Eperzan

RSS

albiglutide

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Eperzan has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 20/02/2019

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
Citywest Business Campus
Dublin 24
Ireland

Product information

14/09/2017 Eperzan - EMEA/H/C/002735 - II/0031

Contents

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Pharmacotherapeutic group

Drugs used in diabetes. Other blood glucose lowering drugs excl. insulins. Glucagon like peptide 1 (GLP 1) analogues.

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).

Assessment history

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