andexanet alfa

This medicine is authorised for use in the European Union.


Ondexxya is a medicine used for stopping life-threatening or uncontrolled bleeding in adults taking the anticoagulant medicines apixaban or rivaroxaban.

Ondexxya contains the active substance andexanet alfa.

This EPAR was last updated on 04/07/2023

Authorisation details

Product details
Agency product number
Active substance
andexanet alfa
International non-proprietary name (INN) or common name
andexanet alfa
Therapeutic area (MeSH)
Drug-Related Side Effects and Adverse Reactions
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Conditional approvalConditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

Publication details
Marketing-authorisation holder
AstraZeneca AB
Date of issue of marketing authorisation valid throughout the European Union
Contact address

AstraZeneca AB
SE-151 85 Sodertalje

Product information

08/06/2023 Ondexxya - EMEA/H/C/004108 - II/0033

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

All other therapeutic products

Therapeutic 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.

Assessment history

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