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EMA approval · 2025-10-15

EMA Authorised: Zutectra (human hepatitis B immunoglobulin) — Biotest Pharma GmbH

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Summary

The European Medicines Agency has authorised Zutectra, a human hepatitis B immunoglobulin, for passive immunization in hepatitis B infection and liver transplan…

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Diseases / indications

Drugs mentioned

  • Zutectra (human hepatitis B immunoglobulin)

Snippet

Status: Authorised. Therapeutic area: Immunization, Passive;Hepatitis B;Liver Transplantation. MAH: Biotest Pharma GmbH. Decision date: 18/09/2025