AMGEN DOMPE' S.P.A. -
Modifica secondaria di una autorizzazione all'immissione in commercio (AIC) di medicinale per uso umano, apportata ai sensi del D.L. 29 dicembre 2007, n. 274 e del Regolamento (CE) 1234/2008 Titolare AIC: Amgen Europe BV rappresentata in Italia dalla societa' Amgen Dompe' S.p.A con sede in via Enrico Tazzoli 6, Milano Medicinale: GRANULOKINE Confezioni e numeri di AIC: "30" 1 flaconcino iniettabile da 1 ml - AIC N°027772033/M "48" 1 flaconcino iniettabile da 1,6 ml - AIC N°027772045/M 1 siringa preriempita da 0,5 ml 30 MU- AIC N°027772096/M 5 siringhe preriempite da 0,5 ml 30 MU- AIC N°027772108/M 1 siringa preriempita da 0,5 ml 48 MU- AIC N°027772110/M 5 siringhe preriempite da 0,5 ml 48 MU- AIC N°027772122/M MRP UK/H/0019/001,010-011/IA/101/G Ai sensi della Determinazione AIFA 25 agosto 2011, si informa della avvenuta approvazione del seguente grouping di variazioni: 2 Variazioni Tipo IA- B.III.1b)3 Presentazione di un certificato di conformita' alla farmacopea europea relativa al rischio EST per una sostanza...
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