Approval · Notice of Compliance 23000 · 2019
DOTAREM: Notice of Compliance 23000
Issued December 11, 2019
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
- 23000
- Date
- December 11, 2019
- 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
- The addition of an alternate supplier of gadolinium oxide and an associated nnew starting material (gadoolinium oxalate)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| DOTAREM | Not yet assigned | — |
Medicinal ingredients
- GADOTERATE MEGLUMINE 376.9 MG per ML