Fondaparinux
Summary
Persistence. It cannot be excluded that fondaparinux is persistent, due to the lack of data.
Bioaccumulation. It cannot be excluded that fondaparinux bioaccumulates, due to the lack of data.
Toxicity. It cannot be excluded that fondaparinux is toxic, due to the lack of data.
Risk. It is stated that fondaparinux is unlikely to result in significant risk to the environment.
This summary information comes from the assessment report for Arixtra (fondaparinux sodium) and is according to the company.
Detailed information
Assessment report
Assessment report for Arixtra (fondaparinux sodium), Procedure No. EMEA/H/C/00403/II/0045, 2010.
The MAH (Marketing Authorization Holder ed. note) has submitted an Environmental risk assessment to support the new indication. The MAH states: “Fondaparinux is a synthetic pentasaccharide and thus as a carbohydrate molecule is listed in the guidance amongst those substances which are considered unlikely to result in significant risk to the environment and therefore do not require an Environmental Risk Assessment.”
Author: Health and Medical Care Administration, Region Stockholm