COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Flunisolide Mylan Generics» (19A06982)
Estratto determina n. 1505/2019 del 16 ottobre 2019 Medicinale: FLUNISOLIDE MYLAN GENERICS. Titolare A.I.C.: Mylan Spa - via Vittor Pisani n. 20 - 20124 Milano - Italia. Confezione: «0,1% soluzione per nebulizzatore» flacone da 30 ml - A.I.C. n. 035352032 (in base 10). Classificazione ai fini della rimborsabilita' La nuova indicazione terapeutica del medicinale «Flunisolide Mylan Generics» (flunisolide) «Patologie allergiche delle vie respiratorie: asma bronchiale, broncostenosi, bronchite cronica asmatiforme, riniti croniche e stagionali, compresa la febbre da fieno» e' rimborsata come segue: confezione: «0,1% soluzione per nebulizzatore» flacone da 30 ml - A.I.C. n. 035352032 (in base 10);
classe di rimborsabilita': «A»;
prezzo ex-factory (IVA esclusa): euro 6,62;
prezzo al pubblico (IVA inclusa): euro 12,41. Validita' del contratto: ventiquattro mesi. Classificazione ai fini della fornitura La classificazione ai fini della fornitura del medicinale «Flunisolide Mylan Generics» (flunisolide) e' la seguente: medicinale soggetto a prescrizione medica (RR). Stampati Le confezioni della specialita' medicinale devono essere poste in commercio con etichette e fogli illustrativi conformi al testo allegato alla presente determina. E' approvato il riassunto...
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