Approval · Notice of Compliance 27222 · 2021
REPATHA: Notice of Compliance 27222
Issued December 9, 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
- 27222
- Date
- December 9, 2021
- Company
- Amgen Canada IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication : - Pediatric Patients with Heterozygous Familial Hypercholesterolemia - REPATHA is indicated as an adjunct to diet and other LDL-C-lowering therapies (e.g., statins, ezetimibe) in pediatric patients aged 10 years and older with HeFH who require additional lowering of LDL-C. -Homozygous Familial Hypercholesterolemia - REPATHA is indicated as an adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) in adult and apediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| REPATHA | Not yet assigned | — |
Medicinal ingredients
- EVOLOCUMAB 140 MG per ML
- EVOLOCUMAB 120 MG per ML