Damoctocog alfa pegol

Detailed information

General information about assessment reports

Since 2006, an Environmental Risk Assessment (ERA) for the active pharmaceutical substance shall accompany an application for a marketing authorisation in EU for a medicinal product for human use. Parts of environmental data can be found in the public investigation report (PAR/EPAR for medicinal product through a centralized procedure). Since the benefit/risk assessment for human medicinal products at present does not include environmental effects, an update of the environmental risk assessment is not required for renewals of marketing authorizations. There is thus no requirement for companies to stay informed about the development of their substances from an environmental point of view and consequently to update the environmental risk assessment as new data are published.

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.