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Aflibercept

Hazard - P - B - T - Risk See below

Information

Assessment report

Assessment report for Eylea (aflibercept) 24 September 2015 EMA/758988/2015.

In line with the Guideline on the environmental risk assessment of medicinal products for human use (CHMP/SWP/4447/00 corr 1), since aflibercept is a protein and unlikely to result in a significant risk to the environment, Eylea is exempted from an environmental risk assessment.

Fass environmental information

Fass environmental information for Eylea from Bayer (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.

Fass environmental information for Zaltrap (aflibercept) from Sanofi AB (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, vaccines and herbal medicinal products are exempted because they are unlikely to result in significant risk to the environment. However, even though biomolecules, such as vaccines and hormones, are exempted they should still be regarded as biologically active.

Author: The Pharmaceutical unit of Region Stockholm