🇪🇺 Local Standard of Care in European Union

EMA authorised Local Standard of Care on 11 February 2021

Marketing authorisation

EMA — authorised 11 February 2021

  • Application: EMEA/H/C/005419
  • Marketing authorisation holder: Accord Healthcare S.L.U.
  • Local brand name: Sunitinib Accord
  • Indication: Gastrointestinal stromal tumour (GIST) Sunitinib Accord is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib treatment due to resistance or intolerance. Metastatic renal cell carcinoma (MRCC) Sunitinib Accord is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults. Pancreatic neuroendocrine tumours (pNET) Sunitinib Accord is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) with disease progres
  • Status: approved

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Other Oncology approved in European Union

Frequently asked questions

Is Local Standard of Care approved in European Union?

Yes. EMA authorised it on 11 February 2021.

Who is the marketing authorisation holder for Local Standard of Care in European Union?

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