Bextra

RSS

valdecoxib

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Bextra has not been renewed by the marketing authorisation holder and is now withdrawn.

This EPAR was last updated on 03/02/2010

Authorisation details

Product details
Name
Bextra
Agency product number
EMEA/H/C/000431
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
Publication details
Marketing-authorisation holder
Pharmacia - Pfizer EEIG
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
27/03/2003
Contact address
Pharmacia-Pfizer EEIG
Sandwich
Kent
CT13 9NJ
United Kingdom

Product information

03/02/2010 Bextra - EMEA/H/C/000431 -

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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).

How useful was this page?

Add your rating