Yesafili
aflibercept
Table of contents
Overview
Yesafili 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, causing 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).
Yesafili is a ‘biosimilar medicine’. This means that Yesafili is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Yesafili is Eylea. For more information on biosimilar medicines, see here.
Yesafili contains the active substance aflibercept.
-
List item
Yesafili : EPAR - Medicine overview (PDF/145.37 KB)
First published: 03/10/2023
EMA/359824/2023 -
-
List item
Yesafili : EPAR - Risk management plan summary (PDF/147.3 KB)
First published: 03/10/2023
Authorisation details
Product details | |
---|---|
Name |
Yesafili
|
Agency product number |
EMEA/H/C/006022
|
Active substance |
aflibercept
|
International non-proprietary name (INN) or common name |
aflibercept
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
S01LA05
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Biosimilar |
This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines. |
Publication details | |
---|---|
Marketing-authorisation holder |
Viatris Limited
|
Date of issue of marketing authorisation valid throughout the European Union |
15/09/2023
|
Contact address |
Damastown Industrial Park |
Product information
Yesafili - EMEA/H/C/006022 -
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:
- 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.
Pharmacotherapeutic group
Ophthalmologicals
Therapeutic indication
Yesafili is indicated for adults for the treatment of
- neovascular (wet) age-related macular degeneration (AMD) (see section 5.1),
- visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) (see section 5.1),
- visual impairment due to diabetic macular oedema (DME) (see section 5.1),
- visual impairment due to myopic choroidal neovascularisation (myopic CNV) (see section 5.1).