COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario «Pracetam 200 mg/ml», soluzione per uso in acqua da bere per suini. (17A02071)
Estratto provvedimento n. 55 del 10 febbraio 2017 Medicinale veterinario «Pracetam 200 mg/ml» soluzione per uso in acqua da bere per suini. Confezioni: A.I.C. n. 104215013-025-037-049. Titolare dell'A.I.C.: Ceva Salute Animale S.p.A., viale Colleoni, 15 - 20864 Agrate Brianza (MB). Oggetto del provvedimento: numero procedura europea: FR/V/0181/001/IB/011/G. Si autorizzano le modifiche di seguito descritte: l'aggiunta della societa' Ceva Sante Animale, Zone Industrielle Tres le Bois - 22603 Loudeac (Francia) come sito responsabile della produzione, del confezionamento primario e secondario e del rilascio dei lotti del prodotto finito;
l'eliminazione della societa' Ceva Sante Animale, 200 avenue de Mayenne, Zone Industrielle des Touches - 53000 Laval (Francia) come sito responsabile del confezionamento secondario e del rilascio dei lotti del prodotto finito;
l'eliminazione della societa' Vetoquinol Biowet, 66-400 Gorzow Wielkopolski - Ponogne come sito responsabile del confezionamento secondario;
l'aggiunta della societa' Ceva Sante Animale, Boulevard de la Communication, Zone Autoroutiere - 53950 Louverne (Francia) come sito responsabile del rilascio dei lotti e del prodotto finito;
l'aggiunta della societa' Ceva Sante Animale. 3 Avenue des Cypres - 53950 Louverne (Fancia) come sito responsabile del confezionamento secondario;
le modifiche minori al processo di produzione del prodotto finito relativamente al nuovo sito di Ceva Sante...
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