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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:

2012-03-19

Original market date: See footnote 1

2012-03-19

Product name:

DURELA

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:

02373017

Product Monograph/Veterinary Labelling:

Date: 2018-03-23 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

CIPHER PHARMACEUTICALS INC
501  209 Oak Park Blvd
Oakville
Ontario
Canada  L6H 0M2

Class: 

Human

Dosage form(s):

Capsule (Extended Release)

Route(s) of administration:

Oral

Number of active ingredient(s):

1

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

28:08.08   OPIATE AGONISTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

N02AX02  TRAMADOL

Active ingredient group (AIG) number:See footnote 5

0151694005

List of active ingredient(s)
Active ingredient(s) Strength
TRAMADOL HYDROCHLORIDE 100 MG

Risk Management Plans See footnote 7

A Canadian Specific Opioid targeted Risk Management Plan (CSO-tRMP) for this product was submitted.

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