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EMA approval · 2026-01-28

EMA Authorised: Heplisav B (hepatitis B surface antigen) — Dynavax GmbH

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Summary

The European Medicines Agency authorised Heplisav B, a hepatitis B vaccine based on hepatitis B surface antigen, for use in the European Union. The marketing au…

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Diseases / indications

Drugs mentioned

  • HEPLISAV-B (hepatitis B vaccine, adjuvanted)

Snippet

Status: Authorised. Therapeutic area: Hepatitis B. MAH: Dynavax GmbH. Decision date: 17/11/2025