🇪🇺 ZIEXTENZO in European Union

EMA authorised ZIEXTENZO on 22 November 2018

Marketing authorisation

EMA — authorised 22 November 2018

  • Application: EMEA/H/C/004802
  • Marketing authorisation holder: Sandoz GmbH
  • Local brand name: Ziextenzo
  • Indication: Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
  • Pathway: biosimilar
  • Status: approved

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ZIEXTENZO 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 ZIEXTENZO approved in European Union?

Yes. EMA authorised it on 22 November 2018.

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

Sandoz GmbH holds the EU marketing authorisation.