Gentium S.p.A. Receives Second List of Outstanding Issues From the European Medicines Agency's CHMP for Defibrotide MAA

Published: Oct 10, 2012

VILLA GUARDIA, Italy, Oct. 10, 2012 (GLOBE NEWSWIRE) -- Gentium S.p.A. (Nasdaq:GENT) (the "Company") today announced that it has received a second List of Outstanding Issues ("LoOIs") from the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP") in connection with the Company's Marketing Authorization Application ("MAA") for Defibrotide to treat and prevent hepatic veno-occlusive disease (VOD) in adults and children undergoing haematopoietic stem cell transplantation therapy.

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