CVMP започва процедура по отнасяне съгласно член 33( 4) на Директива 2001/ 82/ ЕО, както е изменена, за Enurace 50.
The Marketing Authorisation Holder should provide all supporting data (preclinical and clinical documentation, including the expert reports, efficacy and tolerance studies conducted), to justify a positive benefit-risk ratio for the treated animal.