COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Ambisome». (14A02043)
Estratto determinazione V &
A/410 del 25 febbraio 2014 Titolare A.I.C.: GILEAD SCIENCES S.r.l. con sede legale e domicilio fiscale in via Marostica, 1 - 20146 - Milano (MI) codice fiscale n. 11187430159 Medicinale: AMBISOME. Variazione AIC: 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 (compresi quelli fabbricati secondo un metodo asettico), ad esclusione dei medicinali biologici/immunologici B.II.b.3.z) Modifica nel procedimento di fabbricazione del prodotto finito, compreso un prodotto intermedio utilizzato per la fabbricazione del prodotto finito Altra variazione Adeguamento Standard Terms L'autorizzazione all'immissione in commercio e' modificata come di seguito indicata: Sono autorizzate le modifiche come di seguito riportato: Tipo IB - B.II.b.1 Aggiunta di una sito di fabbricazione per una parte del procedimento di fabbricazione del prodotto finito: f) Sito in cui sono effettuate tutte le operazioni ad eccezione della liberazione dei lotti, del controllo dei lotti e dell'imballaggio secondario per i medicinali sterili fabbricati secondo un metodo asettico (Aggiunta del produttore alternativo Jubilant Hollister-Stier Laboratories LCC (JHS) per le fasi di filtrazione finale, riempimento e liofilizzazione dei flaconcini di Ambisome). Parte di provvedimento in formato...
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