Boehringer Ingelheim GmbH Release: PRADAX(TM) (Dabigatran Etexilate) Gains Approval in Canada for Stroke Prevention in Atrial Fibrillation
10/27/2010 11:52:45 AM
INGELHEIM, Germany--(BUSINESS WIRE)--For Media outside the US and Canada - Health Canada, the Canadian health authority, has approved PRADAX™ (dabigatran etexilate),1 Boehringer Ingelheim’s novel, oral direct thrombin inhibitor2 for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF) in whom anticoagulation is appropriate, marking the second approval of this new oral anticoagulant following the recent marketing authorisation by the US Food and Drug Administration (FDA). The Health Canada approval makes PRADAX™ available to AF patients in Canada,1 with the flexibility of two dosing regimens. While overall the 150 mg bid dose is recommended, the 110 mg bid dose is specifically available for elderly patients aged 80 years and above as well as for patients at high risk of bleeding.