L\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM) a rendu, le 8 septembre 2026, un avis favorable sur le m\u00e9dicament Ribavirine Skyepharma 200 mg, comprim\u00e9 pellicul\u00e9, dans le cadre d\u2019une demande d\u2019autorisation d\u2019acc\u00e8s pr\u00e9coce (AAP). La demande a \u00e9t\u00e9 d\u00e9pos\u00e9e par la soci\u00e9t\u00e9 Skyepharma Production SAS le 9 avril 2026 et compl\u00e9t\u00e9e les 27 avril, 4 mai et 15 juillet 2026.<\/p>\n
L\u2019ANSM atteste d\u2019une forte pr\u00e9somption d\u2019efficacit\u00e9 et de s\u00e9curit\u00e9 de ce m\u00e9dicament pour l\u2019indication suivante : traitement de l\u2019infection chronique par le virus de l\u2019h\u00e9patite E chez les patients ayant re\u00e7u une greffe d\u2019organe solide. L\u2019indication initialement revendiqu\u00e9e par le demandeur couvrait le traitement de l\u2019h\u00e9patite virale E chronique et aigu\u00eb s\u00e9v\u00e8re, mais l\u2019avis publi\u00e9 pr\u00e9cise uniquement l\u2019infection chronique chez les patients transplant\u00e9s d\u2019organe solide.<\/p>\n
L\u2019avis de l\u2019ANSM s\u2019accompagne d\u2019annexes comprenant la motivation scientifique, le r\u00e9sum\u00e9 des caract\u00e9ristiques du produit, ainsi que l\u2019\u00e9tiquetage et la notice valid\u00e9s pour cette indication. La d\u00e9cision est sign\u00e9e par le directeur Europe et Innovation de l\u2019ANSM et formalise le cadre d\u2019utilisation de la ribavirine dans cette population sp\u00e9cifique de patients, dans une logique d\u2019acc\u00e8s pr\u00e9coce au traitement.\u00a0(contenu r\u00e9sum\u00e9 par l’IA)Lire la Suite<\/a>\u200b<\/p>","protected":false},"excerpt":{"rendered":" L\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM) a rendu, le 8 septembre 2026, un avis favorable sur le m\u00e9dicament Ribavirine Skyepharma 200 mg, comprim\u00e9 pellicul\u00e9, […]<\/p>\n","protected":false},"author":1,"featured_media":3852,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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