fluciclovine (18F)

This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Axumin. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Axumin.

For practical information about using Axumin, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 19/12/2022

Authorisation details

Product details
Agency product number
Active substance
Fluciclovine (18F)
International non-proprietary name (INN) or common name
fluciclovine (18F)
Therapeutic area (MeSH)
  • Prostatic Neoplasms
  • Radionuclide Imaging
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Blue Earth Diagnostics Ireland Ltd
Date of issue of marketing authorisation valid throughout the European Union
Contact address

6th Floor, 2 Grand Canal Square
Dublin 2

Product information

16/12/2022 Axumin - EMEA/H/C/004197 - IAIN/0030/G

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Diagnostic radiopharmaceuticals

Therapeutic 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.

Assessment history

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