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 authorized 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 after menopause. Raloxifene Teva has been shown to significantly reduce vertebral fractures (of the spine), but not those of the hip.
The medicine can only be obtained with a prescription.
How is Raloxifene Teva used?
The recommended dose for adult women and older women is one tablet a day with meals or between meals. Patients may be given calcium and vitamin D supplements if dietary intake is insufficient. Raloxifene Teva is intended for long-term use.
How does Raloxifene Teva work?
Osteoporosis occurs when new bone is not produced in sufficient quantity to replace what is naturally consumed. The bones become progressively thin and fragile and more prone to breakage (fractures). Osteoporosis is more common in postmenopausal women when levels of the female estrogen hormone decrease: estrogen slows bone degradation and makes it less prone to fracture.
The active substance in Raloxifene Teva, raloxifene, is a selective estrogen receptor modulator (SERM). Raloxifene acts as an "agonist" of the estrogen receptor (a substance that stimulates the estrogen receptor) in certain tissues of the body. Raloxifene has the same effect as estrogen on the bone, but has no effect on the breast or uterus.
What studies have been performed on Raloxifene Teva?
Patient studies were limited to tests to establish that it was bioequivalent to the reference medicine called Evista. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body.
What are the benefits and risks of Raloxifene Teva?
Because Raloxifene Teva is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Why has Raloxifene Teva been approved?
The CHMP (Committee for Medicinal Products for Human Use) concluded that, in accordance with EU requirements, Raloxifene Teva has been shown to have comparable quality and to be bioequivalent to Evista. Therefore, it is the opinion of the CHMP that, as in the case of Evista, the benefits outweigh the identified risks. The committee recommended the granting of a marketing authorization for Raloxifene Teva.
More information on Raloxifene Teva
On 29 April 2010, the European Commission granted Teva Pharma BV a marketing authorization for Raloxifene Teva, valid throughout the European Union. The marketing authorization is valid for five years, after which it can be renewed.
The full EPAR for Raloxifene Teva can be found here. For more information on treatment with Raloxifene Teva, read the package leaflet (also part of the EPAR).
The full EPAR of the reference medicine is also found on the Agency's website.
Last update of this summary: 03-2010.
