Overview

The marketing authorisation for Eperzan has been withdrawn at the request of the marketing-authorisation holder.

Eperzan : EPAR - Summary for the public

Reference Number: EMA/57956/2014

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ελληνικά (EL) (630.45 KB - PDF)

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français (FR) (547.85 KB - PDF)

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hrvatski (HR) (562.04 KB - PDF)

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italiano (IT) (540.11 KB - PDF)

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latviešu valoda (LV) (622.24 KB - PDF)

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Malti (MT) (608.19 KB - PDF)

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Nederlands (NL) (541.07 KB - PDF)

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polski (PL) (605.32 KB - PDF)

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português (PT) (542.53 KB - PDF)

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română (RO) (565.97 KB - PDF)

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slovenčina (SK) (606.51 KB - PDF)

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slovenščina (SL) (598.09 KB - PDF)

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Suomi (FI) (540.84 KB - PDF)

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svenska (SV) (540.92 KB - PDF)

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Product information

Eperzan : EPAR - Product Information

English (EN) (1.3 MB - PDF)

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български (BG) (3.78 MB - PDF)

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español (ES) (1.31 MB - PDF)

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čeština (CS) (2.61 MB - PDF)

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dansk (DA) (1.28 MB - PDF)

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Deutsch (DE) (2.91 MB - PDF)

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eesti keel (ET) (1.28 MB - PDF)

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ελληνικά (EL) (3.79 MB - PDF)

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français (FR) (1.85 MB - PDF)

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hrvatski (HR) (2.06 MB - PDF)

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italiano (IT) (2.35 MB - PDF)

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lietuvių kalba (LT) (2.5 MB - PDF)

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magyar (HU) (2.8 MB - PDF)

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Malti (MT) (3.61 MB - PDF)

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Nederlands (NL) (1.74 MB - PDF)

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norsk (NO) (1.9 MB - PDF)

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polski (PL) (3.46 MB - PDF)

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português (PT) (2.22 MB - PDF)

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română (RO) (1.49 MB - PDF)

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slovenčina (SK) (2.84 MB - PDF)

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slovenščina (SL) (2.84 MB - PDF)

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Suomi (FI) (1.7 MB - PDF)

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svenska (SV) (1.9 MB - PDF)

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Latest procedure affecting product information: II/0031

14/09/2017

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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

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).

Eperzan : EPAR - All Authorised presentations

English (EN) (464.95 KB - PDF)

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български (BG) (530.35 KB - PDF)

First published: 10/04/2014Last updated: 20/02/2019
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español (ES) (464.99 KB - PDF)

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čeština (CS) (512.08 KB - PDF)

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dansk (DA) (461.05 KB - PDF)

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Deutsch (DE) (479.46 KB - PDF)

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eesti keel (ET) (473.97 KB - PDF)

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ελληνικά (EL) (515.98 KB - PDF)

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français (FR) (465.85 KB - PDF)

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hrvatski (HR) (480.51 KB - PDF)

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íslenska (IS) (545.36 KB - PDF)

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italiano (IT) (556.13 KB - PDF)

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latviešu valoda (LV) (511.54 KB - PDF)

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lietuvių kalba (LT) (508.44 KB - PDF)

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magyar (HU) (504.72 KB - PDF)

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Malti (MT) (511.91 KB - PDF)

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Nederlands (NL) (475.83 KB - PDF)

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norsk (NO) (476.21 KB - PDF)

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polski (PL) (522.9 KB - PDF)

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português (PT) (473.83 KB - PDF)

First published: 10/04/2014Last updated: 20/02/2019
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română (RO) (511.84 KB - PDF)

First published: 10/04/2014Last updated: 20/02/2019
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slovenčina (SK) (511.2 KB - PDF)

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slovenščina (SL) (496.05 KB - PDF)

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Suomi (FI) (470.96 KB - PDF)

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svenska (SV) (473.85 KB - PDF)

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Product details

Name of medicine
Eperzan
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

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).

Authorisation details

EMA product number
EMEA/H/C/002735
Marketing authorisation holder
GlaxoSmithKline Trading Services Limited

12 Riverwalk
Citywest Business Campus
Dublin 24
D24 YK11
Ireland

Opinion adopted
22/01/2014
Marketing authorisation issued
20/03/2014
Revision
8

Assessment history

Eperzan : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (656.63 KB - PDF)

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Eperzan : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/705417/2013

English (EN) (4 MB - PDF)

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CHMP summary of positive opinion for Eperzan

AdoptedReference Number: EMA/CHMP/20616/2014

English (EN) (523.8 KB - PDF)

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More information on Eperzan

Public statement on Eperzan: Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/824408/2018

English (EN) (104.26 KB - PDF)

First published:
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