Hazard - P - B - T - Risk Exempt
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.
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.
- European Medicines Agency. European public assessment reports (EPAR). Vectibix (panitumumab) 26 February 2015, EMA/CHMP/113600/2015 - adopted.
- Fass för vårdpersonal.
- European Medicines Agency, EMA: Committee for Medicinal Products for Human Use (CHMP). Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use. 1 June 2006.
Author: Health and Medical Care Administration, Region Stockholm