Eperzan
albiglutide
Table of contents
Overview
The marketing authorisation for Eperzan has been withdrawn at the request of the marketing-authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Eperzan
|
| Agency product number |
EMEA/H/C/002735
|
| Active substance |
Albiglutide
|
| International non-proprietary name (INN) or common name |
albiglutide
|
| Therapeutic area (MeSH) |
Diabetes Mellitus, Type 2
|
| Anatomical therapeutic chemical (ATC) code |
A10BJ04
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
GlaxoSmithKline Trading Services Limited
|
| Revision |
8
|
| Date of issue of marketing authorisation valid throughout the European Union |
20/03/2014
|
| Contact address |
12 Riverwalk |
Product information
14/09/2017 Eperzan - EMEA/H/C/002735 - II/0031
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Drugs used in diabetes
Therapeutic indication
Eperzan is indicated for the treatment of type 2 diabetes mellitus in adults to improve glycaemic control as:
Monotherapy
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).