SANOFI-AVENTIS S.P.A. - Modifica secondaria di un'autorizzazione all'immissione in commercio di specialita' medicinale per uso umano. Modifica apportata ai sensi del Regolamento n. 1234/2008/CE
Modifica secondaria di un'autorizzazione all'immissione in commercio di specialita' medicinale per uso umano. Modifica apportata ai sensi del Regolamento n. 1234/2008/CE Titolare AIC : Genzyme Europe BV Specialita' medicinale: CELSIOR soluzione per conservazione di organi Confezioni e numeri di AIC: 4 sacche contenenti ciascuna 1 litro di soluzione - AIC n. 040594018/M Codice Pratica n. C1A/2012/3014 del 18/12/2012 - procedura n. DE/H/2218/001/DC/IAIN/004 - variazione Tipo IAIN n. B.II.b.2.b.1 - sostituzione di un fabbricante responsabile della liberazione dei lotti. Senza controllo dei lotti/prove (da: Genzyme Polyclonals S.A.S - 1541 avenue...
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