Anpheros Search · Treatment

Lamivudine

Also known as: Epivir · Zeffix · Lamivudine Teva · Lamivudine Teva Pharma B.V.

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In short

In the European Union, lamivudine is indicated as part of antiretroviral combination therapy for the treatment of human immunodeficiency virus (HIV) infected adults and children. In the European Union, it is also indicated for the treatment of chronic hepatitis B in adults with compensated liver disease showing active viral replication, persistently elevated ALT levels, and histological evidence of active liver inflammation or fibrosis, or with decompensated liver disease in combination with a second agent without cross-resistance. In the United States, lamivudine tablets are indicated for the treatment of chronic hepatitis B virus infection associated with evidence of hepatitis B viral replication and active liver inflammation. Initiation of lamivudine for chronic hepatitis B should only be considered when an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate. The cited source also connects lamivudine to human immunodeficiency virus disease without mention of tuberculosis or malaria, clinical stage unspecified.

From: Source: European Medicines Agency (EMA), Epivir — EPAR, 20/08/2026. © European Medicines Agency. · Source: European Medicines Agency (EMA), Zeffix — EPAR, 22/07/2026. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration. · Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.

AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.

Codes

RxNorm
68244 lamivudine
EMA
EMEA/H/C/000107, EMEA/H/C/000242, EMEA/H/C/001113, EMEA/H/C/001111

Official indications

Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.

EMA (EU) Epivir

Epivir is indicated as part of antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV)-infected adults and children.

Source: European Medicines Agency (EMA), Epivir — EPAR, 20/08/2026. © European Medicines Agency.

Document date: 20/08/2026 · Official document →

FDA (USA) Lamivudine

1 INDICATIONS AND USAGE Lamivudine tablets (HBV) are indicated for the treatment of chronic hepatitis B virus (HBV) infection associated with evidence of hepatitis B viral replication and active liver inflammation [see Clinical Studies ( 14.1 , 14.2 )]. The following points should be considered when initiating therapy with lamivudine tablets (HBV): • Due to high rates of resistance development in treated patients, initiation of treatment with lamivudine tablets (HBV) should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate. • Lamivudine tablets (HBV) have not been evaluated in patients co-infected with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis delta virus. • Lamivudine tablets (HBV) have not been evaluated in liver transplant recipients or in patients with chronic hepatitis B virus infection with decompensated liver disease. Lamivudine tablets (HBV) are a nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus (HBV) infection associated with evidence of hepatitis B viral replication and active liver inflammation. ( 1 )

Data provided by the U.S. Food and Drug Administration.

Document date: 20260729 · Official document →

EMA (EU) Zeffix

Zeffix is indicated for the treatment of chronic hepatitis B in adults with: compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and / or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate; decompensated liver disease in combination with a second agent without cross-resistance to lamivudine.

Source: European Medicines Agency (EMA), Zeffix — EPAR, 22/07/2026. © European Medicines Agency.

Document date: 22/07/2026 · Official document →

Related terms in the cited sources

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External resources

Questions

What is Lamivudine approved for in the European Union?

Epivir is indicated as part of antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV)-infected adults and children. (Source: European Medicines Agency (EMA), Epivir — EPAR, 20/08/2026. © European Medicines Agency.)

Sources and attribution

  • Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
  • Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
  • Data provided by the U.S. Food and Drug Administration.
  • This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
  • Source: European Medicines Agency (EMA), Epivir — EPAR, 20/08/2026. © European Medicines Agency.
  • Source: European Medicines Agency (EMA), Zeffix — EPAR, 22/07/2026. © European Medicines Agency.

Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →