Product information

From Health Canada

New search

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:

2013-03-28

Original market date: See footnote 1

2010-11-03

Product name:

PRADAXA

Description:

KNOWN AS PRADAX

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:

02358808

Product Monograph/Veterinary Labelling:

Date: 2020-03-23 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

BOEHRINGER INGELHEIM (CANADA) LTD LTEE
5180 South Service Road
Burlington
Ontario
Canada  L7L 5H4

Class: 

Human

Dosage form(s):

Capsule

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

20:12.04.12   DIRECT THROMBIN INHIBITORS

Anatomical Therapeutic Chemical (ATC): See footnote 4

B01AE07  DABIGATRAN ETEXILATE

Active ingredient group (AIG) number:See footnote 5

0152467003

List of active ingredient(s)
Active ingredient(s) Strength
DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 150 MG

Risk Management Plans See footnote 7

A Risk Management Plan (RMP) for this product was submitted.

Application information

Related information

Contact us

Version 3.8.0
Date modified: