Benlysta

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belimumab

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

Overview

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.

This EPAR was last updated on 14/12/2017

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 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
Glaxo Group Ltd.
Revision
16
Date of issue of marketing authorisation valid throughout the European Union
13/07/2011
Contact address
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex
UB6 0NN
United Kingdom

Product information

10/11/2017 Benlysta - EMEA/H/C/002015 - X/0046/G

Contents

  • 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.

Pharmacotherapeutic group

IMMUNOSUPPRESSANTS

Therapeutic indication

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.

Assessment history

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