rosiglitazone / metformin

This medicine is now withdrawn from use in the European Union.


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

This EPAR was last updated on 08/06/2016

Authorisation details

Product details
Agency product number
Active substance
  • rosiglitazone
  • metformin hydrochloride
International non-proprietary name (INN) or common name
  • rosiglitazone
  • metformin
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
SmithKline Beecham Plc
Date of issue of marketing authorisation valid throughout the European Union
Contact address
SmithKline Beecham plc
980 Great West Road,
Brentford, Middlesex, TW8 9GS
United Kingdom

Product information

03/12/2010 Avandamet - EMEA/H/C/000522 - A20/0063


  • 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

AVANDAMET is indicated in the treatment of type 2 diabetes mellitus patients, particularly overweight patients:

  • who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.
  • in triple oral therapy with sulphonylurea in patients with insufficient glycaemic control despite dual oral therapy with their maximally tolerated dose of metformin and a sulphonylurea (see section 4.4).

Assessment history

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