Leflunomide
Sold as Arava, Aspen leflunomide, Rheunalef, Adco-leflunomide, Lunar, Ravalef, Leflunomide unicorn, Lefosteomide, Lefunar, Efimidel, Arthrod
5-Methyl-N-[4-(trifluoromethyl)phenyl]-1,2-oxazole-4-carboxamide
Drag to rotate. Structure from PubChem CID 3899.
Background
Registration
- Applicants
- 8
- Registrations
- 25
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Sanofi-aventis South Africa (Pty) LtdCancelled | Arava | 10 mg, 20 mg | 330290, 330291 | S4 | None |
| Pharmacare limited û woodmead | Aspen leflunomide | 10 mg, 20 mg | 430489, 430490 | S4 | None |
| Adcock ingram limited | Rheunalef, Adco-leflunomide | 10, 20, 100 | 450404, 450405, 450406, 450407, 450408, 450409 | S4 | None |
| Cipla Medpro (Pty) Ltd | Lunar | 10, 20, 100 | 450811, 450812, 460189 | S4 | None |
| Activo Health (Pty) Ltd | Ravalef | 10 mg, 20 mg, 100 mg | 460236, 460237, 460238 | S4 | None |
| Unicorn Pharmaceuticals (Pty) Ltd | Leflunomide unicorn | 20 | 560001 | S4 | None |
| Biotech Laboratories (Pty) Ltd | Lefosteomide, Lefunar | 10, 20 | 560176, 560177, 560178.176, 560179.177 | S4 | None |
| Aurogen South Africa (Pty) Ltd | Efimidel, Arthrod | 10 mg, 20 mg | 560380, 560381, 560382.380, 560383 | S4 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Arava 10 MG EACH TABLET CONTAINS LEFLUNOMIDE 10,0 mg | 10 mg | 33029033/3.1/0290 | Cancelled | S4 | None |
| Arava 20 MG EACH TABLET CONTAINS LEFLUNOMIDE 20,0 mg | 20 mg | 33029133/3.1/0291 | Cancelled | S4 | None |
| Aspen leflunomide 10 MG EACH TABLET CONTAINS LEFLUNOMIDE 10,0 mg | 10 mg | 43048943/3.1/0489 | Registered | S4 | None |
| Aspen leflunomide 20 MG EACH TABLET CONTAINS LEFLUNOMIDE 20,0 mg | 20 mg | 43049043/3.1/0490 | Registered | S4 | None |
| Rheunalef 10 EACH TABLET CONTAINS: LEFLUNOMIDE 10,0 mg | 10 | 45040445/3.1/0404 | Registered | S4 | None |
| Rheunalef 20 EACH TABLET CONTAINS :LEFLUNOMIDE 20,0 mg | 20 | 45040545/3.1/0405 | Registered | S4 | None |
| Rheunalef 100 EACH TABLET CONTAINS LEFLUNOMIDE 100,0 mg | 100 | 45040645/3.1/0406 | Registered | S4 | None |
| Adco-leflunomide 10 EACH TABLET CONTAINS LEFLUNOMIDE 10,0 mg | 10 | 45040745/3.1/0407 | Registered | S4 | None |
| Adco-leflunomide 20 EACH TABLET CONTAINS LEFLUNOMIDE 20,0 mg | 20 | 45040845/3.1/0408 | Registered | S4 | None |
| Adco-leflunomide 100 EACH TABLET CONTAINS LEFLUNOMIDE 100,0 mg | 100 | 45040945/3.1/0409 | Registered | S4 | None |
| Lunar 10 EACH TABLET CONTAINS LEFLUNOMIDE 10,0 mg | 10 | 45081145/3.1/0811 | Registered | S4 | None |
| Lunar 20 EACH TABLET CONTAINS LEFLUNOMIDE 20,0 mg | 20 | 45081245/3.1/0812 | Registered | S4 | None |
| Lunar 100 EACH TABLET CONTAINS LEFLUNOMIDE 100,0 mg | 100 | 46018946/3.1/0189 | Registered | S4 | None |
| Ravalef 10 MG EACH TABLET CONTAINS : LEFLUNOMIDE 10,0 mg | 10 mg | 46023646/3.1/0236 | Registered | S4 | None |
| Ravalef 20 MG EACH TABLET CONTAINS : LEFLUNOMIDE 20,0 mg | 20 mg | 46023746/3.1/0237 | Registered | S4 | None |
| Ravalef 100 MG EACH TABLET CONTAINS : LEFLUNOMIDE 100,0 mg | 100 mg | 46023846/3.1/0238 | Registered | S4 | None |
| Leflunomide 20 unicorn EACH TABLET CONTAINS LEFLUNOMIDE 20,0 mg | 20 | 56000156/3.1/0001 | Registered | S4 | None |
| Lefosteomide 10 EACH TABLET CONTAINS LEFLUNOMIDE 10,0 mg | 10 | 56017656/3.1/0176 | Registered | S4 | None |
| Lefosteomide 20 EACH TABLET CONTAINS LEFLUNOMIDE 20,0 mg | 20 | 56017756/3.1/0177 | Registered | S4 | None |
| Lefunar 10 EACH TABLET CONTAINS LEFLUNOMIDE 10,0 mg | 10 | 560178.17656/3.1/0178.176 | Registered | S4 | None |
| Lefunar 20 EACH TABLET CONTAINS LEFLUNOMIDE 20,0 mg | 20 | 560179.17756/3.1/0179.177 | Registered | S4 | None |
| Efimidel 10 MG EACH TABLET CONTAINS LEFLUNOMIDE 10,0 mg | 10 mg | 56038056/3.1/0380 | Registered | S4 | None |
| Efimidel 20 MG EACH TABLET CONTAINS LEFLUNOMIDE 20,0 mg | 20 mg | 56038156/3.1/0381 | Registered | S4 | None |
| Arthrod 10 MG EACH TABLET CONTAINS LEFLUNOMIDE 10,0 mg | 10 mg | 560382.38056/3.1/0382.380 | Registered | S4 | None |
| Arthrod 20 MG EACH TABLET CONTAINS LEFLUNOMIDE 20,0 mg | 20 mg | 56038356/3.1/0383.381 | Registered | S4 | None |
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, 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; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
Consolidated Schedules listings for Leflunomide
S4: Leflunomide
Consolidated Schedules 06 July 2026, line 6884
Pharmacological class: Antirheumatics (anti-inflammatory agents). (class 3.1)
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
SAHPRA has not published a professional information or patient information leaflet for this product.