Tenofovir alafenamide (Makovy, Emtritaf)
Tenofovir alafenamide
Macleods Pharmaceuticals SA (Pty) Ltd
Registration
- Applicant
- Macleods Pharmaceuticals SA (Pty) Ltd
- Certificate holder
- Macleods Pharmaceuticals SA (Pty) Ltd
- Registrations
- 2
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| 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 |
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 fumarate equivalent to tenofovir alafenamide
S4: Bictegravir
Consolidated Schedules 06 July 2026, line 5495
S4: Dolutegravir
Consolidated Schedules 06 July 2026, line 6100
S4: Emtricitabine
Consolidated Schedules 06 July 2026, line 6178
S4: Rilpivirine
Consolidated Schedules 06 July 2026, line 7808
S4: Tenofovir
Consolidated Schedules 06 July 2026, line 8130
Pharmacological class: Antiviral agents. (class 20.2.8)
Matched through the components Emtricitabine, Rilpivirine, Dolutegravir, Bictegravir.
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.
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.
SAHPRA documents
Schedule Verification
This medication's schedule (S4) has been verified from official SAHPRA documents with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.