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
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Drugs used in diabetes
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).