Is Gadodiamide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 5 valid registrations of Gadodiamide, including MERISCAN 0.5MMOL/ML VIAL (0.5 mmol/ml, Solution for injection, SAR 1028.45); OMNISCAN (287 mg/ml, Solution, SAR 680.65).

Is Gadodiamide approved by the US FDA?

Drugs@FDA lists 2 application product lines for Gadodiamide, including OMNISCAN (Prescription); OMNISCAN (Discontinued).

Are there safety signals or safety updates for Gadodiamide?

EMA PRAC: 2 entries; US FDA: 2 entries (latest 2025-03-05).

Active substance

Gadodiamide

SFDA 6
US FDA 2
Health Canada 1
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
MERISCAN 0.5MMOL/ML VIAL	0.5 mmol/ml	Solution for injection · Intravenous use	10 Vial	SAR 1028.45	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
MERISCAN 0.5MMOL/ML VIAL	0.5 mmol/ml	Solution for injection · Intravenous use	10 Vial	SAR 2045.00	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
OMNISCAN	287 mg/ml	Solution · Intravenous use	10 Vial	SAR 680.65	NCE · Prescription	GE HEALTHCARE	Valid
OMNISCAN	287 mg/ml	Solution · Intravenous use	10 Vial	SAR 408.40	NCE · Prescription	GE HEALTHCARE	Valid
OMNISCAN	287 mg/ml	Solution · Intravenous use	10 Vial	SAR 510.45	NCE · Prescription	GE HEALTHCARE	Valid
OMNISCAN	287 mg/ml	Solution · Intravenous use	10 Vial	SAR 784.30	NCE · Prescription	GE HEALTHCARE	Invalid · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
OMNISCAN	287MG/ML	injectable · injection	GE HEALTHCARE	Prescription	8 Jan 1993
OMNISCAN	14.35GM/50ML (287MG/ML); 28.7GM/100ML (287MG/ML)	injectable · injection	GE HEALTHCARE	Discontinued	5 Sep 2007

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
OMNISCAN	02172771	287 MG / ML	SOLUTION · INTRAVENOUS	GE HEALTHCARE CANADA INC

Safety signals and safety-related labeling changes

US FDA 5 Mar 2025 OMNISCAN — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 5 Mar 2025 OMNISCAN — safety-related labeling change
Labeling sections changed: Boxed Warning; 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 gadodiamide →

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.