🇪🇺 Herzuma in European Union

EMA authorised Herzuma on 9 February 2018

Marketing authorisation

Application: EMEA/H/C/002575
Marketing authorisation holder: Celltrion Healthcare Hungary Kft.
Local brand name: Herzuma
Indication: Breast cancer Metastatic breast cancer Herzuma is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC): as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments. in combination with paclitaxel for the treatment of those pa
Pathway: biosimilar
Status: approved

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Is Herzuma approved in European Union?

Yes. EMA authorised it on 9 February 2018.

Who is the marketing authorisation holder for Herzuma in European Union?

Celltrion Healthcare Hungary Kft. holds the EU marketing authorisation.