COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Vesanoid» (20A01143)
Estratto determina n. 185/2020 del 12 febbraio 2020 Medicinale: VESANOID. La nuova indicazione terapeutica del medicinale: «Vesanoid (tretinoina) e' indicato in combinazione con triossido di arsenico o chemioterapia per il trattamento di pazienti con leucemia acuta promielocitica (APL) di recente diagnosi, in recidiva o refrattaria alla chemioterapia», e' rimborsata come segue: confezione: «100 capsule molli 10 mg» flacone vetro - A.I.C. n. 029838024 (in base 10);
classe di rimborsabilita': A;
prezzo ex factory (I.V.A. esclusa): euro 350,00;
prezzo al pubblico (I.V.A. inclusa): euro 577,64. Sconto obbligatorio sul prezzo ex factory, da praticarsi alle strutture sanitarie pubbliche, ivi comprese le strutture sanitarie private accreditate con il Servizio sanitario nazionale, come da condizioni negoziali. Validita' del contratto: ventiquattro mesi. Condizioni e modalita' di impiego Prescrizione del medicinale soggetta a diagnosi secondo quanto previsto dall'allegato 2 e successive modifiche, alla...
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