Dabigatran Etexilate
Products in Health Canada’s databases that list Dabigatran Etexilate as a medicinal or active ingredient. Its salts and forms that the databases name on their own have their own pages.
Also listed as “Dabigatran Etexilate (Dabigatran Etexilate Mesilate)” (8). How names are joined
- Drug products
- 8
- 5 authorized now
- Natural health products
- 0
- 0 active licences
- Notices of Compliance
- 4
- Products in all
- 8
Drug products
Authorized products first.
| Name | DIN | Status | Holder | Status since |
|---|---|---|---|---|
| APO-DABIGATRAN (75 MG) | 02468891 | Marketed | Apotex Inc. | |
| APO-DABIGATRAN (110 MG) | 02468905 | Marketed | Apotex Inc. | |
| APO-DABIGATRAN (150 MG) | 02468913 | Marketed | Apotex Inc. | |
| PRADAXA (110 MG) | 02312441 | Marketed | Boehringer Ingelheim (Canada) Ltd. | |
| PRADAXA (150 MG) | 02358808 | Marketed | Boehringer Ingelheim (Canada) Ltd. | |
| PRADAXA (75 MG) | 02312433 | Cancelled Post Market | Boehringer Ingelheim (Canada) Ltd. | |
| TEVA-DABIGATRAN (75 MG) | 02463458 | Cancelled Pre Market | Teva Canada Limited | |
| TEVA-DABIGATRAN (150 MG) | 02463466 | Cancelled Pre Market | Teva Canada Limited |
Notices of Compliance
Approvals of drug submissions that list it, newest first.
- TEVA-DABIGATRANFebruary 19, 2018 · NOC 20497
- PRADAXAAugust 12, 2014 · NOC 15937
- PRADAXASeptember 7, 2012 · NOC 13642
- PRADAXJune 10, 2008 · NOC 9604