"end": 487, "start": 0, "text": "Aucune interaction cliniquement pertinente du bevacizumab n’a été observée sur la pharmacocinétique de l’interféron alfa-2a, de l’erlotinib (et son métabolite actif OSI-420) ou d’autres chimiothérapies: irinotécan (et son métabolite actif SN38), capécitabine, oxaliplatine (déterminée d’après la mesure du platine libre et total) ou cisplatine, lors de leur co-administration. Les conclusions sur l’impact du bevacizumab sur la pharmacocinétique de la gemcitabine ne peuvent être tirées.", "truncated": false}, "before_length": 487, "before_sha256": "3799c71372b64bad698fa7f22f040d9e516baee3f08a5c50c6c1110e2d0ef7dd", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0410ae52a7e67f9128ae5280", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004728", "medicine_name": "Mvasi", "medicine_slug": "mvasi", "observed_at": "2026-10-12T19:05:25Z", "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": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "a52e278712552c88d687c789c8c0efa23c11f88e02e6d8914d109160079d55b7", "source_snapshot_id": "source-96f65d891051b574197708bc", "source_updated_at": "2025-10-16", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/mvasi-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": 307}
{"after": {"end": 227, "start": 0, "text": "Emblaveo peut être dilué avec des solutions contenant du sodium (voir rubrique 6.6) et cela doit être pris en compte par rapport à la quantité totale de sodium provenant de toutes les sources qui seront administrées au patient.", "truncated": false}, "after_length": 227, "after_sha256": "5fb7ff8d3285b4f2904a16ace6750b894ebeeaf533167288c93d90f6f23b932c", "annex": "I", "before": {"end": 227, "start": 0, "text": "Emblaveo peut être dilué avec des solutions contenant du sodium (voir rubrique 6.6) et cela doit être pris en compte par rapport à la quantité totale de sodium provenant de toutes les sources qui seront administrées au patient.", "truncated": false}, "before_length": 227, "before_sha256": "5fb7ff8d3285b4f2904a16ace6750b894ebeeaf533167288c93d90f6f23b932c", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0415579425802e6ebf31723f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006113", "medicine_name": "Emblaveo", "medicine_slug": "emblaveo", "observed_at": "2026-10-12T19:12:01Z", "pipeline_version": "2.0.0", "presentation_label": "Emblaveo 1,5 g/0,5 g, 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": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "2c21d31348fa478f5de5b4a663016755d5452d037826559853c0254f572d415a", "source_snapshot_id": "source-cdaecb76df7734b3152e3f0f", "source_updated_at": "2025-09-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/emblaveo-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": 225}
{"after": {"end": 242, "start": 0, "text": "Strensiq doit être administré à l’aide de seringues et aiguilles stériles à usage unique. Le volume des seringues doit être suffisamment faible pour que la dose prescrite puisse être prélevée à partir du flacon avec une exactitude acceptable.", "truncated": false}, "after_length": 242, "after_sha256": "d3fa238de80af93348ea7aab694757f03569a50e401c1d79f9a9acb45a786993", "annex": "I", "before": {"end": 242, "start": 0, "text": "Strensiq doit être administré à l’aide de seringues et aiguilles stériles à usage unique. Le volume des seringues doit être suffisamment faible pour que la dose prescrite puisse être prélevée à partir du flacon avec une exactitude acceptable.", "truncated": false}, "before_length": 242, "before_sha256": "d3fa238de80af93348ea7aab694757f03569a50e401c1d79f9a9acb45a786993", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-04202792d3ba9829464bf2a3", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003794", "medicine_name": "Strensiq", "medicine_slug": "strensiq", "observed_at": "2026-10-12T13:52:06Z", "pipeline_version": "2.0.0", "presentation_label": "Strensiq 40 mg/ml solution injectable Strensiq 100 mg/ml solution injectable", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "6161d5b8e2abd4c33834351f5f07062f042278ab73aeb30e92df378cfe895d23", "source_snapshot_id": "source-eec4301358a1191a19e95d17", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/strensiq-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 294}
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{"after": {"end": 384, "start": 0, "text": "Par rapport au vénétoclax 400 mg administré seul, l’administration concomitante de 300 mg de posaconazole, un inhibiteur puissant du CYP3A, avec du vénétoclax 50 mg et 100 mg pendant 7 jours chez 12 patients, a augmenté la Cmax du vénétoclax de 1,6 fois et 1,9 fois, ainsi que l’ASC de 1,9 fois et 2,4 fois, respectivement (voir rubriques 4.3 et 4.4). Se référer au RCP du vénétoclax.", "truncated": false}, "after_length": 384, "after_sha256": "03881f824dbf50216982aefc3bb5d3c23615b5532f97b434d63561ca35bc8628", "annex": "I", "before": {"end": 384, "start": 0, "text": "Par rapport au vénétoclax 400 mg administré seul, l’administration concomitante de 300 mg de posaconazole, un inhibiteur puissant du CYP3A, avec du vénétoclax 50 mg et 100 mg pendant 7 jours chez 12 patients, a augmenté la Cmax du vénétoclax de 1,6 fois et 1,9 fois, ainsi que l’ASC de 1,9 fois et 2,4 fois, respectivement (voir rubriques 4.3 et 4.4). Se référer au RCP du vénétoclax.", "truncated": false}, "before_length": 384, "before_sha256": "03881f824dbf50216982aefc3bb5d3c23615b5532f97b434d63561ca35bc8628", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-043c70547d6783e15ae1d587", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005005", "medicine_name": "Posaconazole Accord", "medicine_slug": "posaconazole-accord", "observed_at": "2026-10-12T19:44:30Z", "pipeline_version": "2.0.0", "presentation_label": "Posaconazole Accord 100 mg comprimés gastro-résistants", "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": "307cc53ed0048509787bc0b73f2040c678b1df3cc6f8e722f513a205cc3e6baa", "source_snapshot_id": "source-b5de155abfc26fe489dd1b33", "source_updated_at": "2025-05-06", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/posaconazole-accord-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 241}
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{"after": {"end": 960, "start": 0, "text": "Il s’agissait d’une étude de phase III, randomisée, en double aveugle, contrôlée, évaluant bevacizumab en association à une chimiothérapie IFL en traitement de première ligne du cancer colorectal métastatique. Huit cent treize patients ont été randomisés pour recevoir soit IFL + placebo (groupe 1), soit IFL + bevacizumab (5 mg/kg toutes les 2 semaines, groupe 2). Un troisième groupe de 110 patients a reçu une chimiothérapie 5-FU en bolus/AF + bevacizumab (groupe 3). L’inclusion dans le groupe 3 a été interrompue, comme le prévoyait le protocole, lorsque la tolérance du bevacizumab associé au schéma IFL a été établie et jugée acceptable. Tous les traitements ont été poursuivis jusqu’à progression de la maladie. L’âge moyen des patients était de 59,4 ans et l’indice de performance ECOG était de 0 chez 56,6 %, de 1 chez 43 % et de 2 chez 0,4 % des patients. 15,5 % des patients avaient reçu précédemment une radiothérapie et 28,4 % une chimiothérapie.", "truncated": false}, "after_length": 960, "after_sha256": "7f9d6ecf944b6f9fd020e32b2b80318b085d169eb5859f7785b9370ea47191a4", "annex": "I", "before": {"end": 960, "start": 0, "text": "Il s’agissait d’une étude de phase III, randomisée, en double aveugle, contrôlée, évaluant bevacizumab en association à une chimiothérapie IFL en traitement de première ligne du cancer colorectal métastatique. Huit cent treize patients ont été randomisés pour recevoir soit IFL + placebo (groupe 1), soit IFL + bevacizumab (5 mg/kg toutes les 2 semaines, groupe 2). Un troisième groupe de 110 patients a reçu une chimiothérapie 5-FU en bolus/AF + bevacizumab (groupe 3). L’inclusion dans le groupe 3 a été interrompue, comme le prévoyait le protocole, lorsque la tolérance du bevacizumab associé au schéma IFL a été établie et jugée acceptable. Tous les traitements ont été poursuivis jusqu’à progression de la maladie. L’âge moyen des patients était de 59,4 ans et l’indice de performance ECOG était de 0 chez 56,6 %, de 1 chez 43 % et de 2 chez 0,4 % des patients. 15,5 % des patients avaient reçu précédemment une radiothérapie et 28,4 % une chimiothérapie.", "truncated": false}, "before_length": 960, "before_sha256": "7f9d6ecf944b6f9fd020e32b2b80318b085d169eb5859f7785b9370ea47191a4", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-04615441e302c5ddf3720f29", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004728", "medicine_name": "Mvasi", "medicine_slug": "mvasi", "observed_at": "2026-10-12T19:05:25Z", "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": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a52e278712552c88d687c789c8c0efa23c11f88e02e6d8914d109160079d55b7", "source_snapshot_id": "source-96f65d891051b574197708bc", "source_updated_at": "2025-10-16", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/mvasi-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": 994}
{"after": {"end": 703, "start": 0, "text": "Depuis la commercialisation, une exacerbation sévère de la maladie a été observée rarement chez des patients ayant arrêté le fingolimod. Cela a principalement été observé pendant les 12 semaines suivant l’arrêt du fingolimod, mais a également été rapporté jusqu’à 24 semaines après l’arrêt du traitement. La prudence est donc requise lors de l’arrêt du fingolimod. Si l’arrêt du fingolimod est jugé nécessaire, l’éventualité d’une reprise d’activité exceptionnellement importante de la maladie doit être considérée et les patients doivent être surveillés afin de détecter l’apparition de signes et symptômes évocateurs et initier si besoin un traitement adapté (voir « Arrêt du traitement » ci-dessous).", "truncated": false}, "after_length": 703, "after_sha256": "723f5dfba82a668d535f2783f03b49af6507334b593046e8d12c636797001ec8", "annex": "I", "before": {"end": 703, "start": 0, "text": "Depuis la commercialisation, une exacerbation sévère de la maladie a été observée rarement chez des patients ayant arrêté le fingolimod. Cela a principalement été observé pendant les 12 semaines suivant l’arrêt du fingolimod, mais a également été rapporté jusqu’à 24 semaines après l’arrêt du traitement. La prudence est donc requise lors de l’arrêt du fingolimod. Si l’arrêt du fingolimod est jugé nécessaire, l’éventualité d’une reprise d’activité exceptionnellement importante de la maladie doit être considérée et les patients doivent être surveillés afin de détecter l’apparition de signes et symptômes évocateurs et initier si besoin un traitement adapté (voir « Arrêt du traitement » ci-dessous).", "truncated": false}, "before_length": 703, "before_sha256": "723f5dfba82a668d535f2783f03b49af6507334b593046e8d12c636797001ec8", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0461b46220b6a4d93bf8ba47", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002202", "medicine_name": "Gilenya", "medicine_slug": "gilenya", "observed_at": "2026-10-12T13:30:27Z", "pipeline_version": "2.0.0", "presentation_label": "Gilenya 0,25 mg, gélule Gilenya 0,5 mg, gélule", "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": "83f3661e0a3bbe5c73439ed4ae1f26511ae4bd38a7233fa0d5bdc0d8d330a97e", "source_snapshot_id": "source-dd100ba88d58dedcc7a4d9ed", "source_updated_at": "2026-07-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/gilenya-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": 268}
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{"after": {"end": 1047, "start": 0, "text": "Il s’agissait d’une étude de phase III, randomisée, en double aveugle, qui évaluait l’efficacité et la tolérance du bevacizumab en association à l’interféron (IFN) alfa2a comparativement à l’IFN alfa2a seul, en traitement de première ligne du CRm. Les 649 patients randomisés (641 traités) avaient un score de performance KPS (Karnofsky Performance Status) ≥ 70 %, et ne présentaient aucune métastase du SNC, ni dysfonctionnement organique. Les patients ont subi une néphrectomie pour un carcinome rénal primitif. Le bevacizumab à la posologie de 10 mg/kg toutes les 2 semaines était administré jusqu’à progression de la maladie. L’IFN alfa2a était administré pendant 52 semaines ou jusqu’à progression de la maladie à une posologie initiale recommandée de 9 MUI trois fois par semaine, avec une réduction de la dose à 3 MUI trois fois par semaine autorisée en deux paliers. Les patients ont été stratifiés en fonction du pays et du score de Motzer et les groupes de traitement étaient bien équilibrés en ce qui concerne les facteurs pronostiques.", "truncated": false}, "after_length": 1047, "after_sha256": "00fc8cbc61a69dbe778a298be05e61e6b7268d811df3f05c7644f4a450ea8071", "annex": "I", "before": {"end": 1047, "start": 0, "text": "Il s’agissait d’une étude de phase III, randomisée, en double aveugle, qui évaluait l’efficacité et la tolérance du bevacizumab en association à l’interféron (IFN) alfa2a comparativement à l’IFN alfa2a seul, en traitement de première ligne du CRm. Les 649 patients randomisés (641 traités) avaient un score de performance KPS (Karnofsky Performance Status) ≥ 70 %, et ne présentaient aucune métastase du SNC, ni dysfonctionnement organique. Les patients ont subi une néphrectomie pour un carcinome rénal primitif. Le bevacizumab à la posologie de 10 mg/kg toutes les 2 semaines était administré jusqu’à progression de la maladie. L’IFN alfa2a était administré pendant 52 semaines ou jusqu’à progression de la maladie à une posologie initiale recommandée de 9 MUI trois fois par semaine, avec une réduction de la dose à 3 MUI trois fois par semaine autorisée en deux paliers. Les patients ont été stratifiés en fonction du pays et du score de Motzer et les groupes de traitement étaient bien équilibrés en ce qui concerne les facteurs pronostiques.", "truncated": false}, "before_length": 1047, "before_sha256": "00fc8cbc61a69dbe778a298be05e61e6b7268d811df3f05c7644f4a450ea8071", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-04efb0877d7d8e3988211119", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005106", "medicine_name": "Aybintio", "medicine_slug": "aybintio", "observed_at": "2026-10-12T13:27:44Z", "pipeline_version": "2.0.0", "presentation_label": "Aybintio 25 mg/ml solution à diluer pour perfusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "4a45f4a7b4e7df4dbc475a3f92ce3f16543120b39806a2fc6e5399c3925ecba4", "source_snapshot_id": "source-70a38464ff06de59375a15c3", "source_updated_at": "2026-09-11", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/aybintio-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}
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{"after": {"end": 288, "start": 0, "text": "Synergistic antiviral activity was observed with the combination of emtricitabine and tenofovir in vitro. Additive to synergistic effects were observed in combination studies with protease inhibitors, and with nucleoside and nonnucleoside analogue inhibitors of HIV reverse transcriptase.", "truncated": false}, "after_length": 288, "after_sha256": "8239269b889bc98789fb331ae92eb8fad320c1e9164e5b5b61581e39979a3f39", "annex": "I", "before": {"end": 288, "start": 0, "text": "Synergistic antiviral activity was observed with the combination of emtricitabine and tenofovir in vitro. Additive to synergistic effects were observed in combination studies with protease inhibitors, and with nucleoside and nonnucleoside analogue inhibitors of HIV reverse transcriptase.", "truncated": false}, "before_length": 288, "before_sha256": "8239269b889bc98789fb331ae92eb8fad320c1e9164e5b5b61581e39979a3f39", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-05d5e2c1d1bd2328ef26f85c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004050", "medicine_name": "Emtricitabine/Tenofovir disoproxil Mylan", "medicine_slug": "emtricitabine-tenofovir-disoproxil-mylan", "observed_at": "2026-10-12T13:35:50Z", "pipeline_version": "2.0.0", "presentation_label": "Emtricitabine/Tenofovir disoproxil Mylan 200 mg/245 mg filmcoated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "e39cc7ad47f03eb2ce2ca3a7ee4cb611318362a7f95910dcfd88b0802fb8b704", "source_snapshot_id": "source-d7ee296bef62b33bf153220e", "source_updated_at": "2026-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/emtricitabine-tenofovir-disoproxil-mylan-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1171}
{"after": {"end": 293, "start": 0, "text": "The analysis of PFS as determined by the independent review committee (censoring for NPT) shows a stratified hazard ratio of 0.62 (95% CI: 0.500.77, 1-sided log-rank p-value < 0.0001) when CPB15+ is compared with CPP, with a median PFS of 13.1 in the CPP arm and 19.1 months in the CPB15+ arm.", "truncated": false}, "after_length": 293, "after_sha256": "014100ebbebaeac43b944c8128269f7c8f05dc26b98cc76aa5778a77c3656f0a", "annex": "I", "before": {"end": 293, "start": 0, "text": "The analysis of PFS as determined by the independent review committee (censoring for NPT) shows a stratified hazard ratio of 0.62 (95% CI: 0.500.77, 1-sided log-rank p-value < 0.0001) when CPB15+ is compared with CPP, with a median PFS of 13.1 in the CPP arm and 19.1 months in the CPB15+ arm.", "truncated": false}, "before_length": 293, "before_sha256": "014100ebbebaeac43b944c8128269f7c8f05dc26b98cc76aa5778a77c3656f0a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-05ed920aa3427f4bb4c3c911", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004728", "medicine_name": "Mvasi", "medicine_slug": "mvasi", "observed_at": "2026-10-12T19:05:22Z", "pipeline_version": "2.0.0", "presentation_label": "MVASI 25 mg/mL concentrate for solution for infusion.", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a37a7026b3fe5f943bf2dfae1da40e8922cb9100634f93bc6a182245d68b91bd", "source_snapshot_id": "source-3ab1af890e3622bfbf594b39", "source_updated_at": "2025-10-16", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/mvasi-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": 1835}
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{"after": {"end": 522, "start": 0, "text": "Le tableau 1 présente les effets indésirables observés dans les études cliniques et après la commercialisation avec pegcetacoplan chez des patients atteints d’HPN. Les effets indésirables sont présentés par classe de système d’organes MedDRA et par fréquence, en utilisant la convention suivante : très fréquent (≥ 1/10), fréquent (≥ 1/100, <1/10), peu fréquent (≥ 1/1 000, < 1/100), rare (≥ 1/10 000, < 1/1 000), très rare (< 1/10 000) et fréquence indéterminée (ne peut être estimée sur la base des données disponibles).", "truncated": false}, "after_length": 522, "after_sha256": "5fa9daf2f37b87490f294c5bd2bdb50582c7240c8f89b557a833b2de28453507", "annex": "I", "before": {"end": 522, "start": 0, "text": "Le tableau 1 présente les effets indésirables observés dans les études cliniques et après la commercialisation avec pegcetacoplan chez des patients atteints d’HPN. Les effets indésirables sont présentés par classe de système d’organes MedDRA et par fréquence, en utilisant la convention suivante : très fréquent (≥ 1/10), fréquent (≥ 1/100, <1/10), peu fréquent (≥ 1/1 000, < 1/100), rare (≥ 1/10 000, < 1/1 000), très rare (< 1/10 000) et fréquence indéterminée (ne peut être estimée sur la base des données disponibles).", "truncated": false}, "before_length": 522, "before_sha256": "5fa9daf2f37b87490f294c5bd2bdb50582c7240c8f89b557a833b2de28453507", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-08760877a03a13e405240c8d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005553", "medicine_name": "Aspaveli", "medicine_slug": "aspaveli", "observed_at": "2026-10-12T19:03:46Z", "pipeline_version": "2.0.0", "presentation_label": "ASPAVELI 1 080 mg solution pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "86f4a87b61227842d3e9445141875f8d32664723dce946b7cdbb8f13dd93512e", "source_snapshot_id": "source-1f0c69f5bea684bae12db8c2", "source_updated_at": "2025-11-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/aspaveli-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": 200}
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{"after": {"end": 361, "start": 0, "text": "Safety and efficacy of Toujeo have been demonstrated in a study in children aged 6 to less than 18 years. The frequency, type and severity of adverse reactions in the paediatric population do not indicate differences to the experience in the general diabetes population (see section 5.1). Clinical study safety data are not available for children under 6 years.", "truncated": false}, "after_length": 361, "after_sha256": "ff68892f75a9d8969e48e95833665852ed1a974f2237771ca83adab4c9a6a615", "annex": "I", "before": {"end": 361, "start": 0, "text": "Safety and efficacy of Toujeo have been demonstrated in a study in children aged 6 to less than 18 years. The frequency, type and severity of adverse reactions in the paediatric population do not indicate differences to the experience in the general diabetes population (see section 5.1). Clinical study safety data are not available for children under 6 years.", "truncated": false}, "before_length": 361, "before_sha256": "ff68892f75a9d8969e48e95833665852ed1a974f2237771ca83adab4c9a6a615", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0c6b15b96e9c35047417444f", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000309", "medicine_name": "Toujeo (previously Optisulin)", "medicine_slug": "toujeo-previously-optisulin", "observed_at": "2026-10-12T19:30:06Z", "pipeline_version": "2.0.0", "presentation_label": "Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen Toujeo 300 units/ml DoubleStar, solution for injection in a 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": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "958e68d317ead1784b761df53174f59803bbabb77bcf31c3603b908121943aff", "source_snapshot_id": "source-469265d9b6d6251540ddde37", "source_updated_at": "2025-07-09", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/toujeo-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": 370}
{"after": {"end": 612, "start": 0, "text": "In vitro, l’aprémilast n’a pas ou que peu d’effet inhibiteur (CI50 > 10 µM) sur les transporteurs d’anions organiques (OAT)1 et OAT3, sur le transporteur de cations organiques (OCT)2, sur les protéines de transport des anions organiques (OATP)1B1 et OATP1B3 ou sur la protéine de résistance du cancer du sein (BCRP - Breast Cancer Resistance Protein) et n’est pas un substrat de ces transporteurs. Par conséquent, des interactions cliniquement pertinentes sont peu probables en cas d’administration concomitante de l’aprémilast avec des médicaments qui sont des substrats ou des inhibiteurs de ces transporteurs.", "truncated": false}, "after_length": 612, "after_sha256": "835a77804f33030a37ea3aaea08b8ee19f6bbb0cc49143211efac57c8b05e358", "annex": "I", "before": {"end": 612, "start": 0, "text": "In vitro, l’aprémilast n’a pas ou que peu d’effet inhibiteur (CI50 > 10 µM) sur les transporteurs d’anions organiques (OAT)1 et OAT3, sur le transporteur de cations organiques (OCT)2, sur les protéines de transport des anions organiques (OATP)1B1 et OATP1B3 ou sur la protéine de résistance du cancer du sein (BCRP - Breast Cancer Resistance Protein) et n’est pas un substrat de ces transporteurs. Par conséquent, des interactions cliniquement pertinentes sont peu probables en cas d’administration concomitante de l’aprémilast avec des médicaments qui sont des substrats ou des inhibiteurs de ces transporteurs.", "truncated": false}, "before_length": 612, "before_sha256": "835a77804f33030a37ea3aaea08b8ee19f6bbb0cc49143211efac57c8b05e358", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0c74fc8cac8ecc4472ec0632", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006208", "medicine_name": "Apremilast Accord", "medicine_slug": "apremilast-accord", "observed_at": "2026-10-12T13:35:31Z", "pipeline_version": "2.0.0", "presentation_label": "Apremilast Accord 10 mg comprimés pelliculés Apremilast Accord 20 mg comprimés pelliculés Apremilast Accord 30 mg comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "08c4d3196305b7b0fc9dde2eeb1d81d1bf001562592b1e281d192d8b8fd880b4", "source_snapshot_id": "source-11b725ad337f36a7ee1e46c0", "source_updated_at": "2026-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/apremilast-accord-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1048}
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{"after": {"end": 1330, "start": 0, "text": "Pegcetacoplan(n = 41)Pegcetacoplan(n = 41)En faveur de l’éculizumabEn faveur de l’éculizumabEn faveur du pegcetacoplanEn faveur du pegcetacoplanEn faveur de l’éculizumabEn faveur de l’éculizumabEn faveur de l’éculizumabEn faveur de l’éculizumabEn faveur du pegcetacoplanEn faveur du pegcetacoplanVariation du taux de LDH par rapport à l’inclusion ; U/LMMC (ES)Variation du taux de LDH par rapport à l’inclusion ; U/LMMC (ES)Variation des réticulocytes par rapport à l’inclusion, 109/LMMC (ES)Variation des réticulocytes par rapport à l’inclusion, 109/LMMC (ES)Différence entre le pegcetacoplan et l’éculizumabDifférence entre le pegcetacoplan et l’éculizumabLa marge de non-infériorité pour le critère donné est indiquée pour chaque paramètreLa marge de non-infériorité pour le critère donné est indiquée pour chaque paramètreNon-inférioritéNon-inférioritéDifférence(IC à 95 %)Différence(IC à 95 %)En faveur de l’éculizumabEn faveur de l’éculizumabTransfusions évitées, n (%)Transfusions évitées, n (%)Variation du score FACIT-fatigue par rapport à l’inclusionMMC (ES)Variation du score FACIT-fatigue par rapport à l’inclusionMMC (ES)IC à 95 %IC à 95 %NonNonOuiOuiEn faveur du pegcetacoplanEn faveur du pegcetacoplanEn faveur du pegcetacoplanEn faveur du pegcetacoplanNon testéeNon testéeOuiOuiÉculizumab(n = 39)Éculizumab(n = 39)", "truncated": false}, "after_length": 1330, "after_sha256": "e16c9c758d4d8920db347d672a6103176739cf662c44b5af5db2ece25e62bcd4", "annex": "I", "before": {"end": 1330, "start": 0, "text": "Pegcetacoplan(n = 41)Pegcetacoplan(n = 41)En faveur de l’éculizumabEn faveur de l’éculizumabEn faveur du pegcetacoplanEn faveur du pegcetacoplanEn faveur de l’éculizumabEn faveur de l’éculizumabEn faveur de l’éculizumabEn faveur de l’éculizumabEn faveur du pegcetacoplanEn faveur du pegcetacoplanVariation du taux de LDH par rapport à l’inclusion ; U/LMMC (ES)Variation du taux de LDH par rapport à l’inclusion ; U/LMMC (ES)Variation des réticulocytes par rapport à l’inclusion, 109/LMMC (ES)Variation des réticulocytes par rapport à l’inclusion, 109/LMMC (ES)Différence entre le pegcetacoplan et l’éculizumabDifférence entre le pegcetacoplan et l’éculizumabLa marge de non-infériorité pour le critère donné est indiquée pour chaque paramètreLa marge de non-infériorité pour le critère donné est indiquée pour chaque paramètreNon-inférioritéNon-inférioritéDifférence(IC à 95 %)Différence(IC à 95 %)En faveur de l’éculizumabEn faveur de l’éculizumabTransfusions évitées, n (%)Transfusions évitées, n (%)Variation du score FACIT-fatigue par rapport à l’inclusionMMC (ES)Variation du score FACIT-fatigue par rapport à l’inclusionMMC (ES)IC à 95 %IC à 95 %NonNonOuiOuiEn faveur du pegcetacoplanEn faveur du pegcetacoplanEn faveur du pegcetacoplanEn faveur du pegcetacoplanNon testéeNon testéeOuiOuiÉculizumab(n = 39)Éculizumab(n = 39)", "truncated": false}, "before_length": 1330, "before_sha256": "e16c9c758d4d8920db347d672a6103176739cf662c44b5af5db2ece25e62bcd4", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0d00d8bbe7c38372912d78ce", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005553", "medicine_name": "Aspaveli", "medicine_slug": "aspaveli", "observed_at": "2026-10-12T19:03:46Z", "pipeline_version": "2.0.0", "presentation_label": "ASPAVELI 1 080 mg solution pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "86f4a87b61227842d3e9445141875f8d32664723dce946b7cdbb8f13dd93512e", "source_snapshot_id": "source-1f0c69f5bea684bae12db8c2", "source_updated_at": "2025-11-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/aspaveli-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": 492}
{"after": {"end": 361, "start": 0, "text": "Avant de démarrer le traitement par pegcetacoplan, chez les patients déjà vaccinés, il convient de vérifier que les patients ont bien reçu les vaccins contre les bactéries encapsulées Streptococcus pneumoniae, Neisseria meningitidis de types A, C, W, Y et B, et Haemophilus influenzae de type B dans les 2 ans précédant le début du traitement par pegcetacoplan.", "truncated": false}, "after_length": 361, "after_sha256": "b21811d0d638e2d227481f5a476f7f8f4cb80f335cc27228a2b7620bbfcdfd8f", "annex": "I", "before": {"end": 361, "start": 0, "text": "Avant de démarrer le traitement par pegcetacoplan, chez les patients déjà vaccinés, il convient de vérifier que les patients ont bien reçu les vaccins contre les bactéries encapsulées Streptococcus pneumoniae, Neisseria meningitidis de types A, C, W, Y et B, et Haemophilus influenzae de type B dans les 2 ans précédant le début du traitement par pegcetacoplan.", "truncated": false}, "before_length": 361, "before_sha256": "b21811d0d638e2d227481f5a476f7f8f4cb80f335cc27228a2b7620bbfcdfd8f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0d08e76e667560e29869b6a6", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005553", "medicine_name": "Aspaveli", "medicine_slug": "aspaveli", "observed_at": "2026-10-12T19:03:46Z", "pipeline_version": "2.0.0", "presentation_label": "ASPAVELI 1 080 mg solution pour perfusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "86f4a87b61227842d3e9445141875f8d32664723dce946b7cdbb8f13dd93512e", "source_snapshot_id": "source-1f0c69f5bea684bae12db8c2", "source_updated_at": "2025-11-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/aspaveli-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": 127}
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{"after": {"end": 352, "start": 0, "text": "La dose moyenne d’insuline glargine 100 unités/ml à la fin de l’étude a été de 0,42 U/kg. La valeur médiane de l’HbA1c a été de 6,4% à l’inclusion, puis cette valeur sous traitement a été comprise entre 5,9% et 6,4% dans le groupe insuline glargine 100 unités/ml et entre 6,2% et 6.6% dans le groupe traitement standard pendant toute la durée du suivi.", "truncated": false}, "after_length": 352, "after_sha256": "b1790f485b1f3222add4cd4df69515a17099375d0569d9434adb74a2336027ad", "annex": "I", "before": {"end": 352, "start": 0, "text": "La dose moyenne d’insuline glargine 100 unités/ml à la fin de l’étude a été de 0,42 U/kg. La valeur médiane de l’HbA1c a été de 6,4% à l’inclusion, puis cette valeur sous traitement a été comprise entre 5,9% et 6,4% dans le groupe insuline glargine 100 unités/ml et entre 6,2% et 6.6% dans le groupe traitement standard pendant toute la durée du suivi.", "truncated": false}, "before_length": 352, "before_sha256": "b1790f485b1f3222add4cd4df69515a17099375d0569d9434adb74a2336027ad", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0d8fbcc4a377a970667f6699", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000309", "medicine_name": "Toujeo (previously Optisulin)", "medicine_slug": "toujeo-previously-optisulin", "observed_at": "2026-10-12T19:30:09Z", "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": "002ed116c467ebd888c93443a95c452e0346312b86945e11ab401f6442cf8402", "source_snapshot_id": "source-4e319ccd719735dc0a35b6f8", "source_updated_at": "2025-07-09", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/toujeo-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": 662}
{"after": {"end": 261, "start": 0, "text": "Patients must visually verify the number of selected units on the dose counter of the pen. Patients who are blind or have poor vision should be instructed to get help/assistance from another person who has good vision and is trained in using the insulin device.", "truncated": false}, "after_length": 261, "after_sha256": "8b3b29668902ed3ced3fed76c0bd1d8bdf0f640db419f9d8df9630969344a2ec", "annex": "I", "before": {"end": 261, "start": 0, "text": "Patients must visually verify the number of selected units on the dose counter of the pen. Patients who are blind or have poor vision should be instructed to get help/assistance from another person who has good vision and is trained in using the insulin device.", "truncated": false}, "before_length": 261, "before_sha256": "8b3b29668902ed3ced3fed76c0bd1d8bdf0f640db419f9d8df9630969344a2ec", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0da036ff801f513583c42d40", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000309", "medicine_name": "Toujeo (previously Optisulin)", "medicine_slug": "toujeo-previously-optisulin", "observed_at": "2026-10-12T19:30:06Z", "pipeline_version": "2.0.0", "presentation_label": "Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen Toujeo 300 units/ml DoubleStar, solution for injection in a 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": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "958e68d317ead1784b761df53174f59803bbabb77bcf31c3603b908121943aff", "source_snapshot_id": "source-469265d9b6d6251540ddde37", "source_updated_at": "2025-07-09", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/toujeo-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": 235}
{"after": {"end": 823, "start": 0, "text": "Conformément au plan de l’étude, les patients qui ne présentaient pas une amélioration d’au moins 20 % des nombres d’articulations douloureuses et gonflées à la semaine 16 étaient considérés comme nonrépondeurs. Les patients du groupe placebo qui étaient considérés comme nonrépondeurs ont été re-randomisés selon un rapport 1:1 pour recevoir en aveugle l’aprémilast 20 mg deux fois par jour ou 30 mg deux fois par jour. À la semaine 24, tous les patients qui étaient toujours sous placebo ont permuté pour recevoir l’aprémilast 20 mg ou 30 mg deux fois par jour. Après 52 semaines de traitement, les patients ont pu poursuivre l’aprémilast 20 mg ou 30 mg en ouvert dans le cadre de l’extension à long terme des études PALACE 1, PALACE 2, et PALACE 3, pour une durée de traitement totale de 5 ans au maximum (260 semaines).", "truncated": false}, "after_length": 823, "after_sha256": "9badb79283a1ae4d642f19300a2527b84004f23c5829bb3954da1e8ea7c79d67", "annex": "I", "before": {"end": 823, "start": 0, "text": "Conformément au plan de l’étude, les patients qui ne présentaient pas une amélioration d’au moins 20 % des nombres d’articulations douloureuses et gonflées à la semaine 16 étaient considérés comme nonrépondeurs. Les patients du groupe placebo qui étaient considérés comme nonrépondeurs ont été re-randomisés selon un rapport 1:1 pour recevoir en aveugle l’aprémilast 20 mg deux fois par jour ou 30 mg deux fois par jour. À la semaine 24, tous les patients qui étaient toujours sous placebo ont permuté pour recevoir l’aprémilast 20 mg ou 30 mg deux fois par jour. Après 52 semaines de traitement, les patients ont pu poursuivre l’aprémilast 20 mg ou 30 mg en ouvert dans le cadre de l’extension à long terme des études PALACE 1, PALACE 2, et PALACE 3, pour une durée de traitement totale de 5 ans au maximum (260 semaines).", "truncated": false}, "before_length": 823, "before_sha256": "9badb79283a1ae4d642f19300a2527b84004f23c5829bb3954da1e8ea7c79d67", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0daf235fd7728b9b714d021b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006208", "medicine_name": "Apremilast Accord", "medicine_slug": "apremilast-accord", "observed_at": "2026-10-12T13:35:31Z", "pipeline_version": "2.0.0", "presentation_label": "Apremilast Accord 10 mg comprimés pelliculés Apremilast Accord 20 mg comprimés pelliculés Apremilast Accord 30 mg comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "08c4d3196305b7b0fc9dde2eeb1d81d1bf001562592b1e281d192d8b8fd880b4", "source_snapshot_id": "source-11b725ad337f36a7ee1e46c0", "source_updated_at": "2026-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/apremilast-accord-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 468}
{"after": {"end": 138, "start": 0, "text": "Administration concomitante avec les inhibiteurs de la HMG-CoA réductase (simvastatine, lovastatine et atorvastatine) (voir rubrique 4.5).", "truncated": false}, "after_length": 138, "after_sha256": "6216df786fd13774ad89c947d796c522b82f2397478c43888c48882dbde7aa2d", "annex": "I", "before": {"end": 138, "start": 0, "text": "Administration concomitante avec les inhibiteurs de la HMG-CoA réductase (simvastatine, lovastatine et atorvastatine) (voir rubrique 4.5).", "truncated": false}, "before_length": 138, "before_sha256": "6216df786fd13774ad89c947d796c522b82f2397478c43888c48882dbde7aa2d", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0db600e36099984e241f7a86", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005005", "medicine_name": "Posaconazole Accord", "medicine_slug": "posaconazole-accord", "observed_at": "2026-10-12T19:44:30Z", "pipeline_version": "2.0.0", "presentation_label": "Posaconazole Accord 100 mg comprimés gastro-résistants", "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": "307cc53ed0048509787bc0b73f2040c678b1df3cc6f8e722f513a205cc3e6baa", "source_snapshot_id": "source-b5de155abfc26fe489dd1b33", "source_updated_at": "2025-05-06", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/posaconazole-accord-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 114}
{"after": {"end": 614, "start": 0, "text": "Le fingolimod est largement distribué dans les tissus corporels, avec un volume de distribution d’environ 1 200 ± 260 litres. Une étude chez quatre volontaires sains ayant reçu une dose intraveineuse unique d’un analogue radiomarqué du fingolimod a montré que le fingolimod pénétrait dans le cerveau. Dans une étude chez 13 patients de sexe masculin atteints de sclérose en plaques ayant reçu du fingolimod 0,5 mg/j, la quantité moyenne de fingolimod (et de phosphate de fingolimod) dans le liquide séminal, à l’état d’équilibre, était approximativement 10 000 fois inférieure à la dose orale administrée (0,5 mg).", "truncated": false}, "after_length": 614, "after_sha256": "065a179b9cc1499f9e4c2e359c3eb6f966c0198b0be0d78e4407b412c836d363", "annex": "I", "before": {"end": 614, "start": 0, "text": "Le fingolimod est largement distribué dans les tissus corporels, avec un volume de distribution d’environ 1 200 ± 260 litres. Une étude chez quatre volontaires sains ayant reçu une dose intraveineuse unique d’un analogue radiomarqué du fingolimod a montré que le fingolimod pénétrait dans le cerveau. Dans une étude chez 13 patients de sexe masculin atteints de sclérose en plaques ayant reçu du fingolimod 0,5 mg/j, la quantité moyenne de fingolimod (et de phosphate de fingolimod) dans le liquide séminal, à l’état d’équilibre, était approximativement 10 000 fois inférieure à la dose orale administrée (0,5 mg).", "truncated": false}, "before_length": 614, "before_sha256": "065a179b9cc1499f9e4c2e359c3eb6f966c0198b0be0d78e4407b412c836d363", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0dfa9073e6f45d37423873f3", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002202", "medicine_name": "Gilenya", "medicine_slug": "gilenya", "observed_at": "2026-10-12T13:30:27Z", "pipeline_version": "2.0.0", "presentation_label": "Gilenya 0,25 mg, gélule Gilenya 0,5 mg, gélule", "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": "83f3661e0a3bbe5c73439ed4ae1f26511ae4bd38a7233fa0d5bdc0d8d330a97e", "source_snapshot_id": "source-dd100ba88d58dedcc7a4d9ed", "source_updated_at": "2026-07-30", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/gilenya-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": 769}
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{"after": {"end": 667, "start": 0, "text": "Sur la base des résultats de l’analyse pharmacocinétique de population, il a été conclu que l’asfotase alfa présente une pharmacocinétique linéaire aux doses allant jusqu’à 28 mg/kg par semaine par voie souscutanée. Le modèle a montré que le poids avait une influence sur la clairance et le volume de distribution de l’asfotase alfa. L’exposition pharmacocinétique devrait augmenter avec le poids. L’effet de l’immunogénicité sur la pharmacocinétique de l’asfotase alfa a varié au cours du temps en raison de la nature variable dans le temps de l’immunogénicité et il a été estimé globalement que les expositions pharmacocinétiques étaient diminuées de moins de 20 %.", "truncated": false}, "after_length": 667, "after_sha256": "c619f68ed0d9738166d731d62bd7e103d41902983fdfd90c0573091eaa6fb953", "annex": "I", "before": {"end": 667, "start": 0, "text": "Sur la base des résultats de l’analyse pharmacocinétique de population, il a été conclu que l’asfotase alfa présente une pharmacocinétique linéaire aux doses allant jusqu’à 28 mg/kg par semaine par voie souscutanée. Le modèle a montré que le poids avait une influence sur la clairance et le volume de distribution de l’asfotase alfa. L’exposition pharmacocinétique devrait augmenter avec le poids. L’effet de l’immunogénicité sur la pharmacocinétique de l’asfotase alfa a varié au cours du temps en raison de la nature variable dans le temps de l’immunogénicité et il a été estimé globalement que les expositions pharmacocinétiques étaient diminuées de moins de 20 %.", "truncated": false}, "before_length": 667, "before_sha256": "c619f68ed0d9738166d731d62bd7e103d41902983fdfd90c0573091eaa6fb953", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0e14f3fdd146249ba0490b10", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003794", "medicine_name": "Strensiq", "medicine_slug": "strensiq", "observed_at": "2026-10-12T13:52:06Z", "pipeline_version": "2.0.0", "presentation_label": "Strensiq 40 mg/ml solution injectable Strensiq 100 mg/ml solution injectable", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "6161d5b8e2abd4c33834351f5f07062f042278ab73aeb30e92df378cfe895d23", "source_snapshot_id": "source-eec4301358a1191a19e95d17", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/strensiq-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": 567}
{"after": {"end": 633, "start": 0, "text": "Height, weight and head circumference were plotted on growth charts (series of percentile curves that illustrate distribution) available from the Centers for Disease Control and Prevention (CDC), USA. A total of 24/69 (35%) patients displayed apparent catch-up height-gain and 32/69 (46%) patients displayed apparent catch-up weight-gain, as shown by movement over time to a higher percentile on CDC growth charts. 40/69 patients and 32/69 patients did not show apparent catch-up gain in height and in weight, respectively. 4 patients did not have enough data to permit judgement and 1 patient could not be determined with certainty.", "truncated": false}, "after_length": 633, "after_sha256": "e202d7a10b93037736b011a06a84d2e6c436b6bfdf30f3a8925048c63cab42fa", "annex": "I", "before": {"end": 633, "start": 0, "text": "Height, weight and head circumference were plotted on growth charts (series of percentile curves that illustrate distribution) available from the Centers for Disease Control and Prevention (CDC), USA. A total of 24/69 (35%) patients displayed apparent catch-up height-gain and 32/69 (46%) patients displayed apparent catch-up weight-gain, as shown by movement over time to a higher percentile on CDC growth charts. 40/69 patients and 32/69 patients did not show apparent catch-up gain in height and in weight, respectively. 4 patients did not have enough data to permit judgement and 1 patient could not be determined with certainty.", "truncated": false}, "before_length": 633, "before_sha256": "e202d7a10b93037736b011a06a84d2e6c436b6bfdf30f3a8925048c63cab42fa", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0e2131cede1ae2ccd4e9c4a8", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003794", "medicine_name": "Strensiq", "medicine_slug": "strensiq", "observed_at": "2026-10-12T13:49:10Z", "pipeline_version": "2.0.0", "presentation_label": "Strensiq 40 mg/ml solution for injection Strensiq 100 mg/ml solution for injection", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "1bb7c73286f57e11c88682980aa6f9ee26ad231f7581e9da57e308f067ba93fb", "source_snapshot_id": "source-f9cee1a032291fa10f55a891", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/strensiq-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": 526}
{"after": {"end": 473, "start": 0, "text": "L’aztréonam n’est pas métabolisé par les enzymes du cytochrome P450. In vitro, l’avibactam n’a montré aucune inhibition significative des enzymes du cytochrome P450 et aucune induction du cytochrome P450 aux concentrations cliniquement pertinentes. L’avibactam n’inhibe pas les principaux transporteurs rénaux ou hépatiques in vitro aux concentrations cliniquement pertinentes. Par conséquent, le potentiel d’interaction médicamenteuse via ces mécanismes est estimé faible.", "truncated": false}, "after_length": 473, "after_sha256": "c85c743bea4244ae779733bfd7c8422f14b47cd037ae320dc3115ba0bbb8e77b", "annex": "I", "before": {"end": 473, "start": 0, "text": "L’aztréonam n’est pas métabolisé par les enzymes du cytochrome P450. In vitro, l’avibactam n’a montré aucune inhibition significative des enzymes du cytochrome P450 et aucune induction du cytochrome P450 aux concentrations cliniquement pertinentes. L’avibactam n’inhibe pas les principaux transporteurs rénaux ou hépatiques in vitro aux concentrations cliniquement pertinentes. Par conséquent, le potentiel d’interaction médicamenteuse via ces mécanismes est estimé faible.", "truncated": false}, "before_length": 473, "before_sha256": "c85c743bea4244ae779733bfd7c8422f14b47cd037ae320dc3115ba0bbb8e77b", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0e38f827756a208d63963276", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006113", "medicine_name": "Emblaveo", "medicine_slug": "emblaveo", "observed_at": "2026-10-12T19:12:01Z", "pipeline_version": "2.0.0", "presentation_label": "Emblaveo 1,5 g/0,5 g, 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": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "2c21d31348fa478f5de5b4a663016755d5452d037826559853c0254f572d415a", "source_snapshot_id": "source-cdaecb76df7734b3152e3f0f", "source_updated_at": "2025-09-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/emblaveo-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": 230}
{"after": {"end": 203, "start": 0, "text": "Pegcetacoplan was not mutagenic when tested in in vitro bacterial reverse mutation (Ames) assays and was not genotoxic in an in vitro assay in human TK6 cells or in an in vivo micronucleus assay in mice.", "truncated": false}, "after_length": 203, "after_sha256": "dae5c7ee976ca64bd39edfec9b9bd7ef05bd7d5163d7303a49cd0fab52f00a6c", "annex": "I", "before": {"end": 203, "start": 0, "text": "Pegcetacoplan was not mutagenic when tested in in vitro bacterial reverse mutation (Ames) assays and was not genotoxic in an in vitro assay in human TK6 cells or in an in vivo micronucleus assay in mice.", "truncated": false}, "before_length": 203, "before_sha256": "dae5c7ee976ca64bd39edfec9b9bd7ef05bd7d5163d7303a49cd0fab52f00a6c", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0e418de7a32926418cd721b8", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005553", "medicine_name": "Aspaveli", "medicine_slug": "aspaveli", "observed_at": "2026-10-12T19:03:44Z", "pipeline_version": "2.0.0", "presentation_label": "ASPAVELI 1 080 mg solution for infusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.3", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "cbb36c4bf3fbb1cb92b778a55d4e26d7afb99f7aaa2b5faa3bcf1c82ba3e82d7", "source_snapshot_id": "source-de59fe9b3c9310d9b2f8606e", "source_updated_at": "2025-11-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/aspaveli-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": 207, "start": 0, "text": "Il faut néanmoins effectuer une rotation des sites d’injection dans une même zone d’injection afin de diminuer le risque de développer une lipodystrophie ou une amyloïdose cutanée (voir rubrique 4.4 et 4.8).", "truncated": false}, "after_length": 207, "after_sha256": "d213bee22e76121ca6dabe944633416e29aadc47847be0fd60ebf25ed2510bc1", "annex": "I", "before": {"end": 207, "start": 0, "text": "Il faut néanmoins effectuer une rotation des sites d’injection dans une même zone d’injection afin de diminuer le risque de développer une lipodystrophie ou une amyloïdose cutanée (voir rubrique 4.4 et 4.8).", "truncated": false}, "before_length": 207, "before_sha256": "d213bee22e76121ca6dabe944633416e29aadc47847be0fd60ebf25ed2510bc1", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0e56abe1620c31c52ab40067", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000309", "medicine_name": "Toujeo (previously Optisulin)", "medicine_slug": "toujeo-previously-optisulin", "observed_at": "2026-10-12T19:30:09Z", "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": "002ed116c467ebd888c93443a95c452e0346312b86945e11ab401f6442cf8402", "source_snapshot_id": "source-4e319ccd719735dc0a35b6f8", "source_updated_at": "2025-07-09", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/toujeo-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": 137}
{"after": {"end": 371, "start": 0, "text": "Administration of asfotase alfa may result in local injection site reactions (including, but not limited to, erythema, rash, discoloration, pruritus, pain, papule, nodule, atrophy) defined as any related adverse event occurring during the injection or until the end of the injection day (see section 4.8). Rotation of injection sites may help to minimize these reactions.", "truncated": false}, "after_length": 371, "after_sha256": "6b1b2b229806028d1c4014378c65ca44d17a8f17ee27909ab279e2d800ff9ef6", "annex": "I", "before": {"end": 371, "start": 0, "text": "Administration of asfotase alfa may result in local injection site reactions (including, but not limited to, erythema, rash, discoloration, pruritus, pain, papule, nodule, atrophy) defined as any related adverse event occurring during the injection or until the end of the injection day (see section 4.8). Rotation of injection sites may help to minimize these reactions.", "truncated": false}, "before_length": 371, "before_sha256": "6b1b2b229806028d1c4014378c65ca44d17a8f17ee27909ab279e2d800ff9ef6", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0e6d9a085d7b4da61710ed94", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/003794", "medicine_name": "Strensiq", "medicine_slug": "strensiq", "observed_at": "2026-10-12T13:49:10Z", "pipeline_version": "2.0.0", "presentation_label": "Strensiq 40 mg/ml solution for injection Strensiq 100 mg/ml solution for injection", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "1bb7c73286f57e11c88682980aa6f9ee26ad231f7581e9da57e308f067ba93fb", "source_snapshot_id": "source-f9cee1a032291fa10f55a891", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/strensiq-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": 323}
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{"after": {"end": 412, "start": 0, "text": "Renal tubular degeneration was observed microscopically in both species at exposures (Cmax and AUC) less than or comparable to those for the human dose and was minimal and nonprogressive between 4 weeks and 9 months of daily administration of pegcetacoplan. Although no overt signs of renal dysfunction were observed in animals, the clinical significance and functional consequence of these findings are unknown.", "truncated": false}, "after_length": 412, "after_sha256": "893256ea118e75451b65cd3469b41e2be3eaac2832912d2e69857d28bdf7dcc7", "annex": "I", "before": {"end": 412, "start": 0, "text": "Renal tubular degeneration was observed microscopically in both species at exposures (Cmax and AUC) less than or comparable to those for the human dose and was minimal and nonprogressive between 4 weeks and 9 months of daily administration of pegcetacoplan. Although no overt signs of renal dysfunction were observed in animals, the clinical significance and functional consequence of these findings are unknown.", "truncated": false}, "before_length": 412, "before_sha256": "893256ea118e75451b65cd3469b41e2be3eaac2832912d2e69857d28bdf7dcc7", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-1405fd6ecb0201e63877f80b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005553", "medicine_name": "Aspaveli", "medicine_slug": "aspaveli", "observed_at": "2026-10-12T19:03:44Z", "pipeline_version": "2.0.0", "presentation_label": "ASPAVELI 1 080 mg solution for infusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.3", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "cbb36c4bf3fbb1cb92b778a55d4e26d7afb99f7aaa2b5faa3bcf1c82ba3e82d7", "source_snapshot_id": "source-de59fe9b3c9310d9b2f8606e", "source_updated_at": "2025-11-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/aspaveli-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": 570}
{"after": {"end": 419, "start": 0, "text": "In pregnant New Zealand White rabbits, early delivery/abortion was observed in two rabbits receiving odevixibat during the period of foetal organogenesis at an exposure multiple of ≥ 2.3 of the anticipated clinical exposure (based on total plasma odevixibat AUC0-24). Reductions in maternal body weight and food consumption were noted in all dose groups (transient at the exposure multiple 1.1 of the anticipated dose).", "truncated": false}, "after_length": 419, "after_sha256": "1a9ca5d4c11972f03208a5f4c4a37b0a4543296b02501cc9268f10d66471b01a", "annex": "I", "before": {"end": 419, "start": 0, "text": "In pregnant New Zealand White rabbits, early delivery/abortion was observed in two rabbits receiving odevixibat during the period of foetal organogenesis at an exposure multiple of ≥ 2.3 of the anticipated clinical exposure (based on total plasma odevixibat AUC0-24). Reductions in maternal body weight and food consumption were noted in all dose groups (transient at the exposure multiple 1.1 of the anticipated dose).", "truncated": false}, "before_length": 419, "before_sha256": "1a9ca5d4c11972f03208a5f4c4a37b0a4543296b02501cc9268f10d66471b01a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-143fa8527f76264698a0f7de", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004691", "medicine_name": "Bylvay", "medicine_slug": "bylvay", "observed_at": "2026-10-12T13:37:52Z", "pipeline_version": "2.0.0", "presentation_label": "Bylvay 200 micrograms hard capsules Bylvay 400 micrograms hard capsules Bylvay 600 micrograms hard capsules Bylvay 1 200 micrograms hard capsules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.3", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "3a21680f2ea7dee4e55919ae65d86e8961d918f20c350fe2fd7e3b43ca47dcac", "source_snapshot_id": "source-c9bc5eeae7a25ae2ec1f2cb9", "source_updated_at": "2026-05-08", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/bylvay-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": 826}
{"after": {"end": 261, "start": 0, "text": "Table 4 presents the results of the comparison of the key efficacy results in Study A4250-005 between odevixibat and placebo. These data are displayed graphically over the 24-week treatment period in Figure 1 (serum bile acids) and Figure 2 (scratching scores).", "truncated": false}, "after_length": 261, "after_sha256": "0275bdaa271f3e6cbc5664f337b327e19be174e287bba77163d1b0bdb5e545fd", "annex": "I", "before": {"end": 261, "start": 0, "text": "Table 4 presents the results of the comparison of the key efficacy results in Study A4250-005 between odevixibat and placebo. These data are displayed graphically over the 24-week treatment period in Figure 1 (serum bile acids) and Figure 2 (scratching scores).", "truncated": false}, "before_length": 261, "before_sha256": "0275bdaa271f3e6cbc5664f337b327e19be174e287bba77163d1b0bdb5e545fd", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-14632975d87b3f2e7078415e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004691", "medicine_name": "Bylvay", "medicine_slug": "bylvay", "observed_at": "2026-10-12T13:37:52Z", "pipeline_version": "2.0.0", "presentation_label": "Bylvay 200 micrograms hard capsules Bylvay 400 micrograms hard capsules Bylvay 600 micrograms hard capsules Bylvay 1 200 micrograms hard capsules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "3a21680f2ea7dee4e55919ae65d86e8961d918f20c350fe2fd7e3b43ca47dcac", "source_snapshot_id": "source-c9bc5eeae7a25ae2ec1f2cb9", "source_updated_at": "2026-05-08", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/bylvay-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": 385}
{"after": {"end": 643, "start": 0, "text": "L’odévixibat est très peu absorbé après administration par voie orale ; les données de biodisponibilité absolue chez l’homme ne sont pas disponibles, et la biodisponibilité relative estimée est < 1 %. Le pic de concentration plasmatique de l’odévixibat (Cmax) est atteint en 1 à 5 heures. Les valeurs de Cmax simulées dans une population de patients pédiatriques atteints de PFIC pour des doses de 40 et 120 μg/kg/jour sont respectivement de 0,211 ng/ml et 0,623 ng/ml, et les valeurs de l’ASC sont respectivement de 2,26 ng × h/ml et de 5,99 ng × h/ml. Une accumulation minimale de l’odévixibat est observée après une dose quotidienne unique.", "truncated": false}, "after_length": 643, "after_sha256": "843f8a4ac175acb9e64f7d103466aef1c000d36b1c3cabfebd76f0dcfeeac927", "annex": "I", "before": {"end": 643, "start": 0, "text": "L’odévixibat est très peu absorbé après administration par voie orale ; les données de biodisponibilité absolue chez l’homme ne sont pas disponibles, et la biodisponibilité relative estimée est < 1 %. Le pic de concentration plasmatique de l’odévixibat (Cmax) est atteint en 1 à 5 heures. Les valeurs de Cmax simulées dans une population de patients pédiatriques atteints de PFIC pour des doses de 40 et 120 μg/kg/jour sont respectivement de 0,211 ng/ml et 0,623 ng/ml, et les valeurs de l’ASC sont respectivement de 2,26 ng × h/ml et de 5,99 ng × h/ml. Une accumulation minimale de l’odévixibat est observée après une dose quotidienne unique.", "truncated": false}, "before_length": 643, "before_sha256": "843f8a4ac175acb9e64f7d103466aef1c000d36b1c3cabfebd76f0dcfeeac927", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-14846751e89cf6903b8e6881", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004691", "medicine_name": "Bylvay", "medicine_slug": "bylvay", "observed_at": "2026-10-12T13:37:55Z", "pipeline_version": "2.0.0", "presentation_label": "Bylvay 200 microgrammes, gélules Bylvay 400 microgrammes, gélules Bylvay 600 microgrammes, gélules Bylvay 1200 microgrammes, gélules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "74cbff6904a88609bf126a1a5d75dd0095dbed08e2ba44afa7255f17700a8f26", "source_snapshot_id": "source-68b1486782aa24b2e1780d1a", "source_updated_at": "2026-05-08", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/bylvay-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": 769}
{"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-14ec0ba3abe5820e856da478", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003794", "medicine_name": "Strensiq", "medicine_slug": "strensiq", "observed_at": "2026-10-12T13:52:06Z", "pipeline_version": "2.0.0", "presentation_label": "Strensiq 40 mg/ml solution injectable Strensiq 100 mg/ml solution injectable", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.6", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "6161d5b8e2abd4c33834351f5f07062f042278ab73aeb30e92df378cfe895d23", "source_snapshot_id": "source-eec4301358a1191a19e95d17", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/strensiq-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": 630}
{"after": {"end": 1500, "start": 0, "text": "L’analyse pharmacocinétique à partir de données issues de toutes les études cliniques a été réalisée par approche de population. Les paramètres pharmacocinétiques caractérisés par l’analyse par approche de population représentent l’ensemble de la population de patients atteints d’hypophosphatasie âgés de 1 jour à 66 ans, avec des doses allant jusqu’à 28 mg/kg/semaine par voie souscutanée et un éventail de cohortes d’âge d’apparition de la maladie. Lors de l’inclusion, 25 % (15 patients sur 60) de la population totale était adulte (âge > 18 ans). La biodisponibilité absolue et la vitesse d’absorption après administration par voie souscutanée ont été estimées à respectivement 0,602 (IC à 95 % : 0,567 ; 0,638) ou 60,2 % et 0,572/jour (IC à 95 % : 0,338 ; 0,967) ou 57,2 %. Les estimations des volumes de distribution centrale et périphérique chez un patient pesant 70 kg étaient de respectivement 5,66 litres (IC à 95 % : 2,76 ; 11,6) et 44,8 litres (IC à 95 % : 33,2 ; 60,5). Les estimations de la clairance à partir des compartiments central et périphérique chez un patient pesant 70 kg étaient de respectivement 15,8 litres/jour (IC à 95 % : 13,2 ; 18,9) et 51,9 litres/jour (IC à 95 % : 44,0 ; 61,2). Les facteurs extrinsèques ayant une influence sur les expositions pharmacocinétiques à l’asfotase alfa étaient la formulation activité spécifique et la teneur totale en acide sialique. Après administration par voie souscutanée, la demivie d’élimination moyenne ± ET était de 2,28 ± 0,58 j", "truncated": true}, "after_length": 1505, "after_sha256": "841f9a7bfac5b66298e474950deb8ef04a6e21c56d844e6a6ddb814531cb620e", "annex": "I", "before": {"end": 1500, "start": 0, "text": "L’analyse pharmacocinétique à partir de données issues de toutes les études cliniques a été réalisée par approche de population. Les paramètres pharmacocinétiques caractérisés par l’analyse par approche de population représentent l’ensemble de la population de patients atteints d’hypophosphatasie âgés de 1 jour à 66 ans, avec des doses allant jusqu’à 28 mg/kg/semaine par voie souscutanée et un éventail de cohortes d’âge d’apparition de la maladie. Lors de l’inclusion, 25 % (15 patients sur 60) de la population totale était adulte (âge > 18 ans). La biodisponibilité absolue et la vitesse d’absorption après administration par voie souscutanée ont été estimées à respectivement 0,602 (IC à 95 % : 0,567 ; 0,638) ou 60,2 % et 0,572/jour (IC à 95 % : 0,338 ; 0,967) ou 57,2 %. Les estimations des volumes de distribution centrale et périphérique chez un patient pesant 70 kg étaient de respectivement 5,66 litres (IC à 95 % : 2,76 ; 11,6) et 44,8 litres (IC à 95 % : 33,2 ; 60,5). Les estimations de la clairance à partir des compartiments central et périphérique chez un patient pesant 70 kg étaient de respectivement 15,8 litres/jour (IC à 95 % : 13,2 ; 18,9) et 51,9 litres/jour (IC à 95 % : 44,0 ; 61,2). Les facteurs extrinsèques ayant une influence sur les expositions pharmacocinétiques à l’asfotase alfa étaient la formulation activité spécifique et la teneur totale en acide sialique. Après administration par voie souscutanée, la demivie d’élimination moyenne ± ET était de 2,28 ± 0,58 j", "truncated": true}, "before_length": 1505, "before_sha256": "841f9a7bfac5b66298e474950deb8ef04a6e21c56d844e6a6ddb814531cb620e", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-151ab446b7fb7e6299a87989", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003794", "medicine_name": "Strensiq", "medicine_slug": "strensiq", "observed_at": "2026-10-12T13:52:06Z", "pipeline_version": "2.0.0", "presentation_label": "Strensiq 40 mg/ml solution injectable Strensiq 100 mg/ml solution injectable", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "6161d5b8e2abd4c33834351f5f07062f042278ab73aeb30e92df378cfe895d23", "source_snapshot_id": "source-eec4301358a1191a19e95d17", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/strensiq-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 562}
{"after": {"end": 409, "start": 0, "text": "L’utilisation de l’aztréonam-avibactam pour traiter les patients atteints d’IIAc, de PN, notamment PAVM, et d’IVUc, notamment pyélonéphrite, est basée sur l’expérience acquise avec l’aztréonam en monothérapie, sur les analyses pharmacocinétiques et pharmacodynamiques de l’aztréonam-avibactam et sur les données limitées de l’étude clinique randomisée menée sur 422 adultes présentant des IIAc ou des PN/PAVM.", "truncated": false}, "after_length": 409, "after_sha256": "f2591412b58f656bab25ea28a7a518b1f5336700d35cad5b0944180b56907ff6", "annex": "I", "before": {"end": 409, "start": 0, "text": "L’utilisation de l’aztréonam-avibactam pour traiter les patients atteints d’IIAc, de PN, notamment PAVM, et d’IVUc, notamment pyélonéphrite, est basée sur l’expérience acquise avec l’aztréonam en monothérapie, sur les analyses pharmacocinétiques et pharmacodynamiques de l’aztréonam-avibactam et sur les données limitées de l’étude clinique randomisée menée sur 422 adultes présentant des IIAc ou des PN/PAVM.", "truncated": false}, "before_length": 409, "before_sha256": "f2591412b58f656bab25ea28a7a518b1f5336700d35cad5b0944180b56907ff6", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-155e3c738422e947db7f9d5c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006113", "medicine_name": "Emblaveo", "medicine_slug": "emblaveo", "observed_at": "2026-10-12T19:12:01Z", "pipeline_version": "2.0.0", "presentation_label": "Emblaveo 1,5 g/0,5 g, 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": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "2c21d31348fa478f5de5b4a663016755d5452d037826559853c0254f572d415a", "source_snapshot_id": "source-cdaecb76df7734b3152e3f0f", "source_updated_at": "2025-09-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/emblaveo-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": 195}
{"after": {"end": 759, "start": 0, "text": "L’utilisation de l’aztréonam-avibactam pour traiter les infections dues à des bactéries aérobies à Gram négatif chez les patients dont les options thérapeutiques sont limitées est basée sur l’analyse pharmacocinétique/pharmacodynamique de l’aztréonamavibactam et sur les données limitées de l’étude clinique randomisée menée sur 422 adultes présentant des IIAc ou des PN/PAVM (dont 17 patients présentant des infections dues à des bactéries résistantes aux carbapénèmes [résistantes au méropénème] ont été traités par Emblaveo), et l’étude clinique randomisée menée sur 15 adultes (dont 12 patients ont été traités par Emblaveo) présentant des infections graves dues à des bactéries à Gram négatif productrices de métalloβlactamases (MBL) (voir rubrique 5.1).", "truncated": false}, "after_length": 759, "after_sha256": "bb72aed9f4b65da0fa07bc0d3946d4aef0bcaf5420c5e8bb27ba3af75cd04575", "annex": "I", "before": {"end": 759, "start": 0, "text": "L’utilisation de l’aztréonam-avibactam pour traiter les infections dues à des bactéries aérobies à Gram négatif chez les patients dont les options thérapeutiques sont limitées est basée sur l’analyse pharmacocinétique/pharmacodynamique de l’aztréonamavibactam et sur les données limitées de l’étude clinique randomisée menée sur 422 adultes présentant des IIAc ou des PN/PAVM (dont 17 patients présentant des infections dues à des bactéries résistantes aux carbapénèmes [résistantes au méropénème] ont été traités par Emblaveo), et l’étude clinique randomisée menée sur 15 adultes (dont 12 patients ont été traités par Emblaveo) présentant des infections graves dues à des bactéries à Gram négatif productrices de métalloβlactamases (MBL) (voir rubrique 5.1).", "truncated": false}, "before_length": 759, "before_sha256": "bb72aed9f4b65da0fa07bc0d3946d4aef0bcaf5420c5e8bb27ba3af75cd04575", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-1595d7340e889eddba4e9534", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006113", "medicine_name": "Emblaveo", "medicine_slug": "emblaveo", "observed_at": "2026-10-12T19:12:01Z", "pipeline_version": "2.0.0", "presentation_label": "Emblaveo 1,5 g/0,5 g, 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": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "2c21d31348fa478f5de5b4a663016755d5452d037826559853c0254f572d415a", "source_snapshot_id": "source-cdaecb76df7734b3152e3f0f", "source_updated_at": "2025-09-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/emblaveo-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": 197}
{"after": {"end": 78, "start": 0, "text": "Les volumes de remplissage des flacons sont : 0,3 ml, 0,45 ml, 0,7 ml et 1 ml.", "truncated": false}, "after_length": 78, "after_sha256": "6c7ed156804fd9730955ab77880f2fd16e31a5af920854c23380e62848336ad0", "annex": "I", "before": {"end": 78, "start": 0, "text": "Les volumes de remplissage des flacons sont : 0,3 ml, 0,45 ml, 0,7 ml et 1 ml.", "truncated": false}, "before_length": 78, "before_sha256": "6c7ed156804fd9730955ab77880f2fd16e31a5af920854c23380e62848336ad0", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-15c98548f471be6a2547566e", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003794", "medicine_name": "Strensiq", "medicine_slug": "strensiq", "observed_at": "2026-10-12T13:52:06Z", "pipeline_version": "2.0.0", "presentation_label": "Strensiq 40 mg/ml solution injectable Strensiq 100 mg/ml solution injectable", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "6.5", "section_type": "quality_presentation", "source_provider": "European Medicines Agency", "source_sha256": "6161d5b8e2abd4c33834351f5f07062f042278ab73aeb30e92df378cfe895d23", "source_snapshot_id": "source-eec4301358a1191a19e95d17", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/strensiq-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": 615}
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{"after": {"end": 946, "start": 0, "text": "Au cours des études cliniques réalisées avec l’asfotase alfa, des cas de calcification oculaire (conjonctivale et cornéenne) et de néphrocalcinose ont été rapportés chez des patients atteints d’hypophosphatasie. Il n’existe pas de données suffisantes pour établir une relation causale entre l’exposition à l’asfotase alfa et les calcifications ectopiques. Les calcifications oculaires (conjonctivales et cornéennes) et la néphrocalcinose sont des manifestations de l’hypophosphatasie documentées dans la littérature publiée. Dans une étude de l’histoire naturelle de la maladie chez des patients non traités atteints de la forme infantile de l’hypophosphatasie, une néphrocalcinose a été observée chez 51,6 % des patients entre la naissance et l’âge de 5 ans. Il est recommandé de réaliser un examen ophtalmologique et une échographie rénale avant le début du traitement puis à intervalles réguliers chez les patients atteints d’hypophosphatasie.", "truncated": false}, "after_length": 946, "after_sha256": "d319e2ba652d46967bdbc45f76803d91a6f4e3803a2868ba8e4cf15e01c26c0e", "annex": "I", "before": {"end": 946, "start": 0, "text": "Au cours des études cliniques réalisées avec l’asfotase alfa, des cas de calcification oculaire (conjonctivale et cornéenne) et de néphrocalcinose ont été rapportés chez des patients atteints d’hypophosphatasie. Il n’existe pas de données suffisantes pour établir une relation causale entre l’exposition à l’asfotase alfa et les calcifications ectopiques. Les calcifications oculaires (conjonctivales et cornéennes) et la néphrocalcinose sont des manifestations de l’hypophosphatasie documentées dans la littérature publiée. Dans une étude de l’histoire naturelle de la maladie chez des patients non traités atteints de la forme infantile de l’hypophosphatasie, une néphrocalcinose a été observée chez 51,6 % des patients entre la naissance et l’âge de 5 ans. Il est recommandé de réaliser un examen ophtalmologique et une échographie rénale avant le début du traitement puis à intervalles réguliers chez les patients atteints d’hypophosphatasie.", "truncated": false}, "before_length": 946, "before_sha256": "d319e2ba652d46967bdbc45f76803d91a6f4e3803a2868ba8e4cf15e01c26c0e", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-15fdfdbe428e19f6b1007e9d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003794", "medicine_name": "Strensiq", "medicine_slug": "strensiq", "observed_at": "2026-10-12T13:52:06Z", "pipeline_version": "2.0.0", "presentation_label": "Strensiq 40 mg/ml solution injectable Strensiq 100 mg/ml solution injectable", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "6161d5b8e2abd4c33834351f5f07062f042278ab73aeb30e92df378cfe895d23", "source_snapshot_id": "source-eec4301358a1191a19e95d17", "source_updated_at": "2026-03-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/strensiq-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": 338}
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