Ziihera
What Ziihera is used for
Ziihera as monotherapy is indicated for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC3+) biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy (for biomarker-based patient selection, see section 4.2).
Approved use, as published by the European Medicines Agency.
What the labels mean
- Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).
- Conditional approval: approved on less complete data because the need is high; more data must follow.
Key facts
- Brand
- Ziihera
- Active substance
- zanidatamab
- Disease area
- Biliary Tract Neoplasms
- Medicine group
- Antineoplastic agents
- ATC code
- L01FD07
- Marketing authorisation holder
- Jazz Pharmaceuticals Ireland Limited
- Authorised in the EU since
- 2025
Official information
In the USA
Same active substance: Ziihera
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Ziihera used for?
Ziihera as monotherapy is indicated for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC3+) biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy (for biomarker-based patient selection, see section 4.2).
What is the active substance in Ziihera?
Ziihera contains zanidatamab.
Who makes Ziihera?
The EU marketing authorisation holder is Jazz Pharmaceuticals Ireland Limited.
Is Ziihera an orphan medicine?
Yes. Ziihera is designated an orphan medicine in the EU, for a rare disease (Biliary Tract Neoplasms).
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, EU