Pierre Fabre 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 decreto legislativo 29 dicembre 2007, n. 274. Modifica apportata ai sensi del regolamento n. 1084/2003/CE).
Titolare: Pierre Fabre Italia S.p.a., via G.G. Winckelmann n. 1, 20146 Milano.
Specialita' medicinale: ISORIAC.
Confezioni e numeri di A.I.C.: capsula molle da 10 mg e 20 mg A.I.C. n. 037551/M per tutte le confezioni autorizzate: 28, 30, 50, 56, 60 capsule molli.
Numero di procedura MRP FR/H/250/02-03/IB/13:
IB 17.a Modifica del retest-period del principio attivo da 12 a 36 mesi.
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