Advice

The Marketing Authorisation for valdecoxib (Bextra) expired in March 2008.

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 (see http://www.emea.europa.eu/pdfs/human/press/pus/35823405en.pdf). 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.

Medicine details

Medicine name:
Valdecoxib (Bextra®)
SMC ID:
89/04
Indication:
Primary dysmenorrhoea
Pharmaceutical company
Pfizer Ltd
BNF chapter
Musculoskeletal and joint diseases
Submission type
Full
Status
Withdrawn
Date advice published:
11 July 2004