Clofazimine
Sold as Tubramak, Leproculmin, Lamprene
N,5-Bis(4-chlorophenyl)-3-propan-2-yliminophenazin-2-amine
Drag to rotate. Structure from PubChem CID 2794.
Background
Registration
- Applicants
- 3
- Registrations
- 4
- Schedule source
- SAHPRA documentation
Applicants and registrations
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Tubramak 50 MG EACH TABLET CONTAINS CLOFAZIMINE 50,0 mg | 50 mgTablet | 540238.23654/20.2.3/0238.236Approved 25 April 2023 | Registered | S4 | PIPIL |
| Tubramak 100 MG EACH TABLET CONTAINS CLOFAZIMINE 100,0 mg | 100 mgTablet | 540239.23754/20.2.3/0239.237Approved 25 April 2023 | Registered | S4 | PIPIL |
| Leproculmin EACH CAPSULE CONTAINS CLOFAZIMINE 100,0 mg | Not listed | 56052956/20.0/0529 | Registered | S4 | None |
| Lamprene 100 CAPSULE CLOFAZIMINE A 100 MG | 100Gelatine capsules | A0108Approved 22 August 2024 | Cancelled | S4 | PIPIL |
Regulatory status
Where S4 sits on the scale
Prescription-only medicine.
Schedule 4 covers most ordinary prescription medicines. You need a prescription from an authorised prescriber, such as a doctor or dentist, and a pharmacist dispenses it. 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 S4, read from the product's PI-PIL leaflet.
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; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
Consolidated Schedules listings for Clofazimine
S4: Clofazimine
Consolidated Schedules 06 July 2026, line 5846
Pharmacological class: Tuberculostatics. (class 20.2.3)
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
Schedule Verification
Tubramak 50 MG, Macleods Pharmaceuticals SA (Pty) Ltd is scheduled S4 in its official SAHPRA documents, read with 80% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.