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:
2012-11-26
Original market date: See footnote 1
2012-11-26
Product name:
APO-OXYCODONE CR
DIN:
02366789
Product Monograph/Veterinary Labelling:
Date:
2024-09-19
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
APOTEX INC
150 Signet Drive
Toronto
Ontario
Canada
M9L 1T9
Class:
Human
Dosage form(s):
Tablet (Extended-Release)
Route(s) of administration:
Oral
Number of active ingredient(s):
1
Schedule(s):
Narcotic (CDSA I)
American Hospital Formulary Service (AHFS): See footnote 3
28:08.08
Anatomical Therapeutic Chemical (ATC): See footnote 4
N02AA05 OXYCODONE
Active ingredient group (AIG) number:See footnote5
0107552006
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| OXYCODONE HYDROCHLORIDE | 80.0 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 |