BENEDETTI & CO. S.P.A. - Modifica secondaria di un'Autorizzazione all'Immissione in Commercio di specialita' medicinale per uso umano. Modifica apportata ai sensi del D.L.vo 29/12/2007, n. 274 e del Regolamento (CE) n. 1234/2008.
Modifica secondaria di un'Autorizzazione all'Immissione in Commercio di specialita' medicinale per uso umano. Modifica apportata ai sensi del D.L.vo 29/12/2007, n. 274 e del Regolamento (CE) n. 1234/2008. Titolare A.I.C.: Benedetti &
Co. S.p.A. Specialita' medicinale ASTON (037444015) "70 mg compresse rivestite con film" 4 compresse. Codice Pratica N1B/2012/1882. Singola Variazione Tipo IB foreseen C.I.3.a). Modifica apportata: aggiornamento di SPC e PIL in linea con la nota RNF del 04/07/2012. E' autorizzata la modifica degli stampati richiesta (paragrafi 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9 e 5.1 del Riassunto delle Caratteristiche del Prodotto e corrispondenti paragrafi del Foglio Illustrativo) relativamente alla specialita' sopra indicata e la responsabilita' si ritiene affidata alla Azienda titolare dell'AIC. I lotti gia' prodotti non potranno piu' essere dispensati al pubblico a decorrere dal 120°...
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