🇪🇺 Ibandronate in European Union

EMA authorised Ibandronate on 25 June 1996

Marketing authorisation

EMA — authorised 25 June 1996

  • Application: EMEA/H/C/000101
  • Marketing authorisation holder: Atnahs Pharma Netherlands B.V.
  • Local brand name: Bondronat
  • Indication: Bondronat is indicated for: prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases; treatment of tumour-induced hypercalcaemia with or without metastases.
  • Status: approved

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Ibandronate 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 Ibandronate approved in European Union?

Yes. EMA authorised it on 25 June 1996.

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

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