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Certolizumab pegol

Summary

Risk. Use of amino acids, proteins and peptides is not considered to cause any environmental impact. In Fass also: However, even though biomolecules, such as vaccines and hormones, are exempted they should still be regarded as biologically active.

 

This summary information comes from Fass and corresponding information can be found in assessment reports.

Detailed information

Assessment reports 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."

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 2024-10-23).

Risk

The use of amino acids, proteins and peptides is not expected to have any environmental impact.

Detailed information

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.

Author: Health and Medical Care Administration, Region Stockholm