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