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2 Information about zanidatamab

Anticipated marketing authorisation indication

2.1

Zanidatamab (Ziihera, Jazz Pharmaceuticals) does not have a marketing authorisation in Great Britain yet. It received a marketing authorisation by the European Commission 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'.

Dosage in the marketing authorisation

2.2

The dosage schedule will be available in the summary of product characteristics for zanidatamab.

Price

2.3

The list price per pack of 2 vials of 300-mg zanidatamab is currently confidential.

2.4

The company has an approved commercial arrangement (simple discount patient access scheme), which would have applied if zanidatamab had been recommended.

Carbon Reduction Plan

2.5

Information on the Carbon Reduction Plan for UK carbon emissions for Jazz Pharmaceuticals will be included here when guidance is published.