Venvia

Withdrawn

This medicine's authorisation has been withdrawn

rosiglitazone

Overview

On 11 July 2000, the European Commission granted a marketing authorisation for the whole European Union to SmithKline Beecham plc, for Venvia (rosiglitazone), 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.

Venvia was not marketed anywhere in the European Union. On 1 November 2004, the Marketing Authorisation Holder notified the European Commission of its decision to voluntarily withdraw the Marketing Authorisation for Venvia as there were no plans to market this product in the future. It should be noted that there is still one Community Marketing Authorisation valid throughout the European Union for rosiglitazone i.e., Avandia.

On 8 December 2004, the European Commission adopted the decision withdrawing the Marketing Authorisation for the medicinal product for human use "Venvia". Pursuant to this decision, the European Public Assessment Report for Venvia has been removed from this website.

Product information

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
• Withdrawal of marketing authorisation:
  08/12/2004
• Revision:
  6