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Tuesday, June 4, 2013

Gentium Requests Re-Examination of Negative Opinion of Defibrotide MAA by EMA

Gentium S.p.A. announced today that, the Company has filed the documentation requesting a Re-examination of the negative opinion given by the European Medicines Agency's Committee for Medicinal Products for Human Use , regarding the Marketing Authorisation for Defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children ... (more)

http://www.benzinga.com/news/13/06/3644822/gentium-requests-re-examination-of-negative-opinion-of-defibrotide-maa-by-ema

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