Regulatory PathRegulatory requirements compared

Active substances

Lamivudine + Zidovudine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
COMBIVIR F.C TAB300,150 mg,mgFilm-coated tablet · Oral use60 BlisterSAR 1091.55NCE · PrescriptionGlaxo Saudi Arabia Ltd.Valid
Indications — CHI Daman Drug Formulary

HUMAN IMMUNODEFICIENCY VIRUS

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

ProductStrengthForm · routeApplicantStatusFirst approved
LAMIVUDINE AND ZIDOVUDINE150MG;300MGtablet · oralHETERO LABS LTD VPrescription3 Feb 2014
LAMIVUDINE AND ZIDOVUDINE150MG;300MGtablet · oralHETERO LABS LTD IIIPrescription17 Sep 2015
LAMIVUDINE AND ZIDOVUDINE150MG;300MGtablet · oralAUROBINDO PHARMAPrescription5 May 2017
LAMIVUDINE AND ZIDOVUDINE150MG;300MGtablet · oralEPIC PHARMA LLCPrescription10 Apr 2018
LAMIVUDINE AND ZIDOVUDINE150MG;300MGtablet · oralMACLEODS PHARMSPrescription29 Aug 2018
LAMIVUDINE AND ZIDOVUDINE150MG;300MGtablet · oralCIPLAPrescription7 Sep 2018
COMBIVIR150MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralVIIV HLTHCAREDiscontinued26 Sep 1997
LAMIVUDINE AND ZIDOVUDINE150MG;300MGtablet · oralCHARTWELL RXDiscontinued25 May 2011
LAMIVUDINE AND ZIDOVUDINE150MG;300MGtablet · oralLUPIN LTDDiscontinued15 May 2012
LAMIVUDINE AND ZIDOVUDINE150MG;300MGtablet · oralAUROBINDO PHARMA LTDDiscontinued15 May 2012
LAMIVUDINE AND ZIDOVUDINE150MG;300MGtablet · oralNATCODiscontinued28 Aug 2014
LAMIVUDINE AND ZIDOVUDINE150MG;300MGtablet · oralPHARMOBEDIENTDiscontinued13 May 2015
LAMIVUDINE AND ZIDOVUDINE150MG;300MGtablet · oralPHARMACAREDiscontinued17 Mar 2017
LAMIVUDINE AND ZIDOVUDINE150MG;300MGtablet · oralPHARMOBEDIENTDiscontinued12 Aug 2019

EMA European Union — centrally authorised medicines

Combivir ViiV Healthcare BV · Authorised · authorised 18 Mar 1998 · ATC J05AR01

Therapeutic indication (EMA)

Combivir is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection.

Lamivudine/Zidovudine Teva Teva Pharma B.V. · Withdrawn · authorised 28 Feb 2011 · ATC J05AR01

Therapeutic indication (EMA)

Lamivudine/Zidovudine Teva is indicated in antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV) infection.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-LAMIVUDINE-ZIDOVUDINE02375540150 MG; 300 MGTABLET · ORALAPOTEX INC
AURO-LAMIVUDINE/ZIDOVUDINE02414414300 MG; 150 MGTABLET · ORALAURO PHARMA INC
JAMP LAMIVUDINE / ZIDOVUDINE02502801300 MG; 150 MGTABLET · ORALJAMP PHARMA CORPORATION

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACLAMIVUDINE-ZIDOVUDINE TABLET$0.77072per 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: 30 mg + 60 mg Tablet (EMLc); 150 mg + 300 mg Tablet (EML)

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.