Ondexxya
andexanet alfa · AstraZeneca AB
CONDITIONAL APPROVAL AUTHORISED IN THE EUWhat Ondexxya is used for
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.
Approved use, as published by the European Medicines Agency.
What the labels mean
- Conditional approval: approved on less complete data because the need is high; more data must follow.
Key facts
- Brand
- Ondexxya
- Active substance
- andexanet alfa
- Disease area
- Drug-Related Side Effects and Adverse Reactions
- Medicine group
- All other therapeutic products
- ATC code
- V03AB
- Marketing authorisation holder
- AstraZeneca AB
- Authorised in the EU since
- 2019
Official information
In the USA
Same active substance: Andexxa
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Ondexxya used for?
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.
What is the active substance in Ondexxya?
Ondexxya contains andexanet alfa.
Who makes Ondexxya?
The EU marketing authorisation holder is AstraZeneca AB.
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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