Jevtana

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cabazitaxel

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

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.

This EPAR was last updated on 14/12/2021

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-aventis groupe 
Revision
20
Date of issue of marketing authorisation valid throughout the European Union
17/03/2011
Contact address
sanofi-aventis groupe
54, rue la Boétie
F-75008 Paris
France

Product information

13/12/2021 Jevtana - EMEA/H/C/002018 - N/0046

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

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.

Assessment history

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