COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Zariviz» (18A02177)
Estratto determina AAM/PPA n. 191/2018 del 23 febbraio 2018 C.I.4) Modifica del Riassunto delle Caratteristiche del Prodotto (paragrafi 4.2, 4.4, 4.7, 4.8, 4.9) e relativi paragrafi del Foglio Illustrativo sulla base di una revisione della letteratura e dei dati di sicurezza post-marketing;
C.I.4) Modifica del Riassunto delle Caratteristiche del Prodotto (paragrafo 4.2) e relativi paragrafi del Foglio Illustrativo a seguito di una procedura di worksharing conclusa a livello europeo (IE/H/xxxx/WS/18);
C.I.z) Aggiornamento del Foglio Illustrativo a seguito dello user testing ed adeguamento del RCP e dell'etichettatura al QRD Template (paragrafi 2, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.1, 6.2, 6.3, 6.4, 6.5, 6.6 e 9) relativamente al medicinale «ZARIVIZ» nelle seguenti forme e confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura nazionale, la cui descrizione viene modificata, per adeguamento agli standard terms, cosi' come di seguito indicato: AIC n. 024259032 - «1 g/4 ml polvere e solvente per soluzione iniettabile» 1 flaconcino polvere + 1 fiala solvente 4 ml;
AIC n. 024259044 - «1 g/4 ml polvere e solvente per soluzione iniettabile per uso intramuscolare» 1 flaconcino polvere + 1 fiala solvente 4 ml;
AIC n. 024259069 - «2 g/10 ml polvere e solvente per soluzione iniettabile per uso endovenoso» 1 flaconcino polvere + 1 fiala solvente 10 ml. Gli stampati corretti ed approvati sono allegati alla determinazione, di cui al presente estratto. Titolare AIC: Sanofi S.p.A. Codice pratica: VN2/2017/240 - VN2/2015/547 - N1B/2015/5932 Stampati 1. Il titolare dell'autorizzazione all'immissione in commercio deve apportare le modifiche autorizzate, dalla data di entrata in vigore della presente Determinazione al riassunto delle caratteristiche del prodotto;
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