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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|Auth. number :||EU/1/13/843|
|INN :||alogliptin / 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: A10BD13 - Metformin and alogliptin
(See WHO ATC Index)
|Indication:||Treatment of 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, inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of alogliptin and metformin.
• in combination with pioglitazone (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and pioglitazone.
• in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control.
|Marketing Authorisation Holder:||Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, Danmark
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.
|Close date procedure||Procedure type||EMEA number||Decision||summary publ||decision docs||annex|
|23/09/2013||Centralised - Authorisation||EMEA/H/C/2654||(2013)6214 of 19/09/2013|
|25/04/2014||Centralised - Variation||EMEA/H/C/2654/II/6|
|24/07/2014||Centralised - Variation||EMEA/H/C/2654/WS/519|
|24/07/2014||Centralised - Variation||EMEA/H/C/2654/WS/520|
|21/11/2014||Centralised - Variation||EMEA/H/C/2654/IAin/9/G|
|21/11/2014||Centralised - Variation||EMEA/H/C/2654/IAin/10|