Eylea

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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).

Eylea is also used to treat preterm infants with retinopathy of prematurity (ROP), an eye condition that can occur when a baby is born too early and blood vessels in the eye do not develop normally, causing damage to the retina. Eylea is used for specific stages of the disease: zone I (stage 1+, 2+, 3 or 3+) and zone II (stage 2+ or 3+) as well as the rapidly progressing severe form of the disease called aggressive posterior retinopathy disease. 

Eylea contains the active substance aflibercept.
 

This EPAR was last updated on 10/01/2023

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
28
Date of issue of marketing authorisation valid throughout the European Union
21/11/2012
Contact address

Kaiser-Wilhelm-Allee 1
51373 Leverkusen
Germany

Product information

09/12/2022 Eylea - EMEA/H/C/002392 - II/0077/G

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

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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