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Epoetin alfa

Hazard - P - B - T - Risk See below

Information

EPAR – scientific discussion

Scientific discussion for Epoetin Alfa Hexal (epotein alfa) 13/09/2007.

Risk

No environmental risk assessment was required. In accordance with the guideline on the environmental risk assessment of medicinal products for /human use (EMEA/CHMP/SWP/4447/00) proteins are unlikely to result in significant risk to the environment.

Fass environmental information

Fass environmental information for Eprex (epoetin alfa) from Janssen (downloaded 2019-07-09).

Hazard

Persistence: No data.

Bioaccumulation: "Log D: -0.23 (pH 5.5); Log D: 1.30 (pH7.4) method: prediction module. BCF 1.0 (pH 5.5); 4.97 (pH 7.4) method: unkown. Conclusion: Epoetin alfa has low potential for bioaccumulation."However, the summary environmental information states the following: The potential for bioaccumulation cannot be excluded, due to lack of data.

Toxicity: No data.

Risk

Risk of environmental impact of Epoetin alfa cannot be excluded, since there is not sufficient ecotoxicity data available.

Author: The Pharmaceutical unit of Region Stockholm