Sildenafil

Fass miljöinformation

Fass miljöinformation för Revatio (sildenafil) (hämtad 2011-05-12).

Fara

Persistens: "Substansen bryts ner i miljön."

Bioackumulation: Log P_ow vid pH 7,4 är 2,7.

Akut toxicitet: Finns data för 3 trofinivåer, lägst för fisk (regnbågsforell) 9 500 mikrog/L.

Risk

PEC/PNEC utgår från försäljningsdata i Sverige men oklart vilket år. PEC/PNEC = 0,00003 vilket ger risken försumbar.

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."