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||
6th Floor, 2 Grand Canal Square
11/05/2022 Axumin - EMEA/H/C/004197 - IA/0029/G
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.
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.