COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Cernevit» (20A03339)
Estratto determina AAM/PPA n. 321 del 12 giugno 2020 Si autorizza il seguente grouping di variazioni: tipo II B.II.b.1.c) + IA A7) + IAin B.IV.1.b), aggiunta di un sito responsabile per la produzione completa del prodotto finito (ad esclusione del confezionamento secondario, controllo e rilascio dei lotti), con relative modifiche di processo e controlli in corso di processo, eliminazione di un sito di fabbricazione del prodotto finito ed eliminazione di una linea di produzione. Soppressione del dispositivo di somministrazione «BIO-SET» e delle relative confezioni: A.I.C. n.: 027959030 - «polvere per soluzione iniettabile» 1 flaconcino + dispositivo bio-set;
027959042 - «polvere per soluzione iniettabile» 10 flaconcini + dispositivo bio-set. Modifica dei paragrafi 6.5, 6.6 e 8 del riassunto delle caratteristiche del prodotto, delle corrispondenti sezioni del foglio illustrativo e delle etichette. Il suddetto grouping di variazioni e' relativo al medicinale CERNEVIT nelle forme e confezioni autorizzate al commercio in Italia a seguito di procedura nazionale. A.I.C. n.: 027959016 - «polvere per soluzione iniettabile» 1 flaconcino;
027959028 - «polvere per soluzione iniettabile» 10 flaconcini. Codice pratica: VN2/2018/201. Titolare A.I.C.: Baxter S.p.a. (codice fiscale 00492340583). Stampati 1. Il titolare dell'autorizzazione all'immissione in commercio deve apportare le modifiche autorizzate, dalla data di entrata in vigore della presente determina al riassunto delle caratteristiche del prodotto;
entro e non oltre i sei mesi dalla medesima al foglio illustrativo e all'etichettatura. 2. In...
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