🇪🇺 Palifermin before only in European Union

EMA authorised Palifermin before only on 25 October 2005

Marketing authorisation

EMA — authorised 25 October 2005

  • Application: EMEA/H/C/000609
  • Marketing authorisation holder: Swedish Orphan Biovitrum AB (publ)
  • Local brand name: Kepivance
  • Indication: Kepivance is indicated to decrease the incidence, duration and severity of oral mucositis in adult patients with haematological malignancies receiving myeloablative radiochemotherapy associated with a high incidence of severe mucositis and requiring autologous-haematopoietic-stem-cell support.
  • Status: withdrawn

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Other Oncology approved in European Union

Frequently asked questions

Is Palifermin before only approved in European Union?

Yes. EMA authorised it on 25 October 2005.

Who is the marketing authorisation holder for Palifermin before only in European Union?

Swedish Orphan Biovitrum AB (publ) holds the EU marketing authorisation.