Gilead Sciences - S.r.l.
Modifica secondaria di un'autorizzazione all'immissione in commercio di una specialita' medicinale per uso umano. (Modifica apportata ai sensi del decreto legislativo 29 dicembre 2007, n. 274).
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 n. 1084/2003/CE:
I.A: n. 15a - Presentazione di un certificato di idoneita' della Farmacopea europea aggiornato relativo al principio attivo amfotericina B (R1-CEP2002-079-Rev02) da parte di un produttore attualmente approvato.
I lotti gia' prodotti alla data della...
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