Therabel GiEnne Pharma S.p.A.
Modifica secondaria di un'autorizzazione all'immissione in commercio
di specialita' medicinale per uso umano. Comunicazione Agenzia
Italiana del Farmaco n. AIFA.AIC/128894 del 18/12/2007 - Codice
Pratica n.° N1A/07/2319.
Specialita' medicinale: GADRAL
Confezione e numero di AIC:
"800 mg compresse masticabili" 40 compresse - A.I.C. 033232012.
Modifica apportata ai sensi del Regolamento (CE) 1084/2003 (Decreto Legislativo 24/4/06 n. 219, art. 35). Variazione di tipo IA n. 37.a Inasprimento dei limiti delle specifiche del prodotto finito - titolo magaldrato:
DA: maggiore/uguale 720 mg - minore/uguale 840 mg (maggiore/uguale 90% - minore/uguale 105%)
A: maggiore/uguale 760 mg - minore/uguale 840 mg (maggiore/uguale 95% - minore/uguale 105%)
I lotti gia' prodotti...
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