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Sofosbuvir, velpatasvir

Sold as Epclusa

S4

Combination product

This product contains more than one active ingredient, so it has no single molecular structure.

Background

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Registration

Applicants
1
Registrations
1
Schedule source
Consolidated Schedules 06 July 2026

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Gilead Sciences South Africa (Pty) LtdEpclusa400 mg/100 mg510872S4PIPIL

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Epclusa

EACH TABLET CONTAINS SOFOSBUVIR 400,0 mg and VELPATASVIR 100,0 mg

400 mg/100 mgFilm coated tablet51087251/20.2.8/0872Approved 10 March 2022RegisteredS4PIPIL

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 medium.

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 Sofosbuvir, and velpatasvir

  • S4: Sofosbuvir

    Consolidated Schedules 06 July 2026, line 7957

  • S4: Velpatasvir

    Consolidated Schedules 06 July 2026, line 8362

Pharmacological class: Antiviral agents. (class 20.2.8)

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

Research articles

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