Hazard - P - B - T - Risk Exempt
Assessment report for Keytruda (pembrolizumab), 31 January 2019, EMA/223846/2019.
"Pembrolizumab is a protein, which is expected to be metabolised in the body and biodegrade in the environment. Thus, according to the “Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use” (EMEA/CHMP/SWP/4447/00), pembrolizumab is exempt from the submission of an Environmental Risk Assessment as the product and excipients do not expect to pose a significant risk to the environment."
Fass environmental information
Fass environmental information for Keytruda from MSD (downloaded 2019-09-04).
The use of amino acids, proteins and peptides is not expected to have any environmental impact.
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). Keytruda (pembrolizumab), 31 January 2019, EMA/223846/2019.
- 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