Xtandi

RSS

enzalutamide

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

Overview

This is a summary of the European public assessment report (EPAR) for Xtandi. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Xtandi.

For practical information about using Xtandi, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 11/04/2018

Authorisation details

Product details
Name
Xtandi
Agency product number
EMEA/H/C/002639
Active substance
enzalutamide
International non-proprietary name (INN) or common name
enzalutamide
Therapeutic area (MeSH)
Prostatic Neoplasms
Anatomical therapeutic chemical (ATC) code
L02BB04
Additional 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.

Publication details
Marketing-authorisation holder
Astellas Pharma Europe B.V.
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
21/06/2013
Contact address
Sylviusweg 62
2333 BE Leiden
The Netherlands

Product information

08/02/2018 Xtandi - EMEA/H/C/002639 - R/0037

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

ENDOCRINE THERAPY

Therapeutic indication

Treatment of adult men with metastatic castration‑resistant prostate cancer whose disease has progressed on or after docetaxel therapy.

Assessment history

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