Scientific discussion for Epoetin Alfa Hexal (epotein alfa) 13/09/2007.
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 for Eprex (epoetin alfa) from Janssen (downloaded 2019-07-09).
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 of environmental impact of Epoetin alfa cannot be excluded, since there is not sufficient ecotoxicity data available.
Author: The Pharmaceutical unit of Region Stockholm