Clofarabine
Summary
Persistence. The potential for persistence of clofarabine cannot be excluded, due to lack of data..
Bioaccumulation. Clofarabine has low potential for bioaccumulation.
Toxicity. It cannot be excluded that clofarabine is toxic, due to lack of data.
Risk. Risk of environmental impact of clofarabine cannot be excluded, since no ecotoxicity data are available.
This summary information comes from fass.se.
Detailed information
Fass environmental information
Fass environmental information for Evoltra (clofarabine) from Sanofi AB (retrieved on 2025-10-01).
Hazard
Persistence: No data.
Bioaccumulation: Log Pow = -0.29 at neutral pH.
Toxicity: No data.
Risk
PEC/PNEC is based on sales data in Sweden in year 2012.
PEC = 0.000000178 microg/L.
Risk of environmental impact of clofarabine cannot be excluded, since no ecotoxicity data are available.
General information about assessment reports
Since 2006, an Environmental Risk Assessment (ERA) for the active pharmaceutical substance shall accompany an application for a marketing authorisation in EU for a medicinal product for human use. Parts of environmental data are available in the public assessment report (PAR/EPAR for centrally approved medicines). Environmental considerations are not included in the benefit-risk assessment for human medicines. If new data emerge after approval that necessitate an update of the environmental risk assessment, a variation application (“type IB C.I.z variation”) must be submitted to the regulatory authority.
EMA’s scientific discussion
EMA’s scientific discussion for Evoltra, 2007-05-31.
"The potential environmental impact of clofarabine has been assessed in line with the draft Note for Guidance on Environmental Risk Assessment of Medicinal Products for Human Use (CPMP/SWP/4447/00 draft). Regarding the environmental risk assessment, no adverse environmental effects are expected with clofarabine."
Author: Health and Medical Care Administration, Region Stockholm