Is Cisatracurium registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 10 valid registrations of Cisatracurium, including Bexenta (2 mg/ml, Solution for injection, SAR 69.85); CIS-TAC (2 mg/ml, Solution for injection/infusion, SAR 73.75); Cisatracurium BOS (2 mg/ml, Solution for injection/infusion, SAR 27.85); NIMBEX 2MG\ML SOLUTION FOR INJ (2 mg/ml, Solution for injection, SAR 40.95); NIMBEX 5MG\ML INJ (5 mg/ml, Solution for injection, SAR 245.85).

Is Cisatracurium approved by the US FDA?

Drugs@FDA lists 30 application product lines for Cisatracurium, including CISATRACURIUM BESYLATE PRESERVATIVE FREE (Prescription); CISATRACURIUM BESYLATE (Prescription); CISATRACURIUM BESYLATE PRESERVATIVE FREE (Prescription); CISATRACURIUM BESYLATE (Prescription); CISATRACURIUM BESYLATE (Prescription).

Are there safety signals or safety updates for Cisatracurium?

US FDA: 1 entry (latest 2022-10-14).

Active substance

Cisatracurium

SFDA 17
US FDA 30
Health Canada 2
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
Bexenta	2 mg/ml	Solution for injection · Intravenous use	5 Ampoule	SAR 69.85	Generic · Prescription	SPIMACO	Valid
CIS-TAC	2 mg/ml	Solution for injection/infusion · Intravenous use	5 Ampoule	SAR 73.75	Generic · Prescription	Fresenius Kabi Deutschland GmbH	Valid
Cisatracurium BOS	2 mg/ml	Solution for injection/infusion · Intravenous use	1 Vial	SAR 27.85	Generic · Prescription	Boston Oncology Arabia	Valid
NIMBEX 2MG\ML SOLUTION FOR INJ	2 mg/ml	Solution for injection · Intravenous use	5 Ampoule	SAR 40.95	NCE · Prescription	Aspen Pharmacare Australia Pty Ltd	Valid
NIMBEX 5MG\ML INJ	5 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 245.85	NCE · Prescription	Aspen Pharma Trading Limited	Valid
SISACURE 2MG/ML AMPOULE	2 mg/ml	Solution for injection/infusion · Intravenous use	5 Ampoule	SAR 155.70	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Salocan	2 mg/ml	Solution for injection · Intravenous use	5 Ampoule	SAR 139.30	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Salocan	2 mg/ml	Solution for injection · Intravenous use	5 Ampoule	SAR 68.90	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Traxia	2 mg/ml	Solution for injection · Intravenous use	5 Vial	SAR 65.05	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Traxia	2 mg/ml	Solution for injection/infusion · Intravenous use	5 Vial	SAR 50.00	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
CIS-TAC	2 mg/ml	Solution for injection/infusion · Intravenous use	5 Ampoule	SAR 27.65	Generic · Prescription	Fresenius Kabi Deutschland GmbH	Withdrawn by MAH · Not Marketed
NIMBEX 2MG\ML SOLUTION FOR INJ	2 mg/ml	Solution for injection · Intravenous use	5 Ampoule	SAR 163.90	NCE · Prescription	Aspen Pharmacare Australia Pty Ltd	Withdrawn by MAH · Not Marketed
NIMBEX 2MG\ML SOLUTION FOR INJ	2 mg/ml	Solution for injection · Intravenous use	5 Ampoule	SAR 37.30	NCE · Prescription	GLAXOSMITHKLINE (GSK)	Withdrawn by MAH · Not Marketed
NIMBEX 2MG\ML SOLUTION FOR INJ	2 mg/ml	Solution for injection · Intravenous use	5 Ampoule	SAR 109.40	NCE · Prescription	GLAXOSMITHKLINE (GSK)	Withdrawn by MAH · Not Marketed
NIMBEX 5MG\ML INJ	5 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 194.40	NCE · Prescription	GLAXOSMITHKLINE (GSK)	Withdrawn by MAH · Not Marketed
SISACURE 2MG/ML AMPOULE	2 mg/ml	Solution for injection/infusion · Intravenous use	5 Ampoule	SAR 32.50	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Withdrawn by MAH · Not Marketed
SISACURE 2MG/ML AMPOULE	2 mg/ml	Solution for injection/infusion · Intravenous use	5 Ampoule	SAR 19.50	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	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
CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML; EQ 10MG BASE/ML	injectable · injection	SANDOZ INC	Prescription	3 Feb 2012
CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	injectable · injection	SANDOZ INC	Prescription	3 Feb 2012
CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML; EQ 10MG BASE/ML	injectable · injection	FRESENIUS KABI USA	Prescription	26 Feb 2015
CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	injectable · injection	FRESENIUS KABI USA	Prescription	26 Feb 2015
CISATRACURIUM BESYLATE	EQ 2MG BASE/ML; EQ 10MG BASE/ML	injectable · injection	HOSPIRA	Prescription	30 Mar 2018
CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	injectable · injection	HOSPIRA	Prescription	30 Mar 2018
CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML; EQ 10MG BASE/ML	injectable · injection	SOMERSET THERAPS LLC	Prescription	20 Feb 2019
CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	injectable · injection	SOMERSET	Prescription	24 Apr 2019
CISATRACURIUM BESYLATE	EQ 2MG BASE/ML; EQ 10MG BASE/ML	injectable · injection	MEITHEAL	Prescription	25 Apr 2019
CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	injectable · injection	MEITHEAL	Prescription	25 Apr 2019
CISATRACURIUM BESYLATE	EQ 2MG BASE/ML; EQ 10MG BASE/ML	injectable · injection	ZYDUS PHARMS	Prescription	4 Nov 2019
CISATRACURIUM BESYLATE	EQ 2MG BASE/ML; EQ 10MG BASE/ML	injectable · injection	SAGENT PHARMS INC	Prescription	6 Nov 2020
CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	injectable · injection	SAGENT PHARMS INC	Prescription	6 Nov 2020
CISATRACURIUM BESYLATE	EQ 2MG BASE/ML; EQ 10MG BASE/ML	injectable · injection	PIRAMAL	Prescription	11 Mar 2022
CISATRACURIUM BESYLATE	EQ 2MG BASE/ML; EQ 10MG BASE/ML	injectable · injection	GLAND	Prescription	24 May 2022
CISATRACURIUM BESYLATE	EQ 2MG BASE/ML; EQ 10MG BASE/ML	injectable · injection	HIKMA	Prescription	28 Jun 2022
CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	injectable · injection	HIKMA	Prescription	19 Apr 2023
CISATRACURIUM BESYLATE	EQ 2MG BASE/ML; EQ 10MG BASE/ML	injectable · injection	CAPLIN	Prescription	9 Jun 2023
CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML; EQ 10MG BASE/ML	injectable · injection	HAINAN POLY	Prescription	27 Aug 2024
NIMBEX	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	ABBVIE	Discontinued	15 Dec 1995
NIMBEX PRESERVATIVE FREE	EQ 10MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	ABBVIE	Discontinued	15 Dec 1995
CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML; EQ 10MG BASE/ML	injectable · injection	HENGRUI PHARMA	Discontinued	27 Jan 2017
CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	injectable · injection	HENGRUI PHARMA	Discontinued	27 Jan 2017
CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML; EQ 10MG BASE/ML	injectable · injection	ACCORD HLTHCARE	Discontinued	16 Jun 2017
CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	injectable · injection	ACCORD HLTHCARE	Discontinued	16 Jun 2017

5 more — full table

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
CISATRACURIUM BESYLATE INJECTION USP MULTI-DOSE	02563266	2 MG / ML	SOLUTION · INTRAVENOUS	STERIMAX INC
CISATRACURIUM BESYLATE INJECTION USP MULTIDOSE	02408813	2 MG / ML	SOLUTION · INTRAVENOUS	OMEGA LABORATORIES LIMITED

Safety signals and safety-related labeling changes

US FDA 14 Oct 2022 NIMBEX — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for cisatracurium →

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.