1 Член 29 от Директива 2001/ 83/ ЕО, както е изменена, сезиране на основание на потенциална сериозна опасност за общественото здраве.
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Sabumalin outweigh its risks, and that therefore the marketing authorisation for Sabumalin should be granted in all concerned member states.