European Agency for the Evaluation of Medicinal Products: Committee for Proprietary Medicinal Products Meeting of 25 to 27 June 2002 No opinions on initial marketing authorisation applications were adopted at this meeting.
The CPMP finalised its Community-level review of sibutramine containing medicinal products (Reductil, Meridia, Reduxade, Sibutral and associated brand names). The re-assessment of the efficacy and safety of sibutramine was initiated following a request by Italy in March 2002. The Committee considers that the risk-benefit profile of sibutramine remains positive.
The CPMP will continue to keep the product under regular review, including the follow-up to the clinical trial previously requested by the Committee in November 2000.