Entecavir
Also known as: Baraclude · Entecavir Viatris (previously Entecavir Mylan) · Entecavir Accord
General information only. Anpheros does not diagnose and does not recommend treatment. Talk to a doctor or pharmacist about your situation. In an emergency, call 112 (or your local emergency number).
In short
In the European Union, entecavir is indicated for the treatment of chronic hepatitis B virus infection in adults with decompensated liver disease, or with compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase levels, and histological evidence of active inflammation or fibrosis. The European Union indication is based on clinical trial data in nucleoside-naive patients with HBeAg-positive and HBeAg-negative hepatitis B virus infection, and also covers patients with lamivudine-refractory hepatitis B. In the United States, entecavir is a hepatitis B virus nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients two years of age and older. The United States indication requires evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases or histologically active disease.
From: Source: European Medicines Agency (EMA), Baraclude — EPAR, 03/12/2025. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration.
AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.
Codes
- RxNorm
- 306266 entecavir
- EMA
- EMEA/H/C/000623, EMEA/H/C/004377, EMEA/H/C/004458
Official indications
Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.
EMA (EU) Baraclude
Baraclude is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with: compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis; decompensated liver disease. For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B.
Source: European Medicines Agency (EMA), Baraclude — EPAR, 03/12/2025. © European Medicines Agency.
Document date: 03/12/2025 · Official document →
FDA (USA) ENTECAVIR
1 INDICATIONS AND USAGE Entecavir is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease Entecavir is a hepatitis B virus nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults and children at least 2 years of age with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. (1)
Data provided by the U.S. Food and Drug Administration.
Document date: 20260707 · Official document →
Other treatments A–Z
What people report
Not enough data yet. Anonymous counts appear here only for groups of at least 20 people who agreed to share them.
External resources
Questions
What is Entecavir approved for in the European Union?
Baraclude is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with: compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis; decompensated liver disease. For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B. (Source: European Medicines Agency (EMA), Baraclude — EPAR, 03/12/2025. © 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), Baraclude — EPAR, 03/12/2025. © European Medicines Agency.
Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →
About this page. This page brings together public information from official sources, each cited where it is used. It is not medical advice, it is not a diagnosis, and it does not tell you which treatment to take.
Treatments. Indications are quoted unchanged from official product information (European Medicines Agency, U.S. Food and Drug Administration). They describe what a medicine is approved for, not whether it is right for you. Approved uses can differ between countries. Always read the package leaflet and follow your doctor's or pharmacist's advice.
What people report. Figures marked "reported by Anpheros users" are anonymous counts from at least 20 people who agreed to share them. They show what people report, not what works, and they are not clinical evidence.
Links between terms. "May be associated with" means the link appears in a cited source. It does not mean you have that condition.
In an emergency, call 112 (or your local emergency number). Do not delay seeking medical help because of something you read here.