On 25 September 1996 Germany, related to the concerns about the risk of patients using chlormezanone developing serious skin adverse reactions, requested that the CPMP, under Article 12 of Council Directive 75/ 319/ EEC as amended, provide an opinion on whether there is an unfavourable benefit/ risk relation for chlormezanone in the indication where it is most widely used in the EU, that is lower back pain with muscle contracture.