Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Incresync   
Auth. number : EU/1/13/842
INN : alogliptin / pioglitazone
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: A10BD09 - Pioglitazone and alogliptin
(See WHO ATC Index)
Indication: Incresync is indicated as a second or third line treatment in adult patients aged 18 years and older with type 2 diabetes mellitus.

In addition, Incresync can be used to replace separate tablets of alogliptin and pioglitazone in those adult patients aged 18 years and older with type 2 diabetes mellitus already being treated with this combination.
Marketing Authorisation Holder: Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, 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
23/09/2013 Centralised - Authorisation EMEA/H/C/2178 (2013)6216 of 19/09/2013
25/04/2014 Centralised - Variation EMEA/H/C/2178/II/6
24/07/2014 Centralised - Variation EMEA/H/C/2178/WS/519
24/07/2014 Centralised - Variation EMEA/H/C/2178/II/2
07/11/2014 Centralised - Variation EMEA/H/C/2178/IAin/9