Efmoroctocog alfa

Detailed information

Assessment report

Assessment report for Elocta (efmoroctocog alfa) 24 September 2015, EMA/671791/2015.

"The active substance of ELOCTA, efmoroctocog alfa, is a recombinant human coagulation factor VIII, Fc fusion protein (rFVIIIFc) comprising B-domain deleted (BDD) human FVIII covalently linked to the Fc domain of human immunoglobulin G1(IgG1). It has been developed as a long-acting version of recombinant FVIII (rFVIII). [...] 

No environmental risk assessment was submitted. [...] According to the “Guideline on the environmental risk assessment of medical products for human use” substances like amino acids, peptides, proteins, carbohydrates and lipids are exempted from the guideline since they are unlikely to result in significant risk to the environment; Elocta is thereby exempted and an environmental risk assessment is not required."

Fass environmental information

Fass environmental information for Elocta from Sobi (downloaded 2022-11-29).

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.