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Eculizumab

Information

Hazard - P - B - T - Risk Exempt

This summary information comes scientific discussion/assessment report and Fass environmental information for Soliris (eculizumab).

Risk. Exempt.

Assessment reports

"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).

Risk

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