Darifenacin
Summary
Persistence. It cannot be excluded that darifenacin is persistent, due to the lack of data.
Bioaccumulation. It cannot be excluded that darifenacin bioaccumulates, due to the lack of data.
Toxicity. It cannot be excluded that darifenacin is toxic, due to the lack of data.
Risk. Risk of environmental impact of darifenacin cannot be excluded, due to the lack of environmental toxicity data.
Environmental information is missing on fass.se for darifenacin (2025-05-13).
Detailed information
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.
Scientific Discussion about Emselex 19/01/2006
"A Phase I Environmental Risk Assessment has been carried out to assess the environmental risk of darifenacin. The results of this study show that there are no potential risks to the environment from the use or storage of darifenacin."
Author: Health and Medical Care Administration, Region Stockholm