This is a summary of the European public assessment report (EPAR) for Fulvestrant Mylan. 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 Fulvestrant Mylan.
For practical information about using Fulvestrant Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Fulvestrant Mylan : EPAR - Summary for the public (PDF/91.63 KB)
First published: 02/02/2018
Last updated: 21/02/2018
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This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.
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11/03/2019 Fulvestrant Mylan - EMEA/H/C/004649 - N/0006
- 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.
Fulvestrant is indicated 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 anti-estrogen therapy, or disease progression on antiestrogen therapy.