Avandia

RSS

rosiglitazone

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

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
Name
Avandia
Agency product number
EMEA/H/C/000268
Active substance
rosiglitazone
International non-proprietary name (INN) or common name
rosiglitazone
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BG02
Publication details
Marketing-authorisation holder
SmithKline Beecham Plc
Revision
23
Date of issue of marketing authorisation valid throughout the European Union
11/07/2000
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

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

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

How useful was this page?

Add your rating