COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Vonten» (19A08099)
Estratto determina AAM/PPA n. 997/2019 del 6 dicembre 2019 Autorizzazione delle variazioni: C.I.3.b) - Modifica dei paragrafi 4.6 e 5.3 del riassunto delle caratteristiche del prodotto;
modifiche editoriali minori e adeguamento al QRD template, relativamente al medicinale VONTEN (A.I.C. n. 040747) nelle forme e confezioni autorizzate all'immissione in commercio in Italia;
relativamente al medicinale VOLUVEN (A.I.C. n. 034660) nelle seguenti forme e confezioni autorizzate all'immissione in commercio in Italia: A.I.C. n. 034660314 - «6% soluzione per infusione» 1 flacone Pe (Kabipac) da 250 ml;
A.I.C. n. 034660326 - «6% soluzione per infusione» 10 flaconi Pe (Kabipac) da 250 ml;
A.I.C. n. 034660338 - «6% soluzione per infusione» 20 flaconi Pe (Kabipac) da 250 ml;
A.I.C. n. 034660340 - «6% soluzione per infusione» 30 flaconi Pe (Kabipac) da 250 ml;
A.I.C. n. 034660353 - «6% soluzione per infusione» 1 flaconi Pe (Kabipac) da 500 ml;
A.I.C. n. 034660365 - «6% soluzione per infusione» 10 flaconi Pe (Kabipac) da 500 ml;
A.I.C. n. 034660377 - «6% soluzione per infusione» 20 flaconi Pe (Kabipac) da 500 ml, relativamente al medicinale VOLULYTE (A.I.C. n. 038473) nelle forme e confezioni autorizzate all'immissione in commercio in Italia. Gli stampati corretti e autorizzati sono allegati alla determina di cui al presente estratto. Titolare A.I.C.: Fresenius Kabi Italia S.r.l. Codice pratica: VC2/2017/483. 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 alle etichette. 2. In...
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