Epoetin zeta
Summary
Risk. The use of amino acids, proteins, and peptides is not considered to have any environmental impact. Although biomolecules are exempt from environmental risk classification, it should be taken into account that these molecules may be biologically active.
This summary information comes from fass.se.
Detailed information
EMA's scientific discussion
EMA's scientific discussion for Retacrit (epoetin zeta) 15/01/2008. The same is written in EMA's scientific discussion for Silapo (epoetin zeta) dated 15/01/2008.
"The applicant claimed that because the product does not contain any novel components, and contains a protein that is similar to the endogenous human protein and to that contained in an existing medicinal product, availability of the product will not pose any identifiable extra risk to the environment. The applicant also claimed that CHMP guidance specifically exempts proteins from such assessment, as they are unlikely to result in significant risk to the environment."
Fass environmental information
Fass environmental information for Retacrit from Pfizer (downloaded 2019-07-09).
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.
Although biomolecules are exempt from environmental risk classification, it should be taken into account that these molecules may be biologically active.
Author: Health and Medical Care Administration, Region Stockholm