🇪🇺 DABIGATRAN ETEXILATE in European Union

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE) regulatory status in European Union.

Marketing authorisation

EMA

  • Application: EMEA/H/C/000829
  • Local brand name: Pradaxa
  • Status: approved

DABIGATRAN ETEXILATE in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is DABIGATRAN ETEXILATE approved in European Union?

Yes. EMA has authorised it.

Who is the marketing authorisation holder for DABIGATRAN ETEXILATE in European Union?

Marketing authorisation holder not available in our data.