Abacavir, lamivudine
Sold as Azadar, Auro-abacavir/lamivudine, Dumiva, Abacavir & lamivudine medpro, Abacavir & lamivudine cipla, Coablam, Heteruam, Nabalam, Vexabax, Qulam-co, Virulate, Mylamba, Kivexa
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 10
- Registrations
- 13
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Aurogen South Africa (Pty) Ltd | Azadar | 600/300 mg | 440290 | S4 | None |
| Aurobindo Pharma (Pty) Ltd | Auro-abacavir/lamivudine | 600/300 mg | 440293 | S4 | None |
| Viatris Healthcare (Pty) LtdCertificate held by Mylan (Pty) Ltd | Dumiva, Mylamba | 300 mg, 600 mg | 460012, 550255 | S4 | PIPIL |
| Cipla Medpro (Pty) Ltd | Abacavir & lamivudine medpro | 600/300 | 471104 | S4 | None |
| Cipla Medpro Manufacturing (Pty) Ltd | Abacavir & lamivudine cipla | 600/300 | 471105 | S4 | None |
| Teva Pharmaceuticals (Pty) LtdCancelled | Coablam | 600/300 | 480314 | S4 | None |
| Hetero Drugs South Africa (Pty) Ltd | Heteruam, Nabalam | Not stated | 481243, 491012 | S4 | None |
| Ranbaxy (SA) (Pty) LtdCertificate held by Ranbaxy Pharmaceuticals (Pty) Ltd | Vexabax | 600 mg/300 mg | 540219 | S4 | PIPIL |
| Macleods Pharmaceuticals SA (Pty) Ltd | Qulam-co, Virulate | 300mg, 600mg | 550077, 550078.077 | S4 | PIPIL |
| Glaxosmithkline South Africa (Pty) LimitedCertificate held by Gsk | Kivexa | 300mg, 600mg | A390030 | S4 | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Azadar 600/300 MG tablets EACH TABLET CONTAINS ABACAVIR 600,0 mg LAMIVUDINE 300,0 mg | 600/300 mgTablets | 44029044/20.2.8/0290 | Registered | S4 | None |
| Auro-abacavir/lamivudine 600/300 MG tablets EACH TABLET CONTAINS: ABACAVIR 600,0 mg, LAMIVUDINE 300,0 mg | 600/300 mgTablets | 44029344/20.2.8/0293 | Registered | S4 | None |
| Dumiva EACH TABLET CONTAINS ABACAVIR 600,0 mg LAMIVUDINE 300,0 mg | Not listed | 46001246/20.2.8/0012 | Registered | S4 | None |
| Abacavir & lamivudine medpro 600/300 EACH TABLET CONTAINS ABACAVIR 600,0 mg LAMIVUDINE 300,0 mg | 600/300 | 47110447/20.2.8/1104 | Registered | S4 | None |
| Abacavir & lamivudine 600/300 cipla EACH TABLET CONTAINS ABACAVIR 600,0 mg LAMIVUDINE 300,0 mg | 600/300 | 47110547/20.2.8/1105 | Registered | S4 | None |
| Coablam 600/300 EACH TABLET CONTAINS ABACAVIR 600,0 mg LAMIVUDINE 300,0 mg | 600/300 | 48031448/20.2.8/0314 | Cancelled | S4 | None |
| Heteruam EACH TABLET CONTAINS ABACAVIR 600,0 mg LAMIVUDINE 300,0 mg | Not listed | 48124348/20.2.8/1243 | Registered | S4 | None |
| Nabalam EACH TABLET CONTAINS : ABACAVIR EQUIVALENT TO ABACAVIR 600,0 mg LAMIVUDINE 300,0 mg | Not listed | 49101249/20.2.8/1012 | Registered | S4 | None |
| Vexabax EACH TABLET CONTAINS ABACAVIR 600,0 mgLAMIVUDINE 300,0 mg | 600 mg/300 mgFilm-coated tablets | 54021954/20.2.8/0219Approved 8 April 2024 | Registered | S4 | PIPIL |
| Qulam-co | 300mg. 600mgTablet | 55007755/20.2.8/0077Approved 6 April 2022 | Registered | S4 | PIPIL |
| Virulate | 300mg. 600mgTablet | 550078.07755/20.2.8/0078.077Approved 6 April 2022 | Registered | S4 | PIPIL |
| Mylamba EACH TABLET CONTAINS ABACAVIR SULPHATE 600,0 mg LAMIVUDINE 300,0 mg | 600 mg. 300 mgTablet | 55025555/20.2.8/0255Approved 15 October 2024 | Registered | S4 | PIPIL |
| Kivexa EACH TABLET CONTAINS ABACAVIR 600,0 mg LAMIVUDINE 300,0 mg | 600mg. 300mgTablet | A390030A39/20.2.8/0030Approved 5 August 2019 | 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 Abacavir, lamivudine
S4: Abacavir
Consolidated Schedules 06 July 2026, line 5118
S4: Lamivudine
Consolidated Schedules 06 July 2026, line 6850
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.