Product information
From Health Canada
No match found
No other product was found with the same active ingredient group.
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:
2024-02-07
Original market date: See footnote 1
2024-02-07
Product name:
BYLVAY
DIN:
02542641
Product Monograph/Veterinary Labelling:
Date:
2023-10-30
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
MEDISON PHARMA CANADA INC.
400-154 University Avenue
Toronto
Ontario
Canada
M5H 3Y9
Class:
Human
Dosage form(s):
Capsule
Route(s) of administration:
Oral
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
56:92.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
A05AX05 ODEVIXIBAT
Active ingredient group (AIG) number:See footnote5
0165181001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| ODEVIXIBAT | 200 MCG |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.