Is Bivalirudin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Bivalirudin, including Bilvardi (250 mg, Powder for solution for injection/infusion, SAR 10012.75); Bivalirudin (250 mg, Powder for injection, SAR 10539.75); Novalir (250 mg, Powder for solution for injection/infusion, SAR 11094.50).

Is Bivalirudin approved by the US FDA?

Drugs@FDA lists 14 application product lines for Bivalirudin, including ANGIOMAX (Prescription); BIVALIRUDIN (Prescription); BIVALIRUDIN (Prescription); BIVALIRUDIN (Prescription); BIVALIRUDIN (Prescription).

Is Bivalirudin authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Bivalirudin.

Are there safety signals or safety updates for Bivalirudin?

US FDA: 1 entry; MHRA: 1 entry (latest 2018-12-21).

Active substance

Bivalirudin

SFDA 3
US FDA 14
EMA 1
Health Canada 5
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
Bilvardi	250 mg	Powder for solution for injection/infusion · Intravenous use	10 Vial	SAR 10012.75	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Bivalirudin	250 mg	Powder for injection · Intravenous use	10 Vial	SAR 10539.75	Generic · Prescription	Hainan Shuangcheng Pharmaceuticals Co. Ltd	Valid
Novalir	250 mg	Powder for solution for injection/infusion · Intravenous use	10 Vial	SAR 11094.50	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
ANGIOMAX	250MG/VIAL	injectable · intravenous	SANDOZ	Prescription	15 Dec 2000
BIVALIRUDIN	250MG/VIAL	injectable · intravenous	FRESENIUS KABI USA	Prescription	28 Oct 2016
BIVALIRUDIN	250MG/VIAL	injectable · intravenous	DR REDDYS	Prescription	26 May 2017
BIVALIRUDIN	250MG/VIAL	injectable · intravenous	ACCORD HLTHCARE	Prescription	22 Nov 2017
BIVALIRUDIN	250MG/VIAL	injectable · intravenous	MYLAN INSTITUTIONAL	Prescription	1 Jun 2018
BIVALIRUDIN	250MG/VIAL	injectable · intravenous	MEITHEAL	Prescription	16 Jul 2018
ANGIOMAX RTU	250MG/50ML (5MG/ML)	solution · intravenous	MAIA PHARMS INC	Prescription	25 Jul 2019
BIVALIRUDIN	250MG/VIAL	injectable · intravenous	SHUANGCHENG	Prescription	23 Oct 2019
BIVALIRUDIN	250MG/VIAL	injectable · intravenous	HAINAN POLY	Prescription	28 May 2021
BIVALIRUDIN	250MG/VIAL	injectable · intravenous	HOSPIRA	Discontinued	14 Jul 2015
BIVALIRUDIN	250MG/VIAL	injectable · intravenous	HOSPIRA	Discontinued	14 Jul 2015
BIVALIRUDIN	250MG/VIAL	injectable · intravenous	APOTEX	Discontinued	6 Jul 2017
BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	250MG/50ML (5MG/ML); 500MG/100ML (5MG/ML)	solution · intravenous	BAXTER HLTHCARE CORP	Discontinued	21 Dec 2017
BIVALIRUDIN	250MG/VIAL	injectable · intravenous	EUGIA PHARMA	Discontinued	27 Jul 2018

EMA European Union — centrally authorised medicines

Angiox The Medicines Company UK Ltd · Withdrawn · authorised 20 Sep 2004 · ATC B01AE06

Therapeutic indication (EMA)

Angiox is indicated as an anticoagulant in adult patients undergoing percutaneous coronary intervention (PCI), including patients with ST-segment-elevation myocardial infarction (STEMI) undergoing primary PCI. Angiox is also indicated for the treatment of adult patients with unstable angina / non-ST-segment-elevation myocardial infarction (UA / NSTEMI) planned for urgent or early intervention. Angiox should be administered with aspirin and clopidogrel.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ANGIOMAX	02246533	250 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	SANDOZ CANADA INCORPORATED
BIVALIRUDIN FOR INJECTION	02435268	250 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	FRESENIUS KABI CANADA LTD
BIVALIRUDIN FOR INJECTION	02511452	250 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	JUNO PHARMACEUTICALS CORP.
BIVALIRUDIN FOR INJECTION	02539586	250 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	FORMATIVE PHARMA INC.
BIVALIRUDIN INJECTION	02505517	5 MG / ML	SOLUTION · INTRAVENOUS	AVIR PHARMA INC.

Safety signals and safety-related labeling changes

US FDA 21 Dec 2018 ANGIOMAX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations
MHRA 11 Dec 2014 Bivalirudin: risks associated with incorrect dose
Incorrect dosage of bivalirudin in percutaneous coronary intervention can lead to major adverse cardiac events.

All safety entries for bivalirudin →

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.