Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Incresync   
Auth. number : EU/1/13/842
Active substance : 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:
• as an adjunct to diet and exercise to improve glycaemic control in adult
patients (particularly overweight patients) inadequately controlled on pioglitazone alone, and
for whom metformin is inappropriate due to contraindications or intolerance.
• in combination with metformin (i.e. triple combination therapy) as an adjunct to diet and
exercise to improve glycaemic control in adult patients (particularly overweight patients)
inadequately controlled on their maximal tolerated dose of metformin and pioglitazone.
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.
After initiation of therapy with Incresync, patients should be reviewed after 3 to 6 months to assess
adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate
response, Incresync should be discontinued. In light of potential risks with prolonged pioglitazone
therapy, prescribers should confirm at subsequent routine reviews that the benefit of Incresync is
maintained (see section 4.4).
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
Updated with Decision(2015)230 of 15/01/2015
24/07/2014 Centralised - Variation EMEA/H/C/2178/WS/519
Updated with Decision(2015)230 of 15/01/2015
24/07/2014 Centralised - Variation EMEA/H/C/2178/II/2
Updated with Decision(2015)230 of 15/01/2015
07/11/2014 Centralised - Variation EMEA/H/C/2178/IAIN/9
Updated with Decision(2015)230 of 15/01/2015
19/01/2015 PSUSA - Modification EMEA/H/C/2178/PSUV/8 (2015)230 of 15/01/2015
11/01/2017 Centralised - Variation EMEA/H/C/2178/IB/18/G
Updated with Decision(2017)9094 of 20/12/2017
20/12/2017 Centralised - Yearly update (2017)9094 of 20/12/2017
28/05/2018 Centralised - Renewal EMEA/H/C/2178/R/23 (2018)3347 of 24/05/2018