Venvia

Withdrawn

This medicine's authorisation has been withdrawn

rosiglitazone

Overview

The marketing authorisation for Venvia has been withdrawn at the request of the marketing authorisation holder.

Product information

25/11/2004

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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).

Product details

• Name of medicine:
  Venvia
• 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 as oral monotherapy in type 2 diabetes mellitus patients, particularly overweight patients, inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance.

Rosiglitazone is also indicated for oral combination treatment in type 2 diabetes mellitus patients with insufficient glycaemic control despite maximal tolerated dose of oral monotherapy with either metformin or a sulphonylurea:

• in combination with metformin particularly in overweight patients.
• in combination with a sulphonylurea only in patients who show intolerance to metformin or for whom metformin is contraindicated.

Authorisation details

• EMA product number:
  EMEA/H/C/000270
• 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
• Revision:
  6