Approval · Notice of Compliance 20658 · 2018
DOTAREM: Notice of Compliance 20658
Issued March 23, 2018
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
- 20658
- Date
- March 23, 2018
- 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
- 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).
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| DOTAREM | 02459329 | Marketed |
Medicinal ingredients
- GADOTERATE MEGLUMINE 376.9 MG per ML