COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Albumina Grifols» (14A03761)
Estratto determinazione V &
A 880 del 5 maggio 2014 Titolare A.I.C.:Instituto Grifols S.A. con sede legale e domicilio in Poligono Levante Calle Can Guasch, 2 - 08150 Parets Del Valles -Barcellona (Spagna). Medicinale: ALBUMINA GRIFOLS. Variazione A.I.C.: B.II.b.1.c 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 della liberazione dei lotti, del controllo dei lotti e del confezionamento secondario, o destinato alle forme farmaceutiche prodotte attraverso procedimenti di fabbricazione complessi. L'autorizzazione all'immissione in commercio e' modificata come di seguito indicata: E' autorizzata la modifica relativa all'introduzione dell'officina Grifols Biologicals Inc. Los Angeles (USA) (di seguito GBI) per la produzione della Frazione V utilizzata come starting material del medicinale Albumina Grifols 5% (100 ml, 250 ml e 500 ml), 20% (50 ml e 100 ml) e 25% (50 ml e 100 ml). Grifols Biologicals Inc., 5555 Valley Boulevard, Los Angeles, CA, 90032 USA. Il sito GBI sara' utilizzato come sito di produzione alternativo a Instituto Grifols, S.A. (di seguito IB), gia' autorizzato all'intera produzione di Albumina Grifols, a partire dal plasma. La variazione modifica il modulo 3.2.P.3.1 del CTD Da: 1. Instituto Grifols, SA Poligono Levante, c/Can Guasc, 2 - 08150 Parets...
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