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{"after": {"end": 419, "start": 0, "text": "Following the administration of 24 mg/m2 (maximum of 40 mg) subcutaneously every other week to patients with polyarticular juvenile idiopathic arthritis (JIA) who were 4 to 17 years the mean trough steady-state (values measured from Week 20 to 48) serum adalimumab concentration was 5.6 ± 5.6 µg/ml (102% CV) for adalimumab without concomitant methotrexate and 10.9 ± 5.2 µg/ml (47.7% CV) with concomitant methotrexate.", "truncated": false}, "after_length": 419, "after_sha256": "8f3e9dc806b3f3fa03621497ba6254b3d1ce7a57b6c9c8c8969e40f489df60a0", "annex": "I", "before": {"end": 419, "start": 0, "text": "Following the administration of 24 mg/m2 (maximum of 40 mg) subcutaneously every other week to patients with polyarticular juvenile idiopathic arthritis (JIA) who were 4 to 17 years the mean trough steady-state (values measured from Week 20 to 48) serum adalimumab concentration was 5.6 ± 5.6 µg/ml (102% CV) for adalimumab without concomitant methotrexate and 10.9 ± 5.2 µg/ml (47.7% CV) with concomitant methotrexate.", "truncated": false}, "before_length": 419, "before_sha256": "8f3e9dc806b3f3fa03621497ba6254b3d1ce7a57b6c9c8c8969e40f489df60a0", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-003cdbb8571de45d973c84f1", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000481", "medicine_name": "Humira", "medicine_slug": "humira", "observed_at": "2026-10-12T19:05:51Z", "pipeline_version": "2.0.0", "presentation_label": "Humira 40 mg solution for injection in pre-filled syringe Humira 40 mg solution for injection in pre-filled pen", "presentation_occurrence": 4, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "0ecf37e08cb0de31151fecc637d8f3d6baf2f44a169e36dd20e9e3f3d348320c", "source_snapshot_id": "source-7f08b7886dbefa50c9bbf715", "source_updated_at": "2025-10-08", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/humira-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": 9073}
{"after": {"end": 925, "start": 0, "text": "La clairance médiane systémique (Cl) après administration unique en intraveineuse à des patients présentant un psoriasis était comprise entre 1,99 et 2,34 mL/jour/kg. La demi-vie médiane (t1/2) de l’ustekinumab était d’environ 3 semaines chez les patients présentant un psoriasis, un rhumatisme psoriasique, une maladie de Crohn variant de 15 à 32 jours sur l’ensemble des études ustekinumab réalisées dans le psoriasis et le rhumatisme psoriasique. Dans une analyse pharmacocinétique de population, la clairance apparente (Cl/F) et le volume de distribution apparent (V/F) étaient respectivement de 0,465 L/jour et de 15,7 L chez des patients présentant un psoriasis. La Cl/F de l’ustekinumab n’était pas influencée par le sexe. L’analyse pharmacocinétique de population a montré qu’il y avait une tendance vers une plus grande clairance de l’ustekinumab chez les patients testés positivement aux anticorps anti-ustekinumab.", "truncated": false}, "after_length": 925, "after_sha256": "0e0721e3c65f23da21adc48ff2bc8e040615bdf6e1d999651785914970c714af", "annex": "I", "before": {"end": 925, "start": 0, "text": "La clairance médiane systémique (Cl) après administration unique en intraveineuse à des patients présentant un psoriasis était comprise entre 1,99 et 2,34 mL/jour/kg. La demi-vie médiane (t1/2) de l’ustekinumab était d’environ 3 semaines chez les patients présentant un psoriasis, un rhumatisme psoriasique, une maladie de Crohn variant de 15 à 32 jours sur l’ensemble des études ustekinumab réalisées dans le psoriasis et le rhumatisme psoriasique. Dans une analyse pharmacocinétique de population, la clairance apparente (Cl/F) et le volume de distribution apparent (V/F) étaient respectivement de 0,465 L/jour et de 15,7 L chez des patients présentant un psoriasis. La Cl/F de l’ustekinumab n’était pas influencée par le sexe. L’analyse pharmacocinétique de population a montré qu’il y avait une tendance vers une plus grande clairance de l’ustekinumab chez les patients testés positivement aux anticorps anti-ustekinumab.", "truncated": false}, "before_length": 925, "before_sha256": "0e0721e3c65f23da21adc48ff2bc8e040615bdf6e1d999651785914970c714af", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-004224c198c60843b85602e9", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006444", "medicine_name": "Yesintek", "medicine_slug": "yesintek", "observed_at": "2026-10-12T19:01:45Z", "pipeline_version": "2.0.0", "presentation_label": "Yesintek 45 mg solution injectable en stylo prérempli Yesintek 90 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": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "8c2b3e8345d1587a65069bc2ed38a32860a843ac07d78bef733b8e208f95a8f7", "source_snapshot_id": "source-e6cadd30a86c6c9b1c0915b2", "source_updated_at": "2026-02-16", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/yesintek-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": 2701}
{"after": {"end": 317, "start": 0, "text": "Les résultats de l’étude, avec gel des données le 1er décembre 2016, dans laquelle la durée médiane de suivi de l’ensemble des patients en vie était de 69,0 mois, sont présentés dans le tableau 8. Le bénéfice en faveur de l’association RVd a été observé quelle que soit l’éligibilité à une greffe de cellules souches.", "truncated": false}, "after_length": 317, "after_sha256": "6b69b932950f99030c71a22f8cc77ee68a58203c9380047810ae137933e2c878", "annex": "I", "before": {"end": 317, "start": 0, "text": "Les résultats de l’étude, avec gel des données le 1er décembre 2016, dans laquelle la durée médiane de suivi de l’ensemble des patients en vie était de 69,0 mois, sont présentés dans le tableau 8. Le bénéfice en faveur de l’association RVd a été observé quelle que soit l’éligibilité à une greffe de cellules souches.", "truncated": false}, "before_length": 317, "before_sha256": "6b69b932950f99030c71a22f8cc77ee68a58203c9380047810ae137933e2c878", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0043dad6be78b2b380daa62d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005306", "medicine_name": "Lenalidomide Mylan", "medicine_slug": "lenalidomide-mylan", "observed_at": "2026-10-12T13:36:00Z", "pipeline_version": "2.0.0", "presentation_label": "Lénalidomide Mylan 2,5 mg gélules Lénalidomide Mylan 5 mg gélules Lénalidomide Mylan 7,5 mg gélules Lénalidomide Mylan 10 mg gélules Lénalidomide Mylan 15 mg gélules Lénalidomide Mylan 20 mg gélules Lénalidomide Mylan 25 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": "284a211ae1e378772905f47f912ad76e2359aedbb04aefb942aeab3dde51b7fd", "source_snapshot_id": "source-eaab20b66f37ed2a83bf6050", "source_updated_at": "2026-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/lenalidomide-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": 2035}
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{"after": {"end": 857, "start": 0, "text": "L’induction d’une rémission clinique (définie par un indice CDAI < 150) a été évaluée dans deux études, l’étude I sur la MC (CLASSIC I) et l’étude II sur la MC (GAIN). Dans l’étude I sur la MC, 299 patients non précédemment traités par un anti-TNF ont été randomisés vers l’un des quatre groupes de traitement de l’étude ; placebo aux semaines 0 et 2, 160 mg d’Humira à la semaine 0 et 80 mg à la semaine 2, 80 mg à la semaine 0 et 40 mg à la semaine 2, et 40 mg à la semaine 0 et 20 mg à la semaine 2. Dans l’étude II sur la MC, 325 patients ne répondant plus ou étant intolérants à l’infliximab ont été randomisés pour recevoir soit 160 mg d’Humira à la semaine 0 et 80 mg à la semaine 2 soit un placebo aux semaines 0 et 2. Les non-répondeurs primaires ont été exclus des études et ces patients n’ont par conséquent pas fait l’objet d’autres évaluations.", "truncated": false}, "after_length": 857, "after_sha256": "20aab2f93fbd72996ec88f0200826848b7e79c4925e4144dfff1fdd4ee93dc86", "annex": "I", "before": {"end": 857, "start": 0, "text": "L’induction d’une rémission clinique (définie par un indice CDAI < 150) a été évaluée dans deux études, l’étude I sur la MC (CLASSIC I) et l’étude II sur la MC (GAIN). Dans l’étude I sur la MC, 299 patients non précédemment traités par un anti-TNF ont été randomisés vers l’un des quatre groupes de traitement de l’étude ; placebo aux semaines 0 et 2, 160 mg d’Humira à la semaine 0 et 80 mg à la semaine 2, 80 mg à la semaine 0 et 40 mg à la semaine 2, et 40 mg à la semaine 0 et 20 mg à la semaine 2. Dans l’étude II sur la MC, 325 patients ne répondant plus ou étant intolérants à l’infliximab ont été randomisés pour recevoir soit 160 mg d’Humira à la semaine 0 et 80 mg à la semaine 2 soit un placebo aux semaines 0 et 2. Les non-répondeurs primaires ont été exclus des études et ces patients n’ont par conséquent pas fait l’objet d’autres évaluations.", "truncated": false}, "before_length": 857, "before_sha256": "20aab2f93fbd72996ec88f0200826848b7e79c4925e4144dfff1fdd4ee93dc86", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0050fdd881ae0628db84ff85", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000481", "medicine_name": "Humira", "medicine_slug": "humira", "observed_at": "2026-10-12T19:05:58Z", "pipeline_version": "2.0.0", "presentation_label": "Humira 40 mg, solution injectable en seringue préremplie. Humira 40 mg, solution injectable en stylo prérempli.", "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": "838fa74d683105747766f79fbda32abdc6ca30a43c391bf9460c7303fb89a72d", "source_snapshot_id": "source-3be20854841dd8e6b1c05116", "source_updated_at": "2025-10-08", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/humira-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": 8409}
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{"after": {"end": 257, "start": 0, "text": "Des troubles du transit œsophagien et des inhalations du contenu gastrique ont été associés à l’utilisation d’ antipsychotiques, y compris l’aripiprazole. L’aripiprazole doit être utilisé avec prudence chez les patients à risque de pneumonie de déglutition.", "truncated": false}, "after_length": 257, "after_sha256": "028d642ab8d69d4111716d200a6b0dc771b6fa67191e65790c0c39d06fe05729", "annex": "I", "before": {"end": 257, "start": 0, "text": "Des troubles du transit œsophagien et des inhalations du contenu gastrique ont été associés à l’utilisation d’ antipsychotiques, y compris l’aripiprazole. L’aripiprazole doit être utilisé avec prudence chez les patients à risque de pneumonie de déglutition.", "truncated": false}, "before_length": 257, "before_sha256": "028d642ab8d69d4111716d200a6b0dc771b6fa67191e65790c0c39d06fe05729", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00b2975aa0f735d5d88a75d3", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003899", "medicine_name": "Aripiprazole Zentiva", "medicine_slug": "aripiprazole-zentiva", "observed_at": "2026-10-12T19:23:51Z", "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": "cbf2c8130eb0ea37140be1863f353578bd31b1aca62c69d84c430b16cc285999", "source_snapshot_id": "source-8445bbafd6717edf20828f78", "source_updated_at": "2025-07-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/aripiprazole-zentiva-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": 238}
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{"after": {"end": 219, "start": 0, "text": "The median time to first response of CR or CRi was 1.3 months (range: 0.6 to 9.9 months) with venetoclax + azacitidine treatment. The median time to best response of CR or CRi was 2.3 months (range: 0.6 to 24.5 months).", "truncated": false}, "after_length": 219, "after_sha256": "d1bab27866b39920093d3450b9165d69b9c776661ebf30679b0cd7259d7fb89d", "annex": "I", "before": {"end": 219, "start": 0, "text": "The median time to first response of CR or CRi was 1.3 months (range: 0.6 to 9.9 months) with venetoclax + azacitidine treatment. The median time to best response of CR or CRi was 2.3 months (range: 0.6 to 24.5 months).", "truncated": false}, "before_length": 219, "before_sha256": "d1bab27866b39920093d3450b9165d69b9c776661ebf30679b0cd7259d7fb89d", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00ea64d4e0d2d2835989d38d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004106", "medicine_name": "Venclyxto", "medicine_slug": "venclyxto", "observed_at": "2026-10-12T13:33:36Z", "pipeline_version": "2.0.0", "presentation_label": "Venclyxto 10 mg filmcoated tablets Venclyxto 50 mg filmcoated tablets Venclyxto 100 mg filmcoated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "cb909b1e026c92fa2c7a68aafb5af7a7a6dc62c5e45faa62a526c1c85bfd9f82", "source_snapshot_id": "source-dd55abaf2041fe4e618fed75", "source_updated_at": "2026-07-08", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/venclyxto-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": 1754}
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{"after": {"end": 1092, "start": 0, "text": "Dans l’étude REACH, 112 patients (de 6 à 17 ans, âge médian de 13,0 ans) atteints de maladie de Crohn active, modérée à sévère (PCDAI médian de 40) et ayant eu une réponse inadéquate aux thérapies conventionnelles ont reçu 5 mg/kg d’infliximab aux semaines 0, 2 et 6. Tous les patients devaient être sous une dose stable de 6MP, AZA ou MTX (35 % ont reçu également des corticoïdes à l’inclusion). Les patients répondeurs cliniquement à la semaine 10, évalués par l’investigateur, ont été randomisés et ont reçu 5 mg/kg d’infliximab soit toutes les 8 semaines, soit toutes les 12 semaines en traitement d’entretien. En cas de perte de réponse au cours du traitement d’entretien, le passage à une dose plus élevée (10 mg/kg) et/ou à un intervalle plus court entre chaque dose (toutes les 8 semaines) était autorisé. Trente-deux (32) enfants évaluables ont changé de régime (9 sujets dans le groupe d’entretien toutes les 8 semaines et 23 sujets dans le groupe d’entretien toutes les 12 semaines). Vingt-quatre de ces patients (75,0 %) ont retrouvé une réponse clinique après cette modification.", "truncated": false}, "after_length": 1092, "after_sha256": "28a60f449fa39758e200bbe450509d275b3af10db15a7f3e074116e89ecfd0c8", "annex": "I", "before": {"end": 1092, "start": 0, "text": "Dans l’étude REACH, 112 patients (de 6 à 17 ans, âge médian de 13,0 ans) atteints de maladie de Crohn active, modérée à sévère (PCDAI médian de 40) et ayant eu une réponse inadéquate aux thérapies conventionnelles ont reçu 5 mg/kg d’infliximab aux semaines 0, 2 et 6. Tous les patients devaient être sous une dose stable de 6MP, AZA ou MTX (35 % ont reçu également des corticoïdes à l’inclusion). Les patients répondeurs cliniquement à la semaine 10, évalués par l’investigateur, ont été randomisés et ont reçu 5 mg/kg d’infliximab soit toutes les 8 semaines, soit toutes les 12 semaines en traitement d’entretien. En cas de perte de réponse au cours du traitement d’entretien, le passage à une dose plus élevée (10 mg/kg) et/ou à un intervalle plus court entre chaque dose (toutes les 8 semaines) était autorisé. Trente-deux (32) enfants évaluables ont changé de régime (9 sujets dans le groupe d’entretien toutes les 8 semaines et 23 sujets dans le groupe d’entretien toutes les 12 semaines). Vingt-quatre de ces patients (75,0 %) ont retrouvé une réponse clinique après cette modification.", "truncated": false}, "before_length": 1092, "before_sha256": "28a60f449fa39758e200bbe450509d275b3af10db15a7f3e074116e89ecfd0c8", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-00f6dc11bf011733c45226c6", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002576", "medicine_name": "Remsima", "medicine_slug": "remsima", "observed_at": "2026-10-12T13:38:34Z", "pipeline_version": "2.0.0", "presentation_label": "Remsima 40 mg/mL, solution à diluer pour perfusion", "presentation_occurrence": 3, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "81284f9e87a57aa2b4bb159ee98e1cea5423cbaa00905564e50cc56c9e14fc81", "source_snapshot_id": "source-69612ad0a7130272ef80a0bb", "source_updated_at": "2026-05-08", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/remsima-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": 4722}
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{"after": {"end": 59, "start": 0, "text": "# Algorithme utilisé pour les syndromes myélodysplasiques :", "truncated": false}, "after_length": 59, "after_sha256": "14b09895844290a2fb15a46c3627d69f422163d546c43f40b6672abde01869b7", "annex": "I", "before": {"end": 59, "start": 0, "text": "# Algorithme utilisé pour les syndromes myélodysplasiques :", "truncated": false}, "before_length": 59, "before_sha256": "14b09895844290a2fb15a46c3627d69f422163d546c43f40b6672abde01869b7", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-016381c247971683b1bbcc54", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000717", "medicine_name": "Revlimid", "medicine_slug": "revlimid", "observed_at": "2026-10-12T19:29:57Z", "pipeline_version": "2.0.0", "presentation_label": "Revlimid 2,5 mg gélules Revlimid 5 mg gélules Revlimid 7,5 mg gélules Revlimid 10 mg gélules Revlimid 15 mg gélules Revlimid 20 mg gélules Revlimid 25 mg gélules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "94529922a4f5049c4aa605847cb25208bea7e5a83a59f86fd84cc98c3c0e4e42", "source_snapshot_id": "source-021cd364629616c7e21a924d", "source_updated_at": "2025-07-10", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/revlimid-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": 1508}
{"after": {"end": 534, "start": 0, "text": "Carriers of HBV who require treatment with Humira should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy. Adequate data from treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF-antagonist therapy to prevent HBV reactivation are not available. In patients who develop HBV reactivation, Humira should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.", "truncated": false}, "after_length": 534, "after_sha256": "468dcaf1b003657557862bc8eca43904e0f2a9c6b20f65851b9e6fca2becf727", "annex": "I", "before": {"end": 534, "start": 0, "text": "Carriers of HBV who require treatment with Humira should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy. Adequate data from treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF-antagonist therapy to prevent HBV reactivation are not available. In patients who develop HBV reactivation, Humira should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.", "truncated": false}, "before_length": 534, "before_sha256": "468dcaf1b003657557862bc8eca43904e0f2a9c6b20f65851b9e6fca2becf727", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-016957e6a5daf81224e7719d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000481", "medicine_name": "Humira", "medicine_slug": "humira", "observed_at": "2026-10-12T19:05:51Z", "pipeline_version": "2.0.0", "presentation_label": "Humira 80 mg solution for injection in pre-filled syringe Humira 80 mg solution for injection in pre-filled 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": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "0ecf37e08cb0de31151fecc637d8f3d6baf2f44a169e36dd20e9e3f3d348320c", "source_snapshot_id": "source-7f08b7886dbefa50c9bbf715", "source_updated_at": "2025-10-08", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/humira-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": 9540}
{"after": {"end": 105, "start": 0, "text": "Table 4. ADRs reported in clinical trials in patients with mantle cell lymphoma treated with lenalidomide", "truncated": false}, "after_length": 105, "after_sha256": "49bf4ae7f670a98b6ca6fa483381849b5dea7343d6a2f5e262dc6b786262d5c8", "annex": "I", "before": {"end": 105, "start": 0, "text": "Table 4. ADRs reported in clinical trials in patients with mantle cell lymphoma treated with lenalidomide", "truncated": false}, "before_length": 105, "before_sha256": "49bf4ae7f670a98b6ca6fa483381849b5dea7343d6a2f5e262dc6b786262d5c8", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-016d5aaec86da630fa7baecc", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000717", "medicine_name": "Revlimid", "medicine_slug": "revlimid", "observed_at": "2026-10-12T19:29:54Z", "pipeline_version": "2.0.0", "presentation_label": "Revlimid 2.5 mg hard capsules Revlimid 5 mg hard capsules Revlimid 7.5 mg hard capsules Revlimid 10 mg hard capsules Revlimid 15 mg hard capsules Revlimid 20 mg hard capsules Revlimid 25 mg hard capsules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "276ea93100d5a4dfdad67b04cdb787ef956a8cf71e36b5e9df2e29166b273428", "source_snapshot_id": "source-2125a3aad9630138398a9468", "source_updated_at": "2025-07-10", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/revlimid-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": 1517}
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{"after": {"end": 725, "start": 0, "text": "The safety and efficacy of infliximab were assessed in two (ACT 1 and ACT 2) randomised, doubleblind, placebocontrolled clinical studies in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12; Endoscopy subscore ≥2) with an inadequate response to conventional therapies [oral corticosteroids, aminosalicylates and/or immunomodulators (6MP, AZA)]. Concomitant stable doses of oral aminosalicylates, corticosteroids, and/or immunomodulatory agents were permitted. In both studies, patients were randomised to receive either placebo, 5 mg/kg infliximab, or 10 mg/kg infliximab at weeks 0, 2, 6, 14 and 22, and in ACT 1 at weeks 30, 38 and 46. Corticosteroid taper was permitted after week 8.", "truncated": false}, "after_length": 725, "after_sha256": "efcdb6af8b732ab1b71c4a43e2e8b74bd26d9b2a740cb37a901303b8640c2fb6", "annex": "I", "before": {"end": 725, "start": 0, "text": "The safety and efficacy of infliximab were assessed in two (ACT 1 and ACT 2) randomised, doubleblind, placebocontrolled clinical studies in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12; Endoscopy subscore ≥2) with an inadequate response to conventional therapies [oral corticosteroids, aminosalicylates and/or immunomodulators (6MP, AZA)]. Concomitant stable doses of oral aminosalicylates, corticosteroids, and/or immunomodulatory agents were permitted. In both studies, patients were randomised to receive either placebo, 5 mg/kg infliximab, or 10 mg/kg infliximab at weeks 0, 2, 6, 14 and 22, and in ACT 1 at weeks 30, 38 and 46. Corticosteroid taper was permitted after week 8.", "truncated": false}, "before_length": 725, "before_sha256": "efcdb6af8b732ab1b71c4a43e2e8b74bd26d9b2a740cb37a901303b8640c2fb6", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0174164fea4c4cdf72f3f488", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002576", "medicine_name": "Remsima", "medicine_slug": "remsima", "observed_at": "2026-10-12T13:37:58Z", "pipeline_version": "2.0.0", "presentation_label": "Remsima 40 mg/mL concentrate for solution for infusion", "presentation_occurrence": 3, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "27bfb864f98f7738217c7e9f79f4efc6d3f2f4fd07bff1d83fcc454a50626dee", "source_snapshot_id": "source-d0ae0bf14568ab5adf79e44a", "source_updated_at": "2026-05-08", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/remsima-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": 4455}
{"after": {"end": 556, "start": 0, "text": "Dans l’essai CANVAS, les sujets ont été randomisés selon un rapport de 1:1:1 vers la canagliflozine 100 mg, la canagliflozine 300 mg ou un placebo correspondant. Dans l’essai CANVAS-R, les sujets ont été randomisés selon un rapport de 1:1 vers la canagliflozine 100 mg ou un placebo correspondant et une titration à 300 mg a été autorisée (en fonction de la tolérance et des besoins glycémiques) après la Semaine 13. Les traitements antidiabétiques et de l’athérosclérose concomitants ont pu être ajustés, selon la prise en charge standard de ces maladies.", "truncated": false}, "after_length": 556, "after_sha256": "f4d01211ff3f835c4b8cba155309a1f5569ca477ab5313ffa4081986be2dff6f", "annex": "I", "before": {"end": 556, "start": 0, "text": "Dans l’essai CANVAS, les sujets ont été randomisés selon un rapport de 1:1:1 vers la canagliflozine 100 mg, la canagliflozine 300 mg ou un placebo correspondant. Dans l’essai CANVAS-R, les sujets ont été randomisés selon un rapport de 1:1 vers la canagliflozine 100 mg ou un placebo correspondant et une titration à 300 mg a été autorisée (en fonction de la tolérance et des besoins glycémiques) après la Semaine 13. Les traitements antidiabétiques et de l’athérosclérose concomitants ont pu être ajustés, selon la prise en charge standard de ces maladies.", "truncated": false}, "before_length": 556, "before_sha256": "f4d01211ff3f835c4b8cba155309a1f5569ca477ab5313ffa4081986be2dff6f", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0176623cd77e798a12f51490", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002649", "medicine_name": "Invokana", "medicine_slug": "invokana", "observed_at": "2026-10-12T17:27:36Z", "pipeline_version": "2.0.0", "presentation_label": "Invokana 100 mg comprimés pelliculés Invokana 300 mg comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "5e753bb354983730f0789cadcbccb124df947f5b77daf5d446e1d52f45e8b1fe", "source_snapshot_id": "source-195756913629ec5e8a28f5e1", "source_updated_at": "2025-12-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/invokana-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": 1009}
{"after": {"end": 305, "start": 0, "text": "Lenalidomide Mylan as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.", "truncated": false}, "after_length": 305, "after_sha256": "749319281dcc814fd6a6da2425d14cefadf295ed141534117ab89d3d94aea667", "annex": "I", "before": {"end": 305, "start": 0, "text": "Lenalidomide Mylan as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.", "truncated": false}, "before_length": 305, "before_sha256": "749319281dcc814fd6a6da2425d14cefadf295ed141534117ab89d3d94aea667", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-017fb51cbb15997aa6999488", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005306", "medicine_name": "Lenalidomide Mylan", "medicine_slug": "lenalidomide-mylan", "observed_at": "2026-10-12T13:35:59Z", "pipeline_version": "2.0.0", "presentation_label": "Lenalidomide Mylan 2.5 mg hard capsules Lenalidomide Mylan 5 mg hard capsules Lenalidomide Mylan 7.5 mg hard capsules Lenalidomide Mylan 10 mg hard capsules Lenalidomide Mylan 15 mg hard capsules Lenalidomide Mylan 20 mg hard capsules Lenalidomide Mylan 25 mg hard capsules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.1", "section_type": "indication", "source_provider": "European Medicines Agency", "source_sha256": "ad837a050ae2ebb1149b23c68fd1449d2d3c647a705074e93bcbb79a0787fecc", "source_snapshot_id": "source-49baac54d1d69a53e6772b38", "source_updated_at": "2026-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/lenalidomide-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": 104}
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{"after": {"end": 381, "start": 0, "text": "Careful monitoring and evaluation for TFR is recommended. Tumour flare may mimic PD. Patients who experienced Grade 1 and 2 TFR were treated with corticosteroids, NSAIDs and/or narcotic analgesics for management of TFR symptoms. The decision to take therapeutic measures for TFR should be made after careful clinical assessment of the individual patient (see sections 4.2 and 4.8).", "truncated": false}, "after_length": 381, "after_sha256": "536eaaeb600d16ba7d903a7f9b66d326bb0bd9048cf0a707d75adbfd2ae9246b", "annex": "I", "before": {"end": 381, "start": 0, "text": "Careful monitoring and evaluation for TFR is recommended. Tumour flare may mimic PD. Patients who experienced Grade 1 and 2 TFR were treated with corticosteroids, NSAIDs and/or narcotic analgesics for management of TFR symptoms. The decision to take therapeutic measures for TFR should be made after careful clinical assessment of the individual patient (see sections 4.2 and 4.8).", "truncated": false}, "before_length": 381, "before_sha256": "536eaaeb600d16ba7d903a7f9b66d326bb0bd9048cf0a707d75adbfd2ae9246b", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-018375f93622e6113ec7850d", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005306", "medicine_name": "Lenalidomide Mylan", "medicine_slug": "lenalidomide-mylan", "observed_at": "2026-10-12T13:35:59Z", "pipeline_version": "2.0.0", "presentation_label": "Lenalidomide Mylan 2.5 mg hard capsules Lenalidomide Mylan 5 mg hard capsules Lenalidomide Mylan 7.5 mg hard capsules Lenalidomide Mylan 10 mg hard capsules Lenalidomide Mylan 15 mg hard capsules Lenalidomide Mylan 20 mg hard capsules Lenalidomide Mylan 25 mg hard capsules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "ad837a050ae2ebb1149b23c68fd1449d2d3c647a705074e93bcbb79a0787fecc", "source_snapshot_id": "source-49baac54d1d69a53e6772b38", "source_updated_at": "2026-06-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/lenalidomide-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": 842}
{"after": {"end": 1189, "start": 0, "text": "The blood pressure lowering effects of two doses of telmisartan were assessed in 76 hypertensive, largely overweight patients aged 6 to < 18 years (body weight ≥ 20 kg and ≤ 120 kg, mean 74.6 kg), after taking telmisartan 1 mg/kg (n = 29 treated) or 2 mg/kg (n = 31 treated) over a four-week treatment period. By inclusion the presence of secondary hypertension was not investigated. In some of the investigated patients the doses used were higher than those recommended in the treatment of hypertension in the adult population, reaching a daily dose comparable to160 mg, which was tested in adults. After adjustment for age group effects mean SBP changes from baseline (primary objective) were 14.5 (1.7) mm Hg in the telmisartan 2 mg/kg group, 9.7 (1.7) mm Hg in the telmisartan 1 mg/kg group, and 6.0 (2.4) in the placebo group. The adjusted DBP changes from baseline were 8.4 (1.5) mm Hg, 4.5 (1.6) mm Hg and 3.5 (2.1) mm Hg respectively. The change was dose dependent. The safety data from this study in patients aged 6 to < 18 years appeared generally similar to that observed in adults. The safety of long term treatment of telmisartan in children and adolescents was not evaluated.", "truncated": false}, "after_length": 1189, "after_sha256": "1b08e0913f3f1a64c8b4326f5bc6e614037028ba833f0f5dd1c8562d2de84e2b", "annex": "I", "before": {"end": 1189, "start": 0, "text": "The blood pressure lowering effects of two doses of telmisartan were assessed in 76 hypertensive, largely overweight patients aged 6 to < 18 years (body weight ≥ 20 kg and ≤ 120 kg, mean 74.6 kg), after taking telmisartan 1 mg/kg (n = 29 treated) or 2 mg/kg (n = 31 treated) over a four-week treatment period. By inclusion the presence of secondary hypertension was not investigated. In some of the investigated patients the doses used were higher than those recommended in the treatment of hypertension in the adult population, reaching a daily dose comparable to160 mg, which was tested in adults. After adjustment for age group effects mean SBP changes from baseline (primary objective) were 14.5 (1.7) mm Hg in the telmisartan 2 mg/kg group, 9.7 (1.7) mm Hg in the telmisartan 1 mg/kg group, and 6.0 (2.4) in the placebo group. The adjusted DBP changes from baseline were 8.4 (1.5) mm Hg, 4.5 (1.6) mm Hg and 3.5 (2.1) mm Hg respectively. The change was dose dependent. The safety data from this study in patients aged 6 to < 18 years appeared generally similar to that observed in adults. The safety of long term treatment of telmisartan in children and adolescents was not evaluated.", "truncated": false}, "before_length": 1189, "before_sha256": "1b08e0913f3f1a64c8b4326f5bc6e614037028ba833f0f5dd1c8562d2de84e2b", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01863837243c2da2f59b9c52", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000209", "medicine_name": "Micardis", "medicine_slug": "micardis", "observed_at": "2026-10-12T13:39:20Z", "pipeline_version": "2.0.0", "presentation_label": "Micardis 20 mg tablets Micardis 40 mg tablets Micardis 80 mg tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "cefad9d7ec5d6d66fe79529bd05be84d7c77e317562c1da24ab578d51b115291", "source_snapshot_id": "source-0f57674cde87a4ecc5c19b52", "source_updated_at": "2026-04-28", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/micardis-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": 444}
{"after": {"end": 370, "start": 0, "text": "Patients who develop a new infection while undergoing treatment with infliximab, should be monitored closely and undergo a complete diagnostic evaluation. Administration of infliximab should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.", "truncated": false}, "after_length": 370, "after_sha256": "de16b400ae8aa047fae8c2a694aa449e4512fe59b55071314f8af53936383dc2", "annex": "I", "before": {"end": 370, "start": 0, "text": "Patients who develop a new infection while undergoing treatment with infliximab, should be monitored closely and undergo a complete diagnostic evaluation. Administration of infliximab should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.", "truncated": false}, "before_length": 370, "before_sha256": "de16b400ae8aa047fae8c2a694aa449e4512fe59b55071314f8af53936383dc2", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01864ae483be01f19866cb7b", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002576", "medicine_name": "Remsima", "medicine_slug": "remsima", "observed_at": "2026-10-12T13:37:58Z", "pipeline_version": "2.0.0", "presentation_label": "Remsima 100 mg powder for concentrate for solution for infusion", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "27bfb864f98f7738217c7e9f79f4efc6d3f2f4fd07bff1d83fcc454a50626dee", "source_snapshot_id": "source-d0ae0bf14568ab5adf79e44a", "source_updated_at": "2026-05-08", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/remsima-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": 256}
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{"after": {"end": 484, "start": 0, "text": "La Cmax de la canagliflozine a été modérément augmentée respectivement de 13 %, 29 % et 29 % chez les sujets présentant une insuffisance rénale légère, modérée et sévère, mais pas chez les sujets sous hémodialyse. Comparativement aux sujets sains, l’ASC plasmatique de la canagliflozine a été augmentée respectivement d’environ 17 %, 63 % et 50 % chez les sujets ayant une insuffisance rénale légère, modérée et sévère, mais a été similaire chez les sujets en IRT et les sujets sains.", "truncated": false}, "after_length": 484, "after_sha256": "34698fe4c53fd9a68f438f578454a40490d34f4e7973dd8afeb07ee1a010fd2b", "annex": "I", "before": {"end": 484, "start": 0, "text": "La Cmax de la canagliflozine a été modérément augmentée respectivement de 13 %, 29 % et 29 % chez les sujets présentant une insuffisance rénale légère, modérée et sévère, mais pas chez les sujets sous hémodialyse. Comparativement aux sujets sains, l’ASC plasmatique de la canagliflozine a été augmentée respectivement d’environ 17 %, 63 % et 50 % chez les sujets ayant une insuffisance rénale légère, modérée et sévère, mais a été similaire chez les sujets en IRT et les sujets sains.", "truncated": false}, "before_length": 484, "before_sha256": "34698fe4c53fd9a68f438f578454a40490d34f4e7973dd8afeb07ee1a010fd2b", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-018d139ee20224e9028cbf31", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/002649", "medicine_name": "Invokana", "medicine_slug": "invokana", "observed_at": "2026-10-12T17:27:36Z", "pipeline_version": "2.0.0", "presentation_label": "Invokana 100 mg comprimés pelliculés Invokana 300 mg comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "5e753bb354983730f0789cadcbccb124df947f5b77daf5d446e1d52f45e8b1fe", "source_snapshot_id": "source-195756913629ec5e8a28f5e1", "source_updated_at": "2025-12-18", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/invokana-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": 1340}
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{"after": {"end": 90, "start": 0, "text": "There is no relevant use of Humira in children aged less than 4 years for this indication.", "truncated": false}, "after_length": 90, "after_sha256": "49b1dd03c753418cd4e06e3d530a5461314e1831514b36a347ea0188cb6bb606", "annex": "I", "before": {"end": 90, "start": 0, "text": "There is no relevant use of Humira in children aged less than 4 years for this indication.", "truncated": false}, "before_length": 90, "before_sha256": "49b1dd03c753418cd4e06e3d530a5461314e1831514b36a347ea0188cb6bb606", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01adc986f06c3145f6874ce3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/000481", "medicine_name": "Humira", "medicine_slug": "humira", "observed_at": "2026-10-12T19:05:51Z", "pipeline_version": "2.0.0", "presentation_label": "Humira 20 mg solution for injection in pre-filled syringe", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "0ecf37e08cb0de31151fecc637d8f3d6baf2f44a169e36dd20e9e3f3d348320c", "source_snapshot_id": "source-7f08b7886dbefa50c9bbf715", "source_updated_at": "2025-10-08", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/humira-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 155}
{"after": {"end": 101, "start": 0, "text": "Infection active et cliniquement importante (par exemple une tuberculose active ; voir rubrique 4.4).", "truncated": false}, "after_length": 101, "after_sha256": "4e367c3e9b71695602f13020d8c879f54c31721b15e72eb7acec21c80ad45f99", "annex": "I", "before": {"end": 101, "start": 0, "text": "Infection active et cliniquement importante (par exemple une tuberculose active ; voir rubrique 4.4).", "truncated": false}, "before_length": 101, "before_sha256": "4e367c3e9b71695602f13020d8c879f54c31721b15e72eb7acec21c80ad45f99", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01b0a2c8ac44ddf0f0ca670f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006444", "medicine_name": "Yesintek", "medicine_slug": "yesintek", "observed_at": "2026-10-12T19:01:45Z", "pipeline_version": "2.0.0", "presentation_label": "Yesintek 45 mg solution injectable en stylo prérempli Yesintek 90 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": "4.3", "section_type": "contraindication", "source_provider": "European Medicines Agency", "source_sha256": "8c2b3e8345d1587a65069bc2ed38a32860a843ac07d78bef733b8e208f95a8f7", "source_snapshot_id": "source-e6cadd30a86c6c9b1c0915b2", "source_updated_at": "2026-02-16", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/yesintek-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": 1965}
{"after": {"end": 518, "start": 0, "text": "Au cours des essais cliniques, des réactions allergiques graves associées à Humira ont rarement été rapportées et des réactions allergiques non graves imputables à Humira ont été peu fréquentes. Des cas de réactions allergiques graves, incluant des réactions anaphylactiques, ont été rapportés après administration d’Humira. En cas de survenue d’une réaction anaphylactique ou d’une autre réaction allergique grave, l’administration d’Humira doit être immédiatement interrompue et un traitement approprié mis en œuvre.", "truncated": false}, "after_length": 518, "after_sha256": "d167a67ccaceb25904933853b456ccbdbdc4fbba7550d503096f86dd9f09b30b", "annex": "I", "before": {"end": 518, "start": 0, "text": "Au cours des essais cliniques, des réactions allergiques graves associées à Humira ont rarement été rapportées et des réactions allergiques non graves imputables à Humira ont été peu fréquentes. Des cas de réactions allergiques graves, incluant des réactions anaphylactiques, ont été rapportés après administration d’Humira. En cas de survenue d’une réaction anaphylactique ou d’une autre réaction allergique grave, l’administration d’Humira doit être immédiatement interrompue et un traitement approprié mis en œuvre.", "truncated": false}, "before_length": 518, "before_sha256": "d167a67ccaceb25904933853b456ccbdbdc4fbba7550d503096f86dd9f09b30b", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-01b1c4f0b11c515389050ae0", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000481", "medicine_name": "Humira", "medicine_slug": "humira", "observed_at": "2026-10-12T19:05:58Z", "pipeline_version": "2.0.0", "presentation_label": "Humira 80 mg, solution injectable en seringue préremplie. Humira 80 mg, solution injectable en stylo prérempli.", "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": "838fa74d683105747766f79fbda32abdc6ca30a43c391bf9460c7303fb89a72d", "source_snapshot_id": "source-3be20854841dd8e6b1c05116", "source_updated_at": "2025-10-08", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/humira-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": 9582}
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{"after": {"end": 827, "start": 0, "text": "Dans les phases contrôlées et non-contrôlées des études cliniques sur le psoriasis, le rhumatisme psoriasique, la maladie de Crohn et la rectocolite hémorragique, représentant 15 227 patient-années d’exposition à l’ustekinumab chez 6 710 patients, le suivi médian était de 1,2 année ; 1,7 année pour les études dans les maladies psoriasiques, 0,6 année pour les études dans la maladie de Crohn et 2,3 années pour les études dans la rectocolite hémorragique. Concernant les patients traités par l’ustekinumab, la fréquence des infections a été de 0,85 par patient-année de suivi et celle des infections graves de 0,02 par patient-année (289 infections graves pour 15 227 patient-années de suivi). Les infections graves rapportées incluaient pneumonie, abcès anal, cellulite, diverticulite, gastro-entérite et infections virales.", "truncated": false}, "after_length": 827, "after_sha256": "09c6d2cbbcb10b75136e5e29813f867c695dc2ae0b96269b96f8088b3b83da58", "annex": "I", "before": {"end": 827, "start": 0, "text": "Dans les phases contrôlées et non-contrôlées des études cliniques sur le psoriasis, le rhumatisme psoriasique, la maladie de Crohn et la rectocolite hémorragique, représentant 15 227 patient-années d’exposition à l’ustekinumab chez 6 710 patients, le suivi médian était de 1,2 année ; 1,7 année pour les études dans les maladies psoriasiques, 0,6 année pour les études dans la maladie de Crohn et 2,3 années pour les études dans la rectocolite hémorragique. Concernant les patients traités par l’ustekinumab, la fréquence des infections a été de 0,85 par patient-année de suivi et celle des infections graves de 0,02 par patient-année (289 infections graves pour 15 227 patient-années de suivi). Les infections graves rapportées incluaient pneumonie, abcès anal, cellulite, diverticulite, gastro-entérite et infections virales.", "truncated": false}, "before_length": 827, "before_sha256": "09c6d2cbbcb10b75136e5e29813f867c695dc2ae0b96269b96f8088b3b83da58", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-02ed42dc23082ff4a01c7eca", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006444", "medicine_name": "Yesintek", "medicine_slug": "yesintek", "observed_at": "2026-10-12T19:01:45Z", "pipeline_version": "2.0.0", "presentation_label": "Yesintek 45 mg solution injectable en stylo prérempli Yesintek 90 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": "8c2b3e8345d1587a65069bc2ed38a32860a843ac07d78bef733b8e208f95a8f7", "source_snapshot_id": "source-e6cadd30a86c6c9b1c0915b2", "source_updated_at": "2026-02-16", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/yesintek-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": 2119}
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{"after": {"end": 614, "start": 0, "text": "In the MURANO study, neutropenia (all grades) was reported in 61% of patients in the venetoclax + rituximab arm. Forty-three percent of patients treated with venetoclax + rituximab experienced dose interruption and 3% of patients discontinued venetoclax due to neutropenia. Grade 3 neutropenia was reported in 32% of patients and grade 4 neutropenia in 26% of patients. The median duration of grade 3 or 4 neutropenia was 8 days (range: 1 to 712 days). With venetoclax + rituximab treatment, febrile neutropenia was reported in 4% of patients, grade ≥3 infections in 18%, and serious infections in 21% of patients.", "truncated": false}, "after_length": 614, "after_sha256": "02fdbbf16d0f74f1ab023dd803fab73d2b0b6304e6c58ce9b8c9197d173e7ace", "annex": "I", "before": {"end": 614, "start": 0, "text": "In the MURANO study, neutropenia (all grades) was reported in 61% of patients in the venetoclax + rituximab arm. Forty-three percent of patients treated with venetoclax + rituximab experienced dose interruption and 3% of patients discontinued venetoclax due to neutropenia. Grade 3 neutropenia was reported in 32% of patients and grade 4 neutropenia in 26% of patients. The median duration of grade 3 or 4 neutropenia was 8 days (range: 1 to 712 days). With venetoclax + rituximab treatment, febrile neutropenia was reported in 4% of patients, grade ≥3 infections in 18%, and serious infections in 21% of patients.", "truncated": false}, "before_length": 614, "before_sha256": "02fdbbf16d0f74f1ab023dd803fab73d2b0b6304e6c58ce9b8c9197d173e7ace", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-072c1bed1e0aed61a853a5b9", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004106", "medicine_name": "Venclyxto", "medicine_slug": "venclyxto", "observed_at": "2026-10-12T13:33:36Z", "pipeline_version": "2.0.0", "presentation_label": "Venclyxto 10 mg filmcoated tablets Venclyxto 50 mg filmcoated tablets Venclyxto 100 mg filmcoated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "cb909b1e026c92fa2c7a68aafb5af7a7a6dc62c5e45faa62a526c1c85bfd9f82", "source_snapshot_id": "source-dd55abaf2041fe4e618fed75", "source_updated_at": "2026-07-08", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/venclyxto-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": 851}
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{"after": {"end": 521, "start": 0, "text": "L’absorption du telmisartan est rapide, mais la quantité absorbée est variable. La biodisponibilité absolue moyenne du telmisartan est d’environ 50 %. Lors de la prise de telmisartan avec de la nourriture, l’aire sous la courbe des concentrations plasmatiques de telmisartan en fonction du temps (ASC0) varie d’environ 6 % pour une dose de 40 mg à environ 19 % pour une dose de 160 mg. Trois heures après la prise, les concentrations plasmatiques sont similaires, que le telmisartan ait été pris à jeun ou avec un repas.", "truncated": false}, "after_length": 521, "after_sha256": "4b451f899a18b6e59cb60dbfc5b4266e0de4a4d5c2ce83c18827a5637901877e", "annex": "I", "before": {"end": 521, "start": 0, "text": "L’absorption du telmisartan est rapide, mais la quantité absorbée est variable. La biodisponibilité absolue moyenne du telmisartan est d’environ 50 %. Lors de la prise de telmisartan avec de la nourriture, l’aire sous la courbe des concentrations plasmatiques de telmisartan en fonction du temps (ASC0) varie d’environ 6 % pour une dose de 40 mg à environ 19 % pour une dose de 160 mg. Trois heures après la prise, les concentrations plasmatiques sont similaires, que le telmisartan ait été pris à jeun ou avec un repas.", "truncated": false}, "before_length": 521, "before_sha256": "4b451f899a18b6e59cb60dbfc5b4266e0de4a4d5c2ce83c18827a5637901877e", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-07b600053883758ec32c589d", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000209", "medicine_name": "Micardis", "medicine_slug": "micardis", "observed_at": "2026-10-12T13:39:22Z", "pipeline_version": "2.0.0", "presentation_label": "Micardis 20 mg comprimés Micardis 40 mg comprimés Micardis 80 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": "5.2", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "d102545ad80ecfee02702302c6f96b7445d571e24b76ee9c2b7cfbe2ddb00d0a", "source_snapshot_id": "source-66eff26170aa99059b087fe9", "source_updated_at": "2026-04-28", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/micardis-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": 455}
{"after": {"end": 159, "start": 0, "text": "Patients treated with venetoclax may develop TLS. The appropriate section below should be referred to for specific details on management by disease indication.", "truncated": false}, "after_length": 159, "after_sha256": "013ec94fbfcf23a31e76e9c3bca032df3c04803632f2274c632115caee737150", "annex": "I", "before": {"end": 159, "start": 0, "text": "Patients treated with venetoclax may develop TLS. The appropriate section below should be referred to for specific details on management by disease indication.", "truncated": false}, "before_length": 159, "before_sha256": "013ec94fbfcf23a31e76e9c3bca032df3c04803632f2274c632115caee737150", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-07bcaf88e6af5e3f555091b3", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004106", "medicine_name": "Venclyxto", "medicine_slug": "venclyxto", "observed_at": "2026-10-12T13:33:36Z", "pipeline_version": "2.0.0", "presentation_label": "Venclyxto 10 mg filmcoated tablets Venclyxto 50 mg filmcoated tablets Venclyxto 100 mg filmcoated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.2", "section_type": "posology", "source_provider": "European Medicines Agency", "source_sha256": "cb909b1e026c92fa2c7a68aafb5af7a7a6dc62c5e45faa62a526c1c85bfd9f82", "source_snapshot_id": "source-dd55abaf2041fe4e618fed75", "source_updated_at": "2026-07-08", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/venclyxto-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": 177}
{"after": {"end": 704, "start": 0, "text": "Les effets indésirables sont présentés par classe de systèmes d’organes selon la classification MedDRA (Tableau 1). La fréquence des effets indésirables est basée sur l’étude PALLADIUM. Au sein de chaque classe de systèmes d’organes, les effets indésirables sont présentés suivant un ordre décroissant de fréquence. Dans chaque groupe de fréquence, les effets indésirables sont présentés suivant un ordre décroissant de gravité. De plus, la catégorie de fréquence correspondant à chaque effet indésirable est basée sur la classification suivante (CIOMS III) : 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).", "truncated": false}, "after_length": 704, "after_sha256": "5fa6a0fdb7fc8bc1d304e271b8b31f84d968336c2aade62d5f149274e3b19a3d", "annex": "I", "before": {"end": 704, "start": 0, "text": "Les effets indésirables sont présentés par classe de systèmes d’organes selon la classification MedDRA (Tableau 1). La fréquence des effets indésirables est basée sur l’étude PALLADIUM. Au sein de chaque classe de systèmes d’organes, les effets indésirables sont présentés suivant un ordre décroissant de fréquence. Dans chaque groupe de fréquence, les effets indésirables sont présentés suivant un ordre décroissant de gravité. De plus, la catégorie de fréquence correspondant à chaque effet indésirable est basée sur la classification suivante (CIOMS III) : 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).", "truncated": false}, "before_length": 704, "before_sha256": "5fa6a0fdb7fc8bc1d304e271b8b31f84d968336c2aade62d5f149274e3b19a3d", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-07cabec7afcc62aa47eae6a4", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005067", "medicine_name": "Atectura Breezhaler", "medicine_slug": "atectura-breezhaler", "observed_at": "2026-10-12T17:31:04Z", "pipeline_version": "2.0.0", "presentation_label": "Atectura Breezhaler 125 microgrammes/62,5 microgrammes poudre pour inhalation en gélules Atectura Breezhaler 125 microgrammes/127,5 microgrammes poudre pour inhalation en gélules Atectura Breezhaler 125 microgrammes/260 microgrammes poudre pour inhalation en gélules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "4c80a98be9be1396fc5992c7f178fc47319e94953ae2dde37f50416b41668042", "source_snapshot_id": "source-18063ce7b055d9d4773a9421", "source_updated_at": "2025-11-20", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/atectura-breezhaler-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 248}
{"after": {"end": 371, "start": 0, "text": "In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute clinical measures if required. Canagliflozin was negligibly removed during a 4hour haemodialysis session. Canagliflozin is not expected to be dialysable by peritoneal dialysis.", "truncated": false}, "after_length": 371, "after_sha256": "71f48fe4c85b79a420e50c9bf0b2074bbd54158b3c2d6e121a3cb5453279e8fc", "annex": "I", "before": {"end": 371, "start": 0, "text": "In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute clinical measures if required. Canagliflozin was negligibly removed during a 4hour haemodialysis session. Canagliflozin is not expected to be dialysable by peritoneal dialysis.", "truncated": false}, "before_length": 371, "before_sha256": "71f48fe4c85b79a420e50c9bf0b2074bbd54158b3c2d6e121a3cb5453279e8fc", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0816fc68f63f9ca55702477e", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002649", "medicine_name": "Invokana", "medicine_slug": "invokana", "observed_at": "2026-10-12T17:27:33Z", "pipeline_version": "2.0.0", "presentation_label": "Invokana 100 mg filmcoated tablets Invokana 300 mg filmcoated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.9", "section_type": "overdose", "source_provider": "European Medicines Agency", "source_sha256": "a1af6612347748b5da8c154ebcce6e2aad0bb4a764a46fc2142143b05661d165", "source_snapshot_id": "source-ae325f069ae857fd9d1753a6", "source_updated_at": "2025-12-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/invokana-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": 516}
{"after": {"end": 203, "start": 0, "text": "Each MACE component positively contributed to the overall composite, as shown in Figure 2. Results for the 100 mg and 300 mg canagliflozin doses were consistent with results for the combined dose groups.", "truncated": false}, "after_length": 203, "after_sha256": "a30de8217bc3c62c87f8c62b86aad2c44ea238d8a4a3f914daab187cb84e72d2", "annex": "I", "before": {"end": 203, "start": 0, "text": "Each MACE component positively contributed to the overall composite, as shown in Figure 2. Results for the 100 mg and 300 mg canagliflozin doses were consistent with results for the combined dose groups.", "truncated": false}, "before_length": 203, "before_sha256": "a30de8217bc3c62c87f8c62b86aad2c44ea238d8a4a3f914daab187cb84e72d2", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-08248d6b4b682a287d6fc8ae", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/002649", "medicine_name": "Invokana", "medicine_slug": "invokana", "observed_at": "2026-10-12T17:27:33Z", "pipeline_version": "2.0.0", "presentation_label": "Invokana 100 mg filmcoated tablets Invokana 300 mg filmcoated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "a1af6612347748b5da8c154ebcce6e2aad0bb4a764a46fc2142143b05661d165", "source_snapshot_id": "source-ae325f069ae857fd9d1753a6", "source_updated_at": "2025-12-18", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/invokana-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": 1025}
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{"after": {"end": 716, "start": 0, "text": "Le telmisartan n’est pas éliminé par hémofiltration et n’est pas dialysable. Une surveillance étroite du patient doit être instaurée, ainsi qu’un traitement symptomatique et de soutien. La prise en charge doit tenir compte du temps écoulé depuis l’ingestion et de la sévérité des symptômes. L’administration de médicaments émétiques et/ou un lavage gastrique peuvent être envisagés. Le charbon actif peut s’avérer utile pour le traitement d’un surdosage. Un bilan électrolytique et un contrôle de la créatininémie doivent être effectués fréquemment. En cas d’hypotension, le patient doit être mis en position allongée, et un traitement par une solution saline de remplissage vasculaire doit être instauré rapidement.", "truncated": false}, "after_length": 716, "after_sha256": "cadddff8cb7336a733aa99033e0d4d0a546d7271fd6ea569fc179e97feea9016", "annex": "I", "before": {"end": 716, "start": 0, "text": "Le telmisartan n’est pas éliminé par hémofiltration et n’est pas dialysable. Une surveillance étroite du patient doit être instaurée, ainsi qu’un traitement symptomatique et de soutien. La prise en charge doit tenir compte du temps écoulé depuis l’ingestion et de la sévérité des symptômes. L’administration de médicaments émétiques et/ou un lavage gastrique peuvent être envisagés. Le charbon actif peut s’avérer utile pour le traitement d’un surdosage. Un bilan électrolytique et un contrôle de la créatininémie doivent être effectués fréquemment. En cas d’hypotension, le patient doit être mis en position allongée, et un traitement par une solution saline de remplissage vasculaire doit être instauré rapidement.", "truncated": false}, "before_length": 716, "before_sha256": "cadddff8cb7336a733aa99033e0d4d0a546d7271fd6ea569fc179e97feea9016", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0849db2cb700d1fe8ef3d704", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/000209", "medicine_name": "Micardis", "medicine_slug": "micardis", "observed_at": "2026-10-12T13:39:22Z", "pipeline_version": "2.0.0", "presentation_label": "Micardis 20 mg comprimés Micardis 40 mg comprimés Micardis 80 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": "4.9", "section_type": "overdose", "source_provider": "European Medicines Agency", "source_sha256": "d102545ad80ecfee02702302c6f96b7445d571e24b76ee9c2b7cfbe2ddb00d0a", "source_snapshot_id": "source-66eff26170aa99059b087fe9", "source_updated_at": "2026-04-28", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/micardis-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": 395}
{"after": {"end": 343, "start": 0, "text": "The safety and efficacy of rozanolixizumab was evaluated in patients with gMG in the pivotal phase 3 study MG0003. Long-term safety, tolerability and efficacy of rozanolixizumab were evaluated in 2 phase 3 open-label extension (OLE) studies, with 1 OLE (MG0007) administering rozanolixizumab as 6-week treatment cycles based on clinical needs.", "truncated": false}, "after_length": 343, "after_sha256": "c4f5b0d561742d39a69460bfe7c14027b4bdef096fe69692019579b8c6c576d9", "annex": "I", "before": {"end": 343, "start": 0, "text": "The safety and efficacy of rozanolixizumab was evaluated in patients with gMG in the pivotal phase 3 study MG0003. Long-term safety, tolerability and efficacy of rozanolixizumab were evaluated in 2 phase 3 open-label extension (OLE) studies, with 1 OLE (MG0007) administering rozanolixizumab as 6-week treatment cycles based on clinical needs.", "truncated": false}, "before_length": 343, "before_sha256": "c4f5b0d561742d39a69460bfe7c14027b4bdef096fe69692019579b8c6c576d9", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0895df32481d28578c1d2802", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005824", "medicine_name": "Rystiggo", "medicine_slug": "rystiggo", "observed_at": "2026-10-12T19:41:43Z", "pipeline_version": "2.0.0", "presentation_label": "Rystiggo 140 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": "a1131c65aebcc24dc8660aa335b12baec0c48f66368a4b486014b57008077c81", "source_snapshot_id": "source-25b874486f216b0dbd6ad5f0", "source_updated_at": "2025-05-12", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/rystiggo-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": 304}
{"after": {"end": 935, "start": 0, "text": "Le pertuzumab a été administré par voie intraveineuse à une dose initiale de 840 mg, suivie d’une dose de 420 mg toutes les trois semaines. Le trastuzumab a été administré par voie intraveineuse à une dose initiale de 8 mg/kg, suivie d’une dose de 6 mg/kg toutes les trois semaines. Le docétaxel a été administré par voie intraveineuse à une dose initiale de 75 mg/m², suivie d’une dose de 75 mg/m² ou 100 mg/m² (si tolérée) toutes les 3 semaines. Après la chirurgie, toutes les patientes ont reçu 3 cycles de 5-fluorouracile (600 mg/m²), épirubicine (90 mg/m²) et cyclophosphamide (600 mg/m²) (FEC) administrés par voie intraveineuse toutes les trois semaines et le trastuzumab administré par voie intraveineuse toutes les trois semaines jusqu’à atteindre 1 an de traitement. Les patientes qui avaient reçu uniquement le pertuzumab plus trastuzumab avant la chirurgie ont ensuite reçu à la fois FEC et le docétaxel après la chirurgie.", "truncated": false}, "after_length": 935, "after_sha256": "bad476a161dd63ef2700c668d4c309fdf125936d32650e60cd211fe33394f11b", "annex": "I", "before": {"end": 935, "start": 0, "text": "Le pertuzumab a été administré par voie intraveineuse à une dose initiale de 840 mg, suivie d’une dose de 420 mg toutes les trois semaines. Le trastuzumab a été administré par voie intraveineuse à une dose initiale de 8 mg/kg, suivie d’une dose de 6 mg/kg toutes les trois semaines. Le docétaxel a été administré par voie intraveineuse à une dose initiale de 75 mg/m², suivie d’une dose de 75 mg/m² ou 100 mg/m² (si tolérée) toutes les 3 semaines. Après la chirurgie, toutes les patientes ont reçu 3 cycles de 5-fluorouracile (600 mg/m²), épirubicine (90 mg/m²) et cyclophosphamide (600 mg/m²) (FEC) administrés par voie intraveineuse toutes les trois semaines et le trastuzumab administré par voie intraveineuse toutes les trois semaines jusqu’à atteindre 1 an de traitement. Les patientes qui avaient reçu uniquement le pertuzumab plus trastuzumab avant la chirurgie ont ensuite reçu à la fois FEC et le docétaxel après la chirurgie.", "truncated": false}, "before_length": 935, "before_sha256": "bad476a161dd63ef2700c668d4c309fdf125936d32650e60cd211fe33394f11b", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-089cab09490f0a42ef889b45", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005386", "medicine_name": "Phesgo", "medicine_slug": "phesgo", "observed_at": "2026-10-12T19:04:35Z", "pipeline_version": "2.0.0", "presentation_label": "Phesgo 600 mg/600 mg solution injectable Phesgo 1 200 mg/600 mg solution injectable", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "c9e8c89f95f2ea2fe237554c3b911f0bcb896b6c3fc829d239d38c1ede2eead7", "source_snapshot_id": "source-8b6d2cf3ce7af1f1302a515d", "source_updated_at": "2025-10-28", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/phesgo-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": 987}
{"after": {"end": 540, "start": 0, "text": "Women of childbearing age being treated with Alunbrig should be advised not to become pregnant and men being treated with Alunbrig should be advised not to father a child during treatment. Women of reproductive potential should be advised to use effective nonhormonal contraception during treatment with Alunbrig and for at least 4 months following the final dose. Men with female partners of reproductive potential should be advised to use effective contraception during treatment and for at least 3 months after the last dose of Alunbrig.", "truncated": false}, "after_length": 540, "after_sha256": "ce45b840c2e3896fd94e9402daa0e012b0d01cfdae7fdc82677ef7f0ef12cadd", "annex": "I", "before": {"end": 540, "start": 0, "text": "Women of childbearing age being treated with Alunbrig should be advised not to become pregnant and men being treated with Alunbrig should be advised not to father a child during treatment. Women of reproductive potential should be advised to use effective nonhormonal contraception during treatment with Alunbrig and for at least 4 months following the final dose. Men with female partners of reproductive potential should be advised to use effective contraception during treatment and for at least 3 months after the last dose of Alunbrig.", "truncated": false}, "before_length": 540, "before_sha256": "ce45b840c2e3896fd94e9402daa0e012b0d01cfdae7fdc82677ef7f0ef12cadd", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-08a1a50b49c8c1def90eb548", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004248", "medicine_name": "Alunbrig", "medicine_slug": "alunbrig", "observed_at": "2026-10-12T19:45:22Z", "pipeline_version": "2.0.0", "presentation_label": "Alunbrig 30 mg filmcoated tablets Alunbrig 90 mg filmcoated tablets Alunbrig 180 mg filmcoated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.6", "section_type": "pregnancy", "source_provider": "European Medicines Agency", "source_sha256": "4e301ec6306300d48577788c7c0dfc3b5252d58e41c6a1fef7b451f840163d80", "source_snapshot_id": "source-dd56ffc2c8535636439f2eff", "source_updated_at": "2025-04-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/alunbrig-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": 334}
{"after": {"end": 415, "start": 0, "text": "Venetoclax is a Pgp, BCRP and OATP1B1 inhibitor in vitro. In a drug-drug interaction study, administration of a single 100 mg dose of venetoclax with 0.5 mg digoxin, a P-gp substrate, resulted in a 35% increase in digoxin Cmax and a 9% increase in digoxin AUC. Coadministration of narrow therapeutic index Pgp, or BCRP substrates (e.g., digoxin, dabigatran, everolimus, sirolimus) with venetoclax should be avoided.", "truncated": false}, "after_length": 415, "after_sha256": "b4a5140347625964d724ba3a3db82255f293748281fad7f3a83551c873a11d0a", "annex": "I", "before": {"end": 415, "start": 0, "text": "Venetoclax is a Pgp, BCRP and OATP1B1 inhibitor in vitro. In a drug-drug interaction study, administration of a single 100 mg dose of venetoclax with 0.5 mg digoxin, a P-gp substrate, resulted in a 35% increase in digoxin Cmax and a 9% increase in digoxin AUC. Coadministration of narrow therapeutic index Pgp, or BCRP substrates (e.g., digoxin, dabigatran, everolimus, sirolimus) with venetoclax should be avoided.", "truncated": false}, "before_length": 415, "before_sha256": "b4a5140347625964d724ba3a3db82255f293748281fad7f3a83551c873a11d0a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-08c2a47ea3b0a119764dc909", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/004106", "medicine_name": "Venclyxto", "medicine_slug": "venclyxto", "observed_at": "2026-10-12T13:33:36Z", "pipeline_version": "2.0.0", "presentation_label": "Venclyxto 10 mg filmcoated tablets Venclyxto 50 mg filmcoated tablets Venclyxto 100 mg filmcoated tablets", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.5", "section_type": "interaction", "source_provider": "European Medicines Agency", "source_sha256": "cb909b1e026c92fa2c7a68aafb5af7a7a6dc62c5e45faa62a526c1c85bfd9f82", "source_snapshot_id": "source-dd55abaf2041fe4e618fed75", "source_updated_at": "2026-07-08", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/venclyxto-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": 488}
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{"after": {"end": 806, "start": 0, "text": "A trial of 288 patients aged 2 to < 17 years investigated the safety and efficacy of sugammadex versus neostigmine as a reversal agent for neuromuscular blockade induced by rocuronium or vecuronium. Recovery from moderate block to a train-of-four (TOF) ratio of ≥ 0.9 was significantly faster in the sugammadex 2 mg/kg group compared with the neostigmine group (geometric mean of 1.6 minutes for sugammadex 2 mg/kg and 7.5 minutes for neostigmine, ratio of geometric means 0.22, 95% CI (0.16, 0.32), (p< 0.0001)). Sugammadex 4 mg/kg achieved reversal from deep block with a geometric mean of 2.0 minutes, similar to results observed in adults. These effects were consistent for all age cohorts studied (2 to < 6; 6 to < 12; 12 to < 17 years of age) and for both rocuronium and vecuronium (see section 4.2).", "truncated": false}, "after_length": 806, "after_sha256": "5098de56f5124feda701b5513eb959071244ce3e39dc5e6fd77a30b7f25135f1", "annex": "I", "before": {"end": 806, "start": 0, "text": "A trial of 288 patients aged 2 to < 17 years investigated the safety and efficacy of sugammadex versus neostigmine as a reversal agent for neuromuscular blockade induced by rocuronium or vecuronium. Recovery from moderate block to a train-of-four (TOF) ratio of ≥ 0.9 was significantly faster in the sugammadex 2 mg/kg group compared with the neostigmine group (geometric mean of 1.6 minutes for sugammadex 2 mg/kg and 7.5 minutes for neostigmine, ratio of geometric means 0.22, 95% CI (0.16, 0.32), (p< 0.0001)). Sugammadex 4 mg/kg achieved reversal from deep block with a geometric mean of 2.0 minutes, similar to results observed in adults. These effects were consistent for all age cohorts studied (2 to < 6; 6 to < 12; 12 to < 17 years of age) and for both rocuronium and vecuronium (see section 4.2).", "truncated": false}, "before_length": 806, "before_sha256": "5098de56f5124feda701b5513eb959071244ce3e39dc5e6fd77a30b7f25135f1", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-093669de08582363fefa60fb", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006046", "medicine_name": "Sugammadex Adroiq", "medicine_slug": "sugammadex-adroiq", "observed_at": "2026-10-12T19:07:50Z", "pipeline_version": "2.0.0", "presentation_label": "Sugammadex Adroiq 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": "4f8f3382e28818ead35c9f666aed17ebc79074b43a1ec31a5d7e9fbe7cd6ed89", "source_snapshot_id": "source-8175f531425e04cb590ef72c", "source_updated_at": "2025-09-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/sugammadex-adroiq-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": 530}
{"after": {"end": 310, "start": 0, "text": "Lorsque du valproate ou du lithium ont été administrés en association à l’aripiprazole, aucune variation cliniquement significative des concentrations d'aripiprazole n’a été observée et aucune adaptation posologique n’est donc nécessaire lorsque du valproate ou du lithium sont administrés avec l'aripiprazole.", "truncated": false}, "after_length": 310, "after_sha256": "23009a9388315d07f2018985b9eec5b9de5130de3270e77509d37464d08eef49", "annex": "I", "before": {"end": 310, "start": 0, "text": "Lorsque du valproate ou du lithium ont été administrés en association à l’aripiprazole, aucune variation cliniquement significative des concentrations d'aripiprazole n’a été observée et aucune adaptation posologique n’est donc nécessaire lorsque du valproate ou du lithium sont administrés avec l'aripiprazole.", "truncated": false}, "before_length": 310, "before_sha256": "23009a9388315d07f2018985b9eec5b9de5130de3270e77509d37464d08eef49", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-095693d28344caa74f302cad", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003899", "medicine_name": "Aripiprazole Zentiva", "medicine_slug": "aripiprazole-zentiva", "observed_at": "2026-10-12T19:23:51Z", "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": "cbf2c8130eb0ea37140be1863f353578bd31b1aca62c69d84c430b16cc285999", "source_snapshot_id": "source-8445bbafd6717edf20828f78", "source_updated_at": "2025-07-17", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/aripiprazole-zentiva-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 290}
{"after": {"end": 636, "start": 0, "text": "The QUARTZ study was a 12-week study evaluating Atectura Breezhaler 125 mcg/62.5 mcg once daily (N=398) compared to mometasone furoate 200 mcg once daily (N=404). All subjects were required to be symptomatic and on asthma maintenance therapy using a low-dose ICS (with or without LABA) for at least 1 month prior to study entry. At study entry, the most common asthma medications reported were low-dose ICS (43%) and LABA/low-dose ICS (56%). The primary endpoint of the study was to demonstrate superiority of Atectura Breezhaler 125 mcg/62.5 mcg once daily over mometasone furoate 200 mcg once daily in terms of trough FEV1 at week 12.", "truncated": false}, "after_length": 636, "after_sha256": "5df065e2f9735b9187e529bc4650f84526039435291079aa8a33de30b5798395", "annex": "I", "before": {"end": 636, "start": 0, "text": "The QUARTZ study was a 12-week study evaluating Atectura Breezhaler 125 mcg/62.5 mcg once daily (N=398) compared to mometasone furoate 200 mcg once daily (N=404). All subjects were required to be symptomatic and on asthma maintenance therapy using a low-dose ICS (with or without LABA) for at least 1 month prior to study entry. At study entry, the most common asthma medications reported were low-dose ICS (43%) and LABA/low-dose ICS (56%). The primary endpoint of the study was to demonstrate superiority of Atectura Breezhaler 125 mcg/62.5 mcg once daily over mometasone furoate 200 mcg once daily in terms of trough FEV1 at week 12.", "truncated": false}, "before_length": 636, "before_sha256": "5df065e2f9735b9187e529bc4650f84526039435291079aa8a33de30b5798395", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-095e72c506a50c6240a039f2", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/005067", "medicine_name": "Atectura Breezhaler", "medicine_slug": "atectura-breezhaler", "observed_at": "2026-10-12T17:31:00Z", "pipeline_version": "2.0.0", "presentation_label": "Atectura Breezhaler 125 micrograms/62.5 micrograms inhalation powder, hard capsules Atectura Breezhaler 125 micrograms/127.5 micrograms inhalation powder, hard capsules Atectura Breezhaler 125 micrograms/260 micrograms inhalation powder, hard capsules", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "133bd0404bdbff170159599404a23d36243637d8eae9c8dfe7cb9f3894ad2fdf", "source_snapshot_id": "source-ffe8d8ad10c37b3e6d189f90", "source_updated_at": "2025-11-20", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/atectura-breezhaler-epar-product-information-tracked-changes_en.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 564}
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{"after": {"end": 408, "start": 0, "text": "Cependant, dans les essais cliniques pivots pertuzumab, avec pertuzumab intraveineux en association avec trastuzumab, une diminution de l'appétit, une anémie, une perte de poids, une asthénie, une dysgueusie, une neuropathie périphérique, une hypomagnésémie et une diarrhée sont survenues avec une incidence ≥ 5 % plus élevée chez les patients ≥ 65 ans (n = 418) par rapport aux patients < 65 ans (n = 2926).", "truncated": false}, "after_length": 408, "after_sha256": "e139f20de9b9c10a8469f4c6a9fffc0a4e86a2c51f9e271842c8686322ccfa51", "annex": "I", "before": {"end": 408, "start": 0, "text": "Cependant, dans les essais cliniques pivots pertuzumab, avec pertuzumab intraveineux en association avec trastuzumab, une diminution de l'appétit, une anémie, une perte de poids, une asthénie, une dysgueusie, une neuropathie périphérique, une hypomagnésémie et une diarrhée sont survenues avec une incidence ≥ 5 % plus élevée chez les patients ≥ 65 ans (n = 418) par rapport aux patients < 65 ans (n = 2926).", "truncated": false}, "before_length": 408, "before_sha256": "e139f20de9b9c10a8469f4c6a9fffc0a4e86a2c51f9e271842c8686322ccfa51", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-09f8ff8c9e831eff6f5a849b", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005386", "medicine_name": "Phesgo", "medicine_slug": "phesgo", "observed_at": "2026-10-12T19:04:35Z", "pipeline_version": "2.0.0", "presentation_label": "Phesgo 600 mg/600 mg solution injectable Phesgo 1 200 mg/600 mg solution injectable", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "c9e8c89f95f2ea2fe237554c3b911f0bcb896b6c3fc829d239d38c1ede2eead7", "source_snapshot_id": "source-8b6d2cf3ce7af1f1302a515d", "source_updated_at": "2025-10-28", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/phesgo-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": 838}
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{"after": {"end": 760, "start": 0, "text": "Dans une étude chez des volontaires, des doses de 4 mg/kg et 16 mg/kg de sugammadex ont provoqué respectivement une augmentation maximale moyenne du temps de céphaline activée (TCA) de 17 et 22 % et du taux de prothrombine (TP) / International Normalized Ratio (INR) de 11 et 22 %. Ces faibles augmentations de TCA et de TP (INR) étaient de courte durée (≤ 30 minutes). D’après la base de données cliniques (N = 3 519), et d’après une étude spécifique menée chez 1 184 patients ayant subi une chirurgie pour fracture de la hanche/remplacement d’une articulation majeure, le sugammadex 4 mg/kg, seul ou en association avec des anticoagulants, n’a pas eu d’effet cliniquement significatif sur l’incidence des complications hémorragiques péri ou post-opératoires.", "truncated": false}, "after_length": 760, "after_sha256": "2e22a7250868963c25e703059193b00c7bc5679bdaa74ce72a9373d815b7573a", "annex": "I", "before": {"end": 760, "start": 0, "text": "Dans une étude chez des volontaires, des doses de 4 mg/kg et 16 mg/kg de sugammadex ont provoqué respectivement une augmentation maximale moyenne du temps de céphaline activée (TCA) de 17 et 22 % et du taux de prothrombine (TP) / International Normalized Ratio (INR) de 11 et 22 %. Ces faibles augmentations de TCA et de TP (INR) étaient de courte durée (≤ 30 minutes). D’après la base de données cliniques (N = 3 519), et d’après une étude spécifique menée chez 1 184 patients ayant subi une chirurgie pour fracture de la hanche/remplacement d’une articulation majeure, le sugammadex 4 mg/kg, seul ou en association avec des anticoagulants, n’a pas eu d’effet cliniquement significatif sur l’incidence des complications hémorragiques péri ou post-opératoires.", "truncated": false}, "before_length": 760, "before_sha256": "2e22a7250868963c25e703059193b00c7bc5679bdaa74ce72a9373d815b7573a", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0b98f248605a41414b2056b6", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/006046", "medicine_name": "Sugammadex Adroiq", "medicine_slug": "sugammadex-adroiq", "observed_at": "2026-10-12T19:07:53Z", "pipeline_version": "2.0.0", "presentation_label": "", "presentation_occurrence": null, "presentation_status": "not_identified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.4", "section_type": "warning", "source_provider": "European Medicines Agency", "source_sha256": "0a13dc6281fd01787849893dda4d2eac6ed2655c364a8d8bb784fc13398a51ee", "source_snapshot_id": "source-3c85146f21d9567602052934", "source_updated_at": "2025-09-25", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/sugammadex-adroiq-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": 142}
{"after": {"end": 495, "start": 0, "text": "Les données démographiques étaient bien équilibrées (l’âge médian était de 49-50 ans, la majorité des patients étaient Caucasiens (71 %)) et tous les patients étaient de sexe féminin. Sur l’ensemble des patientes, 7 % présentaient un cancer du sein inflammatoire, 32 % un cancer du sein localement avancé et 61 % un cancer du sein opérable. Environ la moitié des patientes dans chaque groupe de traitement avaient des récepteurs hormonaux positifs (définis comme ER positifs et/ou PgR positifs).", "truncated": false}, "after_length": 495, "after_sha256": "0b5687d2b3f1a11fd659d32a5c8d57b4f00b2a43e30f23d93d1e95564806b332", "annex": "I", "before": {"end": 495, "start": 0, "text": "Les données démographiques étaient bien équilibrées (l’âge médian était de 49-50 ans, la majorité des patients étaient Caucasiens (71 %)) et tous les patients étaient de sexe féminin. Sur l’ensemble des patientes, 7 % présentaient un cancer du sein inflammatoire, 32 % un cancer du sein localement avancé et 61 % un cancer du sein opérable. Environ la moitié des patientes dans chaque groupe de traitement avaient des récepteurs hormonaux positifs (définis comme ER positifs et/ou PgR positifs).", "truncated": false}, "before_length": 495, "before_sha256": "0b5687d2b3f1a11fd659d32a5c8d57b4f00b2a43e30f23d93d1e95564806b332", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0b9cb7ff56b705ef8eedd737", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005386", "medicine_name": "Phesgo", "medicine_slug": "phesgo", "observed_at": "2026-10-12T19:04:35Z", "pipeline_version": "2.0.0", "presentation_label": "Phesgo 600 mg/600 mg solution injectable Phesgo 1 200 mg/600 mg solution injectable", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "c9e8c89f95f2ea2fe237554c3b911f0bcb896b6c3fc829d239d38c1ede2eead7", "source_snapshot_id": "source-8b6d2cf3ce7af1f1302a515d", "source_updated_at": "2025-10-28", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/phesgo-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": 991}
{"after": {"end": 462, "start": 0, "text": "L’étude a atteint son critère principal sur l’allongement de la SSP évaluée par l’investigateur lors de l’analyse intermédiaire réalisée sur 82 % des événements de SSP prévus ; les résultats ont dépassé la limite d’efficacité pré-spécifiée de Haybittle-Peto (α = 0,00135), démontrant un allongement statistiquement significatif de la SSP et un effet cliniquement significatif du traitement. Des données d’efficacité actualisées sont présentées dans le Tableau 5.", "truncated": false}, "after_length": 462, "after_sha256": "1fb7ad0ed41fd41ff834fc447b6d78bcef6353b5b72228ff6f9780ca7f91bf67", "annex": "I", "before": {"end": 462, "start": 0, "text": "L’étude a atteint son critère principal sur l’allongement de la SSP évaluée par l’investigateur lors de l’analyse intermédiaire réalisée sur 82 % des événements de SSP prévus ; les résultats ont dépassé la limite d’efficacité pré-spécifiée de Haybittle-Peto (α = 0,00135), démontrant un allongement statistiquement significatif de la SSP et un effet cliniquement significatif du traitement. Des données d’efficacité actualisées sont présentées dans le Tableau 5.", "truncated": false}, "before_length": 462, "before_sha256": "1fb7ad0ed41fd41ff834fc447b6d78bcef6353b5b72228ff6f9780ca7f91bf67", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0bb79e1fd1215e190b84d9f5", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/004649", "medicine_name": "Fulvestrant Mylan", "medicine_slug": "fulvestrant-mylan", "observed_at": "2026-10-12T13:35:56Z", "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": "81510bbbdea324cc17fdb220f717b73a1d45191982b977c410aad9cce989ec66", "source_snapshot_id": "source-05a14676da56207ac5e3e5e1", "source_updated_at": "2026-06-12", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/fulvestrant-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": 780}
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{"after": {"end": 702, "start": 0, "text": "Sont présentés dans le tableau 2, dans la première colonne, les effets indésirables qui ont été rapportés avec l’utilisation du pertuzumab en association au trastuzumab et à une chimiothérapie lors des études cliniques pivots mentionnées ci-dessous (n = 3 834) et depuis la commercialisation. Le pertuzumab ayant été utilisé en association au trastuzumab et à une chimiothérapie, il est difficile d'évaluer avec certitude le lien de causalité entre un effet indésirable et un médicament particulier. Les deux dernières colonnes détaillent les effets indésirables rapportés dans le bras Phesgo de l'étude FEDERICA (n=243) lorsque Phesgo est administré avec un agent de chimiothérapie et en monothérapie.", "truncated": false}, "after_length": 702, "after_sha256": "cc212374e259327cd4c061134afff3536bc521672d7959756e4c54c79b17fda2", "annex": "I", "before": {"end": 702, "start": 0, "text": "Sont présentés dans le tableau 2, dans la première colonne, les effets indésirables qui ont été rapportés avec l’utilisation du pertuzumab en association au trastuzumab et à une chimiothérapie lors des études cliniques pivots mentionnées ci-dessous (n = 3 834) et depuis la commercialisation. Le pertuzumab ayant été utilisé en association au trastuzumab et à une chimiothérapie, il est difficile d'évaluer avec certitude le lien de causalité entre un effet indésirable et un médicament particulier. Les deux dernières colonnes détaillent les effets indésirables rapportés dans le bras Phesgo de l'étude FEDERICA (n=243) lorsque Phesgo est administré avec un agent de chimiothérapie et en monothérapie.", "truncated": false}, "before_length": 702, "before_sha256": "cc212374e259327cd4c061134afff3536bc521672d7959756e4c54c79b17fda2", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0dda05ec4702787986386b1c", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005386", "medicine_name": "Phesgo", "medicine_slug": "phesgo", "observed_at": "2026-10-12T19:04:35Z", "pipeline_version": "2.0.0", "presentation_label": "Phesgo 600 mg/600 mg solution injectable Phesgo 1 200 mg/600 mg solution injectable", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "c9e8c89f95f2ea2fe237554c3b911f0bcb896b6c3fc829d239d38c1ede2eead7", "source_snapshot_id": "source-8b6d2cf3ce7af1f1302a515d", "source_updated_at": "2025-10-28", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/phesgo-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": 353}
{"after": {"end": 1500, "start": 0, "text": "Dans l’étude clinique pivot FEDERICA, l’incidence d’une insuffisance cardiaque symptomatique (classe III ou IV selon la classification NYHA) associée à une diminution de la FEVG d’au moins 10 points de pourcentage par rapport à la valeur de référence et jusqu’à < 50 % était de 0,4% pour les patients traités par Phesgo versus 0% pour les patients traités par le pertuzumab intraveineux et le trastuzumab pendant la phase néoadjuvante (lorsqu’ils sont administrés en concomitance avec une chimiothérapie). Parmi les patients qui ont présenté une insuffisance cardiaque symptomatique, aucun des patients traités par Phesgo n’était rétabli à la date de clôture du recueil des données et un patient a arrêté Phesgo en raison de l’apparition d'une insuffisance cardiaque symptomatique. Les incidences d'une insuffisance cardiaque symptomatique associées à une diminution de la FEVG d'au moins 10 points de pourcentage par rapport à la valeur de référence et jusqu’à < 50 % étaient similaires dans les phases adjuvantes (lorsque Phesgo était administré seul) et dans les phases de suivi. Des diminutions asymptomatiques ou légèrement symptomatiques (classe II selon la classification NYHA) de la FEVG d’au moins 10 points de pourcentage par rapport à la valeur de référence et jusqu’à < 50 % (confirmées par des mesures secondaires de la FEVG) n’ont pas été rapportées chez des patients traités par Phesgo et ont été rapportés chez 0,4 % des patients traités par le pertuzumab intraveineux et le trastuzum", "truncated": true}, "after_length": 2066, "after_sha256": "9fa668251c7504258ecaa677246dfd2c62653f6460b3f4927007e7e3613b9783", "annex": "I", "before": {"end": 1500, "start": 0, "text": "Dans l’étude clinique pivot FEDERICA, l’incidence d’une insuffisance cardiaque symptomatique (classe III ou IV selon la classification NYHA) associée à une diminution de la FEVG d’au moins 10 points de pourcentage par rapport à la valeur de référence et jusqu’à < 50 % était de 0,4% pour les patients traités par Phesgo versus 0% pour les patients traités par le pertuzumab intraveineux et le trastuzumab pendant la phase néoadjuvante (lorsqu’ils sont administrés en concomitance avec une chimiothérapie). Parmi les patients qui ont présenté une insuffisance cardiaque symptomatique, aucun des patients traités par Phesgo n’était rétabli à la date de clôture du recueil des données et un patient a arrêté Phesgo en raison de l’apparition d'une insuffisance cardiaque symptomatique. Les incidences d'une insuffisance cardiaque symptomatique associées à une diminution de la FEVG d'au moins 10 points de pourcentage par rapport à la valeur de référence et jusqu’à < 50 % étaient similaires dans les phases adjuvantes (lorsque Phesgo était administré seul) et dans les phases de suivi. Des diminutions asymptomatiques ou légèrement symptomatiques (classe II selon la classification NYHA) de la FEVG d’au moins 10 points de pourcentage par rapport à la valeur de référence et jusqu’à < 50 % (confirmées par des mesures secondaires de la FEVG) n’ont pas été rapportées chez des patients traités par Phesgo et ont été rapportés chez 0,4 % des patients traités par le pertuzumab intraveineux et le trastuzum", "truncated": true}, "before_length": 2066, "before_sha256": "9fa668251c7504258ecaa677246dfd2c62653f6460b3f4927007e7e3613b9783", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0decfde40a4d4661ac6ee3b2", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/005386", "medicine_name": "Phesgo", "medicine_slug": "phesgo", "observed_at": "2026-10-12T19:04:35Z", "pipeline_version": "2.0.0", "presentation_label": "Phesgo 600 mg/600 mg solution injectable Phesgo 1 200 mg/600 mg solution injectable", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "4.8", "section_type": "adverse_reactions", "source_provider": "European Medicines Agency", "source_sha256": "c9e8c89f95f2ea2fe237554c3b911f0bcb896b6c3fc829d239d38c1ede2eead7", "source_snapshot_id": "source-8b6d2cf3ce7af1f1302a515d", "source_updated_at": "2025-10-28", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/phesgo-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": 706}
{"after": {"end": 350, "start": 0, "text": "Based on pharmacokinetic (PK) modelling the recommended waiting time in patients with mild or moderate renal impairment for re-use of 0.6 mg/kg rocuronium or 0.1 mg/kg vecuronium after routine reversal with sugammadex should be 24 hours. If a shorter waiting time is required, the rocuronium dose for a new neuromuscular blockade should be 1.2 mg/kg.", "truncated": false}, "after_length": 350, "after_sha256": "9708dfa8c946f605f7cb92d3c6182dce23048b9e78c1f39f7c3ff4fb86cd8210", "annex": "I", "before": {"end": 350, "start": 0, "text": "Based on pharmacokinetic (PK) modelling the recommended waiting time in patients with mild or moderate renal impairment for re-use of 0.6 mg/kg rocuronium or 0.1 mg/kg vecuronium after routine reversal with sugammadex should be 24 hours. If a shorter waiting time is required, the rocuronium dose for a new neuromuscular blockade should be 1.2 mg/kg.", "truncated": false}, "before_length": 350, "before_sha256": "9708dfa8c946f605f7cb92d3c6182dce23048b9e78c1f39f7c3ff4fb86cd8210", "change_kind": "unchanged", "change_operations": [], "classification_method": "documentary_rules_v2", "clinical_candidate": false, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 0, "chars_inserted": 0}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "control-0e0fa021a5d9b644bd0d107c", "language": "en", "medical_validation": false, "medicine_id": "EMEA/H/C/006046", "medicine_name": "Sugammadex Adroiq", "medicine_slug": "sugammadex-adroiq", "observed_at": "2026-10-12T19:07:50Z", "pipeline_version": "2.0.0", "presentation_label": "Sugammadex Adroiq 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": "4f8f3382e28818ead35c9f666aed17ebc79074b43a1ec31a5d7e9fbe7cd6ed89", "source_snapshot_id": "source-8175f531425e04cb590ef72c", "source_updated_at": "2025-09-25", "source_url": "https://www.ema.europa.eu/en/documents/product-information-tracked-changes/sugammadex-adroiq-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": 166}
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