Emtricitabine, tenofovir alafenamide
Sold as Descovy, Priprema, Tafbin, Etavir, Makovy, Emtritaf, Duemtrino, Bintaf, Tridolence, Aurotem
Propan-2-yl (2S)-2-[[[(2R)-1-(6-aminopurin-9-yl)propan-2-yl]oxymethyl-phenoxyphosphoryl]amino]propanoate
Drag to rotate. Structure from PubChem CID 9574768.
Background
Registration
- Applicants
- 7
- Registrations
- 11
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Gilead Sciences South Africa (Pty) Ltd | Descovy | 200/10, 200/25 | 510506, 510507 | Not determined | PIPIL |
| Cipla Medpro Manufacturing (Pty) LtdCertificate held by Cipla Medpro (Pty) Ltd | Priprema, Tafbin | 25mg, 200mg | 550079, 550080.079 | S4 | PIPIL |
| Pharma Dynamics (Pty) Ltd | Etavir | Not stated | 570427 | Not determined | None |
| Macleods Pharmaceuticals SA (Pty) Ltd | Makovy, Emtritaf | 200 /25 mg | 580026, 580027.026 | S4 | PIPIL |
| Austell Pharmaceuticals (Pty) Ltd | Duemtrino | Not stated | 580134 | Not determined | None |
| Aurogen South Africa (Pty) Ltd | Bintaf, Tridolence | Not stated | 580209, 580210.209 | Not determined | None |
| Aurobindo Pharma (Pty) Ltd | Aurotem | 200 mg & 25 mg | 580221 | S4 | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Descovy 200/10 EACH TABLET CONTAINS EMTRICITABINE 200,0 mg TENOFOVIR ALAFENAMIDE FUMARATE EQUIVALENT TO TENOFOVIR ALAFENAMIDE 10,0 mg | 200/10Film coated tablet | 51050651/20.2.8/0506Approved 3 November 2020 | Registered | Not determined | PIPIL |
| Descovy 200/25 EACH TABLET CONTAINS EMTRICITABINE 200,0 mg TENOFOVIR ALAFENAMIDE FUMARATE EQUIVALENT TO TENOFOVIR ALAFENAMIDE 25,0 mg | 200/25Film coated tablet | 51050751/20.2.8/507Approved 3 November 2020 | Registered | Not determined | PIPIL |
| Priprema EACH TABLET CONTAINS EMTRICITABINE 200,0 mg TENOFOVIR ALAFENAMIDE 25,0 mg | 25mg. 200mgTablet | 55007955/20.2.8/0079Approved 25 May 2022 | Registered | S4 | PIPIL |
| Tafbin EACH TABLET CONTAINS EMTRICITABINE 200,0 mg TENOFOVIR ALAFENAMIDE 25,0 mg | 25mg. 200mgTablet | 550080.07955/20.2.8/0080.079Approved 25 May 2022 | Registered | S4 | PIPIL |
| Etavir EACH TABLET CONTAINS EMTRICITABINE 200,0 mg TENOFOVIR ALAFENAMIDE FUMARATE EQUIVALENT TO TENOFOVIR ALAFENAMIDE 25,0 mg | Not listed | 57042757/20.2.8/0427 | Registered | Not determined | None |
| Makovy 200/25 Each Tablet contains: Emtricitabine 200,0 mg, Tenofovir Alafenamide fumarate equivalent to Tenofovir Alafenamide 25,0 mg | 200 /25 mgFilm-coated tablets | 58002658/20.2.8/0026Approved 8 July 2025 | Registered | S4 | PIPIL |
| Emtritaf 200/25 Each Tablet contains: Emtricitabine 200,0 mg, Tenofovir Alafenamide fumarate equivalent to Tenofovir Alafenamide 25,0 mg | 200 /25 mgFilm-coated tablets | 580027.02658/20.2.8/0027.026Approved 8 July 2025 | Registered | S4 | PIPIL |
| Duemtrino EACH TABLET CONTAINS EMTRICITABINE 200,0 mg TENOFOVIR ALAFENAMIDE FUMARATE EQUIVALENT TO TENOFOVIR ALAFENAMIDE 25,0 mg | Not listed | 58013458/20.2.8/0134 | Registered | Not determined | None |
| Bintaf EACH TABLET CONTAINS: EMTRICITABINE 200,0 mg TENOFOVIR ALAFENAMIDE FUMARATE EQUIVALENT TO TENOFOVIR ALAFENAMIDE 25,0 mg | Not listed | 58020958/20.2.8/0209 | Registered | Not determined | None |
| Tridolence EACH TABLET CONTAINS: EMTRICITABINE 200,0 mg TENOFOVIR ALAFENAMIDE FUMARATE EQUIVALENT TO TENOFOVIR ALAFENAMIDE 25,0 mg | Not listed | 580210.20958/20.2.8/0210.209 | Registered | Not determined | None |
| Aurotem EACH TABLET CONTAINS: EMTRICITABINE 200,0 mg TENOFOVIR ALAFENAMIDE FUMARATE EQUIVALENT TO TENOFOVIR ALAFENAMIDE 25,0 mg | 200 mg & 25 mgFilm coated tablets | 58022158/20.2.8/0221Approved 3 February 2026 | 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, read from the product's PI-PIL leaflet.
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 Emtricitabine, tenofovir alafenamide
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.