Approval · Notice of Compliance 25669 · 2021
PROHANCE: Notice of Compliance 25669
Issued April 14, 2021
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
- 25669
- Date
- April 14, 2021
- Company
- Bracco Imaging CanadaVille D'Anjou, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Alternate manufacturer for the starting material of 1,4,7,10-tetraazacyclododecane used in the synthesis of Gadoteridol.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PROHANCE | Not yet assigned | — |
Medicinal ingredients
- GADOTERIDOL 279.3 MG per ML