Romosozumab
Summary
Risk. The use of amino acids, proteins, and peptides is not considered to pose any environmental impact.
This summary information comes from fass.se and assessment report.
Detailed information
Assessment report
Assessment report for Evenity (romosozumab), 17 October 2019, EMA/26554/2020.
"Monoclonal antibodies such as romosozumab are most likely catabolized to individual amino acids and/or small peptides by endogenous proteases and high molecular weight prevents intact urinary excretion and as such, excretion of active drug is not expected. It is not expected to have an adverse effect on the environment. The Applicant has adequately justified the absence of studies to assess the environmental risk of romosozumab."
Fass environmental information
Fass environmental information for Evenity from UCB Nordic (retrieved on 2025-09-05).
According to the European Medicines Agency guideline on environmental risk assessments for pharmaceuticals (EMA/CHMP/SWP/4447/00), vitamins, electrolytes, amino acids, peptides, proteins, carbohydrates, lipids proteins, vaccines and herbal medicinal products are exempted because they are unlikely to result in significant risk to the environment.
Author: Health and Medical Care Administration, Region Stockholm