Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Tresiba   
Auth. number : EU/1/12/807
Active substance : Insulin degludec
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: A10AE06 - insulin degludec
(See WHO ATC Index)
Indication: Treatment of diabetes mellitus in adults, adolescents and children from the age of 1 year.
Marketing Authorisation Holder: Novo Nordisk A/S
Novo Allé, 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
23/01/2013 Centralised - Authorisation EMEA/H/C/2498 (2013)637 of 21/01/2013
13/03/2013 Corrigendum (2013)1533 of 12/03/2013
06/05/2013 Centralised - Variation EMEA/H/C/2498/IAIN/3
Updated with Decision(2014)3134 of 07/05/2014
06/05/2013 Centralised - Variation EMEA/H/C/2498/IAIN/4/G
Updated with Decision(2014)3134 of 07/05/2014
09/05/2014 Centralised - 2-Monthly update EMEA/H/C/2498/II/6 (2014)3134 of 07/05/2014
03/02/2015 Centralised - 2-Monthly update EMEA/H/C/2498/II/11 (2015)587 of 30/01/2015
23/04/2015 Centralised - Variation EMEA/H/C/2498/II/13
Updated with Decision(2016)2276 of 13/04/2016
21/07/2015 Centralised - Notification EMEA/H/C/2498/N/16
Updated with Decision(2016)2276 of 13/04/2016
15/04/2016 Centralised - Yearly update (2016)2276 of 13/04/2016
03/05/2017 Centralised - 2-Monthly update EMEA/H/C/2498/II/24/G (2017)2964 of 28/04/2017
25/09/2017 Centralised - Renewal EMEA/H/C/2498/R/27 (2017)6518 of 21/09/2017
28/09/2017 Centralised - Variation EMEA/H/C/2498/II/28
12/10/2017 Centralised - Variation EMEA/H/C/2498/WS/1222
19/02/2018 Centralised - Notification EMEA/H/C/2498/N/31