Hazard - P - B - T - Risk Exempt
This summary information comes scientific discussion/assessment report and Fass environmental information for Soliris (eculizumab).
"Scientific discussion" for Soliris, EMEA 2007
"The main route of release will be in waste water, and the PECSURFACE/WATER for eculizumab is below the threshold for Phase I assessment, according to the Guideline EMEA/CHMP/SWP/4447/00."
Assessment report Soliris 25 July 2019, EMA/CHMP/400124/2019
"The scope and legal basis of the CHMP guideline on the Environmental Risk Assessment of Medicinal Products for Human Use (EMEA/CHMP/SWP/4447/00) with effective date of December 2006, states that vitamins, electrolytes, amino acids, peptides, proteins, carbohydrates and lipids are exempted of environmental risk assessment because, due to their nature they are unlikely to result in significant risk to the environment. No new clinical data have been submitted in this application, which was considered acceptable by the CHMP. As eculizumab is a protein, no Environmental Risk Assessment is needed for this type II variation."
Fass environmental information
Fass environmental information for Soliris from Alexion Pharma (downloaded 2020-08-11).
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.
- Scientific discussion Soliris (eculizumab). EMEA 2007.
- 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.
- European Medicines Agency. European public assessment report (EPAR). Soliris (eculizumab) 25 July 2019, EMA/CHMP/400124/2019.
- Fass för vårdpersonal.
Author: Health and Medical Care Administration, Region Stockholm