Valdyn

Withdrawn

This medicine's authorisation has been withdrawn

valdecoxib

Overview

On 27 March 2003, the European Commission granted a marketing authorisation for the whole European Union to Pharmacia Europe EEIG, for Valdyn (valdecoxib), indicated for symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis and the treatment of primary dysmenorrhoea.

Valdyn was not marketed anywhere in the European Union. On 23 January 2004, the Marketing Authorisation Holder notified the European Commission of its decision to voluntarily withdraw the Marketing Authorisation for Valdyn as there are no plans to market this product in the future. It should be noted that there are still two Community Marketing Authorisations valid throughout the European Union for medicinal products containing valdecoxib, i.e., Bextra and Kudeq.

On 2 March 2004, the European Commission adopted the decision withdrawing the Marketing Authorisation for the medicinal product for human use Valdyn. Pursuant to this decision, the European Public Assessment Report for Valdyn has been removed from this website.

Product information

Product details

• Name of medicine:
  Valdyn
• Active substance:
  valdecoxib
• International non-proprietary name (INN) or common name:
  valdecoxib
• Therapeutic area (MeSH):
  • Osteoarthritis
  • Arthritis, Rheumatoid
  • 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/000432
• Marketing authorisation holder:
  Pharmacia Europe EEIG

  Hillbottom Road; High Wycombe; Buckinghamshire; HP12 4PX; United Kingdom

• Marketing authorisation issued:
  27/03/2003
• Withdrawal of marketing authorisation:
  02/03/2004