Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Benlysta   
Auth. number : EU/1/11/700
Active substance : belimumab
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L04 - Immunosuppressive agents
Pharmacological subgroup: L04A - Immunosuppressive agents
Chemical subgroup: L04AA - Selective immunosuppressive agents
Chemical substance: L04AA26 - Belimumab
(See WHO ATC Index)
Indication: Benlysta is indicated as add-on therapy in adult patients 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.
Marketing Authorisation Holder: Glaxo Group Ltd
980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
15/07/2011 Centralised - Authorisation EMEA/H/C/2015 (2011)5195 of 13/07/2011
02/02/2012 Centralised - Variation EMEA/H/C/2015/IB/7
Updated with Decision(2012)1923 of 19/03/2012
21/03/2012 Centralised - Variation EMEA/H/C/2015/II/4 (2012)1923 of 19/03/2012
30/05/2012 Centralised - Variation EMEA/H/C/2015/II/5 (2012)3575 of 25/05/2012
26/10/2012 Centralised - Variation EMEA/H/C/2015/II/6 (2012)7646 of 24/10/2012
21/03/2013 Centralised - Variation EMEA/H/C/2015/II/13
Updated with Decision(2013)4623 of 15/07/2013
18/04/2013 Centralised - Variation EMEA/H/C/2015/IA/279
Updated with Decision(2013)4623 of 15/07/2013
14/05/2013 Centralised - Variation EMEA/H/C/2015/IB/16
Updated with Decision(2013)9658 of 17/12/2013
17/07/2013 PSUSA - Modification EMEA/H/C/2015/PSU/16 (2013)4623 of 15/07/2013
19/12/2013 PSUSA - Modification EMEA/H/C/2015/PSUV/19 (2013)9658 of 17/12/2013
25/04/2014 Centralised - Variation EMEA/H/C/2015/II/23
Updated with Decision(2015)2933 of 24/04/2015
01/10/2014 Centralised - Variation EMEA/H/C/2015/IB/30
Updated with Decision(2015)2933 of 24/04/2015
28/04/2015 Centralised - Yearly update (2015)2933 of 24/04/2015
22/02/2016 Centralised - Renewal EMEA/H/C/2015/R/36 (2016)1142 of 18/02/2016
01/04/2016 Centralised - Variation EMEA/H/C/2015/II/37