Cabazitaxel Accord
cabazitaxel
Table of contents
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.
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Cabazitaxel Accord : EPAR - Medicine overview (PDF/130.51 KB)
First published: 28/10/2020
EMA/242602/2020 -
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Cabazitaxel Accord : EPAR - Risk-management-plan summary (PDF/116.73 KB)
First published: 28/10/2020
Last updated: 16/01/2023
Authorisation details
Product details | |
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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
|
Generic |
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 | |
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Marketing-authorisation holder |
Accord Healthcare S.L.U.
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Revision |
3
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Date of issue of marketing authorisation valid throughout the European Union |
28/08/2020
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Contact address |
Accord Healthcare S.L.U. |
Product information
11/01/2023 Cabazitaxel Accord - EMEA/H/C/005178 - IB/0004
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.