Approval · Notice of Compliance 18151 · 2016
BRILINTA: Notice of Compliance 18151
Issued May 30, 2016
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
- 18151
- Date
- May 30, 2016
- Company
- Astrazeneca Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To add a new strength of 60 mg tablet and new indication: patients with a history of myocardial infarction (mi occured at least one year ago) and a high risk of developing an atherothrombotic event
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| BRILINTA | Not yet assigned | — |
| BRILINTA | 02455005 | Marketed |
Medicinal ingredients
- TICAGRELOR 90 MG per TAB
- TICAGRELOR 60 MG per TAB