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Filgrastim

Hazard - P - B - T - Risk Exempt

Information

Assessment report

There are several assessment reports for filgrastim with similar information. Two references are given below.

Assessment report for Ratiograstim

Assessment report for Ratiograstim (filgrastim) EMEA/502481/2008.

"The lack of an environmental risk assessment for XM02 is justified by three reasons:

According to EMEA guideline CHMP/SWP/4447/00 proteins in general are unlikely to result in significant risk to the environment.

XM02 (filgrastim ed. note) active substance is a recombinant protein, which is very similar to naturally occurring human G-CSF. Therefore no potentially harmful effects to the environment are expected.

XM02 is a biosimilar product of existing G-CSF. It is intended to substitute for other identical products on the market. The approval of XM02 should not result in an increase of the total quantity released into the environment."

Assessment report for Accofil

Utredningsrapport för Accofil (filgrastim) 24 July 2014 EMA/CHMP/603430/2014.

"Apo-Filgrastim (filgrastim ed. note) is intended to substitute other identical products on the market, so this product is not expected to cause any additional environmental risk. Therefore no environmental risk assessment report is required for this product."

Fass environmental information for Neupogen

Fass environmental information for Neupogen (filgrastim) from Amgen (downloaded 2020-04-07).

Risk

The use of amino acids, proteins and peptides is not expected 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.

Fass environmental information for Zarzio

Fass environmental information for Zarzio (filgrastim) from Sandoz AS (downloaded 2020-04-07).

Risk

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

Detailedinformation

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.

"Filgrastim is a recombinant, non-pegylated human granulocyte colony stimulating factor (G-CSF) analogue manufactured by recombinant DNA technology. It is a protein consisting of 175 amino acids. As filgastrim is very similar to a naturally occurring protein, it is expected to be degradable in aqueous environments and is generally considered as having low potential for toxicity in aquatic organisms."

Author: Health and Medical Care Administration, Region Stockholm