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.
Benlysta : EPAR - Medicine overview (PDF/126.98 KB)
First published: 09/08/2011
Last updated: 19/05/2021
Benlysta : EPAR - Risk-management-plan summary (PDF/182.34 KB)
First published: 05/07/2019
Last updated: 09/06/2021
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Lupus Erythematosus, Systemic
|Anatomical therapeutic chemical (ATC) code||
GlaxoSmithKline (Ireland) Limited
|Date of issue of marketing authorisation valid throughout the European Union||
06/05/2021 Benlysta - EMEA/H/C/002015 - II/0092
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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.