COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario «Baytril 10% soluzione orale». (14A03909)
Estratto del provvedimento n. 384 del 29 aprile 2014 Oggetto: Medicinale veterinario BAYTRIL 10% SOLUZIONE ORALE. Confezioni: Flacone da 5 litri per polli e tacchini - A.I.C. n. 101063016;
Flacone da 1 litri per polli e tacchini - A.I.C. n. 101063028;
Flacone da 500 ml per polli e tacchini - A.I.C. n. 101063030;
Flacone da 100 ml per polli e tacchini - A.I.C. n. 101063042. Titolare: Bayer S.p.A. con sede in Viale Certosa, 130 - 20156 Milano. Modifica: Variazione di tipo IA. C.I.1.a Viene adeguato il Riassunto delle caratteristiche del prodotto, dell'etichettatura/foglio illustrativo in linea con la Decisione di Esecuzione della Commissione «C(2014)1484 final» del 28 febbraio 2014, riguardante, nel contesto dell'art. 35 della Direttiva 2001/82/CE, le autorizzazioni all'immissione in commercio dei medicinali veterinari contenenti enrofloxacina da somministrare a polli e/o tacchini con l'acqua di bevanda. Per effetto della suddetta variazione gli stampati saranno modificati come segue: Il riassunto delle caratteristiche del prodotto viene modificato nei punti 4.2, 4.3, 4.4, 4.9, 4.11, 5.1 e l'etichetta/foglio illustrativo nei relativi punti...
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