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- Withdrawn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