Neuraceq

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florbetaben (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 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.

This EPAR was last updated on 17/05/2018

Authorisation details

Product details
Name
Neuraceq
Agency product number
EMEA/H/C/002553
Active substance
florbetaben (18F)
International non-proprietary name (INN) or common name
florbetaben (18F)
Therapeutic area (MeSH)
  • Radionuclide Imaging
  • Alzheimer Disease
Anatomical therapeutic chemical (ATC) code
V09AX06
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
Life Radiopharma Berlin GmbH
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
20/02/2014
Contact address
Max-Planck-Straße 4
D-12489 Berlin
Germany

Product information

12/03/2018 Neuraceq - EMEA/H/C/002553 - T/0022

Contents

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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.

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.

Assessment history

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