Ondexxya
andexanet alfa
Table of contents
Overview
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.
-
List item
Ondexxya : EPAR - Medicine overview (PDF/141.61 KB)
First published: 27/06/2019
EMA/161566/2019 -
-
List item
Ondexxya : EPAR - Risk-management-plan summary (PDF/121.38 KB)
First published: 27/06/2019
Last updated: 23/06/2021
Authorisation details
Product details | |
---|---|
Name |
Ondexxya
|
Agency product number |
EMEA/H/C/004108
|
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 |
V03AB
|
Additional 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 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
|
Revision |
15
|
Date of issue of marketing authorisation valid throughout the European Union |
26/04/2019
|
Contact address |
AstraZeneca AB |
Product information
30/05/2023 Ondexxya - EMEA/H/C/004108 - IB/0039
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.