Anpheros Search · Treatment

Human hepatitis B immunoglobulin

Also known as: Zutectra

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In short

In the European Union, human hepatitis B immunoglobulin is indicated for the prevention of hepatitis B virus re-infection in HBsAg and HBV-DNA negative adult patients at least one week after liver transplantation for hepatitis B induced liver failure. HBV-DNA negative status should be confirmed within the last 3 months prior to OLT, and patients should be HBsAg negative before treatment start. The concomitant use of adequate virostatic agents should be considered as standard of hepatitis B re-infection prophylaxis, and the substance is listed by the cited source as having an approved use for acute hepatitis B.

Source: European Medicines Agency (EMA), Zutectra — EPAR, 25/08/2026. © European Medicines Agency. · 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
26744 hepatitis B immune globulin
EMA
EMEA/H/C/001089

Official indications

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

EMA (EU) Zutectra

Prevention of hepatitis B virus (HBV) re-infection in HBsAg and HBV-DNA negative adult patients at least one week after liver transplantation for hepatitis B induced liver failure. HBV-DNA negative status should be confirmed within the last 3 months prior to OLT. Patients should be HBsAg negative before treatment start. The concomitant use of adequate virostatic agents should be considered as standard of hepatitis B re-infection prophylaxis.

Source: European Medicines Agency (EMA), Zutectra — EPAR, 25/08/2026. © European Medicines Agency.

Document date: 25/08/2026 · Official document →

Related terms in the cited sources

Has an official indication for

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What people report

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External resources

Questions

What is Human hepatitis B immunoglobulin approved for in the European Union?

Prevention of hepatitis B virus (HBV) re-infection in HBsAg and HBV-DNA negative adult patients at least one week after liver transplantation for hepatitis B induced liver failure. HBV-DNA negative status should be confirmed within the last 3 months prior to OLT. Patients should be HBsAg negative before treatment start. The concomitant use of adequate virostatic agents should be considered as standard of hepatitis B re-infection prophylaxis. (Source: European Medicines Agency (EMA), Zutectra — EPAR, 25/08/2026. © 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.
  • 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), Zutectra — EPAR, 25/08/2026. © European Medicines Agency.

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