Vabysmo
faricimab
Table of contents
Overview
Vabysmo is a medicine used to treat adults with:
- the ‘wet’ form of age-related macular degeneration (AMD), a disease that affects the central part of the retina (called the macula) at the back of the eye. The wet form of AMD is caused by abnormal growth of blood vessels beneath the retina which may leak fluid and blood and cause swelling;
- impaired vision due to macular oedema caused by diabetes.
The macula provides central vision that is needed to see details 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.
Vabysmo contains the active substance faricimab.
-
List item
Vabysmo : EPAR - Medicine Overview (PDF/145.9 KB)
First published: 13/10/2022
EMEA/H/C/005642 -
-
List item
Vabysmo : EPAR - Risk Management Plan summary (PDF/1013.94 KB)
First published: 13/10/2022
Authorisation details
Product details | |
---|---|
Name |
Vabysmo
|
Agency product number |
EMEA/H/C/005642
|
Active substance |
Faricimab
|
International non-proprietary name (INN) or common name |
faricimab
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
S01L
|
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 |
Roche Registration GmbH
|
Revision |
1
|
Date of issue of marketing authorisation valid throughout the European Union |
15/09/2022
|
Contact address |
Emil-Barell-Strasse 1 |
Product information
22/06/2023 Vabysmo - EMEA/H/C/005642 - II/0002
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
Vabysmo is indicated for the treatment of adult patients with:
- neovascular (wet) age-related macular degeneration (nAMD),
- visual impairment due to diabetic macular oedema (DME).