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Hazard - P - B - T - Risk Exempt

Assessment report

There are assessment reports for several pharmaceuticals. Assessment report for Grasustek (pegfilgrastim) 26 April 2019, EMA/CHMP/323149/2019, is the latest (search EMA's website 2019-08-21).

"Based on the CHMP Guideline on the environmental risk assessment of medicinal products for human use (CHMP/SWP/4447/00 corr. 2) which states that proteins are exempted from the need to submit studies because they are unlikely to result in a significant risk to the environment due to their nature, the applicant submitted a justification for not submitting an environmental risk assessment. Pegfilgrastim is already used in existing marketed products and no significant increase in environmental exposure is anticipated."

Fass environmental information

Fass environmental information for Amgen (Pegfilgrastim) from Amgen (downloaded 2019-08-21).

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

Detailed information

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: Health and Medical Care Administration, Region Stockholm