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 25 luglio 2008). Codice pratica: N1A/08/1537.
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 e decreto legislativo 24 aprile 2006, n. 219, articolo 35:
(n.)22a Presentazione del certificato idoneita' TSE Farm. eur per eccipiente colesterolo da parte di nuovo produttore in sostituzione di quello precedentemente approvato: da: Solvey Pharmaceuticals BV RO-CEP 2001-199 Rev. 00; a: Dishman Netherlands BV RO-CEP 2001-199...
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