COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Interfos». (17A05383)
Estratto determina AAM/PPA n. 752/2017 del 12 luglio 2017 Autorizzazione della variazione relativamente al medicinale INTERFOS. Codice pratica VN2/2016/418. E' autorizzata la seguente variazione di tipo II: B.I.a.1.b) Modifica del fabbricante di una materia prima, di un reattivo o di un prodotto intermedio utilizzati nel procedimento di fabbricazione di un principio attivo o modifica del fabbricante del principio attivo (compresi eventualmente i siti di controllo della qualita'), per i quali non si dispone di un certificato di conformita' alla farmacopea europea - Introduzione di un fabbricante del principio attivo avente il sostegno di un ASMF (master file del principio attivo), relativamente al medicinale «Interfos», nelle forme e confezioni: A.I.C. n. 042195014 - «adulti 3 g granulato per soluzione orale» 1 bustina;
A.I.C. n. 042195026 - «adulti 3 g granulato per soluzione orale» 2 bustine. Aggiornamento dell'ASMF relativo al principio attivo...
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