COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Lenirit» (14A09222)
Estratto determina V &
A n. 2311/2014 del 4 novembre 2014 Autorizzazione della variazione: C.I.4) Modifiche concernenti la sicurezza, l'efficacia e la farmacovigilanza medicinali per uso umano e veterinario - Una o piu' modifiche del riassunto delle caratteristiche del prodotto, dell'etichettatura o del foglio illustrativo in seguito a nuovi dati in materia di qualita', preclinici, clinici o di farmacovigilanza;
C.I z) Modifiche concernenti la sicurezza, l'efficacia e la farmacovigilanza medicinali per uso umano e veterinario - Altra variazione, relativamente al medicinale LENIRIT). E' autorizzato l'aggiornamento del riassunto delle caratteristiche del prodotto ai paragrafi 2, 3, 4.2, 4.3, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 6.4, 6.5 e 6.6 e corrispondenti sezioni del foglio illustrativo, relativamente al medicinale LENIRIT, nelle forme e confezioni A.I.C. n. 025869013 - «0,5% crema» tubo da 20 g. Gli stampati corretti ed approvati sono allegati alla presente determinazione. Titolare A.I.C.: EG S.p.A. con sede legale e domicilio fiscale in via Pavia, 6 - 20136 Milano (Italia) - codice fiscale 12432150154. 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;
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 modifiche ed integrazioni, il foglio illustrativo e le etichette...
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