COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Axil». (20A03338)
Estratto determina AAM/PPA n. 322 del 12 giugno 2020 Si autorizza la seguente variazione: tipo II C.I.4): modifica dei paragrafi 4.2, 4.4, 4.5, 4.6, 4.8, 4.9 e 5.2 del riassunto delle caratteristiche del prodotto e delle corrispondenti sezioni del foglio illustrativo per allineamento alla versione aggiornata del RSI (Reference Safety Information) aziendale;
adeguamento alla versione corrente del QRD template e alla linea guida eccipienti;
modifica delle etichette. La suddetta variazione e' relativa al medicinale AXIL nelle forme e confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura nazionale. A.I.C. n.: 027633041 - «400 mg/7ml soluzione orale» 10 contenitori monodose da 7 ml;
027633039 - «800 mg granulato per soluzione orale» 10 bustine;
Gli stampati corretti ed approvati sono allegati alla determina, di cui al presente estratto. Codice pratica: VN2/2018/92. Titolare A.I.C.: Polichem S.r.l (codice fiscale 12967130159). 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 data al foglio illustrativo e all'etichettatura. 2. In ottemperanza all'art. 80, commi 1 e 3, del decreto legislativo 24 aprile 2006, n. 219 e successive modificazioni ed integrazioni, il foglio illustrativo e le etichette devono essere redatti in lingua italiana e, limitatamente ai medicinali in commercio nella Provincia di Bolzano, anche in lingua tedesca. Il titolare dell'A.I.C. che intende...
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