COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario «Tolfedine CS». (16A07995)
Estratto provvedimento n. 683 del 14 ottobre 2016 Medicinale veterinario TOLFEDINE CS. Confezioni: flacone da 50 ml A.I.C. n. 102502010;
flacone da 100 ml A.I.C. n. 102502022;
flacone da 250 ml A.I.C. n. 102502034. Titolare A.I.C: Vetoquinol SA - Magny Vernois - 70200 Lure (Francia). Oggetto del provvedimento: variazioni raggruppate di tipo IB, in particolare: Var. IA - B.II.b.2.c.2 Modifica delle modalita' di liberazione dei lotti e delle prove di controllo qualitativo del prodotto finito. Sostituzione o aggiunta di un fabbricante responsabile della liberazione dei lotti: con controllo dei lotti/prove. Si autorizza la modifica di seguito descritta: introduzione del sito alternativo responsabile delle operazioni di produzione, confezionamento secondario, controllo e rilascio dei lotti, di seguito riportato: Vetoquinol Biowet S. Zo. O. - ul.13/14 Kosynierow Gdyńskich 66-400 Gorzow Wielkopolski (Poland). Per effetto della suddetta variazione gli stampati sono modificati nel paragrafo «Nome e indirizzo...
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