This medicine is now withdrawn from use in the European Union.


The marketing authorisation for Avandia 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
International non-proprietary name (INN) or common name
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 Avandia - EMEA/H/C/000268 - A20/0075

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Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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

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