Jevtana
cabazitaxel
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Jevtana. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Jevtana.
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Jevtana : EPAR - Summary for the public (PDF/78.05 KB)
First published: 05/04/2011
Last updated: 05/05/2017 -
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Jevtana : EPAR - Risk-management-plan summary (PDF/38.55 KB)
First published: 17/12/2020
Authorisation details
Product details | |
---|---|
Name |
Jevtana
|
Agency product number |
EMEA/H/C/002018
|
Active substance |
cabazitaxel
|
International non-proprietary name (INN) or common name |
cabazitaxel
|
Therapeutic area (MeSH) |
Prostatic Neoplasms
|
Anatomical therapeutic chemical (ATC) code |
L01CD
|
Publication details | |
---|---|
Marketing-authorisation holder |
Sanofi Winthrop Industrie
|
Revision |
22
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Date of issue of marketing authorisation valid throughout the European Union |
17/03/2011
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Contact address |
82 Avenue Raspail |
Product information
30/03/2023 Jevtana - EMEA/H/C/002018 - II/0049
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
Jevtana in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.