Vortioxetine (Makollix, Brintomak)
Vortioxetine
Macleods Pharmaceuticals SA (Pty) Ltd
Registration
- Applicant
- Macleods Pharmaceuticals SA (Pty) Ltd
- Registrations
- 6
- Schedule source
- Consolidated Schedules 06 July 2026
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Makollix 5 EACH TABLET CONTAINS: VORTIOXETINE HYDROBROMIDE EQUIVALENT TO VORTIOXETINE 5,0 mg | 5 | 57057857/1.2/0578 | Registered | S5 | None |
| Makollix 10 EACH TABLET CONTAINS: VORTIOXETINE HYDROBROMIDE EQUIVALENT TO VORTIOXETINE 10,0 mg | 10 | 57057957/1.2/0579 | Registered | S5 | None |
| Makollix 20 EACH TABLET CONTAINS: VORTIOXETINE HYDROBROMIDE EQUIVALENT TO VORTIOXETINE 20,0 mg | 20 | 57058057/1.2/0580 | Registered | S5 | None |
| Brintomak 5 EACH TABLET CONTAINS: VORTIOXETINE HYDROBROMIDE EQUIVALENT TO VORTIOXETINE 5,0 mg | 5 | 570581.57857/1.2/0581.578 | Registered | S5 | None |
| Brintomak 10 EACH TABLET CONTAINS: VORTIOXETINE HYDROBROMIDE EQUIVALENT TO VORTIOXETINE 10,0 mg | 10 | 570582.57957/1.2/0582.579 | Registered | S5 | None |
| Brintomak 20 EACH TABLET CONTAINS: VORTIOXETINE HYDROBROMIDE EQUIVALENT TO VORTIOXETINE 20,0 mg | 20 | 570583.58057/1.2/0583.580 | Registered | S5 | None |
Regulatory status
Where S5 sits on the scale
Prescription-only, with tighter controls on repeats.
Schedule 5 medicines need a prescription, and repeat dispensing is capped at six months in total; the prescriber must state upfront how many times, and at what intervals, it may be repeated. Extra limits apply to some uses: if it is being used for its anxiolytic, antidepressant, tranquillising or analgesic properties, it cannot be prescribed for longer than six months without a further consultation. Its price, name, pack size and strength can still be told to the public, as long as nothing links it to what it treats.
Schedule S5, matched to the Consolidated Schedules by ingredient, confidence high.
Who may supply: A pharmacist dispensing against a written or verbal prescription from an authorised prescriber; a veterinarian, who may also prescribe, compound or dispense it directly; a medical practitioner or dentist, who may prescribe it and may compound or dispense it directly only if licensed under section 22C(1)(a); manufacturers and wholesalers may supply people who may lawfully possess it.
Consolidated Schedules listings for Vortioxetine hydrobromide equivalent to vortioxetine
S5: Vortioxetine
Consolidated Schedules 06 July 2026, line 9765
Pharmacological class: Psychoanaleptics (antidepressants). (class 1.2)
This is an informational summary of the Medicines and Related Substances Act 101 of 1965 and its 2017 General Regulations. It is not medical advice and not legal advice. Always check the medicine's label, which carries the schedule number inside a square border, or ask a pharmacist if you are unsure.
1-[2-(2,4-Dimethylphenyl)sulfanylphenyl]piperazine
Drag to rotate. Structure from PubChem CID 9966051.
SAHPRA documents
SAHPRA has not published a professional information or patient information leaflet for this product.