COMUNICATO - Rinnovo dell'autorizzazione all'immissione in commercio, secondo procedura decentrata, del medicinale per uso umano «Losartan Mylan», con conseguente modifica stampati. (15A07708)
Estratto determina FV n. 221/2015 del 29 settembre 2015 Medicinale: LOSARTAN MYLAN Codice AIC: 041565 Dosaggio/Forma Farmaceutica "12,5 mg compresse rivestite con film" "50 mg compresse rivestite con film" "100 mg compresse rivestite con film" Titolare AIC: MYLAN S.P.A. Procedura Decentrata NO/H/0185/001,003,004/R/001 con scadenza il 27/06/2014 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. E' approvata altresi' la variazione NO/H/0185/001,003,004/IB/008 - C1B/2014/2884, relativa all'aggiornamento del Riassunto delle Caratteristiche del Prodotto e del Foglio Illustrativo. 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 legislativo 24 aprile 2006, n. 219 e s.m.i. il foglio illustrativo e le etichette devono essere redatti in lingua italiana e, limitatamente ai medicinali in commercio nella provincia di Bolzano, anche in lingua tedesca. Il Titolare dell'AIC che intende avvalersi...
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