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EMA approval · 2026-06-12

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

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Summary

Zutectra, a human hepatitis B immunoglobulin product by Biotest Pharma GmbH, has been authorised for use in immunization and passive immunity contexts, includin…

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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: 21/05/2026