Vedolizumab

Assessment report

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

Fass environmental information for Entyvio from Takeda Pharma (downloaded 2020-01-21).

Risk

The use of amino acids, proteins and peptides is not expected to have any environmental impact.

Detailed information

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.