Praxbind (idarucizumab)
Accelerated assessment
- Region
- 🇪🇺 EU
- Active substance
- idarucizumab
- Company
- Boehringer Ingelheim International GmbH
- Status
- Authorised
- Therapeutic area
- Hemorrhage
- CHMP opinion
- Thu 24 Sep 2015
- EU approval
- Fri 20 Nov 2015
- Designations
- Accelerated assessment
- Application
- EMEA/H/C/003986
- ATC
- V03AB
- Official record
- www.ema.europa.eu
Indication
Praxbind is a specific reversal agent for dabigatran and is indicated in adult patients treated with Pradaxa (dabigatran etexilate) when rapid reversal of its anticoagulant effects is required: for emergency surgery/urgent procedures; in life-threatening or uncontrolled bleeding.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.