Protamine sulfate
Summary
Risk. The use of amino acids, proteins and peptides is not expected to result in any environmental impact.
This summary information comes from fass.se.
Detailed information
Fass environmental information
Fass environmental information for Protaminsulfat LEO Pharma, solution for injection/infusion (retrieved on 2026-04-15).
According to the European Medicines Agency guideline on environmental risk assessment (EMA/CHMP/SWP/4447/00), vitamins, electrolytes, amino acids, peptides, proteins, carbohydrates, lipids, vaccines and herbal medicinal products are exempted because they are unlikely to pose any significant environmental risk. The active ingredient in Protaminsulfat LEO Pharma is protamine sulphate, consisting of basic peptides extracted from fish sperm or roe, typically from salmonid species. Only salmonid species are used for the drug substance manufactured by LEO Pharma. According to both the EU and Fass guidelines, peptides are exempted as they are not expected to result in environmental impact. Therefore, no environmental information is required.
References
Author: Health and Medical Care Administration, Region Stockholm