Evista

raloxifene

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This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Evista?

Evista is a medicine containing the active substance raloxifene hydrochloride. It is available as white, oval tablets (60 mg).

What is Evista used for?

Evista is used for the treatment and prevention of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause. Evista has been shown to significantly reduce vertebral fractures (breaks in the spine), but not hip fractures.

The medicine can only be obtained with a prescription.

How is Evista used?

The recommended dose for adults and the elderly is one tablet taken once a day, with or without food. Patients may also receive calcium and vitamin D supplements if they do not get enough from their diet. Evista is intended for long-term use.

How does Evista work?

Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down. Gradually, the bones become thin and fragile, and more likely to break (fracture). Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall: oestrogen slows down bone breakdown and makes the bones less likely to fracture.

The active substance in Evista, raloxifene, is a selective oestrogen receptor modulator (SERM). Raloxifene acts as an ‘agonist’ of the oestrogen receptor (a substance that stimulates the receptor for oestrogen) in some tissues in the body. Raloxifene has the same effect as oestrogen in the bone, but it does not have an effect in the breast or the womb.

How has Evista been studied?

Evista has been studied in the treatment and the prevention of osteoporosis in four main studies.

Three studies looked at the prevention of osteoporosis in 1,764 women who took either Evista or placebo (a dummy treatment) for two years. The studies measured the density of the bones.

The fourth study compared the effects of Evista with those of placebo in the treatment of osteoporosis in 7,705 women over four years. The main measure of effectiveness was how many women had vertebral fractures during the study.

What benefit has Evista shown during the studies?

Evista was more effective than placebo in preventing and treating osteoporosis.

In the prevention of osteoporosis, women receiving Evista had an increase in bone density in the hip or spine of 1.6% over two years, and those receiving placebo had a decrease of 0.8%.

When used to treat osteoporosis, Evista was more effective than placebo in reducing the number of vertebral fractures. Over four years, in comparison with placebo, Evista decreased the number of new vertebral fractures by 46% in women who had osteoporosis and by 32% in women who had osteoporosis and an existing fracture. There was no effect of Evista on hip fractures.

What is the risk associated with Evista?

The most common side effects with Evista (seen in more than 1 patient in 10) are vasodilation (hot flushes) and flu-like symptoms. For the full list of side effects reported with Evista, see the package leaflet.

Evista should not be used in women who:

  • could become pregnant;
  • have or have had any blood clot disorders, including deep vein thrombosis and pulmonary embolism (a blood clot in the lungs);
  • have liver disease, severe kidney disease, unexplained bleeding from the womb or endometrial cancer (cancer of the lining of the womb).

Evista should not be used in people who may be hypersensitive (allergic) to raloxifene or any of the other ingredients.

Why has Evista been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that Evista had shown its effectiveness in preventing and treating osteoporosis, and had no effects on the breast or womb. The Committee decided that Evista’s benefits are greater than its risks for the treatment and prevention of osteoporosis in postmenopausal women. The Committee recommended that Evista be given marketing authorisation.

Other information about Evista:

The European Commission granted a marketing authorisation valid throughout the European Union for Evista on 5 August 1998. The marketing authorisation was renewed on 5 August 2003 and on 5 August 2008. The marketing authorisation holder is Daiichi Sankyo Europe GmbH.

Name Language First published Last updated
Evista : EPAR - Summary for the public BG = bălgarski 31/03/2009  
Evista : EPAR - Summary for the public ES = español 31/03/2009  
Evista : EPAR - Summary for the public CS = čeština 31/03/2009  
Evista : EPAR - Summary for the public DA = dansk 31/03/2009  
Evista : EPAR - Summary for the public DE = Deutsch 31/03/2009  
Evista : EPAR - Summary for the public ET = eesti keel 31/03/2009  
Evista : EPAR - Summary for the public EL = elliniká 31/03/2009  
Evista : EPAR - Summary for the public EN = English 31/03/2009  
Evista : EPAR - Summary for the public FR = français 31/03/2009  
Evista : EPAR - Summary for the public IT = italiano 31/03/2009  
Evista : EPAR - Summary for the public LV = latviešu valoda 31/03/2009  
Evista : EPAR - Summary for the public LT = lietuvių kalba 31/03/2009  
Evista : EPAR - Summary for the public HU = magyar 31/03/2009  
Evista : EPAR - Summary for the public MT = Malti 31/03/2009  
Evista : EPAR - Summary for the public NL = Nederlands 31/03/2009  
Evista : EPAR - Summary for the public PL = polski 31/03/2009  
Evista : EPAR - Summary for the public PT = português 31/03/2009  
Evista : EPAR - Summary for the public RO = română 31/03/2009  
Evista : EPAR - Summary for the public SK = slovenčina 31/03/2009  
Evista : EPAR - Summary for the public SL = slovenščina 31/03/2009  
Evista : EPAR - Summary for the public FI = suomi 31/03/2009  
Evista : EPAR - Summary for the public SV = svenska 31/03/2009  

This EPAR was last updated on 23/01/2014 .

Authorisation details

Product details

Product details for Evista
NameEvista
Agency product numberEMEA/H/C/000184
Active substance

raloxifene hydrochloride

International non-proprietary name (INN) or common name

raloxifene

Therapeutic area Osteoporosis, Postmenopausal
Anatomical therapeutic chemical (ATC) code G03XC01

Publication details

Publication details for Evista
Marketing-authorisation holder

Daiichi Sankyo Europe GmbH

Revision19
Date of issue of marketing authorisation valid throughout the European Union05/08/1998

Contact address:

Daiichi Sankyo Europe GmbH
Zielstattstrasse 48
D-81379 Munich
Germany

Product information

Product information

12/09/2013  Evista -EMEA/H/C/000184 -N/0066

Name Language First published Last updated
Evista : EPAR - Product Information SV = svenska 23/03/2009 23/01/2014
Evista : EPAR - Product Information SV = svenska 23/03/2009 23/01/2014
Evista : EPAR - Product Information SV = svenska 23/03/2009 23/01/2014
Evista : EPAR - Product Information SV = svenska 23/03/2009 23/01/2014
Evista : EPAR - Product Information SV = svenska 23/03/2009 23/01/2014
Evista : EPAR - Product Information SV = svenska 23/03/2009 23/01/2014
Evista : EPAR - Product Information SV = svenska 23/03/2009 23/01/2014
Evista : EPAR - Product Information SV = svenska 23/03/2009 23/01/2014
Evista : EPAR - Product Information SV = svenska 23/03/2009 23/01/2014
Evista : EPAR - Product Information SV = svenska 23/03/2009 23/01/2014
Evista : EPAR - Product Information SV = svenska 23/03/2009 23/01/2014
Evista : EPAR - Product Information SV = svenska 23/03/2009 23/01/2014
Evista : EPAR - Product Information SV = svenska 23/03/2009 23/01/2014
Evista : EPAR - Product Information SV = svenska 23/03/2009 23/01/2014
Evista : EPAR - Product Information SV = svenska 23/03/2009 23/01/2014
Evista : EPAR - Product Information SV = svenska 23/03/2009 23/01/2014
Evista : EPAR - Product Information SV = svenska 23/03/2009 23/01/2014
Evista : EPAR - Product Information SV = svenska 23/03/2009 23/01/2014
Evista : EPAR - Product Information SV = svenska 23/03/2009 23/01/2014
Evista : EPAR - Product Information SV = svenska 23/03/2009 23/01/2014
Evista : EPAR - Product Information SV = svenska 23/03/2009 23/01/2014
Evista : EPAR - Product Information SV = svenska 23/03/2009 23/01/2014
Evista : EPAR - Product Information SV = svenska 23/03/2009 23/01/2014
Evista : EPAR - Product Information SV = svenska 23/03/2009 23/01/2014
Evista : EPAR - Product Information SV = svenska 23/03/2009 23/01/2014

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
Evista : EPAR - All Authorised presentations SV = svenska 29/02/2008  
Evista : EPAR - All Authorised presentations SV = svenska 29/02/2008  
Evista : EPAR - All Authorised presentations SV = svenska 29/02/2008  
Evista : EPAR - All Authorised presentations SV = svenska 29/02/2008  
Evista : EPAR - All Authorised presentations SV = svenska 29/02/2008  
Evista : EPAR - All Authorised presentations SV = svenska 29/02/2008  
Evista : EPAR - All Authorised presentations SV = svenska 29/02/2008  
Evista : EPAR - All Authorised presentations SV = svenska 29/02/2008  
Evista : EPAR - All Authorised presentations SV = svenska 29/02/2008  
Evista : EPAR - All Authorised presentations SV = svenska 29/02/2008  
Evista : EPAR - All Authorised presentations SV = svenska 29/02/2008  
Evista : EPAR - All Authorised presentations SV = svenska 29/02/2008  
Evista : EPAR - All Authorised presentations SV = svenska 29/02/2008  
Evista : EPAR - All Authorised presentations SV = svenska 29/02/2008  
Evista : EPAR - All Authorised presentations SV = svenska 29/02/2008  
Evista : EPAR - All Authorised presentations SV = svenska 29/02/2008  
Evista : EPAR - All Authorised presentations SV = svenska 29/02/2008  
Evista : EPAR - All Authorised presentations SV = svenska 29/02/2008  
Evista : EPAR - All Authorised presentations SV = svenska 29/02/2008  
Evista : EPAR - All Authorised presentations SV = svenska 29/02/2008  
Evista : EPAR - All Authorised presentations SV = svenska 29/02/2008  
Evista : EPAR - All Authorised presentations SV = svenska 29/02/2008  

Pharmacotherapeutic group

Sex hormones and modulators of the genital system

Therapeutic indication

Evista is indicated for the treatment and prevention of osteoporosis in post-menopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated. When determining the choice of Evista or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Evista : EPAR - Procedural steps taken before authorisation SV = svenska 21/10/2005  
Evista : EPAR - Scientific Discussion SV = svenska 21/10/2005  

Authorised

This medicine is approved for use in the European Union