🇪🇺 Ontruzant in European Union

EMA authorised Ontruzant on 15 November 2017

Marketing authorisation

EMA — authorised 15 November 2017

  • Application: EMEA/H/C/004323
  • Marketing authorisation holder: Samsung Bioepis NL B.V.
  • Local brand name: Ontruzant
  • Indication: Breast cancer Metastatic breast cancer Ontruzant 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
  • Pathway: biosimilar
  • Status: approved

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Ontruzant in other countries

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

Other Other approved in European Union

Frequently asked questions

Is Ontruzant approved in European Union?

Yes. EMA authorised it on 15 November 2017.

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

Samsung Bioepis NL B.V. holds the EU marketing authorisation.