Avaglim

rosiglitazone / glimepiride

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The marketing authorisation for Avaglim has been withdrawn for safety reasons following a decision by the European Commission.

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

This EPAR was last updated on 12/08/2011 .

More detail is available in the summary of product characteristics

Authorisation details

Product details

Product details for Avaglim
NameAvaglim
Agency product numberEMEA/H/C/000675
Active substance

rosiglitazone / glimepiride

International non-proprietary name (INN) or common name

rosiglitazone / glimepiride

Therapeutic area Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code A10BD04

Publication details

Publication details for Avaglim
Marketing-authorisation holder

SmithKline Beecham Ltd

Revision11
Date of issue of marketing authorisation valid throughout the European Union27/06/2006

Contact address:

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

Product information

Product information

26/07/2011  Avaglim -EMEA/H/C/000675 -A20/0029

Name Language First published Last updated
Avaglim : EPAR - Product Information BG = bălgarski 08/10/2008 17/01/2011
Avaglim : EPAR - Product Information ES = español 08/10/2008 17/01/2011
Avaglim : EPAR - Product Information CS = čeština 08/10/2008 17/01/2011
Avaglim : EPAR - Product Information DA = dansk 08/10/2008 17/01/2011
Avaglim : EPAR - Product Information DE = Deutsch 08/10/2008 17/01/2011
Avaglim : EPAR - Product Information ET = eesti keel 08/10/2008 17/01/2011
Avaglim : EPAR - Product Information EL = elliniká 08/10/2008 17/01/2011
Avaglim : EPAR - Product Information EN = English 08/10/2008 17/01/2011
Avaglim : EPAR - Product Information FR = français 08/10/2008 17/01/2011
Avaglim : EPAR - Product Information IT = italiano 08/10/2008 17/01/2011
Avaglim : EPAR - Product Information LV = latviešu valoda 08/10/2008 17/01/2011
Avaglim : EPAR - Product Information LT = lietuvių kalba 08/10/2008 17/01/2011
Avaglim : EPAR - Product Information HU = magyar 08/10/2008 17/01/2011
Avaglim : EPAR - Product Information MT = Malti 08/10/2008 17/01/2011
Avaglim : EPAR - Product Information NL = Nederlands 08/10/2008 17/01/2011
Avaglim : EPAR - Product Information PL = polski 08/10/2008 17/01/2011
Avaglim : EPAR - Product Information PT = português 08/10/2008 17/01/2011
Avaglim : EPAR - Product Information RO = română 08/10/2008 17/01/2011
Avaglim : EPAR - Product Information SK = slovenčina 08/10/2008 17/01/2011
Avaglim : EPAR - Product Information SL = slovenščina 08/10/2008 17/01/2011
Avaglim : EPAR - Product Information FI = suomi 08/10/2008 17/01/2011
Avaglim : EPAR - Product Information SV = svenska 08/10/2008 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
Avaglim : EPAR - All Authorised presentations BG = bălgarski 12/04/2007 17/01/2011
Avaglim : EPAR - All Authorised presentations ES = español 12/04/2007 17/01/2011
Avaglim : EPAR - All Authorised presentations CS = čeština 12/04/2007 17/01/2011
Avaglim : EPAR - All Authorised presentations DA = dansk 12/04/2007 17/01/2011
Avaglim : EPAR - All Authorised presentations DE = Deutsch 12/04/2007 17/01/2011
Avaglim : EPAR - All Authorised presentations ET = eesti keel 12/04/2007 17/01/2011
Avaglim : EPAR - All Authorised presentations EL = elliniká 12/04/2007 17/01/2011
Avaglim : EPAR - All Authorised presentations EN = English 12/04/2007 17/01/2011
Avaglim : EPAR - All Authorised presentations FR = français 12/04/2007 17/01/2011
Avaglim : EPAR - All Authorised presentations IT = italiano 12/04/2007 17/01/2011
Avaglim : EPAR - All Authorised presentations LV = latviešu valoda 12/04/2007 17/01/2011
Avaglim : EPAR - All Authorised presentations LT = lietuvių kalba 12/04/2007 17/01/2011
Avaglim : EPAR - All Authorised presentations HU = magyar 12/04/2007 17/01/2011
Avaglim : EPAR - All Authorised presentations NL = Nederlands 12/04/2007 17/01/2011
Avaglim : EPAR - All Authorised presentations PL = polski 12/04/2007 17/01/2011
Avaglim : EPAR - All Authorised presentations PT = português 12/04/2007 17/01/2011
Avaglim : EPAR - All Authorised presentations RO = română 12/04/2007 17/01/2011
Avaglim : EPAR - All Authorised presentations SK = slovenčina 12/04/2007 17/01/2011
Avaglim : EPAR - All Authorised presentations SL = slovenščina 12/04/2007 17/01/2011
Avaglim : EPAR - All Authorised presentations FI = suomi 12/04/2007 17/01/2011
Avaglim : EPAR - All Authorised presentations SV = svenska 12/04/2007 17/01/2011

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

AVAGLIM is indicated in the treatment of type 2 diabetes mellitus patients who are unable to achieve sufficient glycaemic control on optimal dosage of sulphonylurea monotherapy, and for whom metformin is inappropriate because of contraindication or intolerance.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Avaglim : EPAR - Procedural steps taken and scientific information after authorisation (English only) 08/10/2008 17/01/2011
Avaglim-H-C-675-A-20-29: EPAR - Assessment Report (English only) 14/01/2011 17/01/2011

Initial marketing-authorisation documents

Name Language First published Last updated
Avaglim : EPAR - Scientific Discussion (English only) 20/10/2006 17/01/2011
Avaglim : EPAR - Procedural steps taken before authorisation (English only) 20/10/2006 17/01/2011

Withdrawn

This medicine is now withdrawn from use in the European Union

Patient safety


More information on Avaglim