Eylea
aflibercept
Table of contents
Overview
Eylea is a medicine used to treat adults with:
- the ‘wet’ form of age-related macular degeneration (AMD), a disease which affects the central part of the retina (called the macula) at the back of the eye. The wet form of AMD is caused by choroidal neovascularisation (the abnormal growth of blood vessels under the macula), which may leak fluid and blood and cause swelling;
- impaired vision due to macular oedema (swelling) that follows blockage of either the main vein carrying blood from the retina (known as central retinal vein occlusion, CRVO) or of smaller branch veins (known as branch retinal vein occlusion, BRVO);
- impaired vision due to macular oedema caused by diabetes;
- impaired vision due to myopic choroidal neovascularisation (a severe type of short-sightedness where the eyeball continues to grow, becoming longer than it should be).
The macula provides central vision that is needed to see detail for everyday tasks such as driving, reading and recognising faces. The diseases cause the gradual loss of the central part of a person’s vision.
Eylea contains the active substance aflibercept.
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List item
Eylea : EPAR - Medicine overview (PDF/192.86 KB)
First published: 05/12/2012
Last updated: 12/10/2020
EMA/433530/2020 -
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List item
Eylea : EPAR - Risk-management-plan summary (PDF/104.22 KB)
First published: 10/08/2018
Last updated: 06/03/2019
This EPAR was last updated on 12/10/2020
Authorisation details
Product details | |
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Name |
Eylea
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Agency product number |
EMEA/H/C/002392
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Active substance |
aflibercept
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International non-proprietary name (INN) or common name |
aflibercept
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Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
S01LA05
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Publication details | |
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Marketing-authorisation holder |
Bayer AG
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Revision |
19
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Date of issue of marketing authorisation valid throughout the European Union |
21/11/2012
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Contact address |
Product information
24/09/2020 Eylea - EMEA/H/C/002392 - PSUSA/00010020/201911
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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
Pharmacotherapeutic group
Ophthalmologicals
Therapeutic indication
Therapeutic indication
Eylea is indicated for adults for the treatment of:
- neovascular (wet) age-related macular degeneration (AMD);
- visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO);
- visual impairment due to diabetic macular oedema (DME);
- visual impairment due to myopic choroidal neovascularisation (myopic CNV).
Assessment history
News
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25/09/2015
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 January 201523/01/2015
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27/06/2014
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26/07/2013