Miljöpåverkan
Korifollitropin alfa
Miljörisk:
Användning av aminosyror, proteiner och peptider bedöms inte medföra någon miljöpåverkan.
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Detaljerad miljöinformation
Corifollitropin alpha is glycoprotein produced by recombinant DNA technology which contains a primary amino acid sequence which is identical to that of natural human FSH. (Ref III). Use of amino acids/peptides/proteins has been considered to result in insignificant environmental impact. Even though biomolecules are exempted from environmental risk classification it should be remembered that these molecules may be biologically active. (Ref II)
According to the European Medicines Agency guideline on environmental risk assessments for pharmaceuticals (EMA/CMP/SWP/4447/00), vitamins, electrolytes, amino acids, peptides, proteins, carbohydrates, lipids, vaccines and herbal medicinal products are exempted because they are unlikely to result in significant risk to the environment (Ref. I).
References
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ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment. http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm
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Environmental classification of pharmaceuticals at www.fass.se: Guidance for pharmaceutical companies. 2012. https://www.fass.se/pdf/Environmental_classification_of_pharmaceuticals-120816.pdf
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Drug bank online: Corifollitropin alfa: Uses, Interactions, Mechanism of Action | DrugBank Online