Hazard - P - B - T - Risk Exempt
Assessment report for Orencia (abatacept), 31 January 2019, EMA/126226/2019.
"BMS-188667 (abatacept) is a protein composed of natural amino acids. Proteins are expected to biodegrade in the environment and not be a significant risk to the environment. As a protein, BMS-188667 is exempt from preparation of an Environmental Risk Assessment under the 1 June 2006 “Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use” (EMEA/CHMP/ SWP/4447/00). In conclusion, BMS-188667 and the product excipients do not pose a significant risk to the environment."
Fass environmental information
Fass environmental information for Orencia from Bristol-Myers Squibb (downloaded 2019-09-02).
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). Orencia (abatacept), 31 January 2019, EMA/126226/2019.
- 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