This is a summary of the European public assessment report (EPAR) for Neuraceq. 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 Neuraceq.
For practical information about using Neuraceq, patients should read the package leaflet or contact their doctor or pharmacist.
Neuraceq : EPAR - Summary for the public (PDF/156.87 KB)
First published: 11/03/2014
Last updated: 01/07/2016
Neuraceq : EPAR - Risk-management-plan summary (PDF/41.89 KB)
First published: 13/05/2014
Last updated: 13/05/2014
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Life Radiopharma Berlin GmbH
|Date of issue of marketing authorisation valid throughout the European Union||
12/03/2018 Neuraceq - EMEA/H/C/002553 - T/0022
- 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.
Neuraceq is a radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of β amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment. Neuraceq should be used in conjunction with a clinical evaluation.
A negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of AD.