Gentium S.p.A. Provides Update on Re-Examination of Defibrotide MAA to EMA
6/4/2013 9:37:53 AM
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VILLA GUARDIA, Italy, June 4, 2013 (GLOBE NEWSWIRE) -- Gentium S.p.A. (Nasdaq:GENT) (the "Company") announced today that, the Company has filed the documentation requesting a Re-examination of the negative opinion given by the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP"), regarding the Marketing Authorisation (MAA) for Defibrotide to treat and prevent hepatic veno-occlusive disease ("VOD") in adults and children undergoing hematopoietic stem cell transplantation therapy. In accordance with European regulations, the CHMP has 60 days to consider a revision of the initial opinion and consequently a final recommendation may be made by the end of July.
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