Is Atracurium registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 4 valid registrations of Atracurium, including ATACURE 25 MG per 2.5 ML (10 mg/ml, Solution for injection/infusion, SAR 26.95); ATACURE 50 MG per 5 ML (10 mg/ml, Solution for injection/infusion, SAR 46.90); Retalex (10 mg/ml, Solution for injection, SAR 26.95); Retalex 50 mg per 5 ml (10 mg/ml, Solution for injection, SAR 46.90).

Is Atracurium approved by the US FDA?

Drugs@FDA lists 24 application product lines for Atracurium, including ATRACURIUM BESYLATE PRESERVATIVE FREE (Prescription); ATRACURIUM BESYLATE (Prescription); ATRACURIUM BESYLATE PRESERVATIVE FREE (Prescription); ATRACURIUM BESYLATE (Prescription); ATRACURIUM BESYLATE (Prescription).

Is Atracurium on the WHO Model List of Essential Medicines?

Yes — 20. Muscle relaxants (peripherally-acting) and cholinesterase inhibitors (complementary (EML); core (EMLc) list): Therapeutic equivalent to vecuronium for Muscle relaxants.

Active substance

Atracurium

SFDA 14
US FDA 24
WHO EML 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ATACURE 25 MG per 2.5 ML	10 mg/ml	Solution for injection/infusion · Parenteral use	5 Ampoule	SAR 26.95	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
ATACURE 50 MG per 5 ML	10 mg/ml	Solution for injection/infusion · Parenteral use	5 Ampoule	SAR 46.90	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Retalex	10 mg/ml	Solution for injection · Intravenous use	5 Vial	SAR 26.95	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Retalex 50 mg per 5 ml	10 mg/ml	Solution for injection · Intravenous use	5 Vial	SAR 46.90	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
ATRACURIUM BESYLATE 10MG-ML AMP	10 mg/ml	Solution for injection · Parenteral use	5 Ampoule	SAR 72.55	NCE · Prescription	HOSPIRA AUSTRALIA	Withdrawn by MAH · Not Marketed
ATRACURIUM BESYLATE 10MG-ML AMP	10 mg/ml	Solution for injection · Parenteral use	5 Ampoule	SAR 31.55	NCE · Prescription	HOSPIRA AUSTRALIA	Withdrawn by MAH · Not Marketed
ATRACURIUM BESYLATE 10MG-ML AMP	10 mg/ml	Solution for injection · Parenteral use	5 Ampoule	SAR 63.15	NCE · Prescription	HOSPIRA UK LIMITED	Withdrawn by MAH · Not Marketed
ATRACURIUM BESYLATE 10MG-ML AMP	10 mg/ml	Solution for injection · Parenteral use	5 Ampoule	SAR 31.55	NCE · Prescription	HOSPIRA UK LIMITED	Withdrawn by MAH · Not Marketed
ATRACURIUM- HAMELN 10MG-ML SOLU. FOR INJ	10 mg/ml	Solution · Parenteral use	3 Ampoule	SAR 50.65	Generic · Prescription	HAMELN PHARMACEUTICALS	Withdrawn by MAH · Not Marketed
ATRACURIUM- HAMELN 10MG-ML SOLU. FOR INJ	10 mg/ml	Solution · Parenteral use	5 Ampoule	SAR 84.40	Generic · Prescription	HAMELN PHARMACEUTICALS	Withdrawn by MAH · Not Marketed
TRACRIUM 10MG\ML	10 mg/ml	Solution for injection · Parenteral use	5 Ampoule	SAR 30.90	Generic · Prescription	Aspen Pharma Trading Limited	Withdrawn by MAH · Not Marketed
TRACRIUM 10MG\ML	10 mg/ml	Solution for injection · Parenteral use	5 Ampoule	SAR 42.10	Generic · Prescription	Aspen Pharma Trading Limited	Withdrawn by MAH · Not Marketed
TRACRIUM 10MG\ML	10 mg/ml	Solution for injection · Parenteral use	5 Ampoule	SAR 46.65	Generic · Prescription	GLAXOSMITHKLINE (GSK)	Withdrawn by MAH · Not Marketed
TRACRIUM 10MG\ML	10 mg/ml	Solution for injection · Parenteral use	5 Ampoule	SAR 81.40	Generic · Prescription	GLAXOSMITHKLINE (GSK)	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ANESTHESIA

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

Product	Strength	Form · route	Applicant	Status	First approved
ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	injectable · injection	HIKMA PHARMS	Prescription	18 Jul 1997
ATRACURIUM BESYLATE	10MG/ML	injectable · injection	HIKMA PHARMS	Prescription	18 Jul 1997
ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	injectable · injection	MEITHEAL	Prescription	17 Feb 2012
ATRACURIUM BESYLATE	10MG/ML	injectable · injection	MEITHEAL	Prescription	17 Feb 2012
ATRACURIUM BESYLATE	10MG/ML	injectable · injection	HOSPIRA INC	Prescription	18 Oct 2012
ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	injectable · injection	HOSPIRA INC	Prescription	18 Oct 2012
TRACRIUM PRESERVATIVE FREE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	HOSPIRA	Discontinued	23 Nov 1983
TRACRIUM	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	HOSPIRA	Discontinued	23 Nov 1983
ATRACURIUM BESYLATE	10MG/ML	injectable · injection	HOSPIRA	Discontinued	23 Dec 1996
ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	injectable · injection	HOSPIRA	Discontinued	23 Dec 1996
ATRACURIUM BESYLATE	10MG/ML	injectable · injection	BAXTER HLTHCARE CORP	Discontinued	23 Jan 1997
ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	injectable · injection	BAXTER HLTHCARE CORP	Discontinued	23 Jan 1997
ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	injectable · injection	HOSPIRA	Discontinued	25 Mar 1997
ATRACURIUM BESYLATE	10MG/ML	injectable · injection	HOSPIRA	Discontinued	28 Mar 1997
ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	injectable · injection	HOSPIRA	Discontinued	28 Mar 1997
ATRACURIUM BESYLATE	10MG/ML	injectable · injection	TEVA PARENTERAL	Discontinued	11 Jun 1997
ATRACURIUM BESYLATE	10MG/ML	injectable · injection	BAXTER HLTHCARE	Discontinued	30 Sep 1997
ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	injectable · injection	BAXTER HLTHCARE	Discontinued	30 Sep 1997
ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	injectable · injection	WATSON LABS INC	Discontinued	28 Jul 1998
ATRACURIUM BESYLATE	10MG/ML	injectable · injection	WATSON PHARMS TEVA	Discontinued	28 Jul 1998
ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	injectable · injection	EUGIA PHARMA	Discontinued	8 Apr 2015
ATRACURIUM BESYLATE	10MG/ML	injectable · injection	EUGIA PHARMA	Discontinued	8 Apr 2015
ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	injectable · injection	PHARMOBEDIENT	Discontinued	7 Apr 2017
ATRACURIUM BESYLATE	10MG/ML	injectable · injection	PHARMOBEDIENT	Discontinued	22 Jun 2017

WHO WHO Model List of Essential Medicines (2025)

20. Muscle relaxants (peripherally-acting) and cholinesterase inhibitors · complementary (EML); core (EMLc)
Therapeutic equivalent to vecuronium for Muscle relaxants
20. Muscle relaxants (peripherally-acting) and cholinesterase inhibitors · core
Muscle relaxants
Parenteral > General injections > IV: 10 mg per mL (besylate)

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.