EMA — authorised 5 August 1998
- Marketing authorisation holder: ELI LILLY NEDERLAND B.V.
- Status: approved
🇪🇺 Evista in European Union
EMA authorised Evista on 5 August 1998
Marketing authorisations
EMA — authorised 5 August 1998
- Application: EMEA/H/C/000185
- Marketing authorisation holder: Eli Lilly Nederland B.V.
- Local brand name: Optruma
- 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).
- Status: approved
EMA — authorised 29 April 2010
- Application: EMEA/H/C/001075
- Marketing authorisation holder: Teva B.V.
- Local brand name: Raloxifene Teva
- 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.
- Status: approved
Evista in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in European Union
Frequently asked questions
Is Evista approved in European Union?
Yes. EMA authorised it on 5 August 1998; EMA authorised it on 5 August 1998; EMA authorised it on 29 April 2010.
Who is the marketing authorisation holder for Evista in European Union?
ELI LILLY NEDERLAND B.V. holds the EU marketing authorisation.