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lamivudine

Epivir, Zeffix · ATC code J05AF05

Also known as: Lamivudin · Brand names: Epivir, Zeffix, Lamivudin Sandoz, Lamivudin Aurobindo, Lamivudin Mylan, Laveros, Lavirex, Medovir, Mivux, Zefomen

Key facts
Active substance
lamivudine
Drug class
Direct acting antiviral
ATC code
J05AF05
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Epivir 150 mg film-coated tablets / Epivir 300 mg film-coated tablets · Epivir 10 mg/mL oral solution · Zeffix 100 mg film-coated tablets. · Zeffix 5 mg/ml oral solution.
Marketing authorisation holder
ViiV Healthcare BV, GlaxoSmithKline Trading Services Limited
Information as of
2026-10-27

Key facts

Lamivudine is a nucleoside reverse transcriptase inhibitor. It is used as Epivir in combination therapy for HIV infection and as Zeffix for chronic hepatitis B.

What it is used for

  • Epivir: HIV infection in adults and children, as part of antiretroviral combination therapy
  • Zeffix: chronic hepatitis B in adults with compensated liver disease and active viral replication, when an agent with a higher genetic barrier is not available or appropriate
  • Zeffix: decompensated liver disease, combined with a second agent without cross-resistance

Dosing

  • Epivir, at least 25 kg: 300 mg daily, as 150 mg twice daily or 300 mg once daily; with or without food
  • Epivir, children 20 to less than 25 kg: 225 mg daily; 14 to less than 20 kg: 150 mg daily; oral solution for children under 14 kg
  • Zeffix: 100 mg once daily; always combined in decompensated liver disease
  • Zeffix with creatinine clearance < 50 ml/minute: reduced doses using the oral solution (5 mg/ml) per table
  • Epivir dose is also adjusted in moderate to severe renal impairment
  • Zeffix: consider switching or adding an agent if HBV DNA remains detectable at 24 weeks

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Epivir not for monotherapy; high virological failure rate with certain triple nucleoside regimens
  • Hepatitis B exacerbations during treatment and after discontinuation; monitor periodically after stopping
  • Resistance (YMDD mutant HBV) with diminished response
  • Pancreatitis (rare); stop immediately if suspected
  • Opportunistic infections may still occur

Side effects

  • Epivir common: headache, insomnia, cough, nausea, vomiting, abdominal pain, diarrhoea, rash, alopecia, arthralgia, fatigue, fever
  • Uncommon: neutropenia, anaemia, thrombocytopenia, raised liver enzymes
  • Very rare: lactic acidosis, pure red cell aplasia, peripheral neuropathy
  • Zeffix: very common ALT elevations; rare angioedema

Interactions

  • Trimethoprim/sulfamethoxazole increases lamivudine exposure by 40%; avoid high-dose co-trimoxazole (PCP, toxoplasmosis)
  • Low likelihood of metabolic interactions (mainly renal elimination)

Pregnancy and breastfeeding

  • Crosses the placenta; registry data with more than 1,000 first-trimester exposures show no malformative effect; Zeffix can be used in pregnancy if clinically needed

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Austria

  • Lamivudin SandozSandoz Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • Lamivudin AurobindoPuren Pharma Gmbh & Co. Kg · 1 register entry
  • Lamivudin MylanViatris Germany Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • EpivirGLAXOSMİTHKLİNE İLAÇLARI SAN. VE TİC. A.Ş. · 3 register entries
  • LaverosSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • LavirexULKAR İLAÇ PAZARLAMA LTD. ŞTİ. · 2 register entries
  • MedovirSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
  • MivuxNOBEL İLAÇ SAN. VE TİC. A.Ş. · 6 register entries
  • ZeffixGLAXOSMİTHKLİNE İLAÇLARI SAN. VE TİC. A.Ş. · 1 register entry
  • ZefomenGENSENTA İLAÇ SANAYİ VE TİC. A.Ş. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 10 more European countries
Cyprus
Lamivudine Normon
France
Lamivudine Arrow, Lamivudine Sandoz, Lamivudine Viatris
Iceland
Epivir, Lamivudine Teva, Zeffix
Italy
Lamivudina Aurobindo, Lamivudina Mylan
Liechtenstein
Epivir, Lamivudine Teva, Zeffix
Netherlands
Lamivudine Accord, Lamivudine Aurobindo, Lamivudine Sandoz
Norway
Epivir, Lamivudine Teva, Zeffix
Poland
Lamivudine Aurovitas
Portugal
Lamivudina Aurobindo, Lamivudina Farmoz, Lamivudina Viatris
Spain
Lamivudina Accord, Lamivudina Aurovitas, Lamivudina Normon

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Epivir – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/epivir-epar-product-information_en.pdf
  2. European Medicines Agency. Zeffix – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/zeffix-epar-product-information_en.pdf
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  5. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  6. Wikidata (CC0): ATC J05AF.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.