APO-VORTIOXETINE DIN 02552760
Status: Approved
Holder: APOTEX INC
Health Canada record
| Active ingredient(s) | VORTIOXETINE (VORTIOXETINE HYDROBROMIDE) 15 MG |
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| Dosage form | Tablet |
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| Route | Oral |
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| Schedule | PRESCRIPTION |
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| Class | Human |
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| ATC | N06AX26 VORTIOXETINE |
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| Original market date | |
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| Current status date | 07-Mar-2025 |
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| Source | Health Canada DPD |
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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 |
|---|
| 02552744 | APO-VORTIOXETINE | APOTEX INC | Tablet | VORTIOXETINE (VORTIOXETINE HYDROBROMIDE) 5 MG | Marketed |
| 02552752 | APO-VORTIOXETINE | APOTEX INC | Tablet | VORTIOXETINE (VORTIOXETINE HYDROBROMIDE) 10 MG | Marketed |
| 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) | |
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