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Fingolimod

Sold as Tuvigin, Myelenea, Filengia, Glomatin, Modilex, Fingosol, Fingolimod alkem, Finkem, Domilo, Agilomid, Phinmo, Modlifin

S4
Loading the molecular structure
C19H33NO2307.50 g/mol

2-Amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol

Drag to rotate. Structure from PubChem CID 107970.

Background

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Registration

Applicants
10
Registrations
12
Schedule source
Consolidated Schedules 06 July 2026

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Novartis South Africa (Pty) LtdTuvigin0,5 mg460023S4None
Forrester Pharma (Pty) LtdMyeleneaNot stated500830S4None
Teva Pharmaceuticals (Pty) LtdFilengia0,5 mg520364S4PIPIL
Hetero Drugs South Africa (Pty) LtdGlomatin, ModilexNot stated520855, 520856.855S4None
Cipla Medpro (Pty) LtdCertificate held by Cipla medpro (pty)ltdFingosol0,5 mg530486S4PIPIL
Ascend Laboratories (Pty) LtdFingolimod alkem, FinkemNot stated540338, 540339.338S4None
Adcock ingram limitedDomilo0,5 mg550548S4PIPIL
Austell Pharmaceuticals (Pty) LtdAgilomidNot stated550753S4None
Dr Reddyæs Laboratories (Pty) LtdCertificate held by Dr Reddy’s Laboratories (Pty) LtdPhinmo0,5 mg550851S4PIPIL
Accord Healthcare (Pty) LtdModlifin0.5 mg560213S4PIPIL

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Tuvigin 0,5 MG

EACH CAPSULE CONTAINS FINGOLIMOD 0,5 mg

0,5 mg46002346/34/0023RegisteredS4None
Myelenea

EACH CAPSULE CONTAINS FINGOLIMOD 0,5 mg

Not listed50083050/34/0830RegisteredS4None
Filengia0,5 mgHard capsules.52036452/34/0364Approved 2 June 2023RegisteredS4PIPIL
Glomatin

Each capsule contains FINGOLIMOD HYDROCHLORIDE EQUIVALENT TO FINGOLIMOD 0,5 mg

Not listed52085552/34/0855RegisteredS4None
Modilex

Each capsule contains FINGOLIMOD HYDROCHLORIDE EQUIVALENT TO FINGOLIMOD 0,5 mg

Not listed520856.85552/34/0856.855RegisteredS4None
Fingosol 0,5

FINGOLIMOD HYDROCHLORIDE

0,5 mgCapsule53048653/34/0486Approved 24 January 2023RegisteredS4PIPIL
Fingolimod alkem

EACH CAPSULE CONTAINS FINGOLIMOD 0,5 mg

Not listed54033854/34/0338RegisteredS4None
Finkem

EACH CAPSULE CONTAINS FINGOLIMOD 0,5 mg

Not listed540339.33854/34/0339.338RegisteredS4None
Domilo

EACH CAPSULE CONTAINS FINGOLIMOD 0,5 mg

0,5 mgCapsule55054855/34/0548Approved 12 July 2022RegisteredS4PIPIL
Agilomid

EACH CAPSULE CONTAINS FINGOLIMOD HYDROCHLORIDE EQUIVALENT TO FINGOLIMOD 0,5 mg

Not listed55075355/34/0753RegisteredS4None
Phinmo 0,5

EACH CAPSULE CONTAINS FINGOLIMOD HYDROCHLORIDE 0,5 mg

0,5 mgCapsules55085155/34/0851Approved 13 June 2023RegisteredS4PIPIL
Modlifin 0,5 MG

EACH CAPSULE CONTAINS FINGOLIMOD HYDROCHLORIDE EQUIVALENT TO FINGOLIMOD 0,5 mg

0.5 mgCapsule56021356/34/0213Approved 18 April 2023RegisteredS4PIPIL

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 verified from official 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.

Research articles

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