Approval · Notice of Compliance 36212 · 2025
DOTAREM: Notice of Compliance 36212
Issued October 20, 2025
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 36212
- Date
- October 20, 2025
- Company
- GuerbetRoissy Cdg Cedex, Val-D'Oise, France
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update to the Product Monograph as per advisement letter
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| DOTAREM | Not yet assigned | — |
Medicinal ingredients
- GADOTERATE MEGLUMINE 376.9 MG per ML