Ertapenem

Detailed information

Fass environmental information

Fass environmental information for Invanz (ertapenem) from MSD (retrieved on 2025-06-27).

Hazard

Persistence: Ertapenem showed 4.7% mineralization in 28 days (OECD 301B), indicating it is not readily biodegradable. Hydrolysis at pH 7, 25 °C: half-life 15.3 days. Photolysis at pH 8.3, 21 °C: half-life 4.73 days; main degradate from β-lactam ring hydrolysis. Conclusion: Ertapenem is potentially persistent in the environment due to limited biodegradability.

Bioaccumulation: Log K_ow = - 2.22.

Toxicity: There are data for 3 trophic levels, most sensitive blue-green algae NOEC 130 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2021. PEC/PNEC = 0,00013 which gives the risk insignificant.

EMA's scientific discussion Invanz

EMA's scientific discussion Invanz 13/10/2006.

"An assessment of the environmental risk was did not reveal any potential risk to the environment related to the use of ertapenem." No data have been provided.

Assessment report Ertapenem SUN

Assessment report Ertapenem SUN, 19 May 2022, EMA/569175/2022.

"No environmental risk assessment was submitted. This was justified by the applicant as the introduction of Ertapenem SUN manufactured by Sun Pharmaceutical Industries Europe B.V. is considered unlikely to result in any significant increase in the combined sales volumes for all ertapenem containing products and the exposure of the environment to the active substance. Thus, the ERA is expected to be similar."

Statement regarding generic medicines

After the implementation of the latest European Medicines Agency (EMA) ERA guideline (1 September 2024), a generic company has the following options for Article 10 procedures under Directive 2001/83/EC:

i) to argue that a full ERA is not required because the pharmaceutical substance belongs to certain substance groups (e.g., so-called natural substances);

ii) to identify an official ERA from a previously accepted product and use it; or

iii) to develop its own ERA according to the latest EMA ERA guideline.

Arguments for not submitting an Environmental Risk Assessment (ERA) based on the claim that total environmental exposure has not increased (via total sales volumes) belong to the previous ERA guideline system (2006–2024) and are no longer applicable. Regarding option ii), it should be noted that if a reference ERA exists, the generic company must demonstrate that its conclusions remain technically relevant (since the latest ERA guideline introduced several new technical requirements absent in the previous ERA guideline) and in terms of exposure (showing that the estimated exposure used in the reference ERA remains reasonable). Regulatory authorities (national and EMA) recommend that generic companies attempt to obtain reference ERA documentation from other companies via a so-called Letter of Access (LoA). However, if this is not possible, it remains feasible to argue that the conclusions of an existing reference ERA are still relevant based on information gathered from public assessment reports (summarized descriptions of environmental risk assessments) and product information (to confirm that dosages, indications, etc., have not changed). It should be noted that in some cases, reference ERAs approved between 2006 and 2024 may need to be modified (e.g., with additional experimental studies). If no previous reference ERA can be identified or used, the generic company must commit to developing its own ERA.