{"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=es","category":"health","content":{"key_points":[],"paragraphs":["Las tres decisiones de AIFA fechadas el 1 de octubre se publicaron en el Boletín Oficial italiano el 17 de octubre. Clasifican Itvisma, basado en onasemnogén abeparvovec; Jascayd, con nerandomilast; y Liraglutide Stada, con liraglutida, como medicamentos de uso humano de nueva autorización.","Las decisiones entraron en vigor el 18 de octubre. Los tres productos quedaron en la clase C(nn), que AIFA define para medicamentos cuyo reembolso aún no se ha evaluado. Esta clasificación por sí sola no es una decisión de reembolso ni confirma el comienzo de las ventas. Un documento separado de AIFA sobre el régimen de suministro de su reunión del 7 al 11 de septiembre indica uso exclusivamente hospitalario para Itvisma y dispensación con receta 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=es&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=es&format=json"},"id":"aifa-new-medicine-classifications"}],"data_types":["table"],"editorial_illustration":{"alt":"Ilustración conceptual de salud pública, investigación y datos 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":"es","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":"es","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":"Ilustración conceptual de salud pública, investigación y datos 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":"es","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":"La agencia italiana del medicamento publicó el 17 de octubre decisiones fechadas el día 1 para Itvisma, Jascayd y Liraglutide Stada. Los tres quedaron en la clase C(nn), destinada a medicamentos aún no evaluados para su reembolso.","text":"La agencia italiana del medicamento publicó el 17 de octubre decisiones fechadas el día 1 para Itvisma, Jascayd y Liraglutide Stada. Los tres quedaron en la clase C(nn), destinada a medicamentos aún no evaluados para su reembolso.\n\nLas tres decisiones de AIFA fechadas el 1 de octubre se publicaron en el Boletín Oficial italiano el 17 de octubre. Clasifican Itvisma, basado en onasemnogén abeparvovec; Jascayd, con nerandomilast; y Liraglutide Stada, con liraglutida, como medicamentos de uso humano de nueva autorización.\n\nLas decisiones entraron en vigor el 18 de octubre. Los tres productos quedaron en la clase C(nn), que AIFA define para medicamentos cuyo reembolso aún no se ha evaluado. Esta clasificación por sí sola no es una decisión de reembolso ni confirma el comienzo de las ventas. Un documento separado de AIFA sobre el régimen de suministro de su reunión del 7 al 11 de septiembre indica uso exclusivamente hospitalario para Itvisma y dispensación con receta para Liraglutide Stada.","title":"AIFA clasifica tres nuevos medicamentos pendientes de evaluación 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/es/news/italy-aifa-places-three-new-medicines-in-non-negotiated-class-2026"},"version":"1"}