🇪🇺 Ibandronate+alfacalcidol+calcium in European Union

EMA authorised Ibandronate+alfacalcidol+calcium on 23 February 2004

Marketing authorisation

EMA — authorised 23 February 2004

  • Application: EMEA/H/C/000501
  • Marketing authorisation holder: Atnahs Pharma Netherlands B.V.
  • Local brand name: Bonviva
  • Indication: Treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1). A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.
  • Status: approved

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Other Bone metabolism / Osteoporosis approved in European Union

Frequently asked questions

Is Ibandronate+alfacalcidol+calcium approved in European Union?

Yes. EMA authorised it on 23 February 2004.

Who is the marketing authorisation holder for Ibandronate+alfacalcidol+calcium in European Union?

Atnahs Pharma Netherlands B.V. holds the EU marketing authorisation.