🇪🇺 Fluciclovine PET/CT in European Union

EMA authorised Fluciclovine PET/CT on 21 May 2017

Marketing authorisation

EMA — authorised 21 May 2017

  • Application: EMEA/H/C/004197
  • Marketing authorisation holder: Blue Earth Diagnostics Ireland Ltd
  • Local brand name: Axumin
  • Indication: This medicinal product is for diagnostic use only. Axumin is indicated for Positron Emission Tomography (PET) imaging to detect recurrence of prostate cancer in adult men with a suspected recurrence based on elevated blood prostate specific antigen (PSA) levels after primary curative treatment.
  • Status: approved

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Other Oncology approved in European Union

Frequently asked questions

Is Fluciclovine PET/CT approved in European Union?

Yes. EMA authorised it on 21 May 2017.

Who is the marketing authorisation holder for Fluciclovine PET/CT in European Union?

Blue Earth Diagnostics Ireland Ltd holds the EU marketing authorisation.