Raloxifene Teva

raloxifene

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This is a summary of the European Public Assessment Report (EPAR) for Raloxifene Teva. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Raloxifene Teva.

What is Raloxifene Teva?

Raloxifene Teva is a medicine that contains the active substance raloxifene hydrochloride. It is available as tablets (60 mg).

Raloxifene Teva is a ‘generic medicine’. This means that Raloxifene Teva is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Evista.

What is Raloxifene Teva used for?

Raloxifene Teva is used for the treatment and prevention of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause. Raloxifene Teva 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 Raloxifene Teva used?

The recommended dose of Raloxifene Teva is one tablet taken once a day. Patients may also receive calcium and vitamin D supplements if they do not get enough from their diet. Raloxifene Teva is intended for long-term use.

How does Raloxifene Teva 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 Raloxifene Teva, 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 Raloxifene Teva been studied?

Because Raloxifene Teva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Evista. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefit and risk of Raloxifene Teva?

Because Raloxifene Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Why has Raloxifene Teva been approved?

The CHMP concluded that, in accordance with EU requirements, Raloxifene Teva has been shown to have comparable quality and to be bioequivalent to Evista. Therefore, the CHMP’s view was that, as for Evista, the benefit outweighs the identified risk. The Committee recommended that Raloxifene Teva be given marketing authorisation.

Other information about Raloxifene Teva

The European Commission granted a marketing authorisation valid throughout the EU for Raloxifene Teva on 29 April 2010.

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

Name Language First published Last updated
Raloxifene Teva : EPAR - Summary for the public BG = bălgarski 28/05/2010 06/05/2015
Raloxifene Teva : EPAR - Summary for the public ES = español 28/05/2010 06/05/2015
Raloxifene Teva : EPAR - Summary for the public CS = čeština 28/05/2010 06/05/2015
Raloxifene Teva : EPAR - Summary for the public DA = dansk 28/05/2010 06/05/2015
Raloxifene Teva : EPAR - Summary for the public DE = Deutsch 28/05/2010 06/05/2015
Raloxifene Teva : EPAR - Summary for the public ET = eesti keel 28/05/2010 06/05/2015
Raloxifene Teva : EPAR - Summary for the public EL = elliniká 28/05/2010 06/05/2015
Raloxifene Teva : EPAR - Summary for the public EN = English 28/05/2010 06/05/2015
Raloxifene Teva : EPAR - Summary for the public FR = français 28/05/2010 06/05/2015
Raloxifene Teva : EPAR - Summary for the public IT = italiano 28/05/2010 06/05/2015
Raloxifene Teva : EPAR - Summary for the public LV = latviešu valoda 28/05/2010 06/05/2015
Raloxifene Teva : EPAR - Summary for the public LT = lietuvių kalba 28/05/2010 06/05/2015
Raloxifene Teva : EPAR - Summary for the public HU = magyar 28/05/2010 06/05/2015
Raloxifene Teva : EPAR - Summary for the public MT = Malti 28/05/2010 06/05/2015
Raloxifene Teva : EPAR - Summary for the public NL = Nederlands 28/05/2010 06/05/2015
Raloxifene Teva : EPAR - Summary for the public PL = polski 28/05/2010 06/05/2015
Raloxifene Teva : EPAR - Summary for the public PT = português 28/05/2010 06/05/2015
Raloxifene Teva : EPAR - Summary for the public RO = română 28/05/2010 06/05/2015
Raloxifene Teva : EPAR - Summary for the public SK = slovenčina 28/05/2010 06/05/2015
Raloxifene Teva : EPAR - Summary for the public SL = slovenščina 28/05/2010 06/05/2015
Raloxifene Teva : EPAR - Summary for the public FI = suomi 28/05/2010 06/05/2015
Raloxifene Teva : EPAR - Summary for the public SV = svenska 28/05/2010 06/05/2015
Raloxifene Teva : EPAR - Summary for the public HR = Hrvatski 28/05/2010 06/05/2015

This EPAR was last updated on 29/09/2015 .

Authorisation details

Product details

Product details for Raloxifene Teva
NameRaloxifene Teva
Agency product numberEMEA/H/C/001075
Active substance

raloxifene hydrochloride

International non-proprietary name (INN) or common name

raloxifene

Therapeutic area Osteoporosis, Postmenopausal
Anatomical therapeutic chemical (ATC) code G03XC01
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 Raloxifene Teva
Marketing-authorisation holder

Teva B.V.

Revision6
Date of issue of marketing authorisation valid throughout the European Union29/04/2010

Contact address:

Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands

Product information

Product information

29/07/2015  Raloxifene Teva -EMEA/H/C/001075 -N/0018

Name Language First published Last updated
Raloxifene Teva : EPAR - Product Information HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - Product Information HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - Product Information HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - Product Information HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - Product Information HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - Product Information HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - Product Information HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - Product Information HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - Product Information HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - Product Information HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - Product Information HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - Product Information HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - Product Information HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - Product Information HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - Product Information HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - Product Information HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - Product Information HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - Product Information HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - Product Information HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - Product Information HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - Product Information HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - Product Information HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - Product Information HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - Product Information HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - Product Information HR = Hrvatski 28/05/2010 29/09/2015

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
Raloxifene Teva : EPAR - All Authorised presentations HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - All Authorised presentations HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - All Authorised presentations HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - All Authorised presentations HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - All Authorised presentations HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - All Authorised presentations HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - All Authorised presentations HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - All Authorised presentations HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - All Authorised presentations HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - All Authorised presentations HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - All Authorised presentations HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - All Authorised presentations HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - All Authorised presentations HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - All Authorised presentations HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - All Authorised presentations HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - All Authorised presentations HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - All Authorised presentations HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - All Authorised presentations HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - All Authorised presentations HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - All Authorised presentations HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - All Authorised presentations HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - All Authorised presentations HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - All Authorised presentations HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - All Authorised presentations HR = Hrvatski 28/05/2010 29/09/2015
Raloxifene Teva : EPAR - All Authorised presentations HR = Hrvatski 28/05/2010 29/09/2015

Pharmacotherapeutic group

Sex hormones and modulators of the genital system

Therapeutic indication

Raloxifene is indicated for the treatment and prevention of osteoporosis in postmenopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated.

When determining the choice of raloxifene 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.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Raloxifene Teva : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 10/10/2011 29/09/2015

Initial marketing-authorisation documents

Name Language First published Last updated
Raloxifene Teva : EPAR - Public assessment report HR = Hrvatski 28/05/2010  
Committee for Medicinal Products for Human Use positive summary of opinion for Raloxifene Teva HR = Hrvatski 19/02/2010  

Authorised

This medicine is approved for use in the European Union

More information on Raloxifene Teva