Jevtana

RSS

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 05/02/2018

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
16
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

22/01/2018 Jevtana - EMEA/H/C/002018 - N/0039

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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