COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario «Amproline 400 mg/ml», soluzione orale per uso in acqua da bere per polli e tacchini. (19A06399)
Estratto provvedimento n. 548 del 26 settembre 2019 Medicinale veterinario: AMPROLINE 400 mg/ml soluzione orale per uso in acqua da bere per polli e tacchini. Confezioni: flacone da 100 ml - A.I.C. n. 104866013;
flacone da 1 litro - A.I.C. n. 104866025;
tanica da 5 litri - A.I.C. n. 104866037. Titolare A.I.C.: Huvepharma SA 34, Rue Jean Monnet - Zi D'etriche - Segre - 49500 Segre-en- anjou Bleu - Francia. Oggetto del provvedimento: numero di procedura europea FR/V/xxxx/IA/102/G;
numero di procedura europea FR/V/xxxx/IA/103/G. Si accettano le modifiche come di seguito descritte: modifiche del nome e/o dell'indirizzo del titolare dell'autorizzazione all'immissione in commercio;
modifiche del nome e/o dell'indirizzo del fabbricante/importatore del prodotto finito (compreso il rilascio dei lotti e i siti di controllo della qualita'). Attivita' per le quali il fabbricante/importatore e' responsabile, compreso il rilascio dei lotti. Per effetto delle suddette variazioni gli stampati devono essere modificati come...
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