APO-VORTIOXETINE DIN 02552744
Status: Marketed
Holder: APOTEX INC
Molecule: VORTIOXETINE (VORTIOXETINE HYDROBROMIDE)
Available to quote
Health Canada record
| Active ingredient(s) | VORTIOXETINE (VORTIOXETINE HYDROBROMIDE) 5 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | N06AX26 VORTIOXETINE |
| Original market date | 15-Apr-2025 |
| Current status date | 15-Apr-2025 |
| Source | Health Canada DPD |
Establishment licence of the holder
Apotex Inc — licence 100375, currently licensed, last inspection rating C (2026-04-21).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing VORTIOXETINE (VORTIOXETINE HYDROBROMIDE)
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02552752 | APO-VORTIOXETINE | APOTEX INC | Tablet | VORTIOXETINE (VORTIOXETINE HYDROBROMIDE) 10 MG | Marketed |
| 02552760 | APO-VORTIOXETINE | APOTEX INC | Tablet | VORTIOXETINE (VORTIOXETINE HYDROBROMIDE) 15 MG | Approved |
| 02552779 | APO-VORTIOXETINE | APOTEX INC | Tablet | VORTIOXETINE (VORTIOXETINE HYDROBROMIDE) 20 MG | Marketed |
| 02432919 | TRINTELLIX | LUNDBECK CANADA INC | Tablet | VORTIOXETINE (VORTIOXETINE HYDROBROMIDE) 5 MG | Marketed |
| 02432943 | TRINTELLIX | LUNDBECK CANADA INC | Tablet | VORTIOXETINE (VORTIOXETINE HYDROBROMIDE) 20 MG | Marketed |
| 02432927 | TRINTELLIX | LUNDBECK CANADA INC | Tablet | VORTIOXETINE (VORTIOXETINE HYDROBROMIDE) 10 MG | Marketed |
| 02432935 | TRINTELLIX | LUNDBECK CANADA INC | Tablet | VORTIOXETINE (VORTIOXETINE HYDROBROMIDE) 15 MG | Approved |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 34969 | 2025-03-07 | Abbreviated New Drug Submission (ANDS) |