Active substance
Iomeprol
- US FDA 4
- Safety 4
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| IOMERVU | 35GM IODINE/100ML (350MG IODINE/ML); 70GM IODINE/200ML (350MG IODINE/ML); 40GM IODINE/100ML (400MG IODINE/ML); 80GM IODINE/200ML (400MG IODINE/ML) | solution · intra-arterial | BRACCO | Prescription | 27 Nov 2024 |
| IOMERVU | 35GM IODINE/100ML (350MG IODINE/ML); 70GM IODINE/200ML (350MG IODINE/ML); 40GM IODINE/100ML (400MG IODINE/ML); 80GM IODINE/200ML (400MG IODINE/ML) | solution · intravenous | BRACCO | Prescription | 27 Nov 2024 |
| IOMERVU | 25GM IODINE/100ML (250MG IODINE/ML); 15GM IODINE/50ML (300MG IODINE/ML); 30GM IODINE/100ML (300MG IODINE/ML); 45GM IODINE/150ML (300MG IODINE/ML); 60GM IODINE/200ML (300MG IODINE/ML); 17.5GM IODINE/50ML (350MG IODINE/ML); 52.5GM IODINE/150ML (350MG IODINE/ML; 20GM IODINE/50ML (400MG IODINE/ML); 60GM IODINE/150ML (400MG IODINE/ML) | solution · intra-arterial | BRACCO | Discontinued | 27 Nov 2024 |
| IOMERVU | 25GM IODINE/100ML (250MG IODINE/ML); 15GM IODINE/50ML (300MG IODINE/ML); 30GM IODINE/100ML (300MG IODINE/ML); 45GM IODINE/150ML (300MG IODINE/ML); 60GM IODINE/200ML (300MG IODINE/ML); 17.5GM IODINE/50ML (350MG IODINE/ML); 52.5GM IODINE/150ML (350MG IODINE/ML); 20GM IODINE/50ML (400MG IODINE/ML); 60GM IODINE/150ML (400MG IODINE/ML) | solution · intravenous | BRACCO | Discontinued | 27 Nov 2024 |
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 - EMA PRAC 2 Sep 2016 PRAC signal: Haemolysis
Action for MAH: update of the product information: Yes - EMA PRAC 14 Apr 2016 PRAC signal: Haemolysis
Action for MAH: update of the product information: No
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.