Hazard - P - B - T - Risk Exempt
Assessment report for Sylvant (siltuximab), 20 March 2014, EMA/CHMP/258608/2014.
"No environmental risk assessment was submitted. In accordance with the Guideline on the environmental risk assessment (ERA) of medicinal products for human use [EMEA/CHMP/SWP/4447/00], peptides and proteins are excluded from the need for an environmental risk assessment. Therefore, an ERA for siltuximab is not required."
Fass environmental information
Fass environmental information for Sylvant from Janssen (downloaded 2019-09-04).
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.
- European Medicines Agency. European public assessment reports (EPAR). SYLVANT (siltuximab), 20 March 2014, EMA/CHMP/258608/2014.
- 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