Fingolimod
Sold as Tuvigin, Myelenea, Filengia, Glomatin, Modilex, Fingosol, Fingolimod alkem, Finkem, Domilo, Agilomid, Phinmo, Modlifin
2-Amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol
Drag to rotate. Structure from PubChem CID 107970.
Background
Registration
- Applicants
- 10
- Registrations
- 12
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Novartis South Africa (Pty) Ltd | Tuvigin | 0,5 mg | 460023 | S4 | None |
| Forrester Pharma (Pty) Ltd | Myelenea | Not stated | 500830 | S4 | None |
| Teva Pharmaceuticals (Pty) Ltd | Filengia | 0,5 mg | 520364 | S4 | PIPIL |
| Hetero Drugs South Africa (Pty) Ltd | Glomatin, Modilex | Not stated | 520855, 520856.855 | S4 | None |
| Cipla Medpro (Pty) LtdCertificate held by Cipla medpro (pty)ltd | Fingosol | 0,5 mg | 530486 | S4 | PIPIL |
| Ascend Laboratories (Pty) Ltd | Fingolimod alkem, Finkem | Not stated | 540338, 540339.338 | S4 | None |
| Adcock ingram limited | Domilo | 0,5 mg | 550548 | S4 | PIPIL |
| Austell Pharmaceuticals (Pty) Ltd | Agilomid | Not stated | 550753 | S4 | None |
| Dr Reddyæs Laboratories (Pty) LtdCertificate held by Dr Reddy’s Laboratories (Pty) Ltd | Phinmo | 0,5 mg | 550851 | S4 | PIPIL |
| Accord Healthcare (Pty) Ltd | Modlifin | 0.5 mg | 560213 | S4 | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Tuvigin 0,5 MG EACH CAPSULE CONTAINS FINGOLIMOD 0,5 mg | 0,5 mg | 46002346/34/0023 | Registered | S4 | None |
| Myelenea EACH CAPSULE CONTAINS FINGOLIMOD 0,5 mg | Not listed | 50083050/34/0830 | Registered | S4 | None |
| Filengia | 0,5 mgHard capsules. | 52036452/34/0364Approved 2 June 2023 | Registered | S4 | PIPIL |
| Glomatin Each capsule contains FINGOLIMOD HYDROCHLORIDE EQUIVALENT TO FINGOLIMOD 0,5 mg | Not listed | 52085552/34/0855 | Registered | S4 | None |
| Modilex Each capsule contains FINGOLIMOD HYDROCHLORIDE EQUIVALENT TO FINGOLIMOD 0,5 mg | Not listed | 520856.85552/34/0856.855 | Registered | S4 | None |
| Fingosol 0,5 FINGOLIMOD HYDROCHLORIDE | 0,5 mgCapsule | 53048653/34/0486Approved 24 January 2023 | Registered | S4 | PIPIL |
| Fingolimod alkem EACH CAPSULE CONTAINS FINGOLIMOD 0,5 mg | Not listed | 54033854/34/0338 | Registered | S4 | None |
| Finkem EACH CAPSULE CONTAINS FINGOLIMOD 0,5 mg | Not listed | 540339.33854/34/0339.338 | Registered | S4 | None |
| Domilo EACH CAPSULE CONTAINS FINGOLIMOD 0,5 mg | 0,5 mgCapsule | 55054855/34/0548Approved 12 July 2022 | Registered | S4 | PIPIL |
| Agilomid EACH CAPSULE CONTAINS FINGOLIMOD HYDROCHLORIDE EQUIVALENT TO FINGOLIMOD 0,5 mg | Not listed | 55075355/34/0753 | Registered | S4 | None |
| Phinmo 0,5 EACH CAPSULE CONTAINS FINGOLIMOD HYDROCHLORIDE 0,5 mg | 0,5 mgCapsules | 55085155/34/0851Approved 13 June 2023 | Registered | S4 | PIPIL |
| Modlifin 0,5 MG EACH CAPSULE CONTAINS FINGOLIMOD HYDROCHLORIDE EQUIVALENT TO FINGOLIMOD 0,5 mg | 0.5 mgCapsule | 56021356/34/0213Approved 18 April 2023 | Registered | 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, 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 Fingolimod
S4: Fingolimod
Consolidated Schedules 06 July 2026, line 6341
Pharmacological class: Complementary Medicines: Health Supplements (class 34)
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
Filengia, Teva Pharmaceuticals (Pty) Ltd is scheduled S4 in its official SAHPRA documents, read with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.