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.drugs.com/clinical_trials/gentium-provides-update-re-examination-defibrotide-maa-ema-15660.html?
http://www.drugs.com/clinical_trials/gentium-provides-update-re-examination-defibrotide-maa-ema-15660.html?
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