Product information
From Health Canada
The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. While Health Canada reviews the product monograph or the veterinary labelling as part of the drug review process, it remains the responsibility of the drug sponsor to ensure that the product monograph or the veterinary labelling is complete and accurate.
Current status:
Marketed
Current status date:
2011-06-06
Original market date: See footnote 1
2011-06-06
Product name:
XGEVA
Description:
SINGLE-USE VIAL. FOR S.C. USE ONLY. PRESERVATIVE-FREE.
DIN:
02368153
Product Monograph/Veterinary Labelling:
Date:
2023-05-30
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
AMGEN CANADA INC
300
6775 Financial Drive
Mississauga
Ontario
Canada
L5N 0A4
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Subcutaneous
Number of active ingredient(s):
1
Schedule(s):
Schedule D , Prescription
American Hospital Formulary Service (AHFS): See footnote 3
92:24.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
M05BX04 DENOSUMAB
Active ingredient group (AIG) number:See footnote5
0152691002
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| DENOSUMAB | 120 MG / 1.7 ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Patient Wallet Card |
| Pharmacovigilance/Monitoring Activity |
|---|
| Clinical Trials |
| Observational Studies |
| Registry |