Eptacog alfa
Summary
Risk. The use of amino acids, proteins, and peptides is not considered to have any environmental impact.
This summary information comes from fass.se. Corresponding information is also available in the assessment report.
Detailed information
Fass environmental information
Fass environmental information for eptacog alfa (NovoSeven) from Novo Nordisk (retrieved on 2025-06-27).
Risk
The use of amino acids, proteins and peptides is not considered 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.
Assessment report
Assessment report for NovoSeven, extension of indication variation 22 April 2022, EMA/CHMP/2055442022.
"According to the guideline “Guideline on the environmental risk assessment of medical products for human use”, an environmental risk assessment is not required for substances like amino acids, peptides, proteins, carbohydrates, and lipids since they are unlikely to result in significant risk to the environment. Therefore, no ERA is required for this extension of indication for NovoSeven."
Author: Health and Medical Care Administration, Region Stockholm