Approval · Notice of Compliance 16978 · 2015
PRADAXA: Notice of Compliance 16978
Issued June 9, 2015
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
- 16978
- Date
- June 9, 2015
- 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
- Addition of new long term safety information
- Therapeutic class
- Anticoagulant
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PRADAXA | Not yet assigned | — |
Medicinal ingredients
- DABIGATRAN ETEXILATE MESILATE 75 MG per CAP
- DABIGATRAN ETEXILATE MESILATE 110 MG per CAP
- DABIGATRAN ETEXILATE MESILATE 150 MG per CAP