Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Komboglyze   
Auth. number : EU/1/11/731
Active substance : saxagliptin / metformin
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: A10BD - Combinations of oral blood glucose lowering drugs
Chemical substance: A10BD10 - metformin and saxagliptin
(See WHO ATC Index)
Indication: Komboglyze is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:
in patients inadequately controlled on their maximally tolerated dose of metformin alone
in combination with other medicinal products for the treatment of diabetes, including insulin, in patients inadequately controlled with metformin and these medicinal products (see sections 4.4, 4.5 and 5.1 of the SmPC for available data on different combinations)
in patients already being treated with the combination of saxagliptin and metformin as separate tablets.
Marketing Authorisation Holder: AstraZeneca AB
151 85 Södertälje, Sverige
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
28/11/2011 Centralised - Authorisation EMEA/H/C/2059 (2011)8840 of 24/11/2011
27/02/2012 Centralised - Variation EMEA/H/C/2059/IB/1/G
Updated with Decision(2012)6696 of 24/09/2012
24/09/2012 Centralised - Variation (2012)6696 of 24/09/2012
26/10/2012 Centralised - Variation EMEA/H/C/2059/II/4 (2012)7659 of 24/10/2012
04/01/2013 Centralised - Variation EMEA/H/C/2059/IB/8
Updated with Decision(2013)1012 of 18/02/2013
20/02/2013 Centralised - 2-Monthly update EMEA/H/C/2059/WS/295/6 (2013)1012 of 18/02/2013
11/11/2013 Centralised - Notification EMEA/H/C/2059/N/13
Updated with Decision(2014)7660 of 15/10/2014
26/06/2014 Centralised - Variation EMEA/H/C/2059/WS/528
Updated with Decision(2014)7660 of 15/10/2014
24/07/2014 Centralised - Variation EMEA/H/C/2059/WS/529
Updated with Decision(2014)7660 of 15/10/2014
20/10/2014 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2059/T/18 (2014)7660 of 15/10/2014
20/05/2015 Centralised - Variation EMEA/H/C/2059/IA/21/G
Updated with Decision(2015)5888 of 14/08/2015
18/08/2015 PSUSA - Modification EMEA/H/C/2059/PSUSA/2686/201411 (2015)5888 of 14/08/2015
01/10/2015 Centralised - Variation EMEA/H/C/2059/WS/810
Updated with Decision(2016)4741 of 15/07/2016
28/04/2016 Centralised - Variation EMEA/H/C/2059/WS/902
Updated with Decision(2016)4741 of 15/07/2016
19/07/2016 Centralised - Renewal EMEA/H/C/2059/R/32 (2016)4741 of 15/07/2016
14/12/2016 Referral EMEA/H/A-31/1432 (2016)8647 of 12/12/2016
14/03/2017 Rectificative Decision (2017)1735 of 10/03/2017
28/06/2017 Centralised - 2-Monthly update EMEA/H/C/2059/WS/1078 (2017)4518 of 26/06/2017