🇪🇺 Valecoxib in European Union

EMA authorised Valecoxib on 27 March 2003

Marketing authorisations

EMA — authorised 27 March 2003

  • Application: EMEA/H/C/000431
  • Marketing authorisation holder: Pharmacia - Pfizer EEIG
  • Local brand name: Bextra
  • Indication: Symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis.Treatment of primary dysmenorrhoea. The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risk (see sections 4.3, 4.4).
  • Status: withdrawn

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EMA — authorised 27 March 2003

  • Application: EMEA/H/C/000432
  • Marketing authorisation holder: Pharmacia Europe EEIG
  • Local brand name: Valdyn
  • Indication: Symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis.Treatment of primary dysmenorrhoea.
  • Status: withdrawn

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EMA — authorised 27 March 2003

  • Application: EMEA/H/C/000437
  • Marketing authorisation holder: Pfizer Limited
  • Local brand name: Valdyn (previously Kudeq)
  • Indication: Symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis.Treatment of primary dysmenorrhoea.
  • Status: withdrawn

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Valecoxib in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Immunology approved in European Union

Frequently asked questions

Is Valecoxib approved in European Union?

Yes. EMA authorised it on 27 March 2003; EMA authorised it on 27 March 2003; EMA authorised it on 27 March 2003.

Who is the marketing authorisation holder for Valecoxib in European Union?

Pharmacia - Pfizer EEIG holds the EU marketing authorisation.