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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 white, oval 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 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. 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?
Studies in patients have been limited to tests to determine that it is bioequivalent to the reference 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, its benefit and risk are taken as being the same as the reference medicine.
- 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 European Union for Raloxifene Teva to Teva Pharma B.V. on 29 April 2010. The marketing authorisation is valid for five years, after which it can be renewed.
This EPAR was last updated on 10/10/2011 .
More detail is available in the summary of product characteristics
Authorisation details
Product information
Product information
14/02/2011 Raloxifene Teva -EMEA/H/C/001075 -IA/0003/G
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
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 (see section 5.1).
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 | (English only) | 10/10/2011 |
Initial marketing-authorisation documents
| Name | Language | First published | Last updated |
|---|---|---|---|
| Raloxifene Teva : EPAR - Public assessment report | (English only) | 28/05/2010 | |
| Committee for Medicinal Products for Human Use positive summary of opinion for Raloxifene Teva | (English only) | 19/02/2010 | 19/02/2010 |
Authorised
This medicine is approved for use in the European Union
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