Gentium Receives Day 180 List of Outstanding Issues From the CHMP for Defibrotide MAA

Gentium S.p.A.

announced today that it has received the Day 180 List of Outstanding Issues from the European Medicines Agency's Committee for Medicinal Products for Human Use in connection with the Company's Marketing Authorization Application (MAA) for Defibrotide to treat and prevent hepatic veno-occlusive disease (VOD) in adults and children undergoing haematopoietic stem cell transplantation therapy.