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:
Approved
Current status date:
2024-06-19
Product name:
WAINUA
Description:
PRE-FILLED AUTOINJECTOR
DIN:
02548909
Product Monograph/Veterinary Labelling:
Date:
2024-06-19
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
ASTRAZENECA CANADA INC
1004 Middlegate Road, Suite 5000
Mississauga
Ontario
Canada
L4Y 1M4
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Subcutaneous
Number of active ingredient(s):
1
Schedule(s):
Prescription Recommended
American Hospital Formulary Service (AHFS): See footnote 3
92:18.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
N07XX21 EPLONTERSEN
Active ingredient group (AIG) number:See footnote5
0165963001
| Active ingredient(s) | Strength |
|---|---|
| EPLONTERSEN (EPLONTERSEN SODIUM) | 45 MG / 0.8 ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.