Is Idarucizumab registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Idarucizumab, including PRAXBIND 50 mg/ml Solution For Injection/Infusion (50 mg/ml, Solution for injection/infusion, SAR 9115.10).

Is Idarucizumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Idarucizumab, including PRAXBIND (Prescription).

Is Idarucizumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Idarucizumab: Praxbind.

Are there safety signals or safety updates for Idarucizumab?

EMA PRAC: 1 entry; US FDA: 1 entry (latest 2026-09-03).

Active substance

Idarucizumab

SFDA 1
US FDA 1
EMA 1
Health Canada 1
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
PRAXBIND 50 mg/ml Solution For Injection/Infusion	50 mg/ml	Solution for injection/infusion · Intravenous use	2 Vial	SAR 9115.10	Biological · Prescription	BOEHRINGER INGELHEIM	Valid

Indications — CHI Daman Drug Formulary

ATRIAL FIBRILLATION; VENOUS THROMBOEMBOLISM DISEASE (VTE)-LIFE-THREATENING BLEEDING DUE TO ANTICOAGULANTS

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
PRAXBIND	2.5G/50ML	injectable · injection	BOEHRINGER INGELHEIM	Prescription	16 Oct 2015

EMA European Union — centrally authorised medicines

Praxbind Boehringer Ingelheim International GmbH · Authorised · authorised 20 Nov 2015 · ATC V03AB

Therapeutic indication (EMA)

Praxbind is a specific reversal agent for dabigatran and is indicated in adult patients treated with Pradaxa (dabigatran etexilate) when rapid reversal of its anticoagulant effects is required: for emergency surgery/urgent procedures; in life-threatening or uncontrolled bleeding.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
PRAXBIND	02454343	50 MG / ML	SOLUTION · INTRAVENOUS	BOEHRINGER INGELHEIM (CANADA) LTD LTEE

Safety signals and safety-related labeling changes

EMA PRAC 3 Sep 2026 PRAC signal: Disseminated intravascular coagulation
Action for MAH: update of the product information: No
US FDA 12 Apr 2018 PRAXBIND — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations

All safety entries for idarucizumab →

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.