Teriparatide
Summary
Hazard - P - B - T - Risk See below
Assessment report
Assessment report for Movymia (teriparatide) 10 November, 2016EMA/88527/2017.
"RGB-10, as teriparatide is the active substance, is a recombinant human peptide and therefore not expected to pose a risk to the environment.The Applicant provided an appropriate justification for not submitting an Environmental Risk Assessment, as postulated in the CHMP guideline on the environmental risk assessment of medicinal products for human use (EMEA/CHMP/SWP/4447/00)."
Fass environmental information
Fass environmental information for Forsteo (teriparatide) from Lilly (downloaded 2019-09-02).
Risk
The use of amino acids, proteins and peptides is not considered to have any environmental impact.
Detailed information
"Teriparatide is a 4117.8 dalton peptide with a 34-amino acid sequence. As a peptide, teraparatide will be metabolized by humans and degraded in the environment.
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, vaccines and herbal medicinal products are exempted because they are unlikely to result in significant risk to the environment.
Even though biomolecules, such as vaccines and hormones, are exempted they should still be regarded as biologically active."
References
- European Medicines Agency. European public assessment reports (EPAR). Movymia (teriparatide), 10 November 2016, EMA/88527/2017.
- 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.
- Fass för vårdpersonal.
Author: Health and Medical Care Administration, Region Stockholm