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:
2024-03-05
Original market date: See footnote 1
2016-01-27
Product name:
BELKYRA
Description:
2ML SINGLE USE VIALS
DIN:
02443910
Product Monograph/Veterinary Labelling:
Date:
2023-05-25
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
ABBVIE CORPORATION
8401 Trans-Canada Highway
Saint-Laurent
Quebec
Canada
H4S 1Z1
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Subcutaneous
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
92:92.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
D11AX24 DEOXYCHOLIC ACID
Active ingredient group (AIG) number:See footnote5
0157151001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| DEOXYCHOLIC ACID | 10 MG / ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.