Approval · Notice of Compliance 21609 · 2018
TRINTELLIX: Notice of Compliance 21609
Issued December 7, 2018
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
- 21609
- Date
- December 7, 2018
- Company
- Lundbeck Canada IncSt-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Add preliminary pediatric clinical trial data to the product monograph
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TRINTELLIX | Not yet assigned | — |
Medicinal ingredients
- VORTIOXETINE HYDROBROMIDE 5 MG per TAB
- VORTIOXETINE HYDROBROMIDE 10 MG per TAB
- VORTIOXETINE HYDROBROMIDE 15 MG per TAB
- VORTIOXETINE HYDROBROMIDE 20 MG per TAB