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.globenewswire.com/news-release/2013/06/04/551833/10035124/en/Gentium-Provides-Update-on-Re-Examination-of-Defibrotide-MAA-to-EMA.html
http://www.globenewswire.com/news-release/2013/06/04/551833/10035124/en/Gentium-Provides-Update-on-Re-Examination-of-Defibrotide-MAA-to-EMA.html
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