The scope of the referral was to address the safety and efficacy of cefuroxime axetil in uncomplicated gonorrhoea (cervicitis and urethritis) and to conclude on the risk-benefit balance for this sought indication The Summary of Products Characteristic, labelling and package leaflet proposed by the applicant has been assessed based on the documentation submitted and the scientific discussion within the Committee. the CHMP has recommended by consensus that the indication pertaining uncomplicated gonorrhoea (cervicitis and urethritis) should not be included in the product information.