COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Actilyse» (20A03384)
Estratto determina AAM/PPA n. 324 del 12 giugno 2020 Si autorizza il seguente grouping di variazioni tipo II: una variazione B.I.a.1.j) + tre variazioni B.II.b.2.a) + una variazione B.II.b.2.b), aggiunta di due siti per l'esecuzione delle prove di stabilita' (diversi parametri) sul principio attivo e sulle componenti, liofilizzato e solvente, del prodotto finito. Il suddetto grouping di variazioni e' relativo al medicinale ACTILYSE nelle seguenti forme e confezioni autorizzate all'immissione in commercio in Italia. Confezioni e numeri A.I.C.: 026533051 - «20 mg/20 ml polvere e solvente per soluzione iniettabile per infusione» 1 flaconcino polvere + 1 flaconcino solvente da 20 ml;
026533048 - «50 mg/50 ml polvere e solvente per soluzione iniettabile per infusione» 1 flaconcino polvere + 1 flaconcino solvente da 50 ml;
026533099 - «2 mg polvere per soluzione iniettabile per infusione» 5 flaconcini in vetro da 2 mg polvere. Numero procedura: DE/H/XXXX/WS/659. Codice pratica...
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