ALCON ITALIA S.P.A. -
Modifica secondaria di un'autorizzazione all'immissione in commercio di specialita' medicinale per uso umano. Modifica apportata ai sensi del Decreto Legislativo 29 dicembre 2007, n. 274. Modifiche apportate ai sensi del Regolamento (CE) 1234/2008 Specialita' medicinale VIGAMOX. Confezione "5 mg/ml collirio, soluzione" 1 flacone 5 ml - Autorizzazione all'immissione in commercio n. 039559012/M Procedura n. DE/H/1588/IA/016/G. Codice Pratica CIA/2013/647 Gruppo di 2 variazioni Tipo IAin n. C.I.z. Introduzione del Summary of Pharmacovigilance System e Tipo IA n. A.5.b) -Modifica del nome e/o dell'indirizzo del fabbricante del prodotto finito compresi i siti di controllo della qualita'. Modifica del nome del sito di sterilizzazione dei componenti del confezionamento primario da: Isotron Nederland BV a: Synergy Health Specialita' medicinale MEDIFLOX. Confezione "20 mg/100 mg...
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