COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Vimovo» (20A05478)
Estratto determina AAM/PPA n. 562/2020 del 2 ottobre 2020 Si autorizza la seguente variazione: tipo II, C.I.4, aggiornamento del riassunto delle caratteristiche del prodotto e del foglio illustrativo per l'aggiunta di una informazione sull'interazione del naprossene con basse dosi di acido acetilsalicilico e adeguamento alla linea guida eccipienti. Paragrafi impattati dalla modifica: 4.4, 4.5, 4.8 e 6.5 del riassunto delle caratteristiche del prodotto e corrispondenti paragrafi del foglio illustrativo ed etichette. Adeguamento all'ultima versione del QRD template e modifiche editoriali, relativamente al medicinale VIMOVO (A.I.C. n. 040611) nelle forme e confezioni autorizzate all'immissione in commercio in Italia. Numero procedura: NL/H/1848/001/001/II/028. Codice pratica: VC2/2019/319. Titolare A.I.C.: Astrazeneca S.p.a. (codice fiscale 00735390155). Stampati 1. I lotti del medicinale devono essere posti in commercio con gli stampati, cosi' come precedentemente autorizzati da questa Amministrazione, con le sole modifiche riportate nell'allegato alla determina (allegato 1), di cui al presente estratto. 2. 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 ed all'etichettatura. 3. 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...
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