EMA
- Status: approved
🇪🇺 Pradaxa in European Union
Pradaxa (dabigatran etexilate) regulatory status in European Union.
Marketing authorisation
Pradaxa in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in European Union
Frequently asked questions
Is Pradaxa approved in European Union?
Yes. EMA has authorised it.
Who is the marketing authorisation holder for Pradaxa in European Union?
Generic (originally Boehringer Ingelheim) is the originator. The local marketing authorisation holder may differ — check the official source linked above.