Approval · Notice of Compliance 13533 · 2012
PROLIA: Notice of Compliance 13533
Issued August 1, 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
- 13533
- Date
- August 1, 2012
- Company
- Amgen Canada IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New manufacturing site and changes to manufacturing process
- 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