Raloxifene Teva (raloxifene)
- Region
- 🇪🇺 EU
- Active substance
- raloxifene
- Company
- Teva B.V.
- Status
- Authorised
- Therapeutic area
- Osteoporosis, Postmenopausal
- CHMP opinion
- Thu 18 Feb 2010
- EU approval
- Thu 29 Apr 2010
- Designations
- Generic
- Application
- EMEA/H/C/001075
- ATC
- G03XC01
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Optruma Withdrawn · Eli Lilly Nederland B.V.
- 🇪🇺 Evista Authorised · Substipharm
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.