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:
2023-11-17
Product name:
BIO-QUETIAPINE XR
DIN:
02543257
Product Monograph/Veterinary Labelling:
Date:
2023-11-17
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
BIOMED PHARMA
1B
9450 Boul. Langelier
Montreal
Quebec
Canada
H1P 3H8
Class:
Human
Dosage form(s):
Tablet (Extended-Release)
Route(s) of administration:
Oral
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
28:16.08.04
Anatomical Therapeutic Chemical (ATC): See footnote 4
N05AH04 QUETIAPINE
Active ingredient group (AIG) number:See footnote5
0131858004
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| QUETIAPINE (QUETIAPINE FUMARATE) | 150 MG |