Ketorolac

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 data for calculating risk in assessment reports for a medicinal product do not necessarily represent the total emission of all products with the same active substance during use.

Assessment report

Assessment report for Omidria (phenylephrine, ketorolac), 21 May 2015, EMA/CHMP/289528/2015.

Hazard

Persistence: No data.

Bioaccumulation: Log K_OW -0.27.

Toxicity: No data.

Risk

PEC_surfacewater, default or refined (e.g. prevalence, literature) = 0.0013 microg/L.

"The predicted environmental concentration in the surface water (PEC_surfacewater) of PE (phenylephrine HCl ed. note) and KE (ketorolac trometanol ed. note) was calculated based on a dose of 49.5 mg and 17 mg, respectively, to be below the action limit of 0.01 μg/L. For this calculation, the Fpen was refined based on the estimated number cataract surgeries from a recent OECD analysis evaluating data for European countries in 2010. Furthermore, PE and KE are not PBT (persistent, bioaccumulative and toxic) substances as log K_ow does not exceed 4.5. Therefore, the CHMP concluded that Omidria was not expected to pose a risk to the environment."