Is Iotrolan 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 Iotrolan.

Is Iotrolan approved by the US FDA?

Drugs@FDA lists 2 application product lines for Iotrolan, including OSMOVIST 190 (Discontinued); OSMOVIST 240 (Discontinued).

Active substance

Iotrolan

SFDA 2
US FDA 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ISOVIST 240 MG-ML VIAL	240 mg/ml	Injection · Intravenous use	1 Vial	SAR 54.65	Generic · Prescription	BAYER SCHERING PHARMA	Withdrawn by MAH · Not Marketed
ISOVIST 300 MG -MLVIAL	300 mg/ml	Injection · Intravenous use	1 Vial	SAR 61.60	Generic · Prescription	BAYER SCHERING PHARMA	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
OSMOVIST 190	40.6%	injectable · intrathecal	BAYER HLTHCARE	Discontinued
OSMOVIST 240	51.3%	injectable · intrathecal	BAYER HLTHCARE	Discontinued

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.