Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Komboglyze   
Auth. number : EU/1/11/731
INN : 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: A10BD - Combinations of oral blood glucose lowering drugs
(See WHO ATC Index)
Indication: Komboglyze is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type 2 diabetes mellitus inadequately controlled on their maximally tolerated dose of metformin alone or those already being treated with the combination of saxagliptin and metformin as separate tablets.
Komboglyze is also indicated in combination with insulin (ie, triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type 2 diabetes mellitus when insulin and metformin alone do not provide adequate glycaemic control.
Komboglyze is also indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type 2 diabetes mellitus when the maximally tolerated dose of both metformin and the sulphonylurea does not provide adequate glycaemic control.
Marketing Authorisation Holder: AstraZeneca AB
SE-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