COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Osipine». (15A04089)
Estratto determina V&A n. 883/2015 del 13 maggio 2015 Autorizzazione della variazione relativamente al medicinale OSIPINE Procedura EU n. NL/H/0197/001-002/II/027 Variazione di tipo II: B.I.a.2.b) E' autorizzata la seguente variazione: Procedimento alternativo di fabbricazione del principio attivo (Barnidipina) utilizzando un diverso materiale di partenza. Relativamente al medicinale: «Osipine» ed alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di Mutuo riconoscimento. Titolare AIC: Astellas Pharma S.p.a. (Codice fiscale 04754860155) Smaltimento scorte...
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