Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Lyxumia   
Auth. number : EU/1/12/811
INN : 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: A10BX - Other oral blood glucose lowering drugs
Chemical substance: A10BX10 - 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, F-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
24/10/2014 Centralised - Yearly update (2014)7935 of 22/10/2014