The Committee for Proprietary Medicinal Products (CPMP) in the UK has issued a positive opinion for nimesulide (Aulin, Mesulide, Nimed and associated names) that this is a safe and effective non-steroidal anti-inflammatory drug (NSAID). This opinion is based on a 16-months-long evaluation of the safety and the efficacy data for nimesulide by the CPMP that reinforces a favourable benefit/risk profile to the drug. The drug will have a new Summary of Product Characteristics (SPC) harmon-ising available medical information from all the European countries where the drug is marketed. According to Helsinn Healthcare SA, manufacturer of nimesulide, the occurrence of hepatic reactions with nimesulide is similar to that of any other NSAID. The CPMP review of nimesulide was conducted after the Finnish National Agency for Medicine (NAM) decided to temporarily suspend the drug from the market in March 2002, in reaction to hepatic adverse effects reported in a number of patients treated with the drug (see WHO Pharmaceuticals Newsletter No.4, 2002).
EMEA’s July session monthly report, EMEA/CPMP/3754/03, 01 Aug 2003. Available from URL: http://www.emea.eu.int