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Gentium receives marketing authorization for Defitelio (R) for the treatment of severe hepatic veno-occlusive disease.
Gentium S.p.A. has reported that the European Commission has granted a marketing authorization for Defitelio (R)(defibrotide) for the treatment of severe hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem-cell transplantation therapy. Defitelio (R) is the first approved treatment in the European Union for this condition. This authorization is the formal endorsement of the positive opinion received from the EMA Committee for Human Medicinal Product on July 26, 2013. Gentium intends to begin commercialization of Defitelio (R) in the EU in December 2013.