Epoetin zeta

EPAR – scientific discussion

Scientific discussion for Retacrit (epoetin zeta) 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.

Even though biomolecules, such as vaccines and hormones, are exempted they should still be regarded as biologically active.