Active substance
Gadobenate dimeglumine
- US FDA 2
- Health Canada 1
- Safety 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| MULTIHANCE | 2.645GM/5ML (529MG/ML); 5.29GM/10ML (529MG/ML); 7.935GM/15ML (529MG/ML); 10.58GM/20ML (529MG/ML) | injectable · intravenous | BRACCO | Prescription | 23 Nov 2004 |
| MULTIHANCE MULTIPACK | 26.45GM/50ML (529MG/ML); 52.9GM/100ML (529MG/ML) | injectable · intravenous | BRACCO | Prescription | 23 Nov 2004 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| MULTIHANCE | 02248302 | 529 MG / ML | SOLUTION · INTRAVENOUS | BRACCO IMAGING CANADA |
Safety signals and safety-related labeling changes
- US FDA 5 Mar 2025 MULTIHANCE — 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 MULTIHANCE MULTIPACK — 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
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.