Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Lyxumia   
Auth. number : EU/1/12/811
Active substance : lixisenatide
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A10 - Drugs used in diabetes
Pharmacological subgroup: A10B - Blood glucose lowering drugs, excluding insulins
Chemical subgroup: A10BJ - Glucagon-like peptide-1 (GLP-1) analogues
Chemical substance: A10BJ03 - lixisenatide
(See WHO ATC Index)
Indication: Lyxumia is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control
Marketing Authorisation Holder: Sanofi-Aventis groupe
54 rue La Boétie, 75008 Paris, France
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
05/02/2013 Centralised - Authorisation EMEA/H/C/2445 (2013)643 of 01/02/2013
04/10/2013 Centralised - Variation EMEA/H/C/2445/IA/1
Updated with Decision(2014)7935 of 22/10/2014
26/06/2014 Centralised - Variation EMEA/H/C/2445/II/3
Updated with Decision(2014)7935 of 22/10/2014
26/06/2014 Centralised - Variation EMEA/H/C/2445/II/4
Updated with Decision(2014)7935 of 22/10/2014
23/10/2014 Centralised - Variation EMEA/H/C/2445/II/7
Updated with Decision(2015)7204 of 15/10/2015
24/10/2014 Centralised - Yearly update (2014)7935 of 22/10/2014
24/09/2015 Centralised - Variation EMEA/H/C/2445/II/12
Updated with Decision(2016) 2822 of 02/05/2016
19/10/2015 Centralised - Yearly update (2015)7204 of 15/10/2015
01/04/2016 Centralised - Variation EMEA/H/C/2445/II/13
Updated with Decision(2016) 2822 of 02/05/2016
04/05/2016 Centralised - 2-Monthly update EMEA/H/C/2445/II/14 (2016) 2822 of 02/05/2016
14/03/2017 Centralised - Variation EMEA/H/C/2445/IA/21
Updated with Decision(2017)6408 of 18/09/2017
20/09/2017 Centralised - Renewal EMEA/H/C/2445/R/23 (2017)6408 of 18/09/2017