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Sildenafil

Hazard 2 P 0 B 0 T 2 Risk Insignificant

Information

The T-value in the score for hazard refers to acute toxicity. The data on hazard and risk are based on previous environmental information on Fass.se. Environmental information is missing on fass.se (2018-10-11). It is voluntary for manufacturers to provide information about environmental impact on fass.se.

Fass environmental information

Fass environmental information for Revatio (sildenafil) (downloaded 2011-05-12).

Hazard

Persistence: The substance is degraded into the environment.

Bioaccumulation: Log Pow at pH 7.4 is 2.7.

Acute toxicity: There is data for 3 trophic levels, lowest for fish (rainbow trout) 9 500 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden but unclear which year. PEC/PNEC = 0.00003 which gives the risk insignificant.

Assessment report

Assessment report for Revatio Procedure No. EMEA/H/C/000638/II/0028.

"This ERA includes a Phase I Environmental Exposure Assessment. No environmentally related labels are proposed for orphan medicinal product Revatio based on the outcome of the Phase I exposure assessment (PECsurfacewater=0.003 μg/L, below action limit of 0.01 μg/L, according to the Guideline on the environmental risk assessment of medicinal products for human use EMEA/CHMP/SWP/4447). It is agreed that based on the published prevalence data, the addition of the pediatric population to the indication will not lead to a prevalence of higher than 1 in 10,000 assuming that all patients covered by the prevalence will use the product 365 days per year, leads to an Fpen equal to the prevalence, i.e. 1 in 10,000 or 0.0001. Therefore, in this Type II variation application, the PEC surfacewater is derived using a refined Fpen of 0.0001. This worst-case Fpen leads to a PECsurface water of 3 ng L-1, which is below the action limit. A Phase II assessment is not deemed necessary."

Author: Department of Strategic Careers, Stockholm County Council.