EMA — authorised 20 November 2015
- Marketing authorisation holder: Boehringer Ingelheim International GmbH
- Status: approved
🇪🇺 Praxbind in European Union
EMA authorised Praxbind on 20 November 2015
Marketing authorisations
EMA — authorised 20 November 2015
- Application: EMEA/H/C/003986
- Marketing authorisation holder: Boehringer Ingelheim International GmbH
- Local brand name: Praxbind
- 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.
- Pathway: accelerated assessment
- Status: approved
Praxbind in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in European Union
Frequently asked questions
Is Praxbind approved in European Union?
Yes. EMA authorised it on 20 November 2015; EMA authorised it on 20 November 2015.
Who is the marketing authorisation holder for Praxbind in European Union?
Boehringer Ingelheim International GmbH holds the EU marketing authorisation.