Avandamet

rosiglitazone / metformin

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The marketing authorisation for Avandamet has been suspended at the recommendation of the Agency’s Committee for Medicinal Products for Human Use (CHMP).

Name Language First published Last updated
Avandamet : EPAR - Summary for the public BG = bălgarski 18/09/2008 17/01/2011
Avandamet : EPAR - Summary for the public ES = español 18/09/2008 17/01/2011
Avandamet : EPAR - Summary for the public CS = čeština 18/09/2008 17/01/2011
Avandamet : EPAR - Summary for the public DA = dansk 18/09/2008 17/01/2011
Avandamet : EPAR - Summary for the public DE = Deutsch 18/09/2008 17/01/2011
Avandamet : EPAR - Summary for the public ET = eesti keel 18/09/2008 17/01/2011
Avandamet : EPAR - Summary for the public EL = elliniká 18/09/2008 17/01/2011
Avandamet : EPAR - Summary for the public EN = English 18/09/2008 17/01/2011
Avandamet : EPAR - Summary for the public FR = français 18/09/2008 17/01/2011
Avandamet : EPAR - Summary for the public IT = italiano 18/09/2008 17/01/2011
Avandamet : EPAR - Summary for the public LV = latviešu valoda 18/09/2008 17/01/2011
Avandamet : EPAR - Summary for the public LT = lietuvių kalba 18/09/2008 17/01/2011
Avandamet : EPAR - Summary for the public HU = magyar 18/09/2008 17/01/2011
Avandamet : EPAR - Summary for the public MT = Malti 18/09/2008 17/01/2011
Avandamet : EPAR - Summary for the public NL = Nederlands 18/09/2008 17/01/2011
Avandamet : EPAR - Summary for the public PL = polski 18/09/2008 17/01/2011
Avandamet : EPAR - Summary for the public PT = português 18/09/2008 17/01/2011
Avandamet : EPAR - Summary for the public RO = română 18/09/2008 17/01/2011
Avandamet : EPAR - Summary for the public SK = slovenčina 18/09/2008 17/01/2011
Avandamet : EPAR - Summary for the public SL = slovenščina 18/09/2008 17/01/2011
Avandamet : EPAR - Summary for the public FI = suomi 18/09/2008 17/01/2011
Avandamet : EPAR - Summary for the public SV = svenska 18/09/2008 17/01/2011

This EPAR was last updated on 17/01/2011 .

Authorisation details

Product details

Product details for Avandamet
NameAvandamet
Agency product numberEMEA/H/C/000522
Active substance

rosiglitazone / metformin hydrochloride,

International non-proprietary name (INN) or common name

rosiglitazone / metformin

Therapeutic area Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code A10BD03

Publication details

Publication details for Avandamet
Marketing-authorisation holder

SmithKline Beecham Plc

Revision16
Date of issue of marketing authorisation valid throughout the European Union20/10/2003

Contact address:

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

Product information

Product information

03/12/2010  Avandamet -EMEA/H/C/000522 -A20/0063

Name Language First published Last updated
Avandamet : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandamet : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandamet : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandamet : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandamet : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandamet : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandamet : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandamet : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandamet : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandamet : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandamet : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandamet : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandamet : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandamet : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandamet : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandamet : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandamet : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandamet : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandamet : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandamet : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandamet : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandamet : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011

Contents

  • 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.


Name Language First published Last updated
Avandamet : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandamet : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandamet : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandamet : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandamet : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandamet : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandamet : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandamet : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandamet : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandamet : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandamet : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandamet : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandamet : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandamet : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandamet : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandamet : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandamet : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandamet : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandamet : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandamet : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandamet : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandamet : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011

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).

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Avandamet : EPAR - Procedural steps taken before authorisation SV = svenska 15/08/2006 17/01/2011
Avandamet : EPAR - Scientific Discussion SV = svenska 15/08/2006 17/01/2011

Suspended

This medicine is currently suspended for use in the European Union

More information on Avandamet