Approval · Notice of Compliance 13871 · 2012
PROLIA: Notice of Compliance 13871
Issued November 21, 2012
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
- 13871
- Date
- November 21, 2012
- Company
- Amgen Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: treatment to increase bone mass in men with osteoporosis at high risk for fracture
- Therapeutic class
- Human monoclonal antibody rankl; bone metabolism regulator
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PROLIA | Not yet assigned | — |
Medicinal ingredients
- DENOSUMAB 60 MG per ML