Approval · Notice of Compliance 19440 · 2017
DOTAREM: Notice of Compliance 19440
Issued June 19, 2017
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
- 19440
- Date
- June 19, 2017
- 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 improve the safety information in the product monograph (pm) for dotarem in response to health canada's class-labelling request issued on march 30, 2017 for all gadolinium-based contrast agents (gbcas) products with respect to gadolinium (gc) accumulation in brain
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| DOTAREM | Not yet assigned | — |
Medicinal ingredients
- GADOTERATE MEGLUMINE 376.9 MG per ML