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Hazard 4 P 3 B 0 T 1 Risk Low


The data on P, B and T are based on previous environmental information on fass.se. Environmental information is missing on fass.se (2020-10-06). It is voluntary for manufacturers to provide information about environmental impact on fass.se. The risk is based on the Report from Goodpoint 2019.

Assessment report

Assessment report for Pravafenix (fenofibrate, pravastatin) EMA/333119/2011.

"The environmental risk assessment (ERA) is based on data from bibliographic references on fenofibrate and pravastatin. The CHMP raised several concerns regarding the submitted data and considered the ERA as not yet acceptable. Determination of the partition coefficient octanol/water for any of the active substances, the Predicted No Effect Concentration (PNEC) calculation and lower values of assessment factors should be re-assessed. [...] The CHMP requested the conduct of an additional Phase II environmental fate and effect analysis during the post-authorisation phase." No such information has been found on EMA's website.

Report Goodpoint 2019

Comparative assessment of environmental risk when using simvastatin, atorvastatin, rosuvastatin, pravastatin and ezetimibe from a Swedish perspective.

Although there are knowledge gaps in particular regarding relevant toxicity studies, there is no obvious environmental risk with any of the investigated substances in Swedish water given the current state of knowledge. No exchanges are therefore recommended from an environmental point of view. The risk seems entirely insignificant for the highly water-soluble substance rosuvastatin. More fat-soluble statins (simvastatin, atorvastatin) may be quite potent and (together with ezetimibe) represent a slightly higher risk than the others, but the levels in the environment are probably well below the concentrations that give rise to effects. However, more impact studies are needed. For ezetimibe and pravastatin, efficacy data are even more deficient. For pravastatin, however, the risk was assessed based on its relatively low fat solubility (and thus the ability to accumulate in biota) in relation to its potency in humans. Ezetimibe is more fat-soluble, but at least partially separated in the wastewater treatment plants, how much is unclear due to high detection limits. Based on measured bioconcentration potential, there is some, but low risk for this substance.

Author: Health and Medical Care Administration, Region Stockholm