Is Gadoteric acid registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 11 valid registrations of Gadoteric acid, including CLARISCAN (0.5 mmol/ml, Solution for injection, SAR 1058.00); CLARISCAN 0.5MMOL/ML SOL. FOR INJECTION (0.5 mmol/ml, Solution for injection in pre-filled syringe, SAR 597.90); CLARISCAN 0.5MMOL/ML SOL. FOR INJECTION (0.5 mmol/ml, Solution, SAR 1138.55); DOTAREM 0.5MOL-L GLASS BOTTLE W-STOPPER (27.932 g, Solution for injection, SAR 247.30); DOTAREM 376MG-ML PREFILLED SYRINGE (376 mmol/ml, Suspension for injection in pre-filled syringe, SAR 323.00).

Active substance

Gadoteric acid

SFDA 11

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
CLARISCAN	0.5 mmol/ml	Solution for injection · Intravenous use	10 Pre-filled syringe	SAR 1058.00	NCE · Prescription	GE Healthcare AS	Valid
CLARISCAN	0.5 mmol/ml	Solution for injection · Intravenous use	10 Pre-filled syringe	SAR 714.10	Generic · Prescription	GE Healthcare AS	Valid
CLARISCAN	0.5 mmol/ml	Solution for injection · Intravenous use	10 Pre-filled syringe	SAR 1265.05	Generic · Prescription	GE Healthcare AS	Valid
CLARISCAN 0.5MMOL/ML SOL. FOR INJECTION	0.5 mmol/ml	Solution for injection in pre-filled syringe · Intravenous use	10 Vial	SAR 597.90	Generic · Prescription	GE Healthcare AS	Valid
CLARISCAN 0.5MMOL/ML SOL. FOR INJECTION	0.5 mmol/ml	Solution for injection in pre-filled syringe · Intravenous use	10 Vial	SAR 885.80	Generic · Prescription	GE Healthcare AS	Valid
CLARISCAN 0.5MMOL/ML SOL. FOR INJECTION	0.5 mmol/ml	Solution · Intravenous use	10 Vial	SAR 1138.55	Generic · Prescription	GE Healthcare AS	Valid
DOTAREM 0.5MOL-L GLASS BOTTLE W-STOPPER	27.932 g	Solution for injection · Intravenous use	1 Vial	SAR 247.30	Radiopharmaceutical · Prescription	LABORATORIES GUERBET	Valid
DOTAREM 376MG-ML PREFILLED SYRINGE	376 mmol/ml	Suspension for injection in pre-filled syringe · Intravenous use	1 Injection Syringe	SAR 323.00	Radiopharmaceutical · Prescription	LABORATORIES GUERBET	Valid
DOTAREM 376MG-ML PREFILLED SYRINGE	376 mmol/ml	Suspension for injection in pre-filled syringe · Intravenous use	1 Injection Syringe	SAR 398.35	Radiopharmaceutical · Prescription	LABORATORIES GUERBET	Valid
Dotagraf 0.5 mmol/ml Solution for Injection	0.5 mmol/ml	Solution for injection · Intravenous use	1 Vial	SAR 59.80	Generic · Prescription	BAYER AG	Valid
Dotagraf 0.5 mmol/ml Solution for Injection	0.5 mmol/ml	Solution for injection · Intravenous use	1 Vial	SAR 109.60	Generic · Prescription	BAYER AG	Valid

Combinations containing Gadoteric acid

Dota + gadolinium oxide + gadoteric acid

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.