GILEAD SCIENCES - S.r.l.
Modifica secondaria di un'autorizzazione all'immissione in commercio
di specialita' medicinale per uso umano. (Comunicazione Agenzia italiana del farmaco del 15 maggio 2007). Codice pratica: N1A/07/738.
Titolare Gilead Sciences S.r.l., Milano, via Marostica n. 1, codice fiscale e partita I.V.A. n. 11187430159.
Specialita' medicinale: AMBISOME.
Confezione e numero di A.I.C.:
"50 mg, polvere per soluzione per infusione" 10 flaconcini - A.I.C. n. 028581015.
Modifica apportata ai sensi del regolamento (CE) n. 1084/2003: 22a - Present. Cert. idoneita' TSE Farmac. eur. nuovo o aggiorn. per eccipiente da produttore approvato o nuovo produttore (sostit. o agg.)
Presentazione nuovo certificate of suitability TSE della Ph. Eur. R1-CEP 2001-199 Rev. 00, relativo all'eccipiente colesterolo, da parte di produttore gia' approvato...
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