Hazard - P - B - T - Risk See below
Assessment report for Cimzia (certolizumab pegol) 19 November 2015 EMA/CHMP/825080/2015.
"Certolizumab pegol is a recombinant, humanized antibody Fab' fragment against tumour necrosis factor alpha (TNFα), conjugated to polyethylene glycol (PEG) and in accordance with the CHMP guideline on the environmental risk assessment (EMEA/CHMP/SWP/4447/00) is exempted from testing because of its chemical structure."
Assessment report for Cimzia 26 April 2018 EMA/502221/2018.
"An increase in environmental exposure is generally expected when a new indication is added and the patient population is increased and this potential impact should be evaluated by the applicant. The applicant has submitted an acceptable justification for not conducting further environmental risk assessment. Due to the nature of certolizumab pegol (polypeptide) and according to the current Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use (EMEA/CHMP/SWP/4447/00 corr 2), products containing peptides are unlikely to result in significant risk to the environment."
Fass environmental information
Fass environmental information for Cimzia from UCB Nordic (dowloaded 2020-05-05).
The use of amino acids, proteins and peptides is not expected to have any environmental impact.
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.
However, even though biomolecules, such as vaccines and hormones, are exempted they should still be
regarded as biologically active.
- European Medicines Agency. European public assessment report (EPAR). Cimzia (certolizumab pegol) 19 November 2015 EMA/CHMP/825080/2015.
- European Medicines Agency. European public assessment report (EPAR). Cimzia ( certolizumab pegol) 26 April 2018 EMA/502221/2018.
- 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