COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio dei medicinali per uso umano «Eurocollins Monico» e «Soluzione Cardioplegica Monico». (15A09576)
Estratto determina V&A n. 2276/2015 del 2 dicembre 2015 E' autorizzato il seguente grouping di Variazioni: 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 ai medicinali "SOLUZIONE DI EUROCOLLINS MONICO" e "SOLUZIONE CARDIOPLEGICA MONICO", nelle forme e confezioni: SOLUZIONE DI EUROCOLLINS MONICO AIC n. 030874010 - "soluzione per la conservazione di organi" flaconcino 400 ml soluzione A + flaconcino 100 ml soluzione B AIC n. 030874034 - "soluzione per la conservazione di organi" sacca 400 ml soluzione A + sacca 100 ml soluzione B AIC n. 030874046 - "soluzione per la conservazione di organi" flaconcino 400 ml soluzione A AIC n. 030874097 - "soluzione per la conservazione di organi" sacca 400 ml soluzione A AIC n. 030874109 - "soluzione per la conservazione di organi" sacca 800 ml soluzione A AIC n. 030874111 - "soluzione per la conservazione di organi" sacca 1600 ml soluzione A AIC n. 030874123 - "soluzione per la conservazione di organi" sacca 4000 ml soluzione A SOLUZIONE CARDIOPLEGICA MONICO AIC n. 030873018 - "soluzione per circolazione...
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