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EMA approval · 2026-07-14

EMA Authorised: Hemgenix (Etranacogene dezaparvovec) — CSL Behring GmbH

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Summary

The EMA has authorised Hemgenix (etranacogene dezaparvovec) for Hemophilia B under conditional approval as an orphan medicine.

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Diseases / indications

Drugs mentioned

  • Hemgenix (etranacogene dezaparvovec)

Snippet

Status: Authorised. Therapeutic area: Hemophilia B. MAH: CSL Behring GmbH. Decision date: 21/05/2026. Conditional approval. Orphan medicine