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:
2026-06-26
Original market date: See footnote 1
2026-06-26
Product name:
PRZ-TRAMADOL/ACET
DIN:
02551047
Product Monograph/Veterinary Labelling:
Date:
2024-08-22
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
PHARMARIS CANADA INC
102
8310 130th Street
Surrey
British Columbia
Canada
V3W 8J9
Class:
Human
Dosage form(s):
Tablet
Route(s) of administration:
Oral
Number of active ingredient(s):
2
Schedule(s):
NARCOTICS (CDSA I)
Anatomical Therapeutic Chemical (ATC): See footnote 4
N02AJ13 TRAMADOL AND PARACETAMOL
Active ingredient group (AIG) number:See footnote5
0250601001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| ACETAMINOPHEN | 325 MG |
| TRAMADOL HYDROCHLORIDE | 37.5 MG |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.