Basic Information
Fulvestrant Mylan
Regulatory Information
EMEA/H/C/004649
January 8, 2018
November 9, 2007
6
May 22, 2024
Company Information
Ireland
Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN
MYLAN PHARMACEUTICALS PRIVATE LIMITED
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### 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.
Overview Summary
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.