COMUNICATO - Modificazione dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario «Amikavet». (14A07349)
Estratto del provvedimento n. 710 del 28 agosto 2014 Medicinale veterinario: AMIKAVET. Confezioni: flacone da 50 ml - A.I.C. n. 101319085;
flacone da 100 ml - A.I.C. n. 101319097;
flacone da 250 ml - A.I.C. n. 101319109. Titolare: Merial Italia S.p.A., via Vittor Pisani, 16 - 20124 Milano. Variazione di tipo IA B.II.b.2 c2. Modifica delle modalita' di liberazione dei lotti e delle prove di controllo qualitativo del prodotto finito. Sostituzione di un fabbricante responsabile della liberazione dei lotti: con controllo dei lotti/prove. Si autorizza, per il medicinale veterinario indicato in oggetto, la variazione di cui sopra. Per effetto della suddetta variazione il paragrafo nome e indirizzo del titolare dell'autorizzazione all'immissione in commercio alla produzione responsabile del rilascio lotti di fabbricazione, se diversi del foglietto illustrativo, delle etichette interne ed esterne, e' modificato come segue: «Produttore e responsabile rilascio lotti: Izo S.r.l., strada statale 234 -...
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