Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Ryzodeg   
Auth. number : EU/1/12/806
Active substance : Insulin degludec/insulin aspart
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A10 - Drugs used in diabetes
Pharmacological subgroup: A10A - Insulins and analogues
Chemical subgroup: A10AD - Insulins and analogues for injection, intermediate-acting combined with fast-acting
Chemical substance: A10AD06 - insulin degludec and insulin aspart
(See WHO ATC Index)
Indication: Treatment of diabetes mellitus in adults, adolescents and children from the age of 2 years
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/2499 (2013)368 of 21/01/2013
13/03/2013 Corrigendum (2013)1531 of 12/03/2013
06/05/2013 Centralised - Variation EMEA/H/C/2499/IAin/2
Updated with Decision(2014)2817 of 23/04/2014
06/05/2013 Centralised - Variation EMEA/H/C/2499/IAin/3
Updated with Decision(2014)2817 of 23/04/2014
20/11/2013 Centralised - Notification EMEA/H/C/2499/N/5
Updated with Decision(2014)2817 of 23/04/2014
20/12/2013 Centralised - Variation EMEA/H/C/2499/IAin/6/G
Updated with Decision(2014)2817 of 23/04/2014
03/02/2014 Centralised - Variation EMEA/H/C/2499/IA/8
Updated with Decision(2014)2817 of 23/04/2014
25/04/2014 Centralised - Yearly update (2014)2817 of 23/04/2014
23/04/2015 Centralised - Variation EMEA/H/C/2499/II/12
Updated with Decision(2016)2277 of 13/04/2016
21/07/2015 Centralised - Notification EMEA/H/C/2499/N/15
Updated with Decision(2016)2277 of 13/04/2016
15/04/2016 Centralised - Yearly update (2016)2277 of 13/04/2016
26/07/2016 Centralised - 2-Monthly update EMEA/H/C/2499/II/17 (2016)4915 of 22/07/2016
25/09/2017 Centralised - Renewal EMEA/H/C/2499/R/24 (2017)6517 of 21/09/2017
12/10/2017 Centralised - Variation EMEA/H/C/2499/WS/1222