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Burosumab

Information

Hazard - P - B - T - Risk Exempt

This summary information comes from the assessment report.

Exempt.

Assessment report

Assessment report for 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."

Author: Health and Medical Care Administration, Region Stockholm