Avandia

rosiglitazone

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

Name Language First published Last updated
Avandia : EPAR - Summary for the public BG = bălgarski 16/06/2008 17/01/2011
Avandia : EPAR - Summary for the public ES = español 16/06/2008 17/01/2011
Avandia : EPAR - Summary for the public CS = čeština 16/06/2008 17/01/2011
Avandia : EPAR - Summary for the public DA = dansk 16/06/2008 17/01/2011
Avandia : EPAR - Summary for the public DE = Deutsch 16/06/2008 17/01/2011
Avandia : EPAR - Summary for the public ET = eesti keel 16/06/2008 17/01/2011
Avandia : EPAR - Summary for the public EL = elliniká 16/06/2008 17/01/2011
Avandia : EPAR - Summary for the public EN = English 16/06/2008 17/01/2011
Avandia : EPAR - Summary for the public FR = français 16/06/2008 17/01/2011
Avandia : EPAR - Summary for the public IT = italiano 16/06/2008 17/01/2011
Avandia : EPAR - Summary for the public LV = latviešu valoda 16/06/2008 17/01/2011
Avandia : EPAR - Summary for the public LT = lietuvių kalba 16/06/2008 17/01/2011
Avandia : EPAR - Summary for the public HU = magyar 16/06/2008 17/01/2011
Avandia : EPAR - Summary for the public MT = Malti 16/06/2008 17/01/2011
Avandia : EPAR - Summary for the public NL = Nederlands 16/06/2008 17/01/2011
Avandia : EPAR - Summary for the public PL = polski 16/06/2008 17/01/2011
Avandia : EPAR - Summary for the public PT = português 16/06/2008 17/01/2011
Avandia : EPAR - Summary for the public RO = română 16/06/2008 17/01/2011
Avandia : EPAR - Summary for the public SK = slovenčina 16/06/2008 17/01/2011
Avandia : EPAR - Summary for the public SL = slovenščina 16/06/2008 17/01/2011
Avandia : EPAR - Summary for the public FI = suomi 16/06/2008 17/01/2011
Avandia : EPAR - Summary for the public SV = svenska 16/06/2008 17/01/2011

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

Authorisation details

Product details

Product details for Avandia
NameAvandia
Agency product numberEMEA/H/C/000268
Active substance

rosiglitazone

International non-proprietary name (INN) or common name

rosiglitazone

Therapeutic area Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code A10BG02

Publication details

Publication details for Avandia
Marketing-authorisation holder

SmithKline Beecham Plc

Revision23
Date of issue of marketing authorisation valid throughout the European Union11/07/2000

Contact address:

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

Product information

Product information

03/12/2010  Avandia -EMEA/H/C/000268 -A20/0075

Name Language First published Last updated
Avandia : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandia : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandia : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandia : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandia : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandia : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandia : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandia : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandia : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandia : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandia : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandia : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandia : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandia : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandia : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandia : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandia : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandia : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandia : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandia : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandia : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandia : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandia : EPAR - Product Information SV = svenska 01/09/2009 17/01/2011
Avandia : 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
Avandia : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandia : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandia : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandia : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandia : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandia : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandia : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandia : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandia : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandia : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandia : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandia : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandia : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandia : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandia : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandia : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandia : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandia : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandia : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandia : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandia : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011
Avandia : EPAR - All Authorised presentations SV = svenska 15/08/2006 17/01/2011

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Rosiglitazone is indicated in the treatment of type 2 diabetes mellitus:

as monotherapy
-in patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance

as dual oral therapy in combination with
-metformin, in patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin
-a sulphonylurea, only in patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite monotherapy with a sulphonylurea

as triple oral therapy in combination with
-metformin and a sulphonylurea, in patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy (see section 4.4).

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

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