Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Xultophy   
Auth. number : EU/1/14/947
Active substance : insulin degludec / liraglutide
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A10 - Drugs used in diabetes
Pharmacological subgroup: A10A - Insulins and analogues
Chemical subgroup: A10AE - Insulins and analogues for injection, long-acting
Chemical substance: A10AE56 - Insulin degludec and liraglutide
(See WHO ATC Index)
Indication: Xultophy is indicated for the treatment of adults with type 2 diabetes mellitus to improve glycaemic control in combination with oral glucose-lowering medicinal products when these alone or combined with a GLP-1 receptor agonist or basal insulin do not provide adequate glycaemic control (see sections 4.4 and 5.1 for available data on the different combinations).
Marketing Authorisation Holder: Novo Nordisk A/S
Novo Allé, DK-2880 Bagsvaerd, Danmark
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
22/09/2014 Centralised - Authorisation EMEA/H/C/2647 (2014)6802 of 18/09/2014
26/03/2015 Centralised - Variation EMEA/H/C/2647/II/1/G
Updated with Decision(2015)4496 of 25/06/2015
29/06/2015 Centralised - 2-Monthly update EMEA/H/C/2647/II/2 (2015)4496 of 25/06/2015
24/09/2015 Centralised - Variation EMEA/H/C/2647/WS/778
Updated with Decision(2016)1290 of 24/02/2016
22/10/2015 Centralised - Variation EMEA/H/C/2647/II/9
Updated with Decision(2016)1290 of 24/02/2016
23/10/2015 Centralised - Variation EMEA/H/C/2647/IA/11
Updated with Decision(2016)1290 of 24/02/2016
26/02/2016 Centralised - 2-Monthly update EMEA/H/C/2647/II/12 (2016)1290 of 24/02/2016