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:

2016-05-27

Original market date: See footnote 1

2016-05-27

Product name:

TARO-TRAMADOL ER

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:

02450437

Product Monograph/Veterinary Labelling:

Date: 2023-01-04 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

TARO PHARMACEUTICALS INC
130 East Drive
Brampton
Ontario
Canada L6T 1C1

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

N02AX02 TRAMADOL

Active ingredient group (AIG) number:See footnote5

0151694003

List of active ingredient(s)
Active ingredient(s) Strength
TRAMADOL HYDROCHLORIDE 200 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
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