🇪🇺 Axumin in European Union

Axumin (fluciclovine (18F)) regulatory status in European Union.

Marketing authorisation

EMA

  • Application: EMEA/H/C/004197
  • Local brand name: Axumin
  • Status: approved

Axumin 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 Axumin approved in European Union?

Yes. EMA has authorised it.

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

Blue Earth Diagnostics Ltd is the originator. The local marketing authorisation holder may differ — check the official source linked above.