Hazard - P - B - T - Risk Exempt
Assessment report for RoActemra (tocilizumab), 20 September 2018EMA/742879/2018.
"Tocilizumab, the pharmaceutical active ingredient in RoActemra, is a recombinant humanised immunoglobulin IgG1 monoclonal antibody produced by recombinant DNA technology. Tocilizumab is a protein with a molecular mass of approximately 145 kDa and the Chemical Abstracts Services (CAS) number 375823–41–9. Being extensively degraded in the patient’s body by regular proteolytic mechanisms before excretion, like other monoclonal antibodies, tocilizumab is unlikely to result in a significant risk to the environment. Considering human metabolism, rapid biodegradability and acute ecotoxicological properties of tocilizumab, no exposure levels of concern to the environment are to be expected. Therefore, it is considered acceptable that no formal ERA according to the EMA 2006 Guideline (corr. 2) is needed for tocilizumab."
Fass environmental information
Fass environmental information for RoActemra (tocilizumab) from Roche (downloaded 2019-09-02).
The use of amino acids, proteins and peptides is not considered 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.
- European Medicines Agency. European public assessment reports (EPAR). RoActemra (tocilizumab), 20 September 2018, EMA/742879/2018.
- 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