COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Aggrastat». (16A06641)
Estratto determina V&A n. 1277/2016 del 29 luglio 2016 Procedura EU n.: DE/H/0141/002/II/034/G. Medicinale: AGGRASTAT. Relativamente alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento. Variazioni di Tipo IB e di Tipo II: B.II.b.4 z), B.II.b.3.d). Sono autorizzate le seguenti variazioni: modifica della dimensione del lotto da 1150L a 720L. modifica del metodo di sterilizzazione del prodotto finito. Titolare A.I.C.: Correvio (UK) LTD (Codice S.I.S. 3387). Smaltimento scorte: i lotti gia' prodotti possono essere...
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