Persistence. It cannot be excluded that azathioprine is persistent, due to the lack of data.
Bioaccumulation. It cannot be excluded that azathioprine bioaccumulates, due to the lack of data.
Toxicity. It cannot be excluded that azathioprine is toxic, due to the lack of data.
Risk. Risk of environmental impact of azathioprine cannot be excluded, due to the lack of environmental toxicity data.
This summary information comes from Fass.se. It is voluntary for manufacturers to provide information on environmental impact on fass.se.
Fass environmental information for Imurel
Fass environmental information for Imurel (azathioprine) from Aspen Nordic (downloaded 2024-02-01).
Persistence: No data.
Bioaccumulation: No data.
Toxicity: No data.
Risk of environmental impact of azathioprine cannot be excluded, due to the lack of environmental toxicity data.
Fass environmental information for Azathioprin 1A Farma
Fass environmental information for Azathioprin 1A Farma from Sandoz AS (downloaded 2024-02-01). The environmental information for azathioprine is from Aspen Nordic for Imurel. See above.
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 for Jayempi (azathioprine), 22 April 2021, EMA/303143/2021.
"No Environmental Risk Assessment studies were submitted. This was justified by the applicant as the introduction of Jayempi manufactured by Nova Laboratories Ireland Limited is considered unlikely to result in any significant increase in the combined sales volumes for all azathioprine containing products and the exposure of the environment to the active substance. Jayempi has been developed to substitute for approved azathioprine oral tablet products.
According to Guideline on the environmental risk assessment of medicinal products for human use (26 May 2016 EMA/CHMP/SWP/44609/2010 Rev. 1), the justification of the absence of significant increase of the environmental exposure, demonstrated by suitable information, can be accepted as a justification for the absence of a complete ERA.
Thus, the impact on the environment is expected to be unchanged."
No other environmental information about azathioprine has been found on the EMA website (2024-02-01).
Author: Health and Medical Care Administration, Region Stockholm