ZIIHERA Powder for concentrate for solution for infusion Ref.[115391] Active ingredients: Zanidatamab

Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Jazz Pharmaceuticals Ireland Ltd, 5 th Floor, Waterloo Exchange, Waterloo Road, Dublin 4, D04 E5W7, Ireland

Product name and form

Ziihera 300 mg powder for concentrate for solution for infusion.

Pharmaceutical Form
Powder for concentrate for solution for infusion (powder for concentrate). White lyophilised cake.

Qualitative and quantitative composition

One vial of powder contains 300 mg of zanidatamab.

After reconstitution, one vial contains 50 mg/mL of zanidatamab.

Zanidatamab is a humanised (IgG1) bispecific antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.

For the full list of excipients, see section 6.1.

Active Ingredient
Zanidatamab
Zanidatamab is a dual HER2-targeted bispecific antibody that simultaneously binds extracellular domains 2 and 4 on separate HER2 monomers (binding in trans). Binding of zanidatamab with HER2 results in internalization leading to a reduction of the receptor on the cell surface. Zanidatamab induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumour growth inhibition and tumour cell death.

List of Excipients
Polysorbate 20 (E432) Disodium succinate Succinic acid (E363) Sucrose Water for injections

Pack sizes and marketing

20 mL Type I glass vial with a chlorobutyl stopper and flip-off cap.

Each pack contains either 1 vial or 2 vials.

Not all pack sizes may be marketed.

Marketing authorization holder

Jazz Pharmaceuticals Ireland Ltd, 5^th Floor, Waterloo Exchange, Waterloo Road, Dublin 4, D04 E5W7, Ireland

Marketing authorization dates and numbers

EU/1/25/1931/001
EU/1/25/1931/002

Drugs

Drug	Countries
ZIIHERA	United States

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