16 May 2016 - Boehringer Ingelheim (Canada) Ltd. today announced that Health Canada has approved Praxbind (idarucizumab) with conditions.
Praxbind is a specific antidote for the immediate reversal of dabigatran, and is indicated for adult patients treated with Pradaxa® (dabigatran etexilate) when rapid specific reversal of the anticoagulant effects of Pradaxa is required for emergency surgery/urgent procedure or life-threatening or uncontrolled bleeding.
The approval with conditions is based on promising evidence from clinical trials. Pradaxa is approved for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF), in whom anticoagulation is appropriate. The conditional approval of Praxbind makes Pradaxa the first and only novel oral anticoagulant (NOAC) in Canada with a specific antidote.
For more details, go to: http://www.boehringer-ingelheim.ca/en/news/press_releases/2016/16May201611.html