20 May 2016 - The TGA approved idarucizumab (Praxbind) on 11 May 2016.

Praxbind has been approved for use as a specific reversal agent in patients treated with dabigatran etexilate when rapid reversal of the anticoagulant effects is required for emergency surgery/urgent procedures and in life-threatening or uncontrolled bleeding.

Praxbind was approved by the FDA on 16 October 2015, the European Commision on 20 November 2015 and Health Canada on 29 April 2016.

For more details, go to: https://www.tga.gov.au/prescription-medicines-registration-new-chemical-entities-australia