Nepafenac
Summary
Persistence. It cannot be excluded that nepafenac is persistent, due to lack of data.
Bioaccumulation. Nepafenac has low potential for bioaccumulation.
Toxicity. It cannot be excluded that nepafenac is toxic, due to lack of data.
Risk. Risk of environmental impact of nepafenac cannot be excluded, due to the lack of environmental toxicity data.
This summary information comes from assessment reports and fass.se about Nevanac (nepafenac).
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 are available in the public assessment report (PAR/EPAR for centrally approved medicines). Environmental considerations are not included in the benefit-risk assessment for human medicines. If new data emerge after approval that necessitate an update of the environmental risk assessment, a variation application (“type IB C.I.z variation”) must be submitted to the regulatory authority.
Assessment reports
EMA’s scientific discussion and assessment reports for Nevanac (nepafenac) contain similar information. Presented here is the most recent environmental information from the assessment report concerning a type II variation for an extended indication, dated 23 June 2016 (EMA/CHMP/167525/2016).
Hazard
Persistence: No data.
Bioaccumulation: Log Kow value was 1.31.
Toxicity: No data.
Risk
"The Predicted Environmental Concentration in surface waters (PECsw) for nepafenac was 0.00105 µg/L, which is lower than the 0.01 µg/L action value."
Nepafenac has only undergone a phase I study in accordance with regulatory requirements for environmental risk assessments (Guideline on the environmental risk assessment of medicinal products for human use, EMEA/CHMP/SWP/4447/00 Rev. 1- Corr.) A phase I study includes data on bioaccumulation and an estimation of the environmental concentration of nepafenac (PECSurface water). If the specified threshold values are not exceeded, the company is not required to conduct a Phase II study, which includes data on toxicity, persistence, and risk assessment based on PEC/PNEC.
Fass environmental information
Fass environmental information for Nevanac from Novartis (retrieved on 2026-01-09).
Hazard
Persistence: No data.
Bioaccumulation: Log Kow = 2.1.
Toxicity: No data.
Risk
PEC is based on sales data in Sweden in year 2021.
PEC = 0.00013 microg/L.
Risk of environmental impact of nepafenac cannot be excluded, due to the lack of environmental toxicity data.
References
- European Medicines Agency. EMA’s scientific discussion for Nevanac 2008-01-14.
- European Medicines Agency. European public assessment report (EPAR) for Nevanac 21 February 2013, EMA/393189/2013.
- European Medicines Agency. European public assessment report (EPAR) for Nevanac 23 June 2016, EMA/CHMP/167525/2016.
- Fass för vårdpersonal.
Author: Health and Medical Care Administration, Region Stockholm