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 31/03/2021

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
14
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

10/03/2021 Amyvid - EMEA/H/C/002422 - IA/0041

Other EU languages available icon 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:

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.

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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