Sildenafil

Detailed information

Fass environmental information

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

Hazard

Persistence: The substance is degraded into the environment.

Bioaccumulation: Log P_ow 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 (PEC_surfacewater=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 PEC_surfacewater of 3 ng L-1, which is below the action limit. A Phase II assessment is not deemed necessary."