🇪🇺 AG-103736 in European Union

EMA authorised AG-103736 on 19 September 2024

Marketing authorisation

EMA — authorised 19 September 2024

  • Application: EMEA/H/C/006206
  • Marketing authorisation holder: Accord Healthcare S.L.U.
  • Local brand name: Axitinib Accord
  • Indication: Axitinib Accord is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.
  • Status: approved

The European Medicines Agency (EMA) granted marketing authorisation for Axitinib Accord (AG-103736) on 19 September 2024. Axitinib Accord is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine. This authorisation was granted to Accord Healthcare S.L.U. as the marketing authorisation holder.

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Frequently asked questions

Is AG-103736 approved in European Union?

Yes. EMA authorised it on 19 September 2024.

Who is the marketing authorisation holder for AG-103736 in European Union?

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