Clozapine
Sold as Cloment, Clozapine oethmaan, Clozapine-hexal, Aspen clozapine, Leponex
3-Chloro-6-(4-methylpiperazin-1-yl)-11H-benzo[b][1,4]benzodiazepine
Drag to rotate. Structure from PubChem CID 135398737.
Background
Registration
- Applicants
- 4
- Registrations
- 10
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Acino Pharma (Pty) Ltd1 of 3 cancelled | Cloment | 25, 100, suspension | 350373, 350374, 431016 | S5 | None |
| Oethmaan Biosims (Pty) Ltd | Clozapine oethmaan, Clozapine-hexal | 25 mg/50 mg/100 mg, 50, 100 | 370188, 370189, 370190 | S5 | PIPIL |
| Pharmacare limited û woodmead | Aspen clozapine | 25 mg, 100 mg | 380167, 380168 | S5 | None |
| Viatris Healthcare (Pty) Ltd | Leponex | 25 mg, 100 mg | F0070, F0071 | S5 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Cloment 25 EACH TABLET CONTAINS CLOZAPINE 25,0 mg | 25 | 35037335/2.6.5/0373 | Registered | S5 | None |
| Cloment 100 EACH TABLET CONTAINS CLOZAPINE 100,0 mg | 100 | 35037435/2.6.5/0374 | Registered | S5 | None |
| Clozapine 25 oethmaan EACH TABLET CONTAINS CLOZAPINE 25,0 mg | 25 mg/50 mg/100 mgTablet. | 37018837/2.6.5/0188Approved 2 August 2022 | Registered | S5 | PIPIL |
| Clozapine-hexal 50 EACH TABLET CONTAINS CLOZAPINE 50,0 mg | 50 | 37018937/2.6.5/0189 | Registered | S5 | None |
| Clozapine-hexal 100 EACH TABLET CONTAINS CLOZAPINE 100,0 mg | 100 | 37019037/2.6.5/0190 | Registered | S5 | None |
| Aspen clozapine 25 MG EACH TABLET CONTAINS CLOZAPINE 25,0 mg | 25 mg | 38016738/2.6.5/0167 | Registered | S5 | None |
| Aspen clozapine 100 MG EACH TABLET CONTAINS CLOZAPINE 100,0 mg | 100 mg | 38016838/2.6.5/0168 | Registered | S5 | None |
| Cloment suspension EACH 1,0 ml SUSPENSION CONTAINS CLOZAPINE 50,0 mg | Suspension | 43101643/2.6.5/1016 | Cancelled | S5 | None |
| Leponex 25 MG EACH TABLET CONTAINS CLOZAPINE 25 mg | 25 mg | F0070F/2.6/70 | Registered | S5 | None |
| Leponex 100 MG EACH TABLET CONTAINS CLOZAPINE 100 mg | 100 mg | F0071F/2.6/71 | 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 Clozapine
S5: Clozapine
Consolidated Schedules 06 July 2026, line 9343
Pharmacological class: Miscellaneous structures. (class 2.6.5)
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.
SAHPRA documents
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.