COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Mitoxantrone Sandoz». (18A03903)
Estratto determina n. 805/2018 del 21 maggio 2018 Medicinale: MITOXANTRONE SANDOZ. Titolare A.I.C.: Sandoz S.p.A. - l.go U. Boccioni, 1 - 21040 Origgio (VA) - Italia. Classificazione ai fini della rimborsabilita' La nuova indicazione terapeutica del medicinale MITOXANTRONE SANDOZ: il mitoxantrone e' indicato nel trattamento del carcinoma mammario metastatico;
il mitoxantrone e' indicato nel trattamento del linfoma non-Hodgkin;
il mitoxantrone e' indicato nel trattamento della leucemia mieloide acuta (LMA) negli adulti;
il mitoxantrone nei regimi di associazione e' indicato nel trattamento per l'induzione della remissione della «crisi blastica» nella leucemia mieloide cronica;
il mitoxantrone e' indicato in combinazione con corticosteroidi come cura palliativa (ad esempio sollievo dal dolore) correlata al carcinoma prostatico avanzato resistente alla castrazione;
il mitoxantrone e' indicato per il trattamento dei pazienti con sclerosi multipla recidivante altamente attiva, associata a disabilita' a rapida evoluzione, qualora non esistano opzioni terapeutiche alternative e' rimborsata come segue: Confezione: «2 mg/ml concentrato per soluzione per infusione» - 1 flaconcino in vetro da 10 ml - A.I.C. n. 036111021 (in base 10). Classe di rimborsabilita': H prezzo ex factory (IVA esclusa) €
92,97 prezzo al pubblico (IVA inclusa) €
153,43 Confezione: «2 mg/ml concentrato per soluzione per infusione» - 1 flaconcino in vetro da 5 ml - A.I.C. n. 036111019 (in base 10). Classe di rimborsabilita': H prezzo ex factory (IVA esclusa) €
48,48 prezzo al pubblico (IVA inclusa) €
80,01 Validita' del contratto: ventiquattro mesi. Classificazione ai fini della fornitura La classificazione ai fini della fornitura del medicinale MITOXANTRONE SANDOZ e' la seguente: medicinale soggetto a prescrizione...
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