Faslodex

RSS

fulvestrant

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

Overview

This is a summary of the European public assessment report (EPAR) for Faslodex. 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 Faslodex.

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

This EPAR was last updated on 09/04/2018

Authorisation details

Product details
Name
Faslodex
Agency product number
EMEA/H/C/000540
Active substance
fulvestrant
International non-proprietary name (INN) or common name
fulvestrant
Therapeutic area (MeSH)
Breast Neoplasms
Anatomical therapeutic chemical (ATC) code
L02BA03
Publication details
Marketing-authorisation holder
AstraZeneca AB
Revision
19
Date of issue of marketing authorisation valid throughout the European Union
10/03/2004
Contact address
SE-151 85 Södertälje
Sweden

Product information

21/03/2018 Faslodex - EMEA/H/C/000540 - T/0063

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

Anti oestrogen

Therapeutic indication

Faslodex is indicated

  • as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:
    • not previously treated with endocrine therapy, or
    • with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy.
  • in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy.

In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.

Assessment history

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