Miljöpåverkan
Interferon beta-1b
Miljörisk:
Användning av aminosyror, proteiner och peptider bedöms inte medföra någon miljöpåverkan.
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Detaljerad miljöinformation
Detailed background information
According to the European Medicines Agency (EMA) guideline for Environmental Risk Assessment of pharmaceuticals (EMEA/CHMP/SWP/4447/00 corr 2), an ERA consisting of a justification for not submitting ERA studies is sufficient for certain active pharmaceutical ingredients:
“In the case of products containing vitamins, electrolytes, amino acids, peptides, proteins, carbohydrates and lipids as active pharmaceutical ingredient(s), an ERA should be provided. This ERA may consist of a justification for not submitting ERA studies, e.g. due to their nature they are unlikely to result in a significant risk to the environment. The same applies to vaccines and herbal medicinal products.”
Interferon beta is a glycoprotein belonging to the family of interferons. Interferons are naturally occurring messenger substances. Interferon beta for medical use is produced biotechnologically. Interferon beta is not considered stable under environmental conditions and is generally considered as having low potential for toxicity in aquatic organisms.
References
EMEA/CHMP/SWP/4447/00 corr 2. Guideline on the environmental risk assessment of medicinal products for human use. London, 01 June 2006.