Busulfan

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 Busulfan Fresenius Kabi, 24 July 2014, EMA/552423/2014.

"No Environmental Risk Assessment was submitted. This was justified by the applicant as the introduction of Busulfan Fresenius Kabi 6 mg/ml manufactured by Fresenius Kabi is considered unlikely to result in any significant increase in the combined sales volumes for all busulfan containing products and the exposure of the environment to the active substance. Thus, the ERA is expected to be similar and not increased."

Fass environmental information

Fass environmental information for Myleran (busulfan) from Aspen Nordic (downloaded 2024-09-11).

Hazard

Persistence: No data.

Bioaccumulation: No data.

Toxicity: No data.

Risk

Risk of environmental impact of busulfan cannot be excluded, due to the lack of environmental toxicity data.