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.
Axumin : EPAR - Summary for the public (PDF/68.85 KB)
First published: 06/07/2017
Last updated: 06/07/2017
Axumin : EPAR - Risk-management-plan summary (PDF/43.85 KB)
First published: 21/03/2019
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Blue Earth Diagnostics Ireland Ltd
|Date of issue of marketing authorisation valid throughout the European Union||
25/08/2020 Axumin - EMEA/H/C/004197 - PSUSA/00010594/201911
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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.