PRADAXA DIN 02312441
Status: Marketed
Holder: BOEHRINGER INGELHEIM (CANADA) LTD LTEE
Available to quote
Health Canada record
| Active ingredient(s) | DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 110 MG |
|---|---|
| Dosage form | Capsule |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | B01AE07 DABIGATRAN ETEXILATE |
| Original market date | 03-Jul-2008 |
| Current status date | 03-Jul-2008 |
| Source | Health Canada DPD |
Establishment licence of the holder
Boehringer Ingelheim (Canada) Ltd Ltee — licence 100187, currently licensed, last inspection rating C (2025-03-03).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE)
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02468905 | APO-DABIGATRAN | APOTEX INC | Capsule | DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 110 MG | Marketed |
| 02468913 | APO-DABIGATRAN | APOTEX INC | Capsule | DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 150 MG | Marketed |
| 02468891 | APO-DABIGATRAN | APOTEX INC | Capsule | DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 75 MG | Marketed |
| 02358808 | PRADAXA | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | Capsule | DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 150 MG | Marketed |
| 02312433 | PRADAXA | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | Capsule | DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 75 MG | Cancelled Post Market |
| 02463466 | TEVA-DABIGATRAN | TEVA CANADA LIMITED | Capsule | DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 150 MG | Cancelled Pre Market |
| 02463458 | TEVA-DABIGATRAN | TEVA CANADA LIMITED | Capsule | DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 75 MG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 13642 | 2012-09-07 | Supplement to a New Drug Submission (SNDS) | Product name change |
| 9604 | 2008-06-10 | New Drug Submission (NDS) |