COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario ad azione immunologica «Rabigen Mono». (16A02382)
Estratto provvedimento n. 156 del 24 febbraio 2016 Medicinale veterinario ad azione immunologica RABIGEN MONO Confezioni: A.I.C. n. 100181 Titolare A.I.C.: Virbac 1ere Avenue 2065 m - LID 06516 Carros Cedex Francia Oggetto del provvedimento: Variazioni tipo II: - B.II.a.3.b.3: Modifiche nella composizione (eccipienti) del prodotto finito. Altri eccipienti. Modifica concernente un medicinale biologico/immunologico (eliminazione del conservante mercurio tiolato) - C.I.4: Una o piu' modifiche del Riassunto delle caratteristiche del prodotto, dell'etichettatura o del foglio illustrativo in seguito a nuovi dati sulla qualita', preclinici, clinici o di farmacovigilanza. - C.I.6a: Modifica o modifiche della o delle indicazioni terapeutiche. Aggiunta di una nuova indicazione terapeutica o modifica di un'indicazione approvata. Si autorizzano le modifiche di seguito descritte: - Eliminazione del conservante Tiomersale dalla composizione del medicinale immunologico prodotto in confezione monodose (monografia Ph.Eu.0062). - Modifica dei punti 2 - 4.2 del Riassunto delle caratteristiche del prodotto. Per effetto delle suddette variazioni gli stampati devono essere modificati ai seguenti punti del RCP ed ai relativi paragrafi degli altri stampati illustrativi, come di seguito indicato: 2. Composizione qualitativa e quantitativa: Una dose (1 ml) di vaccino contiene...
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