Lamivudine, tenofovir disoproxil
Sold as Tenolam, Tenlam, Mivuten, Medpro lamivudine & tenofovir, Tacidra, Gemuno, Nofdine, Telavir, Lamtenowin, Bitenlam, Lamtodin, Laberef, Tenalate, Relivzate
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 11
- Registrations
- 14
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pharmacare limited û woodmead | Tenolam | Not stated | 441050 | S4 | None |
| Trinity Pharma (Pty) Ltd | Tenlam | Not stated | 450105 | S4 | None |
| Cipla Medpro Manufacturing (Pty) LtdCertificate held by Cipla | Mivuten | 300mg | 450108 | S4 | PIPIL |
| Cipla Medpro (Pty) LtdCancelled | Medpro lamivudine & tenofovir | 300/300 | 450109 | S4 | None |
| Aurobindo Pharma (Pty) LtdCancelled | Tacidra | 300/300 mg | 451008 | S4 | None |
| Aurogen South Africa (Pty) LtdCancelled | Gemuno, Nofdine | 300/300 mg | 451058, 451059 | S4 | None |
| Ranbaxy (SA) (Pty) LtdCancelled | Telavir | Not stated | 470669 | S4 | None |
| Zentiva South Africa (Pty) Ltd | Lamtenowin | Not stated | 481303 | S4 | None |
| Specpharm (Pty) LtdCancelled | Bitenlam | Not stated | 490704 | S4 | None |
| Macleods Pharmaceuticals SA (Pty) LtdCancelled | Lamtodin, Laberef, Tenalate | 300/300 | 520067, 520068.067, 520069.068 | S4 | None |
| Austell Pharmaceuticals (Pty) Ltd | Relivzate | 300 mg, 245 mg | 570166 | S4 | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Tenolam EACH TABLET CONTAINS LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg | Not listed | 44105044/20.2.8/1050 | Registered | S4 | None |
| Tenlam EACH TABLET CONTAINS LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg | Not listed | 45010545/20.2.8/0105 | Registered | S4 | None |
| Mivuten EACH TABLET CONTAINS LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg | 300mg. 300mgTablet | 45010845/20.2.8/0108Approved 8 April 2019 | Registered | S4 | PIPIL |
| Medpro lamivudine & tenofovir 300/300 EACH TABLET CONTAINS LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg | 300/300 | 45010945/20.2.8/0109 | Cancelled | S4 | None |
| Tacidra 300/300 MG tablets EACH TABLET CONTAINS LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg | 300/300 mgTablets | 45100845/20.2.8/1008 | Cancelled | S4 | None |
| Gemuno tablets 300/300 MG EACH TABLET CONTAINS LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg | 300/300 mgTablets | 45105845/20.2.8/1058 | Cancelled | S4 | None |
| Nofdine 300/300 MG tablets EACH TABLET CONTAINS LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg | 300/300 mgTablets | 45105945/20.2.8/1059 | Cancelled | S4 | None |
| Telavir EACH TABLET CONTAINS LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg | Not listed | 47066947/20.2.8/0669 | Cancelled | S4 | None |
| Lamtenowin EACH TABLET CONTAINS LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg | Not listed | 48130348/20.2.8/1303 | Registered | S4 | None |
| Bitenlam EACH TABLET CONTAINS LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg | Not listed | 49070449/20.2.8/0704 | Cancelled | S4 | None |
| Lamtodin 300/300 EACH TABLET CONTAINS: TENOFOVIR DISOPROXIL FUMARATE 300,0 mg LAMIVUDINE 300,0 mg | 300/300 | 52006752/20.2.8/0067 | Cancelled | S4 | None |
| Laberef 300/300 EACH TABLET CONTAINS: TENOFOVIR DISOPROXIL FUMARATE 300,0 mg LAMIVUDINE 300,0 mg | 300/300 | 520068.06752/20.2.8/0068.067 | Cancelled | S4 | None |
| Tenalate 300/300 EACH TABLET CONTAINS: TENOFOVIR DISOPROXIL FUMARATE 300,0 mg LAMIVUDINE 300,0 mg | 300/300 | 520069.06852/20.2.8/0069.068 | Cancelled | S4 | None |
| Relivzate LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE | 300 mg, 245 mgTablet | 57016657/20.2.8/0166Approved 21 November 2024 | 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, 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 Lamivudine, tenofovir disoproxil fumarate
S4: Lamivudine
Consolidated Schedules 06 July 2026, line 6850
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
Schedule Verification
Mivuten, Cipla Medpro Manufacturing (Pty) Ltd is scheduled S4 in its official SAHPRA documents, read with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.