Nivolumab
Summary
Risk. The use of amino acids, proteins and peptides is not expected to have any environmental impact.
This summary information comes from assessment report and fass.se.
Detailed information
Assessment report
Assessment report for OPDIVO (nivolumab), 28 June 2018, EMA/665778/2018.
"The applicant has provided a justification for not performing an environmental risk assessment. As nivolumab is a protein composed of natural amino acids, proteins are expected to biodegrade in the environment and not pose a significant risk. Therefore, nivolumab is exempt from preparation of an Environmental Risk Assessment as per the “Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use” (EMEA/CHMP/SWP/4447/00)."
Fass environmental information
Fass environmental information for OPDIVO from Bristol-Myers Squibb (downloaded 2019-09-04).
Risk
The use of amino acids, proteins and peptides is not expected to have any environmental impact.
Detailed information
Nivolumab is a human monoclonal antibody.
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.
References
- European Medicines Agency. European public assessment reports (EPAR). OPDIVO (nivolumab), 28 June 2018, EMA/665778/2018.
- European Medicines Agency, EMA: Committee for Medicinal Products for Human Use (CHMP). Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use. 1 June 2006.
- Fass för vårdpersonal.
Author: Health and Medical Care Administration, Region Stockholm