COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario «Fosforilene Plus». (16A07250)
Estratto provvedimento n. 541 del 5 agosto 2016 Medicinale veterinario: FOSFORILENE PLUS - A.I.C. n. 101557. Titolare dell'A.I.C.: Ceva Salute Animale S.p.A., viale Colleoni, 15 - Agrate Brianza (MB). Oggetto del provvedimento: domanda di variazione di tipo II: aggiornamento del dossier di tecnica farmaceutica. Si autorizzano le modifiche del dossier di tecnica farmaceutica, in particolare: viene modificato il materiale del confezionamento primario da vetro di tipo I a vetro di tipo II (Eu.Ph.) e aggiornati i dati di stabilita' del prodotto finito su due lotti di dimensione...
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