Eylea

RSS

aflibercept

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 17/10/2018

Authorisation details

Product details
Name
Eylea
Agency product number
EMEA/H/C/002392
Active substance
aflibercept
International non-proprietary name (INN) or common name
aflibercept
Therapeutic area (MeSH)
  • Wet Macular Degeneration
  • Macular Edema
  • Diabetes Complications
Anatomical therapeutic chemical (ATC) code
S01LA05
Publication details
Marketing-authorisation holder
Bayer AG
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
21/11/2012
Contact address
51368 Leverkusen
Germany

Product information

09/09/2018 Eylea - EMEA/H/C/002392 - IB/0047

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

OPHTHALMOLOGICALS

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

Changes since initial authorisation of medicine

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