Ondexxya

RSS

andexanet alfa

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 21/08/2019

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 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
Portola Netherlands B.V.
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
26/04/2019
Contact address

Prins Bernhardplein 200
1097 JB Amsterdam
The Netherlands

Product information

05/07/2019 Ondexxya - EMEA/H/C/004108 - IAIN/0001

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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

How useful was this page?

Add your rating