Active substance
Gadoterate
- US FDA 5
- Health Canada 1
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| DOTAREM | 37.69GM/100ML (376.9MG/ML); 3.769GM/10ML (376.9MG/ML); 5.6535GM/15ML (376.9MG/ML); 7.538GM/20ML (376.9MG/ML); 1.8845GM/5ML (376.9MG/ML) | solution · intravenous | GUERBET | Prescription | 20 Mar 2013 |
| CLARISCAN | 3.769GM/10ML (376.9MG/ML); 5.6535GM/15ML (376.9MG/ML); 7.538GM/20ML (376.9MG/ML); 37.69GM/100ML (376.9MG/ML); 1.8845GM/5ML (376.9MG/ML) | solution · intravenous | GE HEALTHCARE | Prescription | 1 Nov 2019 |
| GADOTERATE MEGLUMINE | 1.8845GM/5ML (376.9MG/ML); 3.769GM/10ML (376.9MG/ML); 5.6535GM/15ML (376.9MG/ML); 7.538GM/20ML (376.9MG/ML); 37.69GM/100ML (376.9MG/ML) | solution · intravenous | HAINAN POLY | Prescription | 17 Jun 2024 |
| GADOTERATE MEGLUMINE | 3.769GM/10ML (376.9MG/ML); 5.6535GM/15ML (376.9MG/ML); 7.538GM/20ML (376.9MG/ML) | solution · intravenous | VIWIT PHARM | Prescription | 10 Aug 2026 |
| GADOTERATE MEGLUMINE | 1.8845GM/5ML (376.9MG/ML); 3.769GM/10ML (376.9MG/ML); 5.6535GM/15ML (376.9MG/ML); 7.538GM/20ML (376.9MG/ML); 37.69GM/100ML (376.9MG/ML) | solution · intravenous | HENGRUI PHARMA | Discontinued | 11 Apr 2022 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| DOTAREM | 02459329 | 376.9 MG / ML | SOLUTION · INTRAVENOUS | GUERBET |
Safety signals and safety-related labeling changes
- US FDA 5 Mar 2025 DOTAREM — 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.