COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario «Immiticide», liofilizzato e solvente per soluzione iniettabile. (16A04559)
Estratto provvedimento n. 345 del 16 maggio 2016 Medicinale veterinario: IMMITICIDE, liofilizzato e solvente per soluzione iniettabile. Confezione: 5 flaconi liofilizzato da 50 mg + 5 flaconi di solvente da 2 ml - A.I.C. n. 101337018. Titolare A.I.C.: Merial Italia S.p.a. via Vittor Pisani, 16 - 20124 Milano. Oggetto del provvedimento: variazione di tipo IAin_BII e 6a. Modifica apportata ad un elemento del materiale di confezionamento (primario) che non e' in contatto con la formulazione del prodotto finito: modifica che ha un impatto sulle informazioni relative al prodotto. Si accetta, per il medicinale veterinario indicato in oggetto, la modifica come di seguito descritta: modifica del sistema di chiusura del contenitore che non e' a contatto con il prodotto finito. Per effetto della suddetta variazione il riassunto delle caratteristiche del prodotto deve essere modificato come di...
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