This is a summary of the European public assessment report (EPAR) for Benlysta. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Benlysta.
For practical information about using Benlysta, patients should read the package leaflet or contact their doctor or pharmacist.
Benlysta : EPAR - Summary for the public (PDF/79.29 KB)
First published: 09/08/2011
Last updated: 14/12/2017
Benlysta : EPAR - Risk-management-plan summary (PDF/75.01 KB) (updated)
First published: 05/07/2019
Last updated: 22/07/2019
|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||
01/07/2019 Benlysta - EMEA/H/C/002015 - II/0065
- 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
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Benlysta is indicated as add-on therapy in adult patients with active, auto-antibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g. positive anti-dsDNA and low complement) despite standard therapy (see section 5.1).