Dolutegravir, emtricitabine, tenofovir alafenamide
Sold as Komycitaf, Ezintaf, Taftrimyl, Mylataf, Cotafy, Tafortrip
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 3
- Registrations
- 6
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Viatris Healthcare (Pty) LtdCertificate held by Mylan (Pty) Ltd, Xixia Pharmaceuticals (Pty) Ltd | Komycitaf, Ezintaf, Taftrimyl, Mylataf | 50 mg, 200 mg,, 120 mg | 530468, 530469.468, 530484, 530485.484 | S4 | PIPIL |
| Pharma Dynamics (Pty) Ltd | Cotafy | Not stated | 570428 | Not determined | None |
| Aurobindo Pharma (Pty) Ltd | Tafortrip | 50 mg, 200 mg, 25 mg | 590290 | Not determined | PIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Komycitaf EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mg EMTRICITABINE 200,0 mg TENOFOVIR ALAFENAMIDE 25,0 mg | 120 mgFilm-coated tablets | 53046853/20.2.8/0468Approved 4 April 2022 | Registered | S4 | PIPIL |
| Ezintaf EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mg EMTRICITABINE 200,0 mg TENOFOVIR ALAFENAMIDE 25,0 mg | Not listed | 530469.46853/20.2.8/0469.468 | Registered | S4 | None |
| Taftrimyl EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mg EMTRICITABINE 200,0 mg TENOFOVIR ALAFENAMIDE 25,0 mg | 50 mg, 200 mg,Film-coated tablets | 53048453/20.2.8/0484Approved 11 May 2022 | Registered | S4 | PIPIL |
| Mylataf EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mg EMTRICITABINE 200,0 mg TENOFOVIR ALAFENAMIDE 25,0 mg | 50 mg, 200 mg,Film-coated tablets | 530485.48453/20.2.8/0485.484Approved 11 May 2022 | Registered | S4 | PIPIL |
| Cotafy EACH TABLET CONTAINS DOLUTEGRAVIR 50 mg EMTRICITABINE 200,0 mg TENOFOVIR ALAFENAMIDE FUMARATE EQUIVALENT TO TENOFOVIR ALAFENAMIDE 25,0 mg | Not listed | 57042857/20.2.8/0428 | Registered | Not determined | None |
| Tafortrip EACH TABLET CONTAINS: DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mg EMTRICITABINE 200,0 mg TENOFOVIR ALAFENAMIDE FUMARATE EQUIVALENT TO TENOFOVIR ALAFENAMIDE 25,0 mg | 50 mg, 200 mg, 25 mgFilm-coated tablet | 59029059/20.2.8/0290Approved 21 July 2026 | Registered | Not determined | PIL |
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 Dolutegravir sodium equivalent to dolutegravir, emtricitabine, tenofovir alafenamide
S4: Dolutegravir
Consolidated Schedules 06 July 2026, line 6100
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.