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.
Faslodex : EPAR - Summary for the public (PDF/82.13 KB)
First published: 30/01/2009
Last updated: 27/01/2018
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
|Date of issue of marketing authorisation valid throughout the European Union||
07/11/2019 Faslodex - EMEA/H/C/000540 - II/0067
- 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.
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.