Bextra

Withdrawn

This medicine's authorisation has been withdrawn

valdecoxib

Overview

The marketing authorisation for Bextra has not been renewed by the marketing authorisation holder and is now withdrawn.

Product information

03/02/2010

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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:
  Bextra
• 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.

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).

Authorisation details

• EMA product number:
  EMEA/H/C/000431
• Marketing authorisation holder:
  Pharmacia - Pfizer EEIG

  Pharmacia-Pfizer EEIG; Sandwich; Kent; CT13 9NJ; United Kingdom

• Marketing authorisation issued:
  27/03/2003
• Revision:
  2