Regulatory PathRegulatory requirements compared

Active substances

Abacavir + Lamivudine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
KIVEXA film-coated tablet600,300 mg,mgFilm-coated tablet · Oral use30 BlisterSAR 1676.80NCE · PrescriptionGlaxo Saudi Arabia LtdValid
Indications — CHI Daman Drug Formulary

HUMAN IMMUNODEFICIENCY VIRUS

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGtablet · oralCIPLAPrescription28 Mar 2017
ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGtablet · oralCHARTWELL RXPrescription28 Mar 2017
ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGtablet · oralAUROBINDO PHARMA LTDPrescription15 Nov 2018
ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGtablet · oralLAURUSPrescription25 Jul 2022
ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGtablet · oralHETERO LABS LTD VPrescription16 Apr 2025
EPZICOMEQ 600MG BASE;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralVIIV HLTHCAREDiscontinued2 Aug 2004
ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGtablet · oralTEVA PHARMS USADiscontinued29 Sep 2016
ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGtablet · oralAUROBINDO PHARMADiscontinued28 Mar 2017
ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGtablet · oralZYDUS PHARMSDiscontinued15 Nov 2018
ABACAVIR SULFATE AND LAMIVUDINEEQ 60MG BASE;30MGtablet, for suspension · oralPHARMOBEDIENTDiscontinued22 Dec 2023
ABACAVIR SULFATE AND LAMIVUDINEEQ 600MG BASE;300MGtablet · oralMACLEODS PHARMSDiscontinued19 Dec 2024

EMA European Union — centrally authorised medicines

Kivexa ViiV Healthcare BV · Authorised · authorised 16 Dec 2004 · ATC J05AR02

Therapeutic indication (EMA)

Kivexa is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children weighing at least 25 kg. Before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin. Abacavir should not be used in patients known to carry the HLA-B*5701 allele.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
AURO-ABACAVIR/LAMIVUDINE02454513600 MG; 300 MGTABLET · ORALAURO PHARMA INC
JAMP ABACAVIR / LAMIVUDINE02497654600 MG; 300 MGTABLET · ORALJAMP PHARMA CORPORATION
MYLAN-ABACAVIR/LAMIVUDINE02450682600 MG; 300 MGTABLET · ORALMYLAN PHARMACEUTICALS ULC
TEVA-ABACAVIR/LAMIVUDINE02416662300 MG; 600 MGTABLET · ORALTEVA CANADA LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACABACAVIR-LAMIVUDINE 600-300 MG$1.48365per EA23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

  • 6.4.2.5. Fixed-dose combinations of antiretrovirals · core
    Human immunodeficiency virus disease without mention of tuberculosis or malaria, clinical stage unspecified
    Oral > Solid: 120 mg (as sulfate) + 60 mg tablet (dispersible, scored)

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.