Cabazitaxel Accord

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cabazitaxel

Authorised
This medicine is authorised for use in the European Union.

Overview

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 28/10/2020

Authorisation details

Product details
Name
Cabazitaxel Accord
Agency product number
EMEA/H/C/005178
Active substance
cabazitaxel
International non-proprietary name (INN) or common name
cabazitaxel
Therapeutic area (MeSH)
Prostatic Neoplasms, Castration-Resistant
Anatomical therapeutic chemical (ATC) code
L01CD04
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

GenericGeneric

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
28/08/2020
Contact address

World Trade Center
Moll de Barcelona
s/n, Edifici Est 6ª planta
08039 Barcelona
Spain

Product information

28/08/2020 Cabazitaxel Accord - EMEA/H/C/005178 -

Contents

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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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