Bictegravir, emtricitabine, tenofovir alafenamide
Sold as Biktarvy, Abictevir, Aletarv
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 2
- Registrations
- 4
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Biktarvy EACH TABLET CONTAINS: BICTEGRAVIR SODIUM 50,0 mg; EMTRICITABINE 200,0 mg; TENOFOVIR ALAFENAMIDE 25,0 mg | 50 mg/200 mg/25 mgFilm-coated tablets | 53045453/20.2.8/0454Approved 19 November 2025 | Registered | S4 | PIPIL |
| Abictevir EACH TABLET CONTAINS TENOFOVIR ALAFENAMIDE 25,0 mg EMTRICITABINE 200,0 mg BICTEGRAVIR SODIUM 50,0 mg | Not listed | 57048257/20.2.8/0482 | Registered | S4 | None |
| Aletarv EACH TABLET CONTAINS TENOFOVIR ALAFENAMIDE 25,0 mg EMTRICITABINE 200,0 mg BICTEGRAVIR SODIUM 50,0 mg | Not listed | 570483.48257/20.2.8/0483.482 | Registered | S4 | None |
| Biktarvy 30 mg/120 mg/15 MG film-coated tablets BICTEGRAVIR SODIUM EQUIVALENT TO BICTEGRAVIR 30,0 mg EMTRICITABINE 120,0 mg TENOFOVIR ALAFENAMIDE FUMARATE EQUIVALENT TO TENOFOVIR ALAFENAMIDE 15,0 mg | 30 mg/120 mg/15 mgFilm-coated tablets | 61029561/20.2.8/0295 | Registered | Not determined | 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 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 Bictegravir sodium, emtricitabine, tenofovir alafenamide
S4: Bictegravir
Consolidated Schedules 06 July 2026, line 5495
S4: Emtricitabine
Consolidated Schedules 06 July 2026, line 6178
S4: Tenofovir
Consolidated Schedules 06 July 2026, line 8130
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
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.