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:
Approved
Current status date:
2018-02-19
Product name:
TEVA-DABIGATRAN
DIN:
02463466
Product Monograph/Veterinary Labelling:
Date:
2017-04-26
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
TEVA CANADA LIMITED
30 Novopharm Court
Toronto
Ontario
Canada
M1B 2K9
Class:
Human
Dosage form(s):
Capsule
Route(s) of administration:
Oral
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
20:12.04.12
Anatomical Therapeutic Chemical (ATC): See footnote 4
B01AE07 DABIGATRAN ETEXILATE
Active ingredient group (AIG) number:See footnote5
0152467003
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) | 150 MG |