The marketing authorisation for Bextra has not been renewed by the marketing authorisation holder and is now withdrawn.
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Pharmacia - Pfizer EEIG
|Date of issue of marketing authorisation valid throughout the European Union||
03/02/2010 Bextra - EMEA/H/C/000431 -
- 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
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Antiinflammatory and antirheumatic products
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).