Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Eperzan   
Auth. number : EU/1/13/908
Active substance : albiglutide
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
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
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
Updated with Decision(2015)4309 of 19/06/2015
05/09/2014 Centralised - Variation EMEA/H/C/2735/IB/4/G
Updated with Decision(2015)4309 of 19/06/2015
18/12/2014 Centralised - Variation EMEA/H/C/2735/II/8
Updated with Decision(2015)4309 of 19/06/2015
23/06/2015 Centralised - Yearly update (2015)4309 of 19/06/2015
08/12/2015 Centralised - Notification EMEA/H/C/2735/N/18
Updated with Decision(2016) 8517 of 08/12/2016
31/03/2016 Centralised - Variation EMEA/H/C/2735/IB/21
Updated with Decision(2016) 8517 of 08/12/2016
21/07/2016 Centralised - Variation EMEA/H/C/2735/II/22
Updated with Decision(2016) 8517 of 08/12/2016
14/12/2016 PSUSA - Modification EMEA/H/C/2735/PSUSA/10175/201603 (2016) 8517 of 08/12/2016
14/07/2017 Centralised - Variation EMEA/H/C/2735/IA/.35
10/08/2017 Centralised - Variation EMEA/H/C/2735/IAIN/37
01/09/2017 Centralised - Variation EMEA/H/C/2735/II/33
14/09/2017 Centralised - Variation EMEA/H/C/2735/II/31