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Emedastine

Summary

This summary information comes from Fass.

Persistence. It cannot be excluded that emedastine is persistent, due to the lack of data.
Bioaccumulation. Emedastine has low potential for bioaccumulation.
Toxicity. It cannot be excluded that emedastine is toxic, due to the lack of data.
Risk. Risk of the environmental impact of emedastine cannot be excluded, since no ecotoxicity data are available.

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/scientific discussion 1 October 2003

"It was concluded that the manufacture and clinical use of Emadine will not cause toxic effects to the environment."

Fass environmental information

Fass environmental information for Emadine (emedastine) from Immedica Pharma (downloaded 2022-01-12).

Hazard

Persistence: No data.

Bioaccumulation: Log Kow = 2.03 (method unknown).

Toxicity: No data.

Risk

Risk of the environmental impact of Emedastine cannot be excluded, since no ecotoxicity data are available.

Author: Health and Medical Care Administration, Region Stockholm