Beovu
brolucizumab
Table of contents
Overview
Beovu is a medicine used to treat adults with certain sight problems caused by damage to the retina (the light-sensing layer at the back of the eye), and more specifically its central region, known as the macula. The macula provides central vision that is needed to see detail for everyday tasks such as driving, reading and recognising faces. In adults, Beovu is used to treat:
• the ‘wet’ form of age-related macular degeneration (AMD). The wet form of AMD is caused by choroidal neovascularisation (the abnormal growth of blood vessels under the macula, which may lead to leakage of fluid and blood and cause swelling);
• visual impairment due to macular oedema (swelling of the macula) caused by diabetes (DME).
Beovu contains the active substance brolucizumab.
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List item
Beovu : EPAR - Medicine overview (PDF/153.34 KB)
First published: 18/02/2020
Last updated: 06/04/2022
EMA/130586/2022 -
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List item
Beovu : EPAR - Risk Management Plan (PDF/739.99 KB) (new)
First published: 26/05/2023
Authorisation details
Product details | |
---|---|
Name |
Beovu
|
Agency product number |
EMEA/H/C/004913
|
Active substance |
brolucizumab
|
International non-proprietary name (INN) or common name |
brolucizumab
|
Therapeutic area (MeSH) |
Wet Macular Degeneration
|
Anatomical therapeutic chemical (ATC) code |
S01
|
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. |
Publication details | |
---|---|
Marketing-authorisation holder |
Novartis Europharm Limited
|
Revision |
8
|
Date of issue of marketing authorisation valid throughout the European Union |
13/02/2020
|
Contact address |
Vista Building |
Product information
11/04/2023 Beovu - EMEA/H/C/004913 - IAIN/0024/G
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
Beovu is indicated in adults for the treatment of neovascular (wet) age-related macular degeneration (AMD).