EMA — authorised 18 March 2008
- Marketing authorisation holder: BOEHRINGER INGELHEIM INTERNATIONAL GMBH
- Status: approved
🇪🇺 Pradaxa in European Union
EMA authorised Pradaxa on 18 March 2008
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 authorised it on 18 March 2008.
Who is the marketing authorisation holder for Pradaxa in European Union?
BOEHRINGER INGELHEIM INTERNATIONAL GMBH holds the EU marketing authorisation.