Vabysmo

RSS

faricimab

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

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.

This EPAR was last updated on 19/07/2023

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)
  • Wet Macular Degeneration
  • Macular Edema
  • Diabetes Complications
Anatomical therapeutic chemical (ATC) code
S01L
Additional monitoringAdditional 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
79639 Grenzach-Wyhlen
Germany

Product information

22/06/2023 Vabysmo - EMEA/H/C/005642 - II/0002

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

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).

Assessment history

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