Avandia

rosiglitazone

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The marketing authorisation for Avandia has expired following the marketing-authorisation holder’s decision not to apply for a renewal.

Name Language First published Last updated
Avandia : EPAR - Summary for the public BG = bălgarski 2008-06-16 2016-06-08
Avandia : EPAR - Summary for the public ES = español 2008-06-16 2016-06-08
Avandia : EPAR - Summary for the public CS = čeština 2008-06-16 2016-06-08
Avandia : EPAR - Summary for the public DA = dansk 2008-06-16 2016-06-08
Avandia : EPAR - Summary for the public DE = Deutsch 2008-06-16 2016-06-08
Avandia : EPAR - Summary for the public ET = eesti keel 2008-06-16 2016-06-08
Avandia : EPAR - Summary for the public EL = elliniká 2008-06-16 2016-06-08
Avandia : EPAR - Summary for the public EN = English 2008-06-16 2016-06-08
Avandia : EPAR - Summary for the public FR = français 2008-06-16 2016-06-08
Avandia : EPAR - Summary for the public IT = italiano 2008-06-16 2016-06-08
Avandia : EPAR - Summary for the public LV = latviešu valoda 2008-06-16 2016-06-08
Avandia : EPAR - Summary for the public LT = lietuvių kalba 2008-06-16 2016-06-08
Avandia : EPAR - Summary for the public HU = magyar 2008-06-16 2016-06-08
Avandia : EPAR - Summary for the public MT = Malti 2008-06-16 2016-06-08
Avandia : EPAR - Summary for the public NL = Nederlands 2008-06-16 2016-06-08
Avandia : EPAR - Summary for the public PL = polski 2008-06-16 2016-06-08
Avandia : EPAR - Summary for the public PT = português 2008-06-16 2016-06-08
Avandia : EPAR - Summary for the public RO = română 2008-06-16 2016-06-08
Avandia : EPAR - Summary for the public SK = slovenčina 2008-06-16 2016-06-08
Avandia : EPAR - Summary for the public SL = slovenščina 2008-06-16 2016-06-08
Avandia : EPAR - Summary for the public FI = suomi 2008-06-16 2016-06-08
Avandia : EPAR - Summary for the public SV = svenska 2008-06-16 2016-06-08

This EPAR was last updated on 08/06/2016 .

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 2009-09-01 2016-06-08
Avandia : EPAR - Product Information SV = svenska 2009-09-01 2016-06-08
Avandia : EPAR - Product Information SV = svenska 2009-09-01 2016-06-08
Avandia : EPAR - Product Information SV = svenska 2009-09-01 2016-06-08
Avandia : EPAR - Product Information SV = svenska 2009-09-01 2016-06-08
Avandia : EPAR - Product Information SV = svenska 2009-09-01 2016-06-08
Avandia : EPAR - Product Information SV = svenska 2009-09-01 2016-06-08
Avandia : EPAR - Product Information SV = svenska 2009-09-01 2016-06-08
Avandia : EPAR - Product Information SV = svenska 2009-09-01 2016-06-08
Avandia : EPAR - Product Information SV = svenska 2009-09-01 2016-06-08
Avandia : EPAR - Product Information SV = svenska 2009-09-01 2016-06-08
Avandia : EPAR - Product Information SV = svenska 2009-09-01 2016-06-08
Avandia : EPAR - Product Information SV = svenska 2009-09-01 2016-06-08
Avandia : EPAR - Product Information SV = svenska 2009-09-01 2016-06-08
Avandia : EPAR - Product Information SV = svenska 2009-09-01 2016-06-08
Avandia : EPAR - Product Information SV = svenska 2009-09-01 2016-06-08
Avandia : EPAR - Product Information SV = svenska 2009-09-01 2016-06-08
Avandia : EPAR - Product Information SV = svenska 2009-09-01 2016-06-08
Avandia : EPAR - Product Information SV = svenska 2009-09-01 2016-06-08
Avandia : EPAR - Product Information SV = svenska 2009-09-01 2016-06-08
Avandia : EPAR - Product Information SV = svenska 2009-09-01 2016-06-08
Avandia : EPAR - Product Information SV = svenska 2009-09-01 2016-06-08
Avandia : EPAR - Product Information SV = svenska 2009-09-01 2016-06-08
Avandia : EPAR - Product Information SV = svenska 2009-09-01 2016-06-08

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 2006-08-15 2016-06-08
Avandia : EPAR - All Authorised presentations SV = svenska 2006-08-15 2016-06-08
Avandia : EPAR - All Authorised presentations SV = svenska 2006-08-15 2016-06-08
Avandia : EPAR - All Authorised presentations SV = svenska 2006-08-15 2016-06-08
Avandia : EPAR - All Authorised presentations SV = svenska 2006-08-15 2016-06-08
Avandia : EPAR - All Authorised presentations SV = svenska 2006-08-15 2016-06-08
Avandia : EPAR - All Authorised presentations SV = svenska 2006-08-15 2016-06-08
Avandia : EPAR - All Authorised presentations SV = svenska 2006-08-15 2016-06-08
Avandia : EPAR - All Authorised presentations SV = svenska 2006-08-15 2016-06-08
Avandia : EPAR - All Authorised presentations SV = svenska 2006-08-15 2016-06-08
Avandia : EPAR - All Authorised presentations SV = svenska 2006-08-15 2016-06-08
Avandia : EPAR - All Authorised presentations SV = svenska 2006-08-15 2016-06-08
Avandia : EPAR - All Authorised presentations SV = svenska 2006-08-15 2016-06-08
Avandia : EPAR - All Authorised presentations SV = svenska 2006-08-15 2016-06-08
Avandia : EPAR - All Authorised presentations SV = svenska 2006-08-15 2016-06-08
Avandia : EPAR - All Authorised presentations SV = svenska 2006-08-15 2016-06-08
Avandia : EPAR - All Authorised presentations SV = svenska 2006-08-15 2016-06-08
Avandia : EPAR - All Authorised presentations SV = svenska 2006-08-15 2016-06-08
Avandia : EPAR - All Authorised presentations SV = svenska 2006-08-15 2016-06-08
Avandia : EPAR - All Authorised presentations SV = svenska 2006-08-15 2016-06-08
Avandia : EPAR - All Authorised presentations SV = svenska 2006-08-15 2016-06-08
Avandia : EPAR - All Authorised presentations SV = svenska 2006-08-15 2016-06-08

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 2006-08-15 2016-06-08
Avandia : EPAR - Scientific Discussion SV = svenska 2006-08-15 2016-06-08

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Avandia