Verteporfin
Summary
Persistence. It cannot be excluded that verteporfin is persistent, due to lack of data.
Bioaccumulation. It cannot be excluded that verteporfin bioaccumulates, due to lack of data.
Toxicity. It cannot be excluded that verteporfin is toxic, due to lack of data.
Risk. Risk of environmental impact of verteporfin cannot be excluded, due to the lack of environmental toxicity data.
Environmental information is missing on fass.se for verteporfin (2025-10-06).
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.
EMA's scientific discussion
EMA's scientific discussion on Visudyne, 2006-01-23.
"No significant impact on the environment can be expected to arise from the use of the product in accordance with the SPC. However, occupational exposure during use and disposal needs to be considered as verteporfin is active in low concentrations when exposed to light, and this is addressed in the SPC." No data are presented.
Author: Health and Medical Care Administration, Region Stockholm