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Fara - P - B - T - Risk Undantagen

Denna sammanfattande information kommer från utredningsrapporten.



Utredningsrapport för Crysvita (burosumab) 14 December 2017 EMA/148319/2018.

"According to the Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use (EMEA/CHMP/SWP/4447/00 corr 2), 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. As the active substance burosumab is a monoclonal antibody, it is not expected to pose a risk to the environment."

Författad vid avdelningen Kunskapsutveckling, Region Stockholm