Hazard - P - B - T - Risk Exempt
This summary information comes from the assessment report for VeraSeal (fibrinogen, thrombin) and Fass environmental information for various drugs with fibrinogen.
Assessment report for VeraSeal 14 September 2017, EMA/734511/2017.
"The active substance is a natural substance, the use of which will not alter the concentration or distribution of the substance in the environment. Therefore, Fibrinogen and Thrombin are not expected to pose a risk to the environment in accordance with the Guideline on environmental risk assessment of medicinal products for human use (EMEA/CHMP/SWP/4447/00)."
Fass environmental information
Fass environmental information for fibrinogen (Fibryga, Riastap and Tachosil) from Octapharma, CSL Behring and Takeda Pharma respectively.
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 report (EPAR). VeraSeal 14 September 2017, EMA/734511/2017.
- 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