Canakinumab

Detailed information

Assessment report

Assessment report for Ilaris (canakinumab), 15 December 2016 EMA/26517/2017.

"As a protein, canakinumab is not expected to pose a risk to the environment.

According to Directive 2001/83/EC and Guideline EMEA/CHMP/SWP/4447/00 corr2, medicinal products consisting of substances occurring naturally in the environment, such as electrolytes, vitamins, proteins etc. do not need to be accompanied by an environmental risk assessment because they are unlikely to result in significant risk to the environment."

Fass environmental information

Fass environmental information for Ilaris from Novartis (retrieved on 2026-07-06).

"Use of amino acids/peptides/proteins has been considered to result in insignificant 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, vaccines and herbal medicinal products are exempted because they are unlikely to result in significant risk to the environment.
It is expected that any administered monoclonal antibody is completely metabolized and absorbed in the body. Any medicinal product that reaches water streams via spills during an application or after disposal of the unused drug, is expected to be very rapidly degraded and mineralized to CO₂ by microbial activity."