Fulvestrant Mylan

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 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.

This EPAR was last updated on 02/02/2018

Authorisation details

Product details
Name
Fulvestrant Mylan
Agency product number
EMEA/H/C/004649
Active substance
fulvestrant
International non-proprietary name (INN) or common name
fulvestrant
Therapeutic area (MeSH)
Breast Neoplasms
Anatomical therapeutic chemical (ATC) code
L02BA03
Generic

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.

Publication details
Marketing-authorisation holder
Mylan S.A.S
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
07/01/2018
Contact address

117 Allee des Parcs
69800
Saint-Priest
France

Product information

07/01/2018 Fulvestrant Mylan - EMEA/H/C/004649 - -

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

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.

Assessment history

How useful was this page?

Add your rating
Average
1 rating