COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Prolastin» (14A02804)
Estratto determinazione V &
A/505 del 13 marzo 2014 Specialita' Medicinale: PROLASTIN Confezioni: relativamente alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di Mutuo Riconoscimento Titolare AIC: Instituto Grifols S.A. N° Procedura Mutuo Riconoscimento: DE/H/0472/001/II/026/G Tipo di Modifica: 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 di fabbricazione, ad eccezione del rilascio dei lotti, del controllo dei lotti e del confezionamento secondario, o destinato alle forme farmaceutiche prodotte attraverso procedimenti di fabbricazione complessi) B.I.a.1.e (Modifica del fabbricante di una materia prima, di un reattivo o di un prodotto intermedio utilizzati nel procedimento di fabbricazione di un principio attivo o modifica del fabbricante del principio attivo (compresi eventualmente i siti di controllo della qualita'), per i quali non si dispone di un certificato di conformita' alla farmacopea europea;
La modifica riguarda un principio attivo biologico o una materia prima, un reattivo o un prodotto intermedio utilizzati nella fabbricazione di un prodotto biologico o immunologico) 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) Modifica Apportata: Modifica del Produttore del principio attivo da: Grifols Therapeutics, Inc. 8368 US 70 Bus Hwy W, Clayton, North Carolina, USA 27520 a: 1) Grifols Therapeutics, Inc. 8368 US 70 Bus Hwy W, Clayton, North Carolina, USA 27520 2) Produttore del principio attivo a partire dalla Frazione IV: Instituto...
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