Assessment report for Entyvio (vedolizumab) 20 March 2014, EMA/CHMP/676643/2013.
"Vedolizumab is a sequence of amino acids and a protein and in accordance with the CHMP guideline on the environmental risk assessment (EMEA/CHMP/SWP/4447/00) is exempted from testing because of the chemical structure."
Fass environmental information for Entyvio from Takeda Pharma (downloaded 2020-01-21).
The use of amino acids, proteins and peptides is not expected to have any environmental impact.
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