🇪🇺 Raloxifene HCL in European Union

EMA authorised Raloxifene HCL on 5 August 1998

Marketing authorisation

EMA — authorised 5 August 1998

  • Application: EMEA/H/C/000184
  • Marketing authorisation holder: Substipharm
  • Local brand name: Evista
  • Indication: Evista 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 Evista 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

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Raloxifene HCL in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Raloxifene HCL approved in European Union?

Yes. EMA authorised it on 5 August 1998.

Who is the marketing authorisation holder for Raloxifene HCL in European Union?

Substipharm holds the EU marketing authorisation.