Dolutegravir, lamivudine, tenofovir disoproxil
Sold as Acriptega, Ranega, Odystra, Divtrida, Diltra, Volutrip, Aedatri, Reydin, Myteladov, Lanograv, Telatri, Viraten, Ornitraz, Kovatrax, Damtov, Tladeez, Trebicom, Milutin, Luvigen, Nuvaco, Lumivo, Vulante, Tridozia, Tenolam plus, Temiv, Lavem, Rarudine, Envuteg, Teglataf, Tolevtri, Mydoltaf, Dotenal, Minolavid, Trilated, Folanovid, Valheena, Lutovir
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 20
- Registrations
- 37
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Viatris Healthcare (Pty) LtdCertificate held by Mylan (Pty) Ltd | Acriptega, Ranega, Odystra, Envuteg, Teglataf, Tolevtri, Mydoltaf | 23 mg, 23 mg), 25 mg, 50 mg, 300 mg /300 mg /50 mg, 300 mg | 520199, 520200.199, 520201.199, 540705, 540706.705, 540707.705, 540708.705 | S4 | PIPIL |
| Novagen Pharma (Pty) Ltd | Divtrida | 300 mg | 520210 | S4 | PIPIL |
| Aurogen South Africa (Pty) Ltd | Diltra | Not stated | 520211.21 | S4 | None |
| Aurobindo Pharma (Pty) LtdCertificate held by Aurobindo | Volutrip | 50mg, 300mg | 520212.21 | S4 | PIPIL |
| Cipla Medpro Manufacturing (Pty) LtdCertificate held by Cipla Medpro Manufacturing (Pty) Ltd., Cipla Medpro (Pty) Ltd. | Aedatri, Reydin | 300 mg | 520450, 520451.45 | S4 | PIPIL |
| Innovata pharmaceuticals | Myteladov | Not stated | 520533 | S4 | None |
| Ranbaxy (SA) (Pty) Ltd | Lanograv, Telatri | Not stated | 520718, 520719.718 | S4 | None |
| Macleods Pharmaceuticals SA (Pty) Ltd | Viraten, Ornitraz, Kovatrax | tablets | 520770, 520771.77, 520772.77 | S4 | None |
| Specpharm Holdings (Pty) LtdCancelled | Damtov | Not stated | 520944 | S4 | None |
| Kiara Health (Pty) Ltd | Tladeez | 300 mg | 520945 | S4 | PIPIL |
| Hetero Drugs South Africa (Pty) Ltd | Trebicom, Milutin, Luvigen | Not stated | 520946, 520947.946, 520948.946 | S4 | None |
| Adcock ingram limited | Nuvaco, Lumivo | 300 mg, 50 mg | 520949, 520950.949 | S4 | PIPIL |
| Pharmacare limited û woodmeadCertificate held by Pharmacare limited2 of 3 cancelled | Vulante, Tridozia, Tenolam plus | 300 mg/300 mg/50 mg | 530082, 530087, 530088.087 | S4 | PIPIL |
| Barrs Pharmaceutical Industries (Pty) Ltd | Temiv | Not stated | 530089 | S4 | None |
| Emcure- Pharmaceutical South Africa (Pty) LtdCertificate held by Emcure Pharmaceuticals SA (Pty) Ltd. | Lavem, Valheena, Lutovir | 300 mg | 530090.089, 590347, 600363 | S4 | PIPIL |
| Pharma Dynamics (Pty) Ltd | Rarudine | 50 mg, 300 mg, 300 mg | 540343 | S4 | PIPIL |
| Austell Pharmaceuticals (Pty) Ltd | Dotenal | Not stated | 550349 | S4 | None |
| Umsebe healthcare | Minolavid | 150,40 mg | 560849 | S4 | PIPIL |
| Encha Health (Pty) Ltd | Trilated | 50mg, 300 mg & 300 mg | 561001 | S4 | PIPIL |
| Laurus Generics SA (Pty) Ltd | Folanovid | 50 mg/300 mg | 580048 | S4 | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Acriptega EACH TABLET CONTAINS DOLUTEGRAVIR 50,0 mgLAMIVUDINE 300,0 mgTENOFOVIR DISOPROXIL FUMARATE 300,0 mg | 300 mg /300 mg /50 mgFilm-coated tablets | 52019952/20.2.8/0199Approved 21 November 2024 | Registered | S4 | PIPIL |
| Ranega EACH TABLET CONTAINS:DOLUTEGRAVIR 50,0 mg; LAMIVUDINE 300,0 mg; TENOFOVIR DISOPROXIL FUMARATE 300,0 mg | 23 mgFilm-coated tablets | 520200.19952/20.2.8/0200.199Approved 21 November 2024 | Registered | S4 | PIPIL |
| Odystra EACH TABLET CONTAINS:DOLUTEGRAVIR 50,0 mg; LAMIVUDINE 300,0 mg; TENOFOVIR DISOPROXIL FUMARATE 300,0 mg | 23 mg)Film-coated tablets | 520201.19952/20.2.8/0201.199Approved 21 November 2024 | Registered | S4 | PIPIL |
| Divtrida EACH TABLET CONTAINS :DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mgLAMIVUDINE 300,0 mgTENOFOVIR DISOPROXIL FUMARATE 300,0 mg | 300 mgFilm-coated tablet | 52021052/20.2.8/0210Approved 31 August 2018 | Registered | S4 | PIPIL |
| Diltra EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg | Not listed | 520211.2152/20.2.8/0211.210 | Registered | S4 | None |
| Volutrip EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg | 50mg. 300mg. 300mgTablet | 520212.2152/20.2.8/0212.210Approved 22 January 2025 | Registered | S4 | PIPIL |
| Aedatri EACH TABLET CONTAINS DOLUTEGRAVIR 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg | 300 mg.Film-coated tablet | 52045052/20.2.8/0450Approved 28 March 2025 | Registered | S4 | PIPIL |
| Reydin EACH TABLET CONTAINS DOLUTEGRAVIR 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg | 300 mg.Film-coated tablets | 520451.4552/20.2.8/0451.450Approved 28 March 2025 | Registered | S4 | PIPIL |
| Myteladov Each Tablet contains: Dolutegravir sodium equivalent to Dolutegravir 50,0 mg, Tenofovir Disoproxil fumarate 300,0 mg, Lamivudine 300,0 mg | Not listed | 52053352/20.2.8/0533 | Registered | S4 | None |
| Lanograv EACH TABLET CONTAINS DOLUTEGRAVIR 50,0 mgLAMIVUDINE 300,0 mgTENOFOVIR DISOPROXIL FUMARATE 300,0 mg | Not listed | 52071852/20.2.8/0718 | Registered | S4 | None |
| Telatri EACH TABLET CONTAINS DOLUTEGRAVIR 50,0 mgLAMIVUDINE 300,0 mgTENOFOVIR DISOPROXIL FUMARATE 300,0 mg | Not listed | 520719.71852/20.2.8/0719.718 | Registered | S4 | None |
| Viraten EACH TABLET CONTAINS DOLUTEGRAVIR 50,0 mgLAMIVUDINE 300,0 mgTENOFOVIR DISOPROXIL FUMARATE 300,0 mg | Not listed | 52077052/20.2.8/0770 | Registered | S4 | None |
| Ornitraz tablets EACH TABLET CONTAINS DOLUTEGRAVIR 50,0 mgLAMIVUDINE 300,0 mgTENOFOVIR DISOPROXIL FUMARATE 300,0 mg | Tablets | 520771.7752/20.2.8/0771.770 | Registered | S4 | None |
| Kovatrax tablets EACH TABLET CONTAINS DOLUTEGRAVIR 50,0 mgLAMIVUDINE 300,0 mgTENOFOVIR DISOPROXIL FUMARATE 300,0 mg | Tablets | 520772.7752/20.2.8/0772.770 | Registered | S4 | None |
| Damtov EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mgLAMIVUDINE 300,0 mgTENOFOVIR DISOPROXIL FUMARATE 300,0 mg | Not listed | 52094452/20.2.8/0944 | Cancelled | S4 | None |
| Tladeez EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg | 300 mgFilm-coated tablets | 52094552/20.2.8/0945Approved 28 October 2022 | Registered | S4 | PIPIL |
| Trebicom EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg | Not listed | 52094652/20.2.8/0946 | Registered | S4 | None |
| Milutin EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg | Not listed | 520947.94652/20.2.8/0947.946 | Registered | S4 | None |
| Luvigen EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg | Not listed | 520948.94652/20.2.8/0948.946 | Registered | S4 | None |
| Nuvaco EACH TABLET CONTAINS :DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mg, LAMIVUDINE 300,0 mg, TENOFOVIR DISOPROXIL FUMARATE 300,0 mg | 300 mg, 50 mgFilm-coated tablets | 52094952/20.2.8/0949Approved 23 September 2025 | Registered | S4 | PIPIL |
| Lumivo EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mgLAMIVUDINE 300,0 mgTENOFOVIR DISOPROXIL FUMARATE 300,0 mg | 300 mg, 50 mgFilm-coated tablets | 520950.94952/20.2.8/0950.949Approved 10 February 2022 | Registered | S4 | PIPIL |
| Vulante EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM 50,0 mgLAMIVUDINE 300,0 mgTENOFOVIR DISOPROXIL FUMARATE 300,0 mg | 300 mg/300 mg/50 mgFilm-coated tablets | 53008253/20.2.8/0082Approved 3 October 2024 | Registered | S4 | PIPIL |
| Tridozia EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM 50,0 mgLAMIVUDINE 300,0 mgTENOFOVIR DISOPROXIL FUMARATE 300,0 mg | Not listed | 53008753/20.2.8/0087 | Cancelled | S4 | None |
| Tenolam plus EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM 50,0 mgLAMIVUDINE 300,0 mgTENOFOVIR DISOPROXIL FUMARATE 300,0 mg | Not listed | 530088.08753/20.2.8/0088.087 | Cancelled | S4 | None |
| Temiv EACH TABLET CONTAINS DOLUTEGRAVIR 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg | Not listed | 53008953/20.2.8/0089 | Registered | S4 | None |
| Lavem EACH TABLET CONTAINS DOLUTEGRAVIR 50,0 mgLAMIVUDINE 300,0 mgTENOFOVIR DISOPROXIL FUMARATE 300,0 mg | 300 mgTablets | 530090.08952/20.2.8/0090.089Approved 3 February 2025 | Registered | S4 | PIPIL |
| Rarudine EACH TABLET CONTAINS DOLOTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg | 50 mg, 300 mg, 300 mgTablet | 54034354/20.2.8/0343Approved 28 March 2023 | Registered | S4 | PIPIL |
| Envuteg EACH TABLET CONTAINS DOLUTEGRAVIR 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 25,0 mg | 300 mg. 25 mg. 50 mgTablets | 54070554/20.2.8/0705Approved 12 September 2025 | Registered | S4 | PIPIL |
| Teglataf EACH TABLET CONTAINS DOLUTEGRAVIR 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 25,0 mg | 300 mg. 25 mg. 50 mgTablets | 540706.70554/20.2.8/0706.705Approved 3 August 2021 | Registered | S4 | PIPIL |
| Tolevtri EACH TABLET CONTAINS DOLUTEGRAVIR 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 25,0 mg | 300 mg. 25 mg. 50 mgTablets | 540707.70554/20.2.8/0707.705Approved 3 August 2021 | Registered | S4 | PIPIL |
| Mydoltaf EACH TABLET CONTAINS DOLUTEGRAVIR 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 25,0 mg | 300 mg. 25 mg. 50 mgTablets | 540708.70554/20.2.8/0708.705Approved 3 August 2021 | Registered | S4 | PIPIL |
| Dotenal EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg | Not listed | 55034955/20.2.8/0349 | Registered | S4 | None |
| Minolavid EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg | 150,40 mgFilm-coated tablets | 56084956/20.2.8/0849Approved 17 December 2024 | Registered | S4 | PIPIL |
| Trilated EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE EQUIVALENT TO TENOFOVIR DISOPROXIL 300,0 mg | 50mg, 300 mg & 300 mgFilm-coated tablet | 56100156/20.2.8/1001Approved 11 March 2025 | Registered | S4 | PIPIL |
| Folanovid EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg | 50 mg/300 mgFim-coated tablets | 58004858/20.2.8/0048Approved 25 April 2026 | Registered | S4 | PIPIL |
| Valheena Each Tablet contains: Dolutegravir Sodium equivalent to Dolutegravir 50,0 mg, Tenofovir Disoproxil Fumarate 300,0 mg; Lamivudine 300,0 mg | Not listed | 59034759/20.2.8/0347 | Registered | S4 | None |
| Lutovir Each Tablet contains: Dolutegravir sodium equivalent to Dolutegravir 50,0 mg, Tenofovir Disoproxil fumarate 300,0 mg, Lamivudine 300,0 mg | Not listed | 60036360/20.2.8/0363 | Registered | S4 | 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, 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 Dolutegravir, lamivudine, tenofovir disoproxil fumarate
S4: Dolutegravir
Consolidated Schedules 06 July 2026, line 6100
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
Acriptega, Viatris Healthcare (Pty) Ltd is scheduled S4 in its official SAHPRA documents, read with 70% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.