Approval · Notice of Compliance 11817 · 2010
PRADAX: Notice of Compliance 11817
Issued October 26, 2010
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 11817
- Date
- October 26, 2010
- Company
- Boehringer Ingelheim (Canada) Ltd.Burlington, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication and new strength
- Therapeutic class
- Anticoagulant
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PRADAX | Not yet assigned | — |
| PRADAX | 02358808 | Marketed |
Medicinal ingredients
- DABIGATRAN ETEXILATE MESILATE 75 MG per CAP
- DABIGATRAN ETEXILATE MESILATE 110 MG per CAP
- DABIGATRAN ETEXILATE MESILATE 150 MG per CAP