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Damoctocog alfa pegol

Information

This summary information comes from the assessment report and Fass.

Risk. The use of amino acids, proteins and peptides is not considered to have any environmental impact.

Detailed information

Assessment report

Assessment report for Jivi (damoctocog alfa pegol) 20 September 2018, EMA/698571/2018.

"Jivi is a recombinant replacement protein of the naturally occurring coagulation factor VIII. It is catabolised during human metabolism and no active molecule is excreted by the patient. In accordance with the guideline CHMP/SWP/4447/00 (1). Jivi as a protein is exempted from an environmental risk assessment since proteins are unlikely to result in a significant risk to the environment."

Fass environmental information

Fass environmental information for Jivi from Bayer (downloaded 2021-01-18).

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.

Author: Health and Medical Care Administration, Region Stockholm