This medicine is authorised for use in the European Union.


Benlysta is a medicine used as an add-on treatment in patients aged 5 years and older with systemic lupus erythematosus (SLE), a disease in which the immune system (the body’s natural defences) attacks normal cells and tissues, causing inflammation and organ damage. Benlysta is given to patients whose disease is still highly active despite standard treatment. 

Benlysta is also used in adults to treat active lupus nephritis, a manifestation of SLE causing kidney damage. In this case, it is given in combination with different immunosuppressants (medicines that reduce the activity of the immune system). 

Benlysta contains the active substance belimumab.

This EPAR was last updated on 11/09/2023

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Lupus Erythematosus, Systemic
Anatomical therapeutic chemical (ATC) code
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
GlaxoSmithKline (Ireland) Limited
Date of issue of marketing authorisation valid throughout the European Union
Contact address

12 Riverwalk
Citywest Business Campus
Dublin 24

Product information

24/11/2022 Benlysta - EMEA/H/C/002015 - II/0107

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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


Therapeutic indication

Benlysta is indicated as add-on therapy in patients aged 5 years and older with active, autoantibody positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti dsDNA and low complement) despite standard therapy.

Benlysta is indicated in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis.

Assessment history

Changes since initial authorisation of medicine

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