COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Yovis». (16A01001)
Estratto determina V&A n. 69/2016 del 14 gennaio 2016 E' autorizzato il seguente grouping di Variazioni: B.I.a.2 z) Modifiche nel procedimento di fabbricazione del principio attivo - Altra variazione, B.II.b.4 b) Modifica della dimensione del lotto (comprese le categorie di dimensione del lotto) del prodotto finito - Sino a 10 volte inferiore, 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.II.b.3.a) Modifica nel procedimento di fabbricazione del prodotto finito, compreso un prodotto intermedio utilizzato per la fabbricazione del prodotto finito Modifica minore nel procedimento di fabbricazione, 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.I.a.3.b) Modifica della dimensione del lotto (comprese le classi di dimensione del lotto) del principio attivo o del...
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