COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Dotarem» (18A00464)
Estratto determina AAM/ PPA n. 1202 del 20 dicembre 2017 Autorizzazione della variazione: B.I.a.1.g) 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 nuovo fabbricante del principio attivo che non ha il sostegno di un ASMF e che richiede un aggiornamento significativo della pertinente sezione del fascicolo del principio attivo, relativamente al medicinale: DOTAREM. Numero procedura europea: NL/H/xxxx/WS/166. Titolare A.I.C.: Guerbet. E' autorizzato il seguente grouping di variazioni: Introduzione di un nuovo fabbricante del principio attivo Ossido di gadolinio: Treibacher Industrie AG - Auer von Welsbach-Straße 1 - 9330 Althofen - Austria, relativamente al medicinale «Dotarem», nelle forme e confezioni: A.I.C. n. 029724022 - «0,5 mmol/ ml soluzione iniettabile per uso endovenoso» 1 flacone 10 ml;
A.I.C. n. 029724034 - «0,5 mmol/ ml soluzione iniettabile per uso endovenoso» 1 flacone 15 ml;
A.I.C. n. 029724046 - «0,5 mmol/ ml soluzione iniettabile per uso endovenoso» 1 flacone 20 ml;
A.I.C. n. 029724059 - «0,5 mmol/ ml soluzione iniettabile per uso endovenoso» 1 siringa...
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