Cabazitaxel Accord



This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 27/07/2023

Authorisation details

Product details
Cabazitaxel Accord
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Prostatic Neoplasms, Castration-Resistant
Anatomical therapeutic chemical (ATC) code

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Accord Healthcare S.L.U.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Accord Healthcare S.L.U.
Edificio Este Planta 6a
World Trade Center
Moll De Barcelona S/n
08039 Barcelona

Product information

27/07/2023 Cabazitaxel Accord - EMEA/H/C/005178 - IB/0007

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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

Assessment history

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