COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale veterinario «Ferrosil Forte». (14A06516)
Estratto del provvedimento n. 606 del 22 luglio 2014 Oggetto: medicinale veterinario FERROSIL FORTE (A.I.C. 102012). Confezioni: 034 Flacone da 50 ml;
046 Flacone da 100 ml. Titolare A.I.C.: IZO S.p.A con sede in via Bianchi 9 - 25124 Brescia - Codice fiscale n. 00291440170. Modifica: variazione di tipo IA: B.II.b.1 a) - Sostituzione o aggiunta di un sito di fabbricazione per una parte o per la totalita' del procedimento di fabbricazione del prodotto finito: sito di confezionamento secondario. Variazione di tipo IB: B.II.b.1 f) - Sostituzione o aggiunta di un sito di fabbricazione per una parte o per la totalita' del procedimento di fabbricazione del prodotto finito: sito in cui sono effettuate tutte le operazioni, ad eccezione del rilascio dei lotti, del controllo dei lotti e del confezionamento secondario, per i medicinali sterili (compressi quelli fabbricati in asepsi), ad esclusione dei medicinali biologici/immunologici. Variazione di tipo IA: B.II.b.2.c.2) - Modifica dell'importatore, della modalita' di rilascio dei lotti e delle prove di controllo qualitativo del prodotto finito. Sostituzione o aggiunta di un fabbricante responsabile dell'importazione e/o del rilascio dei lotti, compresi il controllo dei lotti/le prove. Variazione di tipo IA A.1 Modifiche del nome e/o dell'indirizzo del titolare dell'autorizzazione all'immissione in commercio. Si autorizzano le...
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