Benlysta

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belimumab

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

Overview

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 09/06/2021

Authorisation details

Product details
Name
Benlysta
Agency product number
EMEA/H/C/002015
Active substance
belimumab
International non-proprietary name (INN) or common name
belimumab
Therapeutic area (MeSH)
Lupus Erythematosus, Systemic
Anatomical therapeutic chemical (ATC) code
L04AA26
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
Revision
26
Date of issue of marketing authorisation valid throughout the European Union
13/07/2011
Contact address

12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland

Product information

06/05/2021 Benlysta - EMEA/H/C/002015 - II/0092

Contents

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Pharmacotherapeutic group

Immunosuppressants

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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