Mylan - S.p.a. (ex Merck Generics Italia - S.p.a.)
Modifica secondaria di un'autorizzazione all'immissione in commercio di una specialita' medicinale per uso umano.(Modifica apportata ai sensi del regolamento (CE) n. 1084/2003).
Specialita' medicinale: CASUCAP.
Confezione e numero di A.I.C.:
"50 mg + 25 mg compresse" 12 cpr - A.I.C. n. 036770016.
(Provv. AIFA.AIC/45390 del 2 maggio 2008) Codice pratica: N1B/08/135.
Modifica n: 17. Mod. del periodo di ripetizione della prova del principio attivo. Introduzione di un retest period di 3 anni per il principio attivo captopril, prodotto presso il sito farmhispania SA.
I lotti gia' prodotti sono mantenuti in commercio fino alla data di scadenza indicata in etichetta...
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