Approval · Notice of Compliance 21196 · 2018
REPATHA: Notice of Compliance 21196
Issued August 10, 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
- 21196
- Date
- August 10, 2018
- Company
- Amgen Canada IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Extension of an indication: primary hyperlipidemia (including heterozygous familial hyperchloesterolemia)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| REPATHA | Not yet assigned | — |
Medicinal ingredients
- EVOLOCUMAB 140 MG per ML
- EVOLOCUMAB 140 MG per SYR
- EVOLOCUMAB 120 MG per ML