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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|Auth. number :||EU/1/13/908|
|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: A10BX - Other oral blood glucose lowering drugs
Chemical substance: A10BX13 - Albiglutide
(See WHO ATC Index)
|Indication:||Eperzan is indicated for the treatment of type 2 diabetes mellitus in adults to improve glycaemic control as:|
When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of
metformin is considered inappropriate due to contraindications or intolerance.
Add-on combination therapy
In combination with other glucose-lowering medicinal products including basal insulin, when these,
together with diet and exercise, do not provide adequate glycaemic control (see section 4.4 and 5.1 for available data on different combinations).
|Marketing Authorisation Holder:||GlaxoSmithKline Trading Services Limited
Currabinny, Carrigaline, County Cork, Ireland
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|
|26/03/2014||Centralised - Authorisation||EMEA/H/C/2735||(2014)2052 of 21/03/2014|
|05/06/2014||Centralised - Variation||EMEA/H/C/2735/IG/442|
|05/09/2014||Centralised - Variation||EMEA/H/C/2735/IB/04/G|