EMA Authorised: Ziihera (zanidatamab) — Jazz Pharmaceuticals Ireland Limited

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Summary

EMA authorised zanidatamab (Ziihera) for biliary tract neoplasms under conditional approval and orphan medicine designation.

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Diseases / indications

• Biliary Tract Neoplasms

Drugs mentioned

• ZIIHERA (ZANIDATAMAB-HRII)

Snippet

Status: Authorised. Therapeutic area: Biliary Tract Neoplasms. MAH: Jazz Pharmaceuticals Ireland Limited. Decision date: 17/12/2025. Conditional approval. Orphan medicine