Further to discussions at the CHMP October 2004 plenary meeting, the European Commission recommended that this public health issue on all aspects of cardiovascular safety including thrombotic events and cardio-renal events is the subject of Community referrals under Article 31 of Directive 2001/ 83/ EC, as amended regarding decentrally authorised products containing celecoxib, etoricoxib and lumiracoxib and subject to a review procedure under Article 18 of Council Regulation (EEC) No 2309/ 93, as amended regarding the centrally authorised products containing celecoxib (Onsenal), parecoxib (Dynastat/ Rayzon) and valdecoxib (Bextra/ Valdyn), which were started in November 2004.
2309/ 93 del Consiglio e successive modifiche in merito ai prodotti contenenti celecoxib (Onsenal), parecoxib (Dynastat/ Rayzon) e valdecoxib (Bextra/ Valdyn) autorizzati con procedura centralizzata, deferimenti che sono stati avviati nel novembre 2004.