Optruma (raloxifene)
- Region
- 🇪🇺 EU
- Active substance
- raloxifene
- Company
- Eli Lilly Nederland B.V.
- Status
- Withdrawn
- Therapeutic area
- Osteoporosis, Postmenopausal
- EU approval
- Wed 05 Aug 1998
- Application
- EMEA/H/C/000185
- ATC
- G03XC01
- Official record
- www.ema.europa.eu
Indication
Optruma is indicated for the treatment and prevention of osteoporosis in post-menopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated. When determining the choice of Optruma 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).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Evista Authorised · Substipharm
- 🇪🇺 Raloxifene Teva Authorised · Teva B.V.
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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.