Burosumab

Detaljerad information

Utredningsrapport Crysvita 2017

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."

Utredningsrapport Crysvita 2022

Utredningsrapport för Crysvita, "extension of indication", 23 June 2022, EMA/634749/2022.

"A signed ERA justification statement is included. There are no major updates to this compared with that already registered within the dossier. The only changes reflect the proposed additional indication. KRN23 (burosumab, red. anm.) is a human IgG monoclonal antibody and can reasonably be expected to be subject to the same degradative pathways and to have the same environmental impact as naturally occurring human antibodies, therefore due to their nature they are unlikely to result in a significant risk to the environment."