Infliximab
Summary
Hazard - P - B - T - Risk Exempt
Assessment report
There are assessment reports for different medicinal products with infliximab. The latest information is 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 2019-09-03.
Risk
The use of amino acids, proteins and peptides is not expected to have any environmental impact.
Detailed information from MSD and Orion Pharma
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.
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