Vilanterol

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

Assessment report for Anoro (umeclidinium bromide/vilanterol) and vilanterol 28 March 2014, EMA/CHMP/163509/2014.

Hazard

Persistence: No data.

Bioaccumulation: log K_ow 0.092 (to pH 5), 1.354 (to pH 7), 1.390 (to pH 9). Conclusion: not B.

Chronic toxicity: There is NOEC for 3 trophic levels, lowest NOEC for algae 95.4 microg/L.

Risk

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

PEC = 0.000 13 microg/L

PNEC = Lowest NOEC, 95.4 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 9.54 microg/L

PEC/PNEC = 0.000 0136, i.e. insignificant.

Fass environmental information

Fass environmental information for Relvar Ellipta (fluticasone furoate, vilanterol) and vilanterol from GlaxoSmithKline (downloaded 2022-01-18).

Hazard

Persistence: It can not be excluded that vilanterol is persistent, as data is missing.

Bioaccumulation: Log P_ow = 1.26

Chronic toxicity: There is NOEC for 3 trophic levels, lowest NOEC for algae 62.50 microg/L

Risk

PEC/PNEC is based on estimated sales in Sweden in 2018. PEC/PNEC = 2.5 x 10^-6, i.e. insignificant.