Notice of Compliance Information
From Health Canada
- Notice of Compliance date :
- 2010-08-06
- Manufacturer :
- AMGEN CANADA INC
- Product type:
- Biologic
- NOC with conditions:
- No
- Submission type:
- New Drug Submission (NDS)
- Submission class:
- New Active Substance (NAS)
- Therapeutic class:
- Human monoclonal antibody to RANKL: Bone metabolism regulator
Brand 1 of 2 :
PROLIA (PRE-FILLED SYRINGE)
Product 1 of 1 :
Drug identification number:
02343541
Dosage form(s):
Solution
Route(s) of administration:
Subcutaneous
| Ingredient | Strength |
|---|---|
| DENOSUMAB | 60 MG/ML |
Brand 2 of 2 :
PROLIA (VIAL)
Product 1 of 1 :
Drug identification number:
02343568
Dosage form(s):
Solution
Route(s) of administration:
Subcutaneous
| Ingredient | Strength |
|---|---|
| DENOSUMAB | 60 MG/ML |