Pravastatin

Detailed information

Assessment report Pravafenix 2011

Assessment report for pravastatin from 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 data have been found on the EMA website (2026‑04‑15).

Assessment report Pravafenix 2024

Assessment report for Pravafenix, extension of indication, EMA/569435/2024.

No new ERA data were submitted, which is acceptable. The updated PEC calculation showed no increase in environmental exposure. The previous 2012 ERA, including a Phase II assessment, concluded that pravastatin is not expected to pose an environmental risk. These conclusions remain valid, and disposal precautions in the SmPC are maintained. The extended indication does not result in any significant increase in environmental exposure to pravastatin.

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, the effect data are even more limited. However, the risk for pravastatin is considered low, based on its relatively low lipophilicity (and thus limited potential 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.