🇪🇺 OMP-54F28 with Sorafenib in European Union

EMA authorised OMP-54F28 with Sorafenib on 9 November 2022

Marketing authorisation

EMA — authorised 9 November 2022

  • Application: EMEA/H/C/005921
  • Marketing authorisation holder: Accord Healthcare S.L.U.
  • Local brand name: Sorafenib Accord
  • Indication: Hepatocellular carcinomaSorafenib Accord is indicated for the treatment of hepatocellular carcinoma (see section 5.1). Renal cell carcinomaSorafenib Accord is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.
  • Status: approved

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Frequently asked questions

Is OMP-54F28 with Sorafenib approved in European Union?

Yes. EMA authorised it on 9 November 2022.

Who is the marketing authorisation holder for OMP-54F28 with Sorafenib in European Union?

Accord Healthcare S.L.U. holds the EU marketing authorisation.