Is Fomepizole registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Fomepizole, including Fomepizole BOS (1 g/ml, Solution for injection/infusion, SAR 6655.00); Fomepizole Injection (1 g/ml, Concentrate for solution for infusion, SAR 2767.85).

Is Fomepizole approved by the US FDA?

Drugs@FDA lists 6 application product lines for Fomepizole, including FOMEPIZOLE (Prescription); FOMEPIZOLE (Prescription); FOMEPIZOLE (Prescription); FOMEPIZOLE (Prescription); ANTIZOL (Discontinued).

Is Fomepizole on the WHO Model List of Essential Medicines?

Yes — 4.2. Antidotes and other substances used in poisonings > Specific (complementary list): Harmful effects of or exposure to noxious substances, chiefly nonmedicinal as to source, not elsewhere classified.

Are there safety signals or safety updates for Fomepizole?

US FDA: 1 entry (latest 2020-12-23).

Active substance

Fomepizole

SFDA 2
US FDA 6
Health Canada 2
WHO EML 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Fomepizole BOS	1 g/ml	Solution for injection/infusion · Intravenous use	2 Vial	SAR 6655.00	Generic · Prescription	Boston Oncology Arabia	Valid
Fomepizole Injection	1 g/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 2767.85	Generic · Prescription	Navinta LLC	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
FOMEPIZOLE	1.5GM/1.5ML (1GM/ML)	injectable · injection	AM REGENT	Prescription	14 Dec 2007
FOMEPIZOLE	1.5GM/1.5ML (1GM/ML)	injectable · injection	MYLAN INSTITUTIONAL	Prescription	3 Mar 2008
FOMEPIZOLE	1.5GM/1.5ML (1GM/ML)	injectable · injection	NAVINTA LLC	Prescription	6 Mar 2008
FOMEPIZOLE	1.5GM/1.5ML (1GM/ML)	injectable · injection	GLAND	Prescription	6 Jul 2023
ANTIZOL	1.5GM/1.5ML (1GM/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	PAR PHARM INC	Discontinued	4 Dec 1997
FOMEPIZOLE	1.5GM/1.5ML (1GM/ML)	injectable · injection	MYLAN INSTITUTIONAL	Discontinued	7 Apr 2009

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ANTIZOL	02242980	1 G / ML	LIQUID · INTRAVENOUS	KNIGHT THERAPEUTICS INC.
FOMEPIZOLE FOR INJECTION	02435667	1 G / ML	SOLUTION · INTRAVENOUS	STERIMAX INC

WHO WHO Model List of Essential Medicines (2025)

4.2. Antidotes and other substances used in poisonings > Specific · complementary
Harmful effects of or exposure to noxious substances, chiefly nonmedicinal as to source, not elsewhere classified
Parenteral > General injections > IV: 5 mg per mL in 20 mL ampoule or vial (sulfate); 1 g per mL in 1.5 mL ampoule or vial (base)

Safety signals and safety-related labeling changes

US FDA 23 Dec 2020 ANTIZOL — safety-related labeling change
Labeling sections changed: Warnings and Precautions

All safety entries for fomepizole →

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.