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Hazard - P - B - T - Risk Exempt

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 (downloaded 2019-07-10).

"Use of amino acids/peptides/proteins has been considered to result in insignificant environmental impact.

In the case of products containing vitamins, electrolytes, amino acids, peptides, proteins, carbohydrates and lipids as active pharmaceutical ingredient(s), an ERA should be provided. This ERA may consist of a justification for not submitting ERA studies, e.g. due to their nature they are unlikely to result in a significant risk to the environment. The same applies to vaccines and herbal medicinal products (European Medicines Agency guideline on Doc. Ref. EMEA/CHMP/SWP/4447/00 corr 2). It can be expected that any medicinal absorbed monoclonal antibody is completely metabolized and adsorbed in the body. Any medicinal product that reaches water streams via eventual spills during application or after disposal of unused drug is expected to be very rapidly degraded and mineralized to CO2 by microbial activity."

Author: Health and Medical Care Administration, Region Stockholm