Approval · Notice of Compliance 31132 · 2023
DOTAREM: Notice of Compliance 31132
Issued July 6, 2023
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
- 31132
- Date
- July 6, 2023
- 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
- Response to advisement letter and conversion of the Product Monograph to the Master Template
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| DOTAREM | Not yet assigned | — |
Medicinal ingredients
- GADOTERATE MEGLUMINE 376.9 MG per ML