english.prescrire.org > Spotlight > Archives : 2011 > In the November issue of Prescrire International: marketing authorisation for Onsenal° (celecoxib) withdrawn in EU

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In the November issue of Prescrire International:
marketing authorisation for Onsenal° (celecoxib) withdrawn in EU

FREE DOWNLOADAuthorisation was withdrawn after the company  failed to supply required data. This example is representative of the drawbacks of the insufficiently demanding marketing authorisation procedure. Also featured on this page: the INN common stem "- conazole".
Full text available for free download.

Marketing authorisation for celecoxib withdrawn in EU (Summary)

  • In late March 2011, European marketing authorisation for Onsenal° (celecoxib; Pfizer) was withdrawn at the company’s request.
     
  • This nonsteroidal anti-inflammatory drug, a “selective” cox-2 inhibitor, was authorised in the European Union for “the reduction of the number of adenomatous intestinal polyps in familial adenomatous polyposis”, despite a negative harm-benefit balance.
     
  • Marketing authorisation had been granted in 2003 under “exceptional circumstances”,  with the company obligated to continue the assessment in order “to provide further data".
     
  • In early 2011, the company had still not provided these data, and asked that marketing authorisation be withdrawn.
     
  • This is an example representative of the failings of current EU health policies.

Common stem "-conazole" (Summary)

  • The International Nonproprietary Name, or INN, is a drug's real name.
     
  • The common stem "-conazole" is used at the end of the INNs of antifungal drugs derived from miconazole. 

Full text available for free download.

 ©Prescrire 1 November 2011

"Onsenal°: marketing authorisation withdrawn in the European Union" + "Common stem
-conazole" Prescrire Int 2011; 20 (121) : 263. (Pdf, free)

 
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