Axumin

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fluciclovine (18F)

Authorised
This medicine is authorised for use in the European Union.

Overview

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 11/09/2018

Authorisation details

Product details
Name
Axumin
Agency product number
EMEA/H/C/004197
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
V09IX12
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Blue Earth Diagnostics Ltd
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
22/05/2017
Contact address
215 Euston Road
London NW1 2BE
United Kingdom

Product information

11/06/2018 Axumin - EMEA/H/C/004197 - IAIN/0007/G

Contents

  • 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.

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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