FIDIA FARMACEUTICI S.P.A. - Modifica di un'AIC di medicinale per uso umano apportata ai sensi del D.Lvo 219/2006 e s.m.i.
Modifica di un'AIC di medicinale per uso umano apportata ai sensi del D.Lvo 219/2006 e s.m.i. Titolare: FIDIA Farmaceutici S.p.A. - Via Ponte della Fabbrica 3/A - 35031 Abano Terme PD Medicinale: TAZIDIF (AIC 036495) Codice confezioni: 036495012 - 036495024 - 036495036 - 036495048 Codice pratica: N1B/2012/2657 Modifica apportata ai sensi del Regolamento (CE) n. 1234/2008/CE: Raggruppamento di variazioni: n. 1 variazione IB n. B.III.1.a)1 Presentazione di un certificato di conformita' alla Farmacopea Europea nuovo per una sostanza attiva da un fabbricante gia' approvato - n. 3 variazioni IA n. B.III.1.a.2) Presentazione di un certificato di conformita' alla Farmacopea Europea aggiornato per una sostanza attiva da un fabbricante gia' approvato Orchid Chemicals &
Pharmaceuticals Ltd. (India) (da DMF all'ultima versione aggiornata del CEP R1-CEP 2005-028-Rev.01) - n. 1 variazione IB n. B.II.b.1 Aggiunta di un sito di fabbricazione per una parte o per la...
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