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:
Cancelled Pre Market
Current status date:
2022-05-30
Original market date: See footnote 1
Product name:
BYDUREON BCISE
Description:
SINGLE DOSE AUTOINJECTOR
DIN:
02483203
Product Monograph/Veterinary Labelling:
Date:
2022-03-02
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):
Suspension (Extended-Release)
Route(s) of administration:
Subcutaneous
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
68:20.06
Anatomical Therapeutic Chemical (ATC): See footnote 4
A10BJ01 EXENATIDE
Active ingredient group (AIG) number:See footnote5
0152872002
Active ingredient(s) See footnote8 | Strength |
---|---|
EXENATIDE | 2 MG / DOSE |