Is Andexanet alfa registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Andexanet alfa.

Is Andexanet alfa authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Andexanet alfa: Ondexxya.

Are there safety signals or safety updates for Andexanet alfa?

EMA PRAC: 3 entries (latest 2020-05-14).

Active substance

Andexanet alfa

SFDA 1
EMA 1
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Andexxa	200 mg	Powder for solution for infusion · Intravenous use	4 Vial	SAR 46282.50	Biological · Prescription	AstraZeneca AB	Suspended · Not Marketed

EMA European Union — centrally authorised medicines

Ondexxya AstraZeneca AB · Authorised · authorised 26 Apr 2019 · ATC V03AB

Therapeutic indication (EMA)

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.

Safety signals and safety-related labeling changes

EMA PRAC 14 May 2020 PRAC signal: Erroneous assay results for levels of anti-factor Xa activity with use of andexanet alfa
Action for MAH: update of the product information: No
EMA PRAC 17 Apr 2020 PRAC signal: Erroneous assay results for levels of anti-factor Xa activity with use of andexanet alfa
Action for MAH: update of the product information: Yes
EMA PRAC 28 Nov 2019 PRAC signal: Erroneous assay results for levels of anti-factor Xa activity with use of andexanet alfa
Action for MAH: update of the product information: No

All safety entries for andexanet alfa →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.