Is Sugammadex registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 20 valid registrations of Sugammadex, including BRIDION 100 MG/ML SOLUTION FOR INJECTION (100 mg/ml, Solution for injection, SAR 5445.65); BRIDION 100 mg/ml Solution for Injection (100 mg/ml, Solution for injection, SAR 2178.25); Malsy (100 mg/ml, Solution for injection, SAR 1742.60); Muscodex (100 mg/ml, Solution for injection, SAR 1742.60); Relavers (100 mg/ml, Solution for injection, SAR 1476.40).

Is Sugammadex approved by the US FDA?

Drugs@FDA lists 21 application product lines for Sugammadex, including BRIDION (Prescription); SUGAMMADEX SODIUM (Prescription); SUGAMMADEX SODIUM (Prescription); SUGAMMADEX SODIUM (Prescription); SUGAMMADEX SODIUM (Prescription).

Is Sugammadex authorised in the European Union?

EMA lists 6 centrally authorised medicines containing Sugammadex: Bridion, Sugammadex Mylan, Sugammadex Fresenius Kabi, Sugammadex Amomed, Sugammadex Adroiq, Sugammadex Piramal.

Are there safety signals or safety updates for Sugammadex?

EMA PRAC: 3 entries; US FDA: 1 entry (latest 2024-12-12).

Active substance

Sugammadex

SFDA 20
US FDA 21
EMA 7
Health Canada 5
Safety 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
BRIDION 100 MG/ML SOLUTION FOR INJECTION	100 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 5445.65	NCE · Prescription	MERCK SHARP & DOHME LIMITED	Valid
BRIDION 100 mg/ml Solution for Injection	100 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 2178.25	NCE · Prescription	MERCK SHARP & DOHME LIMITED	Valid
Malsy	100 mg/ml	Solution for injection · Intravenous use	10 Ampoule	SAR 1742.60	Generic · Prescription	SPIMACO	Valid
Muscodex	100 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 1742.60	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Relavers	100 mg/ml	Solution for injection · Intravenous bolus use	10 Vial	SAR 1476.40	Generic · Prescription	AL RAZI PHARMA INDUSTRIES	Valid
Ricavo	100 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 1887.80	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Sudex 200 mg per 2 ml	100 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 174.25	Generic · Prescription	Saudi Amarox	Valid
Sudex 500 mg per 5 ml	100 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 435.65	Generic · Prescription	Saudi Amarox	Valid
Sugammadex ALH	100 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 1414.20	Generic · Prescription	Alhobail Pharm	Valid
Sugammadex Kabi	100 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 1742.60	Generic · Prescription	Fresenius Kabi Deutschland GmbH	Valid
Sugammadex Kabi	100 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 4356.60	Generic · Prescription	Fresenius Kabi Deutschland GmbH	Valid
Sugarelax-TV	100 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 1414.20	Generic · Prescription	Ratiopharm GmbH	Valid
Sugmastad	100 mg/ml	Solution for injection · Intravenous bolus use	10 Vial	SAR 1742.50	Generic · Prescription	Hemofarm AD Vrsac	Valid
Sugmastad	100 mg/ml	Solution for injection · Intravenous bolus use	10 Vial	SAR 4356.50	Generic · Prescription	Hemofarm AD Vrsac	Valid
Sumadix 200 per 2 ml Vials	100 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 1742.60	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Sumadix 500 per 5 ml Vials	100 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 4356.55	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Surlex 200 mg / 2 ml	100 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 2033.05	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Surlex 500 mg / 5 ml	100 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 5082.65	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Wekasurg 200 mg per 2 ml	100 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 1742.60	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
sugmadon	100 mg/ml	Injection · Intravenous use	1 Vial	SAR 147.60	Generic · Prescription	Pharma Pharmaceutical Industries (PPI)	Valid

Indications — CHI Daman Drug Formulary

ANESTHESIA

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

Product	Strength	Form · route	Applicant	Status	First approved
BRIDION	EQ 500MG BASE/5ML (EQ 100MG BASE/ML); EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	solution · intravenous	MSD SUB MERCK	Prescription	15 Dec 2015
SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML); EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	solution · intravenous	ASPIRO	Prescription	9 Jun 2023
SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML); EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	solution · intravenous	ZYDUS PHARMS	Prescription	4 Oct 2023
SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	solution · intravenous	B BRAUN MEDICAL	Prescription	5 Aug 2025
SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML); EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	solution · intravenous	MYLAN	Prescription	28 Jul 2026
SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML); EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	solution · intravenous	TEVA PHARMS USA INC	Prescription	28 Jul 2026
SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML); EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	solution · intravenous	MANKIND PHARMA	Prescription	28 Jul 2026
SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML); EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	solution · intravenous	DR REDDYS	Prescription	28 Jul 2026
SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML); EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	solution · intravenous	ZENARA	Prescription	28 Jul 2026
SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML); EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	solution · intravenous	SANDOZ	Prescription	28 Jul 2026
SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML); EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	solution · intravenous	SUN PHARM INDS INC	Prescription	28 Jul 2026
SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML); EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	solution · intravenous	LUPIN	Prescription	28 Jul 2026
SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML); EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	solution · intravenous	GLAND	Prescription	28 Jul 2026
SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML); EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	solution · intravenous	MSN	Prescription	28 Jul 2026
SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML); EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	solution · intravenous	TAMARANG	Prescription	28 Jul 2026
SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML); EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	solution · intravenous	QILU PHARM HAINAN	Prescription	28 Jul 2026
SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	solution · intravenous	HIKMA PHARMS	Prescription	28 Jul 2026
SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML); EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	solution · intravenous	HIKMA PHARMS	Prescription	28 Jul 2026
SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML); EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	solution · intravenous	STERISCIENCE	Prescription	28 Jul 2026
SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	solution · intravenous	FRESENIUS KABI USA	Prescription	28 Jul 2026
SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML); EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	solution · intravenous	SHANDONG	Prescription	6 Oct 2026

EMA European Union — centrally authorised medicines

Bridion Merck Sharp & Dohme B.V. · Authorised · authorised 25 Jul 2008 · ATC V03AB35

Therapeutic indication (EMA)

Reversal of neuromuscular blockade induced by rocuronium or vecuronium. For the peadiatric population: sugammadex is only recommended for routine reversal of rocuronium-induced blockade in children and adolescents.

Sugammadex Mylan Mylan Pharmaceuticals Limited · Authorised · authorised 15 Nov 2021 · ATC V03AB35

Therapeutic indication (EMA)

Reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults. For the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

Sugammadex Fresenius Kabi Fresenius Kabi Deutschland GmbH · Authorised · authorised 15 Jul 2022 · ATC V03AB35

Therapeutic indication (EMA)

Sugammadex Amomed AOP Orphan Pharmaceuticals GmbH · Authorised · authorised 10 Jan 2023 · ATC V03AB35

Therapeutic indication (EMA)

Reversal of neuromuscular blockade induced by rocuronium or vecuronium. For the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in paediatric patients from birth to 17 years.

Sugammadex Adroiq Extrovis EU Ltd · Authorised · authorised 26 May 2023 · ATC V03AB35

Therapeutic indication (EMA)

Reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults.For the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

Sugammadex Piramal Piramal Critical Care B.V. · Authorised · authorised 23 Jun 2023 · ATC V03AB35

Therapeutic indication (EMA)

Sugammadex Lorien LABORATORIOS LORIEN, S.L · Application withdrawn · ATC V03AB35

Therapeutic indication (EMA)

reversal of neuromuscular blockade induced by rocuronium or vecuronium

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
BRIDION	02451816	100 MG / ML	SOLUTION · INTRAVENOUS	MERCK CANADA INC
PMS-SUGAMMADEX	02550067	100 MG / ML	SOLUTION · INTRAVENOUS	PHARMASCIENCE INC
SUGAMMADEX INJECTION	02532700	100 MG / ML	SOLUTION · INTRAVENOUS	DR REDDY'S LABORATORIES LTD
SUGAMMADEX INJECTION	02539144	100 MG / ML	SOLUTION · INTRAVENOUS	JUNO PHARMA CANADA INC.
SUGAMMADEX INJECTION	02548666	100 MG / ML	SOLUTION · INTRAVENOUS	SANDOZ CANADA INCORPORATED

Safety signals and safety-related labeling changes

US FDA 12 Dec 2024 BRIDION — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations
EMA PRAC 7 Feb 2013 PRAC signal: Respiratory symptoms unrelated to hypersensitivity reaction
Action for MAH: update of the product information: Yes
EMA PRAC 31 Oct 2012 PRAC signal: Bradycardia and cardiac arrest
Action for MAH: update of the product information: No
EMA PRAC 3 Oct 2012 PRAC signal: Respiratory symptoms unrelated to hypersensitivity reaction
Action for MAH: update of the product information: No

All safety entries for sugammadex →

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.