Avaglim

RSS

rosiglitazone / glimepiride

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Avaglim has been withdrawn for safety reasons following a decision by the European Commission.

This EPAR was last updated on 12/08/2011

Authorisation details

Product details
Name
Avaglim
Agency product number
EMEA/H/C/000675
Active substance
  • rosiglitazone
  • glimepiride
International non-proprietary name (INN) or common name
rosiglitazone / glimepiride
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BD04
Publication details
Marketing-authorisation holder
SmithKline Beecham Ltd
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
27/06/2006
Contact address
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom

Product information

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

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.

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

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