Assessment report for Zirabev (bevacizumab) 13 December 2018EMA/97237/2019.
Bevacizumab is a protein, which is expected to biodegrade in the environment and not be a significant risk to the environment. Thus, according to the “Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use” (EMEA/CHMP/SWP/4447/00), bevacizumab is exempt from preparation of an Environmental Risk Assessment as the product and excipients do not pose a significant risk to the environment.
Fass environmental information for Avastin (bevacizumab) from Roche (downloaded 2019-07-10).
The use of amino acids, proteins and peptides is not considered 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: The Pharmaceutical unit of Region Stockholm