ISTITUTO LUSO FARMACO D'ITALIA S.P.A. -
Modifica secondaria di un'autorizzazione all'immissione in commercio di specialita' medicinale per uso umano Modifica apportata ai sensi del D.L.vo 29 dicembre 2007, n. 274 Titolare: Istituto Luso Farmaco d'Italia S.p.A. Specialita' medicinale: PRASTEROL Confezioni e numeri di A.I.C.: "20 mg compresse" - 10 compresse (AIC 027776018) "40 mg compresse" - 14 compresse (AIC 027776032) Ai sensi della Determina AIFA 25 agosto 2011 si informa dell'avvenuta approvazione della seguente modifica apportata in accordo al Regolamento (CE) 1234/2008 e successive integrazioni: Grouping of variations: Tipo IA n. B.III.1.a.2 - Aggiornamento del Certificato di Conformita' alla Farmacopea europea relativo al principio attivo pravastatina (R1-CEP 2003-122-Rev 01) da parte del produttore attualmente...
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