Approval · Notice of Compliance 18766 · 2016
REPATHA: Notice of Compliance 18766
Issued December 15, 2016
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
- 18766
- Date
- December 15, 2016
- Company
- Amgen Canada IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of a new dosage form (amd) and drug product manufacturing site
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| REPATHA | Not yet assigned | — |
| REPATHA | 02459779 | Cancelled Post Market |
Medicinal ingredients
- EVOLOCUMAB 140 MG per ML
- EVOLOCUMAB 120 MG per ML