Hazard - P - B - T - Risk exempt
Assessment report for NovoEight (turoctocog alfa) 19 September 2013, EMA/612026/2013.
"Turoctocog alfa is a recombinant human coagulation factor VIII and once activated by thrombin cleavage the resulting rFVIIIa has the same structure as endogenous FVIIIa. According to the European Medicines Agency Guideline “Guideline on the environmental risk assessment of medicinal products for human use”, an environmental risk assessment is not required for proteins."
Fass environmental information for NovoEight from Novo Nordisk (downloaded 2020-01-16).
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.
"Turoctocog alfa is a polypeptide and thereby exempted from the guideline. Consequently, an environmental risk assessment of the drug is not required."
Author: Health and Medical Care Administration, Region Stockholm