{"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=pt","category":"health","content":{"key_points":[],"paragraphs":["As três decisões da AIFA, datadas de 1 de outubro, foram publicadas no Diário Oficial italiano em 17 de outubro. Classificam Itvisma, à base de onasemnogene abeparvovec; Jascayd, com nerandomilast; e Liraglutide Stada, com liraglutido, como medicamentos de uso humano com nova autorização.","As decisões entraram em vigor em 18 de outubro. Os três produtos foram colocados na classe C(nn), que a AIFA define para medicamentos ainda não avaliados para reembolso. Esta classificação, por si só, não constitui decisão de reembolso nem confirma o início das vendas. Um documento separado da AIFA sobre o regime de fornecimento da reunião de 7 a 11 de setembro indica uso exclusivamente hospitalar para Itvisma e dispensa mediante receita para 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=pt&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=pt&format=json"},"id":"aifa-new-medicine-classifications"}],"data_types":["table"],"editorial_illustration":{"alt":"Ilustração conceitual de saúde pública, pesquisa e dados conectados.","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":"pt","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":"pt","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":"Ilustração conceitual de saúde pública, pesquisa e dados conectados.","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":"pt","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":"A agência italiana do medicamento publicou em 17 de outubro decisões de 1 de outubro relativas a Itvisma, Jascayd e Liraglutide Stada. Os três foram colocados na classe C(nn), destinada a medicamentos ainda não avaliados para reembolso.","text":"A agência italiana do medicamento publicou em 17 de outubro decisões de 1 de outubro relativas a Itvisma, Jascayd e Liraglutide Stada. Os três foram colocados na classe C(nn), destinada a medicamentos ainda não avaliados para reembolso.\n\nAs três decisões da AIFA, datadas de 1 de outubro, foram publicadas no Diário Oficial italiano em 17 de outubro. Classificam Itvisma, à base de onasemnogene abeparvovec; Jascayd, com nerandomilast; e Liraglutide Stada, com liraglutido, como medicamentos de uso humano com nova autorização.\n\nAs decisões entraram em vigor em 18 de outubro. Os três produtos foram colocados na classe C(nn), que a AIFA define para medicamentos ainda não avaliados para reembolso. Esta classificação, por si só, não constitui decisão de reembolso nem confirma o início das vendas. Um documento separado da AIFA sobre o regime de fornecimento da reunião de 7 a 11 de setembro indica uso exclusivamente hospitalar para Itvisma e dispensa mediante receita para Liraglutide Stada.","title":"AIFA classifica três novos medicamentos numa categoria pendente de avaliação de reembolso","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/pt/news/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026"},"version":"1"}