Avandia

Expired

This medicine's authorisation has expired

rosiglitazone

Overview

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

Avandia : EPAR - Summary for the public

Product information

Avandia : EPAR - Product Information

Latest procedure affecting product information: A20/0075

03/12/2010

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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).

Avandia : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Avandia
• 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

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).

Authorisation details

• EMA product number:
  EMEA/H/C/000268
• Marketing authorisation holder:
  SmithKline Beecham Plc

  SmithKline Beecham plc; 980 Great West Road,; Brentford, Middlesex, TW8 9GS; United Kingdom

• Marketing authorisation issued:
  11/07/2000
• Expiry of marketing authorisation:
  11/07/2015
• Revision:
  23

Assessment history

Changes since initial authorisation of medicine

Avandia : EPAR - Procedural steps taken and scientific information after authorisation

Avandia-H-C-268-A20-75: EPAR - Assessment Report

AdoptedReference Number: EMA/831385/2010

Committee for medicinal products for human use post-authorisation summary of positive opinion for Avandia on 24 January 2008

Reference Number: EMEA/CHMP/42712/2008

Avandia-H-C-268-II-23 : EPAR - Scientific Discussion - Variation

Adopted

Avandia : EPAR - Steps taken after authorisation when a cutoff date has been used

Initial marketing authorisation documents

Avandia : EPAR - Procedural steps taken before authorisation

Avandia : EPAR - Scientific Discussion