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Latanoprost

Summary

Persistence. It cannot be excluded that latanoprost is persistent, due to the lack of data.
Bioaccumulation. Latanoprost has low potential for bioaccumulation.
Toxicity. It cannot be excluded that latanoprost is toxic, due to the lack of data.
Risk. Risk of environmental impact of latanoprost cannot be excluded, due to the lack of environmental toxicity data.

Information on bioaccumulation comes from the assessment report for Roclanda (latanoprost, netarsudil) 2020.

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 can be found in the public investigation report (PAR/EPAR for medicinal product through a centralized procedure). Since the benefit/risk assessment for human medicinal products at present does not include environmental effects, an update of the environmental risk assessment is not required for renewals of marketing authorizations. There is thus no requirement for companies to stay informed about the development of their substances from an environmental point of view and consequently to update the environmental risk assessment as new data are published.

Assessment report

Assessment report for Roclanda (latanoprost, netarsudil), 12 November 2020, EMA/CHMP/637805/2020.

Hazard

Persistence: No data.

Bioaccumulation: "The log Kow for latanoprost were 4.22 for pH 5, 4.29 for pH 7, and 4.22 for pH 9. The values are below the trigger value for the bioaccumulation criterion (log Kow > 4.5). Since log Kow > 3, a bioaccumulation study would have been triggered if latanoprost had entered a Phase II assessment."

Toxicity: No data.

Risk

"The PECSURFACE WATER for both netarsudil and latanoprost is concluded to be less than 0.01 µg/L. No further analysis is therefore required." The PEC values in the manufacturers' assessment reports are based on the estimated use of the medicinal product to which the assessment report relates, not all medicinal products containing the same active substance.

Fass environmental information

Environmental information is missing on fass.se for latanoprost (2022-09-23). It is voluntary for manufacturers to provide information about environmental impact on fass.se.

Pharmaceuticals residues in the aquatic environment in Region Stockholm, Sweden

In the report Pharmaceutial residues in the Stockholm aquatic environment, it was decided not to include latanoprost with the reasoning that is "natural".

Author: Health and Medical Care Administration, Region Stockholm