🇪🇺 Fosamax in European Union

EMA authorised Fosamax on 4 January 2007

Marketing authorisations

EMA — authorised 4 January 2007

  • Application: EMEA/H/C/000759
  • Marketing authorisation holder: Organon N.V.
  • Local brand name: Adrovance
  • Indication: Treatment of postmenopausal osteoporosis in patients at risk of vitamin-D insufficiency. Adrovance reduces the risk of vertebral and hip fractures.
  • Status: approved

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EMA — authorised 16 October 2009

  • Application: EMEA/H/C/001180
  • Marketing authorisation holder: Organon N.V.
  • Local brand name: Vantavo (previously Alendronate sodium and colecalciferol, MSD)
  • Indication: Treatment of postmenopausal osteoporosis in patients at risk of vitamin-D insufficiency. Vantavo reduces the risk of vertebral and hip fractures. Treatment of postmenopausal osteoporosis in patients who are not receiving vitamin-D supplementation and are at risk of vitamin-D insufficiency. Vantavo reduces the risk of vertebral and hip fractures.
  • Status: approved

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EMA — authorised 24 June 2016

  • Application: EMEA/H/C/004172
  • Marketing authorisation holder: Mylan S.A.S.
  • Local brand name: Alendronic Acid / Colecalciferol Mylan
  • Indication: Treatment of postmenopausal osteoporosis
  • Status: withdrawn

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Fosamax in other countries

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

Other Bone approved in European Union

Frequently asked questions

Is Fosamax approved in European Union?

Yes. EMA authorised it on 4 January 2007; EMA authorised it on 16 October 2009; EMA authorised it on 24 June 2016.

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

Organon N.V. holds the EU marketing authorisation.