Aztreonam

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.

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, not all medicinal products containing the same active substance.

Assessment report for Emblaveo

Assessment report for Emblaveo (aztreonam, avibactam) for aztreonam, 21 March 2024, EMA/147600/2024.

Hazard

Persistence: "In OECD308, aztreonam remains predominantly in the water phase, in sediment only small amounts of 6.3% parent in maximum are detected. Therefore, the trigger values for freshwater are relevant and the DT₅₀-total system can be transferred to the trigger values of 40 days (P) and 60 days (vP). As the DT₅₀ total system, 12 °C amounts to 45 and 89 days (Brandywine Creek clay loam and Choptank River sand respectively) the vP trigger for the water phase (> 60 days) is exceeded and aztreonam is to be considered as very persistent. The vP -trigger value is also fulfilled in the water phase itself (DT₅₀ water, 12 °C = 41 / 83 days)."

Bioaccumulation: OECD 107:
Log D_ow (pH 5) = -2.73
Log D_ow (pH 7) = -2.97
Log D_ow (pH 9) = -2.98

Toxicity: There are data for 3 trophic levels, most sensitive blue green alga (Anabaena flos-aquae) NOEC 830 mikrog/L.

Risk

The risk, PEC/PNEC, calculated from data in the assessment report from a European perspective:

PEC_{surfacewater (refined)} = 1,4 microg/L

PNEC = Lowest NOEC, 830 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 83 microg/L

PEC/PNEC = 0.017 which gives the risk insignificant. "... the available data do not allow to conclude definitively on the potential risk of aztreonam to the environment. However, aztreonam is considered very persistent (vP) in the environment."

Assessment report for Cayston

Assessment report for Cayston (aztreonam) EMEA/461825/2009.

"The environmental risk assessment was completed. Based on the results of the phase II Tier A assessment, risks to the environment are assumed to be negligible."