Avandamet

RSS
Expired

This medicine's authorisation has expired

rosiglitazone / metformin
Medicine Human Expired
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

The marketing authorisation for Avandamet (rosiglitazone/metformin) expired on 20 October 2013 following the decision of the marketing authorisation holder, Smithkline Beecham Ltd., not to apply for a renewal of the marketing authorisation. The marketing authorisation for Avandamet in the European Union (EU) was suspended at that time. 

Avandamet was granted marketing authorisation in the European Union (EU) on 20 October 2003 for treatment of type 2 diabetes mellitus treatment of type 2 diabetes mellitus treatment of type 2 diabetes mellitus treatment of type 2 diabetes mellitus. 

The marketing authorisation was valid for a 5-year period. It was subsequently renewed for an additional 5-year period on 13 August 2008. 

The European Public Assessment Report (EPAR) for Avandamet is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Avandamet : EPAR - Summary for the public

English (EN) (752.38 KB - PDF)

First published: Last updated:
View

български (BG) (1.42 MB - PDF)

First published: 18/09/2008 Last updated: 08/06/2016
View

español (ES) (1.25 MB - PDF)

First published: 18/09/2008 Last updated: 08/06/2016
View

čeština (CS) (1.36 MB - PDF)

First published: 18/09/2008 Last updated: 08/06/2016
View

dansk (DA) (1.25 MB - PDF)

First published: 18/09/2008 Last updated: 08/06/2016
View

Deutsch (DE) (1.25 MB - PDF)

First published: 18/09/2008 Last updated: 08/06/2016
View

eesti keel (ET) (1.25 MB - PDF)

First published: 18/09/2008 Last updated: 08/06/2016
View

ελληνικά (EL) (1.44 MB - PDF)

First published: 18/09/2008 Last updated: 08/06/2016
View

français (FR) (1.25 MB - PDF)

First published: 18/09/2008 Last updated: 08/06/2016
View

italiano (IT) (1.25 MB - PDF)

First published: 18/09/2008 Last updated: 08/06/2016
View

latviešu valoda (LV) (1.37 MB - PDF)

First published: 18/09/2008 Last updated: 08/06/2016
View

lietuvių kalba (LT) (1.28 MB - PDF)

First published: 18/09/2008 Last updated: 08/06/2016
View

magyar (HU) (1.35 MB - PDF)

First published: 18/09/2008 Last updated: 08/06/2016
View

Malti (MT) (1.36 MB - PDF)

First published: 18/09/2008 Last updated: 08/06/2016
View

Nederlands (NL) (1.25 MB - PDF)

First published: 18/09/2008 Last updated: 08/06/2016
View

polski (PL) (1.36 MB - PDF)

First published: 18/09/2008 Last updated: 08/06/2016
View

português (PT) (1.25 MB - PDF)

First published: 18/09/2008 Last updated: 08/06/2016
View

română (RO) (1.29 MB - PDF)

First published: 18/09/2008 Last updated: 08/06/2016
View

slovenčina (SK) (1.36 MB - PDF)

First published: 18/09/2008 Last updated: 08/06/2016
View

slovenščina (SL) (1.35 MB - PDF)

First published: 18/09/2008 Last updated: 08/06/2016
View

Suomi (FI) (1.25 MB - PDF)

First published: 18/09/2008 Last updated: 08/06/2016
View

svenska (SV) (1.25 MB - PDF)

First published: 18/09/2008 Last updated: 08/06/2016
View

Product information

Avandamet : EPAR - Product Information

English (EN) (1.85 MB - PDF)

First published: Last updated:
View

български (BG) (10.3 MB - PDF)

First published: 01/09/2009 Last updated: 08/06/2016
View

español (ES) (2.02 MB - PDF)

First published: 01/09/2009 Last updated: 08/06/2016
View

čeština (CS) (6.07 MB - PDF)

First published: 01/09/2009 Last updated: 08/06/2016
View

dansk (DA) (3.29 MB - PDF)

First published: 01/09/2009 Last updated: 08/06/2016
View

Deutsch (DE) (3.06 MB - PDF)

First published: 01/09/2009 Last updated: 08/06/2016
View

eesti keel (ET) (2.86 MB - PDF)

First published: 01/09/2009 Last updated: 08/06/2016
View

ελληνικά (EL) (8.76 MB - PDF)

First published: 01/09/2009 Last updated: 08/06/2016
View

français (FR) (3.04 MB - PDF)

First published: 01/09/2009 Last updated: 08/06/2016
View

italiano (IT) (2.05 MB - PDF)

First published: 01/09/2009 Last updated: 08/06/2016
View

latviešu valoda (LV) (6.65 MB - PDF)

First published: 01/09/2009 Last updated: 08/06/2016
View

lietuvių kalba (LT) (4.2 MB - PDF)

First published: 01/09/2009 Last updated: 08/06/2016
View

magyar (HU) (5.83 MB - PDF)

First published: 01/09/2009 Last updated: 08/06/2016
View

Malti (MT) (6.11 MB - PDF)

First published: 01/09/2009 Last updated: 08/06/2016
View

Nederlands (NL) (3.31 MB - PDF)

First published: 01/09/2009 Last updated: 08/06/2016
View

polski (PL) (6.46 MB - PDF)

First published: 01/09/2009 Last updated: 08/06/2016
View

português (PT) (3.63 MB - PDF)

First published: 01/09/2009 Last updated: 08/06/2016
View

română (RO) (3.79 MB - PDF)

First published: 01/09/2009 Last updated: 08/06/2016
View

slovenčina (SK) (6.38 MB - PDF)

First published: 01/09/2009 Last updated: 08/06/2016
View

slovenščina (SL) (3.49 MB - PDF)

First published: 01/09/2009 Last updated: 08/06/2016
View

Suomi (FI) (2.89 MB - PDF)

First published: 01/09/2009 Last updated: 08/06/2016
View

svenska (SV) (3.25 MB - PDF)

First published: 01/09/2009 Last updated: 08/06/2016
View
Latest procedure affecting product information:A20/0063
03/12/2010
icon globe

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).

Avandamet : EPAR - All Authorised presentations

English (EN) (725.2 KB - PDF)

First published: Last updated:
View

български (BG) (1.23 MB - PDF)

First published: 15/08/2006 Last updated: 08/06/2016
View

español (ES) (1.15 MB - PDF)

First published: 15/08/2006 Last updated: 08/06/2016
View

čeština (CS) (1.19 MB - PDF)

First published: 15/08/2006 Last updated: 08/06/2016
View

dansk (DA) (1.15 MB - PDF)

First published: 15/08/2006 Last updated: 08/06/2016
View

Deutsch (DE) (1.15 MB - PDF)

First published: 15/08/2006 Last updated: 08/06/2016
View

eesti keel (ET) (1.15 MB - PDF)

First published: 15/08/2006 Last updated: 08/06/2016
View

ελληνικά (EL) (1.25 MB - PDF)

First published: 15/08/2006 Last updated: 08/06/2016
View

français (FR) (1.17 MB - PDF)

First published: 15/08/2006 Last updated: 08/06/2016
View

italiano (IT) (1.15 MB - PDF)

First published: 15/08/2006 Last updated: 08/06/2016
View

latviešu valoda (LV) (1.2 MB - PDF)

First published: 15/08/2006 Last updated: 08/06/2016
View

lietuvių kalba (LT) (1.18 MB - PDF)

First published: 15/08/2006 Last updated: 08/06/2016
View

magyar (HU) (1.23 MB - PDF)

First published: 15/08/2006 Last updated: 08/06/2016
View

Malti (MT) (1.21 MB - PDF)

First published: 15/08/2006 Last updated: 08/06/2016
View

Nederlands (NL) (1.15 MB - PDF)

First published: 15/08/2006 Last updated: 08/06/2016
View

polski (PL) (1.19 MB - PDF)

First published: 15/08/2006 Last updated: 08/06/2016
View

português (PT) (1.15 MB - PDF)

First published: 15/08/2006 Last updated: 08/06/2016
View

română (RO) (1.19 MB - PDF)

First published: 15/08/2006 Last updated: 08/06/2016
View

slovenčina (SK) (1.18 MB - PDF)

First published: 15/08/2006 Last updated: 08/06/2016
View

slovenščina (SL) (1.18 MB - PDF)

First published: 15/08/2006 Last updated: 08/06/2016
View

Suomi (FI) (1.15 MB - PDF)

First published: 15/08/2006 Last updated: 08/06/2016
View

svenska (SV) (1.16 MB - PDF)

First published: 15/08/2006 Last updated: 08/06/2016
View

Product details

Name of medicine
Avandamet
Active substance
  • rosiglitazone
  • metformin hydrochloride
International non-proprietary name (INN) or common name
  • rosiglitazone
  • metformin
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BD03

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

AVANDAMET is indicated in the treatment of type 2 diabetes mellitus patients, particularly overweight patients:

  • who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.
  • in triple oral therapy with sulphonylurea in patients with insufficient glycaemic control despite dual oral therapy with their maximally tolerated dose of metformin and a sulphonylurea (see section 4.4).

Authorisation details

EMA product number
EMEA/H/C/000522
Marketing authorisation holder
SmithKline Beecham Plc

SmithKline Beecham plc
980 Great West Road,
Brentford, Middlesex, TW8 9GS
United Kingdom

Marketing authorisation issued
20/10/2003
Expiry of marketing authorisation
20/10/2013
Revision
16

Assessment history

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

English (EN) (1.12 MB - PDF)

First published: Last updated:
View

Avandamet-H-C-522-A20-0063: EPAR - Assessment Report

Adopted

English (EN) (1.52 MB - PDF)

First published: Last updated:
View

CHMP post-authorisation summary of positive opinion for Avandamet on 24 January 2008

Adopted Reference Number: EMEA/CHMP/42782/2008

English (EN) (490.91 KB - PDF)

First published: Last updated:
View

Avandamet-H-C-522-II-17 : EPAR - Scientific Discussion - Variation

Adopted

English (EN) (897.2 KB - PDF)

First published: Last updated:
View

Avandamet : EPAR - Procedural steps taken before authorisation

English (EN) (744.05 KB - PDF)

First published: Last updated:
View

Avandamet : EPAR - Scientific Discussion

English (EN) (1 MB - PDF)

First published: Last updated:
View

More information on Avandamet

This page was last updated on

Share this page

Back to top