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Fass environmental information

Fass environmental information for Simulect (basiliximab) from Novartis (downloaded 2019-07-10).

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

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