Drug · DIN 02459329
DOTAREM
Yes: authorized and sold in Canada
Authorized, and the company reports that it sells it in Canada.
Status Marketed since September 22, 2017; first marketed September 22, 2017.
- Drug Identification Number (DIN)
- 02459329
- Company (DIN owner)
- GuerbetRoissy Cdg Cedex, Val-D'Oise, France
- Schedule
- Ethical
- Dosage form
- Solution
- Route
- Intravenous
- Therapeutic class (ATC)
- Gadoteric acid V08CA02
- Class
- Human
- Record last updated
- November 17, 2025
Active ingredients
As listed in the Drug Product Database.
| Ingredient | Strength | Per |
|---|---|---|
| GADOTERATE MEGLUMINE | 376.9 MG | ML |
Notices of Compliance
Health Canada approvals that name this DIN.
- March 23, 2018: NOC 20658Supplement to a New Drug Submission (SNDS) · To update the safety information in the Product Monograph with respect to risk of brain deposition of gadolinium with repeated use of Gadolinium-Based Contrast Agents (GBCAs).
- November 25, 2016: NOC 18694New Drug Submission (NDS)
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “dotarem”. A notice may cover another product or only some lots: read it to see what it covers.
- Dotarem Injection: Product SterilityNovember 22, 2021 · Drugs · Product safety · Type I