🇪🇺 KANJINTI in European Union

EMA authorised KANJINTI on 16 May 2018

Marketing authorisation

Application: EMEA/H/C/004361
Marketing authorisation holder: Amgen Europe B.V.
Local brand name: Kanjinti
Indication: Metastatic breast cancer Kanjinti 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 patients who ha
Pathway: biosimilar
Status: approved

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

Is KANJINTI approved in European Union?

Yes. EMA authorised it on 16 May 2018.

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

Amgen Europe B.V. holds the EU marketing authorisation.