Ondexxya (andexanet alfa)
ConditionalAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- andexanet alfa
- Company
- AstraZeneca AB
- Status
- Authorised
- Therapeutic area
- Drug-Related Side Effects and Adverse Reactions
- CHMP opinion
- Thu 28 Feb 2019
- EU approval
- Fri 26 Apr 2019
- Designations
- Conditional, Additional monitoring
- Application
- EMEA/H/C/004108
- ATC
- V03AB
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.