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.
Therapeutic Indication
### 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.
Therapeutic Area (MeSH)
N/AATC Code
G03XC01
ATC Item
raloxifene
Pharmacotherapeutic Group
Sex hormones and modulators of the genital system
Active Substance (Summary)
INN / Common Names
N/A| Substance | CAS | Monograph |
|---|---|---|
| raloxifene hydrochloride | N/A | 雷洛昔芬 |
EMA Name
Raloxifene Teva
Medicine Name
Raloxifene Teva
Aliases
N/ANo risk management plan link.
