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 are available in the public assessment report (PAR/EPAR for centrally approved medicines). Environmental considerations are not included in the benefit-risk assessment for human medicines. If new data emerge after approval that necessitate an update of the environmental risk assessment, a variation application (“type IB C.I.z variation”) must be submitted to the regulatory authority.

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 (accessed on 2025-05-13).

The protein damoctocog alfa pegol is quickly metabolized in the human body and considered to be readily biodegradable in the environment. Risk or hazard in the environment is not expected.

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.

Generally, even though biomolecules are exempted from environmental risk classification it should be remembered that these molecules may be biologically active.