Medicinal products containing daclizumab are no longer authorised in the European union. The data on risk is based on previous environmental information in assessment report.
Assessment report for Zinbryta (daclizumab) 28 April 2016 EMA/458317/2016. Zinbryta is no longer authorised in the European union.
"According to the Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use (EMEA/CHMP/SWP/4447/00 corr 21*), the environmental risk assessment for proteins may consist of a justification for not submitting ERA studies as they are unlikely to result in significant risk to the environment. The active substance daclizumab is a monoclonal antibody and, therefore, is not expected to pose a risk to the environment."
Author: Health and Medical Care Administration, Region Stockholm