Doxorubicin

Detailed information

Fass environmental information

Fass environmental information for Doxorubicin Teva (retrieved on 2025-06-25).

Hazard

Persistence: No data.

Bioaccumulation: "Experimental LogP = -1.39. If Log P < 4 at pH 7 the substance has low potential for bioaccumulation."

Toxicity: No data.

Risk

Risk of environmental impact of doxorubicin cannot be excluded, since there is not sufficient ecotoxicity data available. No data have been provided.

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 are available in the public assessment report (PAR/EPAR for centrally approved medicines). Environmental considerations are not included in the benefit-risk assessment for human medicines. If new data emerge after approval that necessitate an update of the environmental risk assessment, a variation application (“type IB C.I.z variation”) must be submitted to the regulatory authority.

The PEC (predicted environmental concentration) values used to calculate risk in the manufacturers' assessment reports are based on the estimated use of the medicinal product to which the assessment report relates, as well as possibly other products from the same company, not all medicinal products containing the same active substance.

EMA’s scientific discussion on Myocet

EMA’s scientific discussion on Myocet (doxorubicin) 2006-08-16.

"Based on the pattern of use and disposal of Myocet coupled to the predicted annual usage and low estimates for concentrations in the environment it has been considered that no immediate risk for the environment is associated to the therapeutic use of Myocet."

Assessment report Celdoxome pegylated liposomal

Assessment report Celdoxome pegylated liposomal (doxorubicin) 21 July 2022, EMA/685994/2022.

"A justification for not providing ERA studies was provided (see discussion on non-clinical aspects). The introduction of Celdoxome pegylated liposomal is considered unlikely to result in any significant increase in the combined sales volumes for all doxorubicin hydrochloride containing products and the exposure of the environment to the active substance."

Assessment report Zolsketil pegylated liposomal

Assessment report Zolsketil pegylated liposomal (doxorubicin) 24 March 2022, EMA/CHMP/212114/2022.

"No dedicated environmental risk assessment (ERA) has been provided. The introduction of Zolsketil pegylated liposomal is considered unlikely to result in any significant increase in the combined sales volumes for all Doxorubicin hydrochloride, liposomal, containing products and the exposure of the environment to the active substance."