Valdyn (previously Kudeq)

Withdrawn

This medicine's authorisation has been withdrawn

valdecoxib

Overview

On 24 June 2005 the European Commission adopted the decision withdrawing the Marketing Authorisation for the medicinal product for human use Valdyn. This followed the notification by the Marketing Authorisation Holder (Pharmacia Europe EEIG) on 21 June 2005 to voluntarily withdraw the Marketing Authorisation for Valdyn as there are no plans to market this product in the future. 

Valdyn (valdecoxib) was indicated in the treatment of symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis and the treatment of primary dysmenorrhoea. It should be noted that there is still one Community Marketing Authorisation valid but suspended throughout the European Union for medicinal products containing valdecoxib, i.e. Bextra. 

As a consequence to this decision the European Public Assessment Report for Valdyn has been removed from this website.

Product information

Product details

• Name of medicine:
  Valdyn (previously Kudeq)
• Active substance:
  valdecoxib
• International non-proprietary name (INN) or common name:
  valdecoxib
• Therapeutic area (MeSH):
  • Arthritis, Rheumatoid
  • Osteoarthritis
  • Dysmenorrhea
• Anatomical therapeutic chemical (ATC) code:
  M01AH03

Pharmacotherapeutic group

Antiinflammatory and antirheumatic products

Therapeutic indication

Symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis.
Treatment of primary dysmenorrhoea.

Authorisation details

• EMA product number:
  EMEA/H/C/000437
• Marketing authorisation holder:
  Pfizer Limited

  Ramsgate Road; Sandwich; Kent; CT13 9NJ; United Kingdom

• Marketing authorisation issued:
  27/03/2003
• Withdrawal of marketing authorisation:
  25/06/2005