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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:

2017-08-30

Original market date: See footnote 1

2012-03-20

Product name:

NUCYNTA IR

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section .

DIN:

02378280

Product Monograph/Veterinary Labelling:

Date: 2018-05-22 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

ENDO VENTURES 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)  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

28:08.08   OPIATE AGONISTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

N02AX06  TAPENTADOL

Active ingredient group (AIG) number:See footnote 5

0152846006

List of active ingredient(s)
Active ingredient(s) Strength
TAPENTADOL (TAPENTADOL HYDROCHLORIDE) 75 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) study

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