This is a summary of the European public assessment report (EPAR) for Ibrance. 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 Ibrance.
For practical information about using Ibrance, patients should read the package leaflet or contact their doctor or pharmacist.
Ibrance : EPAR - Summary for the public (PDF/82.83 KB)
First published: 25/11/2016
Last updated: 25/11/2016
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Pfizer Europe MA EEIG
|Date of issue of marketing authorisation valid throughout the European Union||
30/07/2018 Ibrance - EMEA/H/C/003853 - T/0014
- 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.
Ibrance is indicated for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer:
- in combination with an aromatase inhibitor;
- in combination with fulvestrant in women who have received prior endocrine therapy.
In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.