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Efmoroctocog alfa

Hazard - P - B - T - Risk Exempt

Information

Environmental information is missing on fass.se (2020-01-16). It is voluntary for manufacturers to provide information about environmental impact on fass.se.

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."

Author: Health and Medical Care Administration, Region Stockholm