Table of contents
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.
Amyvid : EPAR - Summary for the public (PDF/121.92 KB)
First published: 23/01/2013
Last updated: 23/01/2013
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Eli Lilly Nederland B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
10/03/2021 Amyvid - EMEA/H/C/002422 - IA/0041
This medicine’s product information is available in all official EU languages.
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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.
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.