Lurasidone (Latumak, Maktuda)
Lurasidone
Macleods Pharmaceuticals SA (Pty) Ltd
Registration
- Applicant
- Macleods Pharmaceuticals SA (Pty) Ltd
- Certificate holder
- Macleods Pharmaceuticals SA (Pty) Ltd
- Registrations
- 10
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Latumak 20 MG EACH TABLET CONTAINS LURASIDONE HYDROCHLORIDE 20,0 mg | 20 mgFilm coated tablet | 57076757/1.2/0767Approved 27 August 2024 | Registered | S5 | PIPIL |
| Latumak 40 MG EACH TABLET CONTAINS LURASIDONE HYDROCHLORIDE 40,0 mg | 40 mgFilm coated tablet | 57076857/1.2/0768Approved 27 August 2024 | Registered | S5 | PIPIL |
| Latumak 60 MG EACH TABLET CONTAINS LURASIDONE HYDROCHLORIDE 60,0 mg | 60 mgFilm coated tablet | 57076957/1.2/0769Approved 27 August 2024 | Registered | S5 | PIPIL |
| Latumak 80 MG EACH TABLET CONTAINS LURASIDONE HYDROCHLORIDE 80,0 mg | 80 mgFilm coated tablet | 57077057/1.2/0770Approved 27 August 2024 | Registered | S5 | PIPIL |
| Latumak 120 MG EACH TABLET CONTAINS LURASIDONE HYDROCHLORIDE 120,0 mg | 120 mgFilm coated tablet | 57077157/1.2/0771Approved 27 August 2024 | Registered | S5 | PIPIL |
| Maktuda 20 MG EACH TABLET CONTAINS LURASIDONE HYDROCHLORIDE 20,0 mg | 20 mgFilm coated tablet | 570772.76757/1.2/0772.767Approved 27 August 2024 | Registered | Not determined | PIPIL |
| Maktuda 40 MG EACH TABLET CONTAINS LURASIDONE HYDROCHLORIDE 40,0 mg | 40 mgFilm coated tablet | 570773.76857/1.2/0773.768Approved 27 August 2024 | Registered | Not determined | PIPIL |
| Maktuda 60 MG EACH TABLET CONTAINS LURASIDONE HYDROCHLORIDE 60,0 mg | 60 mgFilm coated tablet | 570774.76957/1.2/0774.769Approved 27 August 2024 | Registered | Not determined | PIPIL |
| Maktuda 80 MG EACH TABLET CONTAINS LURASIDONE HYDROCHLORIDE 80,0 mg | 80 mgFilm coated tablet | 570775.77057/1.2/0775/770Approved 27 August 2024 | Registered | Not determined | PIPIL |
| Maktuda 120 MG EACH TABLET CONTAINS LURASIDONE HYDROCHLORIDE 120,0 mg | 120 mgFilm coated tablet | 570776.77157/1.2/0776.771Approved 27 August 2024 | Registered | Not determined | PIPIL |
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, read from the product's PI-PIL leaflet.
The Consolidated Schedules list this ingredient up to S4; the leaflet's S5 applies to this product.
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 Lurasidone hydrochloride
S4: Lurasidone
Consolidated Schedules 06 July 2026, line 6978
Pharmacological class: Psychoanaleptics (antidepressants). (class 1.2)
5 of 5 approved products with this ingredient carry S5 on their leaflet.
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.
(1R,2S,6R,7S)-4-[[(1R,2R)-2-[[4-(1,2-Benzothiazol-3-yl)piperazin-1-yl]methyl]cyclohexyl]methyl]-4-azatricyclo[5.2.1.02,6]decane-3,5-dione
Drag to rotate. Structure from PubChem CID 213046.
SAHPRA documents
Schedule Verification
This medication's schedule (S5) has been verified from official SAHPRA documents with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.