Fulvestrant Mylan

fulvestrant

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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.

What is Fulvestrant Mylan and what is it used for?

Fulvestrant Mylan is an anti-oestrogen medicine used to treat advanced or metastatic breast cancer (cancer that has spread to other parts of the body) in postmenopausal women with a type of breast cancer known as ‘oestrogen-receptor positive cancer’ who have not previously had hormonal treatment, or whose cancer had come back after treatment with another anti-oestrogen.

Fulvestrant Mylan contains the active substance fulvestrant.

Fulvestrant Mylan is a ‘generic medicine’. This means that Fulvestrant Mylan contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the European Union (EU) called Faslodex.

How is Fulvestrant Mylan used?

Fulvestrant Mylan can only be obtained with a prescription and is available as a solution for injection in prefilled syringes (250 mg). The recommended dose is 500 mg given once a month, with an additional 500-mg dose given two weeks after the first dose. The dose is given as two injections, each given into the muscle of one buttock over one to two minutes.

How does Fulvestrant Mylan work?

Most types of breast cancer are stimulated to grow when the hormone oestrogen attaches to targets (receptors) on cancer cells. The active substance in Fulvestrant Mylan, fulvestrant, is an anti-oestrogen. It blocks the receptors for oestrogen on cells and causes the number of oestrogen receptors to fall. As a result, the cancer cells are not stimulated to grow by oestrogen and this slows down the growth of the tumour.

How has Fulvestrant Mylan been studied?

Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Faslodex, and do not need to be repeated for Fulvestrant Mylan.

As for every medicine, the company provided studies on the quality of Fulvestrant Mylan. There was no need for ‘bioequivalence’ studies to investigate whether Fulvestrant Mylan is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because the composition of Fulvestrant Mylan is the same as the reference medicine and when given by injection into the muscle, the active substance in both products is expected to be absorbed in the same way.

What are the benefits and risks of Fulvestrant Mylan?

Because Fulvestrant Mylan is a generic medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Why is Fulvestrant Mylan approved?

The European Medicines Agency concluded that, in accordance with EU requirements, Fulvestrant Mylan has been shown to be comparable to Faslodex. Therefore, the Agency’s view was that, as for Faslodex, the benefit outweighs the identified risk. The Agency recommended that Fulvestrant Mylan be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Fulvestrant Mylan?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fulvestrant Mylan have been included in the summary of product characteristics and the package leaflet.

Other information about Fulvestrant Mylan

The European Commission granted a marketing authorisation valid throughout the European Union for Fulvestrant Mylan on 8 January 2018.

For more information about treatment with Fulvestrant Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Fulvestrant Mylan : EPAR - Summary for the public BG = bălgarski 2018-02-02 2018-02-21
Fulvestrant Mylan : EPAR - Summary for the public ES = español 2018-02-02 2018-02-21
Fulvestrant Mylan : EPAR - Summary for the public CS = čeština 2018-02-02 2018-02-21
Fulvestrant Mylan : EPAR - Summary for the public DA = dansk 2018-02-02 2018-02-21
Fulvestrant Mylan : EPAR - Summary for the public DE = Deutsch 2018-02-02 2018-02-21
Fulvestrant Mylan : EPAR - Summary for the public ET = eesti keel 2018-02-02 2018-02-21
Fulvestrant Mylan : EPAR - Summary for the public EL = elliniká 2018-02-02 2018-02-21
Fulvestrant Mylan : EPAR - Summary for the public EN = English 2018-02-02 2018-02-21
Fulvestrant Mylan : EPAR - Summary for the public FR = français 2018-02-02 2018-02-21
Fulvestrant Mylan : EPAR - Summary for the public IT = italiano 2018-02-02 2018-02-21
Fulvestrant Mylan : EPAR - Summary for the public LV = latviešu valoda 2018-02-02 2018-02-21
Fulvestrant Mylan : EPAR - Summary for the public LT = lietuvių kalba 2018-02-02 2018-02-21
Fulvestrant Mylan : EPAR - Summary for the public HU = magyar 2018-02-02 2018-02-21
Fulvestrant Mylan : EPAR - Summary for the public MT = Malti 2018-02-02 2018-02-21
Fulvestrant Mylan : EPAR - Summary for the public NL = Nederlands 2018-02-02 2018-02-21
Fulvestrant Mylan : EPAR - Summary for the public PL = polski 2018-02-02 2018-02-21
Fulvestrant Mylan : EPAR - Summary for the public PT = português 2018-02-02 2018-02-21
Fulvestrant Mylan : EPAR - Summary for the public RO = română 2018-02-02 2018-02-21
Fulvestrant Mylan : EPAR - Summary for the public SK = slovenčina 2018-02-02 2018-02-21
Fulvestrant Mylan : EPAR - Summary for the public SL = slovenščina 2018-02-02 2018-02-21
Fulvestrant Mylan : EPAR - Summary for the public FI = suomi 2018-02-02 2018-02-21
Fulvestrant Mylan : EPAR - Summary for the public SV = svenska 2018-02-02 2018-02-21
Fulvestrant Mylan : EPAR - Summary for the public HR = Hrvatski 2018-02-02 2018-02-21

This EPAR was last updated on 02/02/2018 .

Authorisation details

Product details

Product details for Fulvestrant Mylan
NameFulvestrant Mylan
Agency product numberEMEA/H/C/004649
Active substance

fulvestrant

International non-proprietary name (INN) or common name

fulvestrant

Therapeutic area Breast Neoplasms
Anatomical therapeutic chemical (ATC) code L02BA03
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Fulvestrant Mylan
Marketing-authorisation holder

Mylan S.A.S

Revision0
Date of issue of marketing authorisation valid throughout the European Union08/01/2018

Contact address:

117 Allee des Parcs 
69800 Saint-Priest 
France

Product information

Product information

08/01/2018  Fulvestrant Mylan -EMEA/H/C/004649 --

Name Language First published Last updated
Fulvestrant Mylan : EPAR - Product Information HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - Product Information HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - Product Information HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - Product Information HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - Product Information HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - Product Information HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - Product Information HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - Product Information HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - Product Information HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - Product Information HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - Product Information HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - Product Information HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - Product Information HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - Product Information HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - Product Information HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - Product Information HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - Product Information HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - Product Information HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - Product Information HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - Product Information HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - Product Information HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - Product Information HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - Product Information HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - Product Information HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - Product Information HR = Hrvatski 2018-02-02  

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.


Name Language First published Last updated
Fulvestrant Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-02  
Fulvestrant Mylan : EPAR - All Authorised presentations HR = Hrvatski 2018-02-02  

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

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Fulvestrant Mylan : EPAR - Public assessment report HR = Hrvatski 2018-02-02  
CHMP summary of positive opinion for Fulvestrant Mylan HR = Hrvatski 2017-11-10  

Authorised

This medicine is approved for use in the European Union

More information on Fulvestrant Mylan