Approval · Notice of Compliance 20472 · 2018
PROLIA: Notice of Compliance 20472
Issued February 13, 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
- 20472
- Date
- February 13, 2018
- Company
- Amgen Canada IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: treatment to increase bone mass for the treatment and prevention of glucocorticoid- induced osteoporosis in women and men at high risk for fracture. prolia is indicated as a treatment to increase bone mass in women and men at high risk for fracture due to sustained systemic glucocorticoid therapy prolia is indicated as a treatment to increase bone mass in women and men at high risk for fracture who are starting or have recently started long term glucocorticoid therapy
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PROLIA | Not yet assigned | — |