Avandamet

Withdrawn

This medicine's authorisation has been withdrawn

rosiglitazone / metformin

Overview

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

Avandamet : EPAR - Summary for the public

Product information

Avandamet : EPAR - Product Information

Latest procedure affecting product information: A20/0063

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).

Avandamet : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Avandamet
• 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:
  A10BD03

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).

Authorisation details

• EMA product number:
  EMEA/H/C/000522
• Marketing authorisation holder:
  SmithKline Beecham Plc

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

• Marketing authorisation issued:
  20/10/2003
• Revision:
  16

Assessment history

Changes since initial authorisation of medicine

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

Avandamet-H-C-522-A20-0063: EPAR - Assessment Report

Adopted

CHMP post-authorisation summary of positive opinion for Avandamet on 24 January 2008

AdoptedReference Number: EMEA/CHMP/42782/2008

Avandamet-H-C-522-II-17 : EPAR - Scientific Discussion - Variation

Adopted

Initial marketing authorisation documents

Avandamet : EPAR - Procedural steps taken before authorisation

Avandamet : EPAR - Scientific Discussion