Amyvid

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florbetapir (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 Amyvid. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Amyvid.

This EPAR was last updated on 13/06/2018

Authorisation details

Product details
Name
Amyvid
Agency product number
EMEA/H/C/002422
Active substance
florbetapir (18F)
International non-proprietary name (INN) or common name
florbetapir (18F)
Therapeutic area (MeSH)
Radionuclide Imaging
Anatomical therapeutic chemical (ATC) code
V09AX05
Publication details
Marketing-authorisation holder
Eli Lilly Nederland B.V.
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
14/01/2013
Contact address
Papendorpseweg 83
3528 BJ Utrecht
The Netherlands

Product information

04/06/2018 Amyvid - EMEA/H/C/002422 - IB/0034/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.

Amyvid 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. Amyvid 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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