{"article":{"annotation":{"article_id":"italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026","available_at":"2026-10-18T23:00:44.205658Z","geography_revision":"ef6ee0010dda5fe7b240fd514749b43e214c57da73222d2e40ec83b276dd0977","id":"91607dc32224bfc2b76f4fcb5f464a5d976ae5d31ad8fcb0e809adef5c6530b6","input_sha256":"59f92305552651aaeb0c296b9178e59220c41657688b881e22c40e287b45b9ac","limitations":["Rule-derived subjects are candidates, not verified editorial labels or calibrated model probabilities.","Coverage is distinct from event location. Unknown country/city/coordinates remain absent; no automatic geocoding.","Article geometries keep their stated precision and methodology; reproducing them is not independent coordinate verification."],"method":"controlled-rules-v1","places":[{"admin1":null,"city":null,"coordinate_note":null,"coordinate_reference_system":"OGC:CRS84","coordinate_source":null,"country":"IT","evidence":[{"field":"country","language":"en","note":"Explicit preserved editorial country/region; no city or national centroid inferred","source_urls":["https://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.codiceRedazionale=26A05366&atto.dataPubblicazioneGazzetta=2026-10-17&atto.tipoProvvedimento=DETERMINA"]}],"geometry":null,"id":"iso3166-1:IT","kind":"country-or-area","labels":{"ar":"إيطاليا","en":"Italy","es":"Italia","fr":"Italie"},"match_status":"candidate","precision":"regional","role":"coverage","uncertainty_m":null}],"rules_sha256":"fb5ad3c27c91cb840f7a0a05f7f64a5cb26ad0374409ff9457f277c7092e22b4","schema_version":1,"subjects":[{"concept_id":"medtop:07000000","confidence":null,"confidence_method":null,"evidence":[{"field":"category+topics","language":"en","note":"Preserved editorial category/topic; broad candidate only","source_urls":["https://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.codiceRedazionale=26A05366&atto.dataPubblicazioneGazzetta=2026-10-17&atto.tipoProvvedimento=DETERMINA"]}],"method":"controlled-rules-v1","rule_id":"health-broad","status":"candidate"}],"taxonomy_revision":"1f2db31d811fca07e99b16d402c10e2cc2965c9df1c7b41d9be348b40a24e7fb","taxonomy_version":"IPTC Media Topics 2026-Q2"},"api_url":"https://newsverum.com/api/v1/articles/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026?lang=fr","category":"health","content":{"key_points":[],"paragraphs":["Les trois décisions de l’AIFA datées du 1er octobre ont été publiées au Journal officiel italien le 17 octobre. Elles classent Itvisma, à base d’onasemnogène abéparvovec, Jascayd, contenant du nérandomilast, et Liraglutide Stada, contenant du liraglutide, comme médicaments à usage humain nouvellement autorisés.","Les décisions sont entrées en vigueur le 18 octobre. Les trois produits ont été placés en classe C(nn), que l’AIFA réserve aux médicaments dont le remboursement n’a pas encore été évalué. Ce classement ne constitue pas à lui seul une décision de remboursement ni la confirmation d’un début de vente. Un document distinct de l’AIFA sur le régime de délivrance pour sa réunion du 7 au 11 septembre indique un usage hospitalier pour Itvisma et une délivrance sur ordonnance pour Liraglutide Stada."],"sections":[]},"corrections":[],"country":"IT","data":{"blocks":[{"columns":[{"key":"product","label":{"ar":"الدواء","de":"Arzneimittel","en":"Medicine","es":"Medicamento","fr":"Médicament","pt":"Medicamento","tr":"İlaç"},"language":"en","type":"text"},{"key":"active_substance","label":{"ar":"المادة الفعالة","de":"Wirkstoff","en":"Active substance","es":"Principio activo","fr":"Substance active","pt":"Substância ativa","tr":"Etken madde"},"language":"en","type":"text"},{"key":"class","label":{"ar":"فئة تقييم التعويض","de":"Erstattungsbewertungsklasse","en":"Reimbursement assessment class","es":"Clase de evaluación del reembolso","fr":"Classe d’évaluation du remboursement","pt":"Classe de avaliação do reembolso","tr":"Geri ödeme değerlendirme sınıfı"},"language":"en","type":"text"}],"description":{"ar":"اتُخذت القرارات في 1 أكتوبر وأدرجت كل منتج في الفئة C(nn) قبل تقييم التعويض.","de":"Die Entscheidungen ergingen am 1. Oktober; jedes Präparat wurde vor einer Erstattungsbewertung der Klasse C(nn) zugeordnet.","en":"The determinations were adopted on 1 October and place each product in class C(nn), before reimbursement assessment.","es":"Las decisiones se adoptaron el 1 de octubre y sitúan cada producto en la clase C(nn), antes de evaluar el reembolso.","fr":"Les décisions ont été prises le 1er octobre et placent chaque produit en classe C(nn), avant évaluation du remboursement.","pt":"As decisões foram adotadas em 1 de outubro e colocam cada produto na classe C(nn), antes da avaliação de reembolso.","tr":"Kararlar 1 Ekim’de kabul edildi ve her ürün henüz geri ödeme değerlendirmesi yapılmamış C(nn) sınıfına yerleştirildi."},"id":"aifa-new-medicine-classifications","methodology":{"ar":"الفئات والمواد الفعالة مأخوذة من قرارات الهيئة. ولا يعني الإدراج في C(nn) اكتمال تقييم التعويض.","de":"Klassen und Wirkstoffe stammen aus den AIFA-Entscheidungen. Die Einstufung C(nn) bedeutet nicht, dass die Erstattungsbewertung abgeschlossen ist.","en":"Classes and active substances are taken from AIFA’s determinations. C(nn) placement does not mean reimbursement assessment is complete.","es":"Las clases y principios activos proceden de las decisiones de AIFA. La inclusión en C(nn) no significa que haya concluido la evaluación del reembolso.","fr":"Classes et substances actives proviennent des décisions de l’AIFA. Le classement C(nn) ne signifie pas que l’évaluation du remboursement est achevée.","pt":"As classes e substâncias ativas constam das decisões da AIFA. A inclusão em C(nn) não significa que a avaliação do reembolso esteja concluída.","tr":"Sınıf ve etken maddeler AIFA karar metinlerinden alınmıştır. C(nn) yerleşimi geri ödeme değerlendirmesinin tamamlandığını göstermez."},"rowTranslations":[{"active_substance":{"ar":"أوناسمنوجين أبيبارفوفيك","de":"Onasemnogen-Abeparvovec","en":"onasemnogene abeparvovec","es":"onasemnogén abeparvovec","fr":"onasemnogène abéparvovec","pt":"onasemnogene abeparvovec","tr":"onasemnogene abeparvovec"},"class":{"ar":"C(nn) - لم يُقيّم التعويض بعد","de":"C(nn) - Erstattungsfähigkeit noch nicht bewertet","en":"C(nn) - not yet assessed for reimbursement","es":"C(nn) - reembolso aún no evaluado","fr":"C(nn) - remboursement pas encore évalué","pt":"C(nn) - reembolso ainda não avaliado","tr":"C(nn) – geri ödeme açısından henüz değerlendirilmedi"},"product":{"ar":"إيتفيسما","de":"Itvisma","en":"Itvisma","es":"Itvisma","fr":"Itvisma","pt":"Itvisma","tr":"Itvisma"}},{"active_substance":{"ar":"نيرانْدوميلاست","de":"Nerandomilast","en":"nerandomilast","es":"nerandomilast","fr":"nérandomilast","pt":"nerandomilast","tr":"nerandomilast"},"class":{"ar":"C(nn) - لم يُقيّم التعويض بعد","de":"C(nn) - Erstattungsfähigkeit noch nicht bewertet","en":"C(nn) - not yet assessed for reimbursement","es":"C(nn) - reembolso aún no evaluado","fr":"C(nn) - remboursement pas encore évalué","pt":"C(nn) - reembolso ainda não avaliado","tr":"C(nn) – geri ödeme açısından henüz değerlendirilmedi"},"product":{"ar":"جاسكايد","de":"Jascayd","en":"Jascayd","es":"Jascayd","fr":"Jascayd","pt":"Jascayd","tr":"Jascayd"}},{"active_substance":{"ar":"ليراغلوتايد","de":"Liraglutid","en":"liraglutide","es":"liraglutida","fr":"liraglutide","pt":"liraglutido","tr":"liraglutide"},"class":{"ar":"C(nn) - لم يُقيّم التعويض بعد","de":"C(nn) - Erstattungsfähigkeit noch nicht bewertet","en":"C(nn) - not yet assessed for reimbursement","es":"C(nn) - reembolso aún no evaluado","fr":"C(nn) - remboursement pas encore évalué","pt":"C(nn) - reembolso ainda não avaliado","tr":"C(nn) – geri ödeme açısından henüz değerlendirilmedi"},"product":{"ar":"ليراغلوتايد ستادا","de":"Liraglutide Stada","en":"Liraglutide Stada","es":"Liraglutide Stada","fr":"Liraglutide Stada","pt":"Liraglutide Stada","tr":"Liraglutide Stada"}}],"rows":[{"active_substance":"onasemnogene abeparvovec","class":"C(nn) - not yet assessed for reimbursement","product":"Itvisma"},{"active_substance":"nerandomilast","class":"C(nn) - not yet assessed for reimbursement","product":"Jascayd"},{"active_substance":"liraglutide","class":"C(nn) - not yet assessed for reimbursement","product":"Liraglutide Stada"}],"sourceUrls":["https://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.codiceRedazionale=26A05366&atto.dataPubblicazioneGazzetta=2026-10-17&atto.tipoProvvedimento=DETERMINA"],"title":{"ar":"ثلاثة تصنيفات دوائية نشرتها الهيئة في 17 أكتوبر","de":"Drei Arzneimitteleinstufungen der AIFA vom 17. Oktober","en":"Three medicine classifications published by AIFA on 17 October","es":"Tres clasificaciones de medicamentos publicadas por AIFA el 17 de octubre","fr":"Trois classifications de médicaments publiées par l’AIFA le 17 octobre","pt":"Três classificações de medicamentos publicadas pela AIFA em 17 de outubro","tr":"AIFA’nın 17 Ekim’de yayımladığı üç ilaç sınıflandırması"},"type":"table","updatedAt":"2026-10-18T22:08:02Z"}],"version":1},"data_downloads":[{"formats":{"csv":"https://newsverum.com/api/v1/articles/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026/data/aifa-new-medicine-classifications?lang=fr&format=csv","json":"https://newsverum.com/api/v1/articles/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026/data/aifa-new-medicine-classifications?lang=fr&format=json"},"id":"aifa-new-medicine-classifications"}],"data_types":["table"],"editorial_illustration":{"alt":"Illustration conceptuelle de la santé publique, de la recherche et des données connectées.","asset_id":"newsverum-v1-health","avif_variants":[{"height":320,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-480.avif","width":480},{"height":480,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-720.avif","width":720},{"height":640,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-960.avif","width":960},{"height":800,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1200.avif","width":1200},{"height":1024,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1536.avif","width":1536}],"credit":"Newsverum","documentary":false,"height":1024,"kind":"symbolic-editorial-illustration","language":"fr","scope":"topic","url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1536.webp","variants":[{"height":320,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-480.webp","width":480},{"height":640,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-960.webp","width":960},{"height":1024,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1536.webp","width":1536}],"width":1536},"event_id":"event-2046d0ae-ea54-5d54-8426-aac66d609f37","event_period":"2026-10-18","event_period_basis":"event-or-reference-period","id":"italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026","image":null,"importance":0.6,"language":"fr","modified_at":"2026-10-18T23:00:19+00:00","publication_basis":"publication-record","published_at":"2026-10-18T23:00:19+00:00","reading_minutes":1,"region":"world","section_illustration":{"alt":"Illustration conceptuelle de la santé publique, de la recherche et des données connectées.","asset_id":"newsverum-v1-health","avif_variants":[{"height":320,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-480.avif","width":480},{"height":480,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-720.avif","width":720},{"height":640,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-960.avif","width":960},{"height":800,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1200.avif","width":1200},{"height":1024,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1536.avif","width":1536}],"credit":"Newsverum","documentary":false,"height":1024,"kind":"symbolic-editorial-illustration","language":"fr","scope":"section","url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1536.webp","variants":[{"height":320,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-480.webp","width":480},{"height":640,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-960.webp","width":960},{"height":1024,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1536.webp","width":1536}],"width":1536},"slug":"italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026","sources":[{"checkedAt":"2026-10-19","name":"Agenzia Italiana del Farmaco (AIFA)","publishedAt":"2026-10-17","url":"https://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.codiceRedazionale=26A05366&atto.dataPubblicazioneGazzetta=2026-10-17&atto.tipoProvvedimento=DETERMINA"}],"summary":"L’agence italienne du médicament a publié le 17 octobre des décisions du 1er octobre concernant Itvisma, Jascayd et Liraglutide Stada. Les trois médicaments ont été placés en classe C(nn), réservée à ceux dont le remboursement n’a pas encore été évalué.","text":"L’agence italienne du médicament a publié le 17 octobre des décisions du 1er octobre concernant Itvisma, Jascayd et Liraglutide Stada. Les trois médicaments ont été placés en classe C(nn), réservée à ceux dont le remboursement n’a pas encore été évalué.\n\nLes trois décisions de l’AIFA datées du 1er octobre ont été publiées au Journal officiel italien le 17 octobre. Elles classent Itvisma, à base d’onasemnogène abéparvovec, Jascayd, contenant du nérandomilast, et Liraglutide Stada, contenant du liraglutide, comme médicaments à usage humain nouvellement autorisés.\n\nLes décisions sont entrées en vigueur le 18 octobre. Les trois produits ont été placés en classe C(nn), que l’AIFA réserve aux médicaments dont le remboursement n’a pas encore été évalué. Ce classement ne constitue pas à lui seul une décision de remboursement ni la confirmation d’un début de vente. Un document distinct de l’AIFA sur le régime de délivrance pour sa réunion du 7 au 11 septembre indique un usage hospitalier pour Itvisma et une délivrance sur ordonnance pour Liraglutide Stada.","title":"L’AIFA classe trois nouveaux médicaments en attente d’évaluation du remboursement","topics":[],"translations":[{"api_url":"https://newsverum.com/api/v1/articles/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026?lang=tr","language":"tr","url":"https://newsverum.com/tr/news/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026"},{"api_url":"https://newsverum.com/api/v1/articles/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026?lang=en","language":"en","url":"https://newsverum.com/en/news/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026"},{"api_url":"https://newsverum.com/api/v1/articles/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026?lang=ar","language":"ar","url":"https://newsverum.com/ar/news/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026"},{"api_url":"https://newsverum.com/api/v1/articles/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026?lang=fr","language":"fr","url":"https://newsverum.com/fr/news/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026"},{"api_url":"https://newsverum.com/api/v1/articles/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026?lang=es","language":"es","url":"https://newsverum.com/es/news/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026"},{"api_url":"https://newsverum.com/api/v1/articles/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026?lang=de","language":"de","url":"https://newsverum.com/de/news/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026"},{"api_url":"https://newsverum.com/api/v1/articles/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026?lang=pt","language":"pt","url":"https://newsverum.com/pt/news/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026"}],"url":"https://newsverum.com/fr/news/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026"},"version":"1"}