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:
2022-07-29
Original market date: See footnote 1
2022-07-29
Product name:
ALBRIOZA
DIN:
02527707
Product Monograph/Veterinary Labelling:
Date:
2024-04-09
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
AMYLYX PHARMACEUTICALS INC.
43 Thorndike Street
Cambridge
Massachusetts
United States
02141
Class:
Human
Dosage form(s):
Powder For Suspension
Route(s) of administration:
Oral
Number of active ingredient(s):
2
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
28:92.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
N07XX19 SODIUM PHENYLBUTYRATE AND URSODOXICOLTAURINE
Active ingredient group (AIG) number:See footnote5
0263762001
Active ingredient(s) | Strength |
---|---|
SODIUM PHENYLBUTYRATE | 3 G / SACHET |
URSODOXICOLTAURINE | 1 G / SACHET |