🇪🇺 Ogsiveo in European Union

EMA authorised Ogsiveo on 14 August 2025

Marketing authorisation

EMA — authorised 14 August 2025

  • Application: EMEA/H/C/006071
  • Marketing authorisation holder: Merck Europe B.V.
  • Local brand name: Ogsiveo
  • Indication: Ogsiveo as monotherapy is indicated for the treatment of adult patients with progressing desmoid tumours who require systemic treatment.
  • Pathway: orphan
  • Status: approved

On 14 August 2025, the European Medicines Agency (EMA) granted marketing authorisation for Ogsiveo, a treatment for adult patients with progressing desmoid tumours. This authorisation was granted under the orphan designation, which is reserved for medicines that treat rare diseases. Ogsiveo is indicated for use as monotherapy in patients who require systemic treatment.

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Ogsiveo in other countries

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

Other Oncology approved in European Union

Frequently asked questions

Is Ogsiveo approved in European Union?

Yes. EMA authorised it on 14 August 2025.

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

Merck Europe B.V. holds the EU marketing authorisation.