Is Gadoversetamide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Gadoversetamide.

Is Gadoversetamide approved by the US FDA?

Drugs@FDA lists 3 application product lines for Gadoversetamide, including OPTIMARK (Discontinued); OPTIMARK (Discontinued); OPTIMARK IN PLASTIC CONTAINER (Discontinued).

Is Gadoversetamide authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Gadoversetamide.

Are there safety signals or safety updates for Gadoversetamide?

EMA PRAC: 2 entries; US FDA: 3 entries (latest 2018-04-26).

Active substance

Gadoversetamide

SFDA 7
US FDA 3
EMA 1
Safety 5

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
OPTIMARK 0.5MMOL-ML SOLN. FOR I.V. INJ	0.5 mmol/ml	Injection · Intravenous use	1 Bottle	SAR 2212.05	NCE · Prescription	LIEBEL FLARSHEIM COMPANY LLC	Withdrawn by MAH · Not Marketed
OPTIMARK 0.5MMOL-ML SOLUTION For I.V. Injection*	0.5 mmol/ml	Injection · Intravenous use	10 Vial	SAR 1474.70	NCE · Prescription	LIEBEL FLARSHEIM COMPANY LLC	Withdrawn by MAH · Not Marketed
OPTIMARK 0.5MMOL-ML SOLUTION For I.V. Injection*	0.5 mmol/ml	Injection · Intravenous use	10 Vial	SAR 2949.00	NCE · Prescription	LIEBEL FLARSHEIM COMPANY LLC	Withdrawn by MAH · Not Marketed
OPTIMARK 0.5MMOL-ML SOLUTION For I.V. Injection*	0.5 mmol/ml	Injection · Intravenous use	10 Vial	SAR 2005.55	NCE · Prescription	LIEBEL FLARSHEIM COMPANY LLC	Withdrawn by MAH · Not Marketed
OPTIMARK 0.5MMOL-ML SOLUTION For I.V. Injection*	0.5 mmol/ml	Injection · Intravenous use	10 Vial	SAR 3008.30	NCE · Prescription	LIEBEL FLARSHEIM COMPANY LLC	Withdrawn by MAH · Not Marketed
OPTIMARK 0.5MMOL-ML SOLUTION For I.V. Injection*	0.5 mmol/ml	Injection · Intravenous use	10 Vial	SAR 4011.10	NCE · Prescription	LIEBEL FLARSHEIM COMPANY LLC	Withdrawn by MAH · Not Marketed
OPTIMARK 0.5MMOL-ML SOLUTION For I.V. Injection*	0.5 mmol/ml	Injection · Intravenous use	10 Vial	SAR 6016.65	NCE · Prescription	LIEBEL FLARSHEIM COMPANY LLC	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
OPTIMARK	1654.5MG/5ML (330.9MG/ML); 3309MG/10ML (330.9MG/ML); 4963.5MG/15ML (330.9MG/ML); 6618MG/20ML (330.9MG/ML)	injectable · injection	LIEBEL-FLARSHEIM	Discontinued	8 Dec 1999
OPTIMARK	16.545GM/50ML (330.9MG/ML)	injectable · injection	LIEBEL-FLARSHEIM	Discontinued	8 Dec 1999
OPTIMARK IN PLASTIC CONTAINER	9927MG/30ML (330.9MG/ML); 3309MG/10ML (330.9MG/ML); 4963.5MG/15ML (330.9MG/ML); 6618MG/20ML (330.9MG/ML)	injectable · injection	LIEBEL-FLARSHEIM	Discontinued	8 Dec 1999

EMA European Union — centrally authorised medicines

Optimark Mallinckrodt Deutschland GmbH · Withdrawn · authorised 23 Jul 2007 · ATC V08CA06

Therapeutic indication (EMA)

This medicinal product is for diagnostic use only. Optimark is indicated for use with magnetic resonance imaging (MRI) of the central nervous system (CNS) and liver. It provides contrast enhancement and facilitates visualisation and helps with the characterisation of focal lesions and abnormal structures in the CNS and liver in patients with known or highly suspected pathology.

Safety signals and safety-related labeling changes

US FDA 26 Apr 2018 OPTIMARK — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 26 Apr 2018 OPTIMARK — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 26 Apr 2018 OPTIMARK IN PLASTIC CONTAINER — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 9 Jan 2015 PRAC signal: Nephrogenic systemic fibrosis in patients with acute kidney injury
Action for MAH: update of the product information: Yes
EMA PRAC 6 Nov 2014 PRAC signal: Nephrogenic systemic fibrosis in patients with acute kidney injury
Action for MAH: update of the product information: No

All safety entries for gadoversetamide →

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.