Infliximab
Summary
Risk. Use of amino acids, proteins and peptides is not considered to cause any environmental impact.
This summary information comes from Fass and corresponding information can be found in assessment reports. In the environmental information from MSD: "Even though biomolecules are exempted from environmental risk classification it should be remembered that these molecules may be biologically active."
Detailed information
Assessment report
There are assessment reports for different medicinal products with infliximab, e.g., for Zessly (infliximab) 22 March 2018, EMA/223369/2018.
"The active substance is a natural substance, a protein and therefore unlikely to pose a significant risk to the environment. This is in accordance with the CHMP Guideline on the environmental risk assessment of medicinal products for human use (EMEA/CHMP/SWP/4447/00 corr 2)."
Fass environmental information
There is environmental information about infliximab from Pfizer (Inflectra), MSD (Remicade) och Orion Pharma (Remsima), downloaded 2023-10-24.
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.
MSD
"Even though biomolecules are exempted from environmental risk classification it should be remembered that these molecules may be biologically active."
References
- European Medicines Agency. European public assessment reports (EPAR). Zessly (infliximab), 22 March 2018, EMA/223369/2018.
- 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