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EMA Product

Cabazitaxel Accord

Product approved by European Medicines Agency (EU)

Basic Information

Cabazitaxel Accord

Regulatory Information

EMEA/H/C/005178

Authorised

August 28, 2020

April 30, 2020

7

August 1, 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 Treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.

Overview Summary

Cabazitaxel Accord is a cancer medicine used to treat men with metastatic castration-resistant prostate cancer. This is a cancer that affects the prostate gland that produces the liquid in semen (prostate fluid). Cabazitaxel Accord is used when the cancer has spread to other parts of the body (metastatic) despite treatments to prevent the production of testosterone or after surgical removal of the testes (castration). Cabazitaxel Accord is used in combination with prednisone or prednisolone (anti-inflammatory medicines) in patients who have previously been treated with docetaxel (another cancer medicine). Cabazitaxel Accord contains the active substance cabazitaxel and is a ‘hybrid’ and a ‘generic’ medicine. This means that it is similar to a reference medicine containing the same active substance, but comes in a different concentration and is prepared (diluted) differently. The reference medicine for Cabazitaxel Accord is Jevtana.

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