COMUNICATO - Rinnovo dell'autorizzazione all'immissione in commercio, secondo procedura nazionale, del medicinale per uso umano «Broncovaleas» con conseguente modifica stampati. (14A08303)
Estratto determinazione FV n. 343/2014 del 14 ottobre 2014 L'autorizzazione all'immissione in commercio del medicinale: BRONCOVALEAS Confezioni: 022991 032 "2mg/5ml sciroppo" flacone da 120 ml 022991 057 "0,5% soluzione da nebulizzare" flacone da 15 ml 022991 133 25 compresse 2 mg 022991 158 "100 mcg/spruzzo sospensione pressurizzata per inalazione" contenitore sotto pressione per 200 spruzzi Titolare AIC: VALEAS S.P.A. INDUSTRIA CHIMICA E FARMACEUTICA Procedura Nazionale con scadenza il 30 maggio 2010 e' rinnovata, con validita' illimitata, l'autorizzazione all'immissione in commercio previa modifica del Riassunto delle Caratteristiche del Prodotto, del Foglio Illustrativo e dell'Etichettatura ed a condizione che, alla data di entrata in vigore della presente determinazione, i requisiti di qualita', sicurezza ed efficacia siano ancora presenti. In adeguamento alla lista degli Standard Terms della Farmacopea Europea e' inoltre autorizzata la modifica della denominazione delle confezioni: da: AIC n. 022991 057 "0,5% soluzione da nebulizzare" flacone da 15 ml a: AIC n. 022991 057 "5mg/ml soluzione da nebulizzare" flacone da 15 ml e da: AIC n. 022991 158 "100 mcg/spruzzo sospensione pressurizzata per inalazione" contenitore sotto pressione per 200 spruzzi a: AIC n. 022991 158 "100 microgrammi/spruzzo sospensione pressurizzata per inalazione" contenitore sotto pressione per 200 spruzzi Le modifiche devono essere apportate immediatamente per il Riassunto delle Caratteristiche del Prodotto mentre per il Foglio Illustrativo ed Etichettatura entro e non oltre sei mesi dalla pubblicazione nella Gazzetta Ufficiale della Repubblica italiana della presente determinazione. In ottemperanza all'art. 80, commi 1 e 3, del decreto...
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