COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Vincristina Teva Italia» (17A01793)
Estratto determina PPA n. 140 del 16 febbraio 2017 Autorizzazione della variazione relativamente al medicinale VINCRISTINA TEVA ITALIA E' autorizzata la seguente variazione: B.II.e.1.a.3 - Modifica del confezionamento primario del prodotto finito - Composizione qualitativa e quantitativa - Medicinali sterili e medicinali biologici o immunologici. In aggiunta a quanto gia' autorizzato, si autorizza l'utilizzo dei tappi di gomma bromo butilica Omniflex 3G. relativamente alla specialita' medicinale ed alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di Mutuo Riconoscimento Procedura: NL/H/1092/001/II/022 Titolare AIC: Teva Italia S.r.l. Smaltimento scorte I lotti gia' prodotti possono...
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