European Medicines Agency Recommends Approval Of Novel Oral Anticoagulant, Dabigatran Etexilate (Pradaxa(R))

Boehringer Ingelheim announced that the Committee for Medicinal Products in Human Use (CHMP) of the European Medicines Agency has issued a positive opinion to recommend marketing authorisation of their novel, oral direct thrombin inhibitor, dabigatran etexilate. The CHMP recommends approval of dabigatran etexilate for the prevention of venous thromboembolic events in patients who have undergone total hip replacement surgery or total knee replacement surgery.

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Filed under: Blood on January 29th, 2008