Active substance
Gadoteridol
- US FDA 3
- Health Canada 1
- Safety 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| PROHANCE | 279.3MG/ML | injectable · injection | BRACCO | Prescription | 16 Nov 1992 |
| PROHANCE MULTIPACK | 279.3MG/ML | injectable · injection | BRACCO | Prescription | 9 Oct 2003 |
| GADOTERIDOL | 279.3MG/ML | injectable · injection | HAINAN POLY | Prescription | 11 Feb 2025 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| PROHANCE | 02229056 | 279.3 MG / ML | SOLUTION · INTRAVENOUS | BRACCO IMAGING CANADA |
Safety signals and safety-related labeling changes
- US FDA 5 Mar 2025 PROHANCE — 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 PROHANCE 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.