COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Clexane T». (16A00197)
Estratto determina V&A n. 2480/2015 del 30 dicembre 2015 E' autorizzata la seguente variazione: B.II.b.4.f Modifica della dimensione del lotto (comprese le categorie di dimensione del lotto) del prodotto finito La scala per un medicinale biologico o immunologico e' aumentata/diminuita senza modifica del procedimento (ad esempio duplicazione di una linea), B.II.b.5.c Modifica delle prove in corso di fabbricazione o dei limiti applicati durante la fabbricazione del prodotto finito Soppressione di una prova non significativa in corso di fabbricazione, B.II.e.4.c Modifica della forma o delle dimensioni del contenitore o della chiusura Medicinali sterili, 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, B.II.b.5 z) Modifica delle prove in corso di fabbricazione o dei limiti applicati durante la fabbricazione del prodotto finito - Altra variazione, 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.2.c)3 Modifiche a livello di importatore, di modalita' di rilascio dei lotti e di 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 per un medicinale biologico/immunologico, e tutti i metodi di prova applicati...
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