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:
2016-01-07
Product name:
IPG-TRAMADOL/ACET
DIN:
02387123
Product Monograph/Veterinary Labelling:
Date:
2022-09-28
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
MARCAN PHARMACEUTICALS INC
2 Gurdwara Rd., Suite 112
Ottawa
Ontario
Canada
K2E 1A2
Class:
Human
Dosage form(s):
Tablet
Route(s) of administration:
Oral
Number of active ingredient(s):
2
Schedule(s):
Narcotic (CDSA I)
American Hospital Formulary Service (AHFS): See footnote 3
28:08.08 , 28:08.92
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 Canadian Specific Opioid targeted Risk Management Plan (CSO-tRMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Healthcare Professional Education |
| Pharmacovigilance/Monitoring Activity |
|---|
| Observational Studies |