Imiquimod

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 for Zyclara (imiquimod) 3 August 2012, EMA/525140/2012

Hazard

Persistence: No data.

Bioaccumulation: Log K_ow = 2.19 (OECD 117).

Toxicity: No data.

Risk

"PEC_surfacewater, default or refined (e.g. prevalence, literature) 0.0048 microg/L. Conclusion: below 0.01 threshold. [---] Further to the CHMP request, the Applicant has provided three separate calculations of the PEC_sufacewater for imiquimod, all of which are below the action limit and hence indicate that there will be no risk to the environment, and that further work is not necessary. The CHMP considers that the original ERA submitted based on actual sales figures is likely to provide the most realistic estimate of the PEC_sufacewater. This figure was corroborated by the use of independently published figures on the amount of imiquimod sold. A third calculation, using yet another mean of deriving the PEC_sufacewater, also led to the same conclusion."

Fass environmental information

Fass environmental information for Aldara (imiquimod) from Meda (downloaded 2021-01-19).

Hazard

Persistence: No data.

Bioaccumulation: "An experimentally derived Log P_ow of 2,19 (OECD 117) indicates that imiquimod has low potential for bioaccumulation."

Toxicity: No data.

Risk

PEC is based on sales data in Sweden in year 2017.

PEC = 5,42*10-4 μg/L. "According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of imiquimod is unlikely to represent a risk for the environment, because the predicted environmental concentration (PEC) is below the action limit 0,01 μg/L."