Eperzan : EPAR - Summary for the public (PDF/562.4 KB)
First published: 10/04/2014
Last updated: 20/02/2019
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Diabetes Mellitus, Type 2
|Anatomical therapeutic chemical (ATC) code||
GlaxoSmithKline Trading Services Limited
|Date of issue of marketing authorisation valid throughout the European Union||
14/09/2017 Eperzan - EMEA/H/C/002735 - II/0031
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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).