Avaglim

rosiglitazone / glimepiride

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About

The marketing authorisation for Avaglim has been withdrawn for safety reasons following a decision by the European Commission.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 2008-06-16 2011-01-17
Avaglim : EPAR - Summary for the public ES = español 2008-06-16 2011-01-17
Avaglim : EPAR - Summary for the public CS = čeština 2008-06-16 2011-01-17
Avaglim : EPAR - Summary for the public DA = dansk 2008-06-16 2011-01-17
Avaglim : EPAR - Summary for the public DE = Deutsch 2008-06-16 2011-01-17
Avaglim : EPAR - Summary for the public ET = eesti keel 2008-06-16 2011-01-17
Avaglim : EPAR - Summary for the public EL = elliniká 2008-06-16 2011-01-17
Avaglim : EPAR - Summary for the public EN = English 2008-06-16 2011-01-17
Avaglim : EPAR - Summary for the public FR = français 2008-06-16 2011-01-17
Avaglim : EPAR - Summary for the public IT = italiano 2008-06-16 2011-01-17
Avaglim : EPAR - Summary for the public LV = latviešu valoda 2008-06-16 2011-01-17
Avaglim : EPAR - Summary for the public LT = lietuvių kalba 2008-06-16 2011-01-17
Avaglim : EPAR - Summary for the public HU = magyar 2008-06-16 2011-01-17
Avaglim : EPAR - Summary for the public MT = Malti 2008-06-16 2011-01-17
Avaglim : EPAR - Summary for the public NL = Nederlands 2008-06-16 2011-01-17
Avaglim : EPAR - Summary for the public PL = polski 2008-06-16 2011-01-17
Avaglim : EPAR - Summary for the public PT = português 2008-06-16 2011-01-17
Avaglim : EPAR - Summary for the public RO = română 2008-06-16 2011-01-17
Avaglim : EPAR - Summary for the public SK = slovenčina 2008-06-16 2011-01-17
Avaglim : EPAR - Summary for the public SL = slovenščina 2008-06-16 2011-01-17
Avaglim : EPAR - Summary for the public FI = suomi 2008-06-16 2011-01-17
Avaglim : EPAR - Summary for the public SV = svenska 2008-06-16 2011-01-17

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

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 SV = svenska 2008-10-08 2011-01-17
Avaglim : EPAR - Product Information SV = svenska 2008-10-08 2011-01-17
Avaglim : EPAR - Product Information SV = svenska 2008-10-08 2011-01-17
Avaglim : EPAR - Product Information SV = svenska 2008-10-08 2011-01-17
Avaglim : EPAR - Product Information SV = svenska 2008-10-08 2011-01-17
Avaglim : EPAR - Product Information SV = svenska 2008-10-08 2011-01-17
Avaglim : EPAR - Product Information SV = svenska 2008-10-08 2011-01-17
Avaglim : EPAR - Product Information SV = svenska 2008-10-08 2011-01-17
Avaglim : EPAR - Product Information SV = svenska 2008-10-08 2011-01-17
Avaglim : EPAR - Product Information SV = svenska 2008-10-08 2011-01-17
Avaglim : EPAR - Product Information SV = svenska 2008-10-08 2011-01-17
Avaglim : EPAR - Product Information SV = svenska 2008-10-08 2011-01-17
Avaglim : EPAR - Product Information SV = svenska 2008-10-08 2011-01-17
Avaglim : EPAR - Product Information SV = svenska 2008-10-08 2011-01-17
Avaglim : EPAR - Product Information SV = svenska 2008-10-08 2011-01-17
Avaglim : EPAR - Product Information SV = svenska 2008-10-08 2011-01-17
Avaglim : EPAR - Product Information SV = svenska 2008-10-08 2011-01-17
Avaglim : EPAR - Product Information SV = svenska 2008-10-08 2011-01-17
Avaglim : EPAR - Product Information SV = svenska 2008-10-08 2011-01-17
Avaglim : EPAR - Product Information SV = svenska 2008-10-08 2011-01-17
Avaglim : EPAR - Product Information SV = svenska 2008-10-08 2011-01-17
Avaglim : EPAR - Product Information SV = svenska 2008-10-08 2011-01-17

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 SV = svenska 2007-04-12 2011-01-17
Avaglim : EPAR - All Authorised presentations SV = svenska 2007-04-12 2011-01-17
Avaglim : EPAR - All Authorised presentations SV = svenska 2007-04-12 2011-01-17
Avaglim : EPAR - All Authorised presentations SV = svenska 2007-04-12 2011-01-17
Avaglim : EPAR - All Authorised presentations SV = svenska 2007-04-12 2011-01-17
Avaglim : EPAR - All Authorised presentations SV = svenska 2007-04-12 2011-01-17
Avaglim : EPAR - All Authorised presentations SV = svenska 2007-04-12 2011-01-17
Avaglim : EPAR - All Authorised presentations SV = svenska 2007-04-12 2011-01-17
Avaglim : EPAR - All Authorised presentations SV = svenska 2007-04-12 2011-01-17
Avaglim : EPAR - All Authorised presentations SV = svenska 2007-04-12 2011-01-17
Avaglim : EPAR - All Authorised presentations SV = svenska 2007-04-12 2011-01-17
Avaglim : EPAR - All Authorised presentations SV = svenska 2007-04-12 2011-01-17
Avaglim : EPAR - All Authorised presentations SV = svenska 2007-04-12 2011-01-17
Avaglim : EPAR - All Authorised presentations SV = svenska 2007-04-12 2011-01-17
Avaglim : EPAR - All Authorised presentations SV = svenska 2007-04-12 2011-01-17
Avaglim : EPAR - All Authorised presentations SV = svenska 2007-04-12 2011-01-17
Avaglim : EPAR - All Authorised presentations SV = svenska 2007-04-12 2011-01-17
Avaglim : EPAR - All Authorised presentations SV = svenska 2007-04-12 2011-01-17
Avaglim : EPAR - All Authorised presentations SV = svenska 2007-04-12 2011-01-17
Avaglim : EPAR - All Authorised presentations SV = svenska 2007-04-12 2011-01-17
Avaglim : EPAR - All Authorised presentations SV = svenska 2007-04-12 2011-01-17

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

Initial marketing-authorisation documents

Name Language First published Last updated
Avaglim : EPAR - Procedural steps taken before authorisation SV = svenska 2006-10-20 2011-01-17
Avaglim : EPAR - Scientific Discussion SV = svenska 2006-10-20 2011-01-17

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Avaglim