Overview
The marketing authorisation for Bextra has not been renewed by the marketing authorisation holder and is now withdrawn.
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) |
|
| 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 -
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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).