Hazard - P - B - T - Risk Exempt
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).
The use of amino acids, proteins and peptides is not expected to have any environmental impact.
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.
- 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