🇪🇺 Andexanet in European Union

EMA authorised Andexanet on 26 April 2019

Marketing authorisation

EMA — authorised 26 April 2019

  • Application: EMEA/H/C/004108
  • Marketing authorisation holder: AstraZeneca AB
  • Local brand name: Ondexxya
  • Indication: For adult patients treated with a direct factor Xa (FXa) inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
  • Pathway: conditional
  • Status: approved

Read official source →

Andexanet 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 Andexanet approved in European Union?

Yes. EMA authorised it on 26 April 2019.

Who is the marketing authorisation holder for Andexanet in European Union?

AstraZeneca AB holds the EU marketing authorisation.