Is Iopromide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 7 valid registrations of Iopromide, including ULTRAVIST (370 mg, Injection, SAR 555.85); ULTRAVIST (300 mg, Injection, SAR 2132.10); ULTRAVIST 370 (769 mg/ml, Solution for injection, SAR 555.85); ULTRAVIST300 (623 mg/ml, Solution for injection, SAR 1066.05).

Is Iopromide approved by the US FDA?

Drugs@FDA lists 7 application product lines for Iopromide, including ULTRAVIST 370 (Prescription); ULTRAVIST 300 (Prescription); ULTRAVIST (PHARMACY BULK) (Prescription); ULTRAVIST 240 (Discontinued); ULTRAVIST 150 (Discontinued).

Are there safety signals or safety updates for Iopromide?

EMA PRAC: 2 entries; US FDA: 6 entries (latest 2026-06-11).

Active substance

Iopromide

SFDA 7
US FDA 7
Health Canada 2
Safety 8

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ULTRAVIST	370 mg	Injection · Intravenous use	1 Bottle	SAR 555.85	NCE · Prescription	BAYER AG	Valid
ULTRAVIST	300 mg	Injection · Intravenous use	10 Bottle	SAR 2132.10	NCE · Prescription	BAYER AG	Valid
ULTRAVIST	370 mg	Injection · Intravenous use	10 Bottle	SAR 2223.35	NCE · Prescription	BAYER AG	Valid
ULTRAVIST 370	769 mg/ml	Solution for injection · Intravenous use	10 Bottle	SAR 555.85	NCE · Prescription	BAYER AG	Valid
ULTRAVIST 370	769 mg/ml	Solution for injection · Intravenous use	10 Bottle	SAR 1066.15	NCE · Prescription	BAYER AG	Valid
ULTRAVIST300	623 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 1066.05	NCE · Prescription	BAYER AG	Valid
ULTRAVIST300	623 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 556.00	NCE · Prescription	BAYER AG	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
ULTRAVIST 370	76.9%	injectable · injection	BAYER HLTHCARE	Prescription	10 May 1995
ULTRAVIST 300	62.3%	injectable · injection	BAYER HLTHCARE	Prescription	10 May 1995
ULTRAVIST (PHARMACY BULK)	62.3%; 76.9%	injectable · injection	BAYER HLTHCARE	Prescription	20 Sep 2002
ULTRAVIST 240	49.9%	injectable · injection	BAYER HLTHCARE	Discontinued	10 May 1995
ULTRAVIST 150	31.2%	injectable · injection	BAYER HLTHCARE	Discontinued	10 May 1995
ULTRAVIST 300 IN PLASTIC CONTAINER	62.3%	injectable · injection	BAYER HLTHCARE	Discontinued	10 May 1995
ULTRAVIST (PHARMACY BULK)	49.9%	injectable · injection	BAYER HLTHCARE	Discontinued	20 Sep 2002

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ULTRAVIST 300	02078600	62 %	SOLUTION · INTRAVASCULAR	BAYER INC
ULTRAVIST 370	02078619	77 %	SOLUTION · INTRAVASCULAR	BAYER INC

Safety signals and safety-related labeling changes

EMA PRAC 11 Jun 2026 PRAC signal: Fixed drug eruption
Action for MAH: update of the product information: Yes
EMA PRAC 15 Jan 2026 PRAC signal: Fixed drug eruption
Action for MAH: update of the product information: No
US FDA 25 May 2023 ULTRAVIST (PHARMACY BULK) — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 25 May 2023 ULTRAVIST 300 — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 25 May 2023 ULTRAVIST 370 — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 25 Apr 2023 ULTRAVIST 150 — 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 25 Apr 2023 ULTRAVIST 240 — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 25 Apr 2023 ULTRAVIST 300 IN PLASTIC CONTAINER — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for iopromide →

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.