Gentium S.p.A. to Present Oral Explanations to European Medicines Agency's CHMP for Defibrotide MAA

Published: Sep 11, 2012

VILLA GUARDIA, Italy, Sept. 11, 2012 (GLOBE NEWSWIRE) -- Gentium S.p.A. (Nasdaq:GENT) (the "Company") announced today that it has been asked to present Oral Explanations on September 19, 2012 to the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP") as part of the review process of 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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