COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Vancomicina Mylan» (14A09818)
Estratto determina V &
A n. 2425/2014 del 20 novembre 2014 E' autorizzata la seguente variazione: modifiche applicate al sito di produzione del prodotto finito «Vianex S.A. plant C (Grecia)»: aggiunta di una nuova dimensione di lotto pari a 194.0L (equivalente a 47.549 fiale) per la Vancomycina Mylan 500 mg.;
aumento della dimensione del lotto implicante alcune modifiche minori del processo di produzione: utilizzo di acqua per preparazioni iniettabili all'80% piuttosto che al 90%, per la fase di dissoluzione;
modifica dei parametri del processo di sterilizzazione delle fiale in vetro, relativamente al medicinale VANCOMICINA MYLAN ed alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento. Procedura: CZ/H/0351/001/II/005/G. Tipologia della variazione: B.II.b.4.d Modifica della dimensione del lotto (comprese le categorie di dimensione del lotto) del prodotto finito - La modifica riguarda tutte le altre forme farmaceutiche fabbricate secondo procedimenti di fabbricazione complessi - B.II.b.3.a) Modifiche qualitative...
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