Approval · Notice of Compliance 15413 · 2014
PROLIA: Notice of Compliance 15413
Issued March 13, 2014
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
- 15413
- Date
- March 13, 2014
- Company
- Amgen Canada IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: prolia is indicated as a treatment to increase bone mass in women with nonmetastatic breast cancer receiving adjuvant aromatase inhibitor (ai) therapy, who have low bone mass and are 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