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Hazard - P - B - T - Risk Exempt

Assessment report

Assessment report for Vectibix (panitumumab) 26 February 2015, EMA/CHMP/113600/2015 - adopted.

"Since the pharmacologically active substance in Vectibix, panitumumab, is a monoclonal antibody, a sequence of amino acids and a protein, it is exempted from the requirement of providing an ERA as in accordance with the Guideline on the Environmental Risk Assessment (ERA) of Medicinal Products for Human Use (CHMP/SWP/4447/00), it is unlikely to result in significant risk to the environment."

Fass environmental information

Fass environmental information for Vectibix från 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