MedPath
EMA Product

Axumin

Product approved by European Medicines Agency (EU)

Basic Information

Axumin

Regulatory Information

EMEA/H/C/004197

Authorised

May 21, 2017

March 22, 2017

18

October 8, 2024

Company Information

ιreland

6th Floor, 2 Grand Canal Square Dublin 2

Blue Earth Diagnostics Ltd

Active Substances Detail

Detailed Information

Therapeutic Indication

### 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.

Overview Summary

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.

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