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:
2017-09-12
Original market date: See footnote 1
2012-03-20
Product name:
NUCYNTA IR
DIN:
02378272
Product Monograph/Veterinary Labelling:
Date:
2021-10-15
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
ENDO OPERATIONS LTD.
1st Floor, Minerva House, Simmonscourt Road
Ballsbridge
Dublin
Ireland
D04 H9P8
Class:
Human
Dosage form(s):
Tablet (Immediate 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
N02AX06 TAPENTADOL
Active ingredient group (AIG) number:See footnote5
0152846001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| TAPENTADOL (TAPENTADOL HYDROCHLORIDE) | 50 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 |
|---|
| Drug Utilisation Study (DUS) |