Valeant Pharmaceuticals Germany Gmbh
Modifica secondaria di un'autorizzazione all'immissione in commercio di specialita' medicinale per uso umano. (Modifica apportata ai sensi del decreto legislativo 29 dicembre 2007, n. 274. Modifica apportata ai sensi del regolamento n. 1084/2003/CE).
Titolare: Valeant Pharmaceuticals Germany Gmbh Dusseldorfer Strasse 40A, D-65760 Eschborn, Germania.
Specialita' medicinale: LIBRAX.
Confezione e numero di A.I.C.:
20 compresse rivestite da 2.5 mg/5 mg - A.I.C. n. 019711035.
IA.32. Modifica della dimensione dei lotti del prodotto finito:
aumento della dimensione originale del lotto approvata al momento della concessione dell'autorizzazione all'immissione in commercio da 300 kg a 437.5 kg.
I lotti gia' prodotti sono mantenuti in commercio...
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