Vizamyl

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flutemetamol (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 Vizamyl. 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 Vizamyl.

For practical information about using Vizamyl, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 06/10/2017

Authorisation details

Product details
Name
Vizamyl
Agency product number
EMEA/H/C/002557
Active substance
flutemetamol (18F)
International non-proprietary name (INN) or common name
flutemetamol (18F)
Therapeutic area (MeSH)
  • Radionuclide Imaging
  • Alzheimer Disease
Anatomical therapeutic chemical (ATC) code
V09AX04
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
GE Healthcare Ltd
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
22/08/2014
Contact address
Amersham Place
Little Chalfont
Buckinghamshire
HP7 9NA
United Kingdom

Product information

31/07/2017 Vizamyl - EMEA/H/C/002557 - IB/0013/G

Contents

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.

Vizamyl is a radiopharmaceutical medicinal product 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. Vizamyl 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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