Vizamyl
flutemetamol (18F)
Table of contents
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.
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List item
Vizamyl : EPAR - Summary for the public (PDF/113.17 KB)
First published: 17/09/2014
Last updated: 29/09/2016
EMA/389993/2014 -
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List item
Vizamyl : EPAR - Risk-management-plan summary (PDF/56.2 KB)
First published: 17/09/2014
Last updated: 17/09/2014
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) |
|
Anatomical therapeutic chemical (ATC) code |
V09AX04
|
Publication details | |
---|---|
Marketing-authorisation holder |
GE Healthcare AS
|
Revision |
16
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Date of issue of marketing authorisation valid throughout the European Union |
22/08/2014
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Contact address |
Nycoveien 1 |
Product information
20/09/2023 Vizamyl - EMEA/H/C/002557 - IB/0035/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.