Bextra
Withdrawn
This medicine's authorisation has been withdrawn
valdecoxib
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 27 March 2003 the European Commission granted a marketing authorisation for the whole European Union to Pharmacia – Pfizer EEIG for Bextra (valdecoxib).
Bextra (valdecoxib) is a non-steroidal anti-inflammatory drug (NSAID) with Cox-2 selectivity. In the context of the review of Cox-2 inhibitors, the European Commission issued a decision for suspension of the marketing authorisation of Bextra in October 2005. Bextra has not been marketed in Europe since 2005. The Marketing Authorisation Holder did not apply to renew the marketing authorisation. Consequently, the five-year marketing authorisation for Bextra expired on 27 March 2008.
Product information
03/02/2010
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
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 productsTherapeutic 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).
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