🇪🇺 Istodax in European Union

Istodax (ROMIDEPSIN) regulatory status in European Union.

Marketing authorisation

EMA

  • Application: EMEA/H/C/002122
  • Local brand name: Istodax
  • Status: refused

Istodax 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 Istodax approved in European Union?

Yes. EMA has authorised it.

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

Teva Pharms Usa Inc is the originator. The local marketing authorisation holder may differ — check the official source linked above.