Daklizumab
Sammanfattning
Fara - P - B - T - Risk Undantagen
Avregistrerat i Sverige och Europa. Uppgifterna om risk baseras på tidigare miljöinformation i utredningsrapport.
Utredningsrapport
Utredningsrapport för Zinbryta (daklizumab) 28 April 2016 EMA/458317/2016. Zinbryta är inte längre registrerat i Europa.
"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."
Författad vid avdelningen Kunskapsutveckling, Region Stockholm