COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario «Rapidexon». (14A05091)
Estratto del provvedimento n. 512 del 13 giugno 2014 Medicinale veterinario: "RAPIDEXON". Confezioni e numeri A.I.C.: flacone da 25 ml - AIC n. 103870010;
flacone da 30 ml - A.I.C. n. 103870022;
flacone da 50 ml - A.I.C. n. 103870034;
flacone da 100 ml - A.I.C. n. 103870046. Titolare: Eurovet Animal Health B.V Handelsweg 25 - 5531 AE Bladel - Paesi Bassi. Modifica: Variazione tipo IAIN - Modifica del riassunto delle caratteristiche del prodotto, dell'etichettatura o del foglio illustrativo in ottemperanza all'esito di una procedura di referral europeo (Decisione di esecuzione della Commissione del 18 ottobre 2013), secondo l'art. 35, della direttiva 2001/82/CE riguardante il medicinale veterinario Dexadreson e i relativi prodotti generici contenenti il principio attivo "Desametasone". Si autorizza, per il medicinale veterinario indicato in oggetto, la variazione tipo IAIN concernente la modifica dei paragrafi 4.2, 4.9 e 4.11 del riassunto delle caratteristiche del prodotto (RCP) e delle relative sezioni delle etichette e foglietto illustrativo, conformemente all'allegato III della decisione di esecuzione della Commissione EU del 18 ottobre 2013. Per effetto delle suddette variazioni gli stampati devono essere modificati come segue: Punto 4.2 "Indicazioni...
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