🇪🇺 Aclasta in European Union

EMA authorised Aclasta on 15 April 2005

Marketing authorisation

EMA — authorised 15 April 2005

  • Application: EMEA/H/C/000595
  • Marketing authorisation holder: Sandoz Pharmaceuticals d.d.
  • Local brand name: Aclasta
  • Indication: Treatment of osteoporosis: in post-menopausal women; in men; at increased risk of fracture, including those with a recent low-trauma hip fracture. Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in post-menopausal women and in men at increased risk of fracture. Treatment of Paget's disease of the bone.
  • Status: approved

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Other Other approved in European Union

Frequently asked questions

Is Aclasta approved in European Union?

Yes. EMA authorised it on 15 April 2005.

Who is the marketing authorisation holder for Aclasta in European Union?

Sandoz Pharmaceuticals d.d. holds the EU marketing authorisation.