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EMA Product

Axitinib Accord

Product approved by European Medicines Agency (EU)

Basic Information

Axitinib Accord

Regulatory Information

EMEA/H/C/006206

Authorised

September 19, 2024

July 25, 2024

1

December 19, 2024

Company Information

Spain

Edificio Este Planta 6a World Trade Center Moll De Barcelona S/n 08039 Barcelona

ACCORD HEALTHCARE SL

Drug Classification

Generic Medicine

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic 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.

Overview Summary

Axitinib Accord is used to treat adults with advanced renal cell carcinoma, a type of kidney cancer. ‘Advanced’ means that the cancer has started to spread. Axitinib Accord is used when treatment with a medicine containing sunitinib or with ‘cytokines’ (other cancer medicines) has failed. Axitinib Accord contains the active substance axitinib and is a ‘generic medicine’. This means that Axitinib Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Axitinib Accord is Inlyta. For more information on generic medicines, see the question-and-answer document [here](https://www.ema.europa.eu/en/documents/other/questions-and-answers-generic-medicines_en.pdf).

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