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Hazard - P - B - T - Risk Exempt

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).


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.

Author: Health and Medical Care Administration, Region Stockholm