Latanoprost

Detailed information

General information about assessment reports

Since 2006, an Environmental Risk Assessment (ERA) for the active pharmaceutical substance shall accompany an application for a marketing authorisation in EU for a medicinal product for human use. Parts of environmental data are available in the public assessment report (PAR/EPAR for centrally approved medicines). Environmental considerations are not included in the benefit-risk assessment for human medicines. If new data emerge after approval that necessitate an update of the environmental risk assessment, a variation application (“type IB C.I.z variation”) must be submitted to the regulatory authority.

The PEC (predicted environmental concentration) values used to calculate risk in the manufacturers' assessment reports are based on the estimated use of the medicinal product to which the assessment report relates, as well as possibly other products from the same company, not all medicinal products containing the same active substance.

Assessment report Roclanda

Assessment report for Roclanda (latanoprost, netarsudil), 12 November 2020, EMA/CHMP/637805/2020.

Hazard

Persistence: No data.

Bioaccumulation: "The log K_ow for latanoprost were 4.22 for pH 5, 4.29 for pH 7, and 4.22 for pH 9. The values are below the trigger value for the bioaccumulation criterion (log K_ow > 4.5). Since log K_ow > 3, a bioaccumulation study would have been triggered if latanoprost had entered a Phase II assessment."

Toxicity: No data.

Risk

"The PEC_{SURFACE WATER} for both netarsudil and latanoprost is concluded to be less than 0.01 µg/L. No further analysis is therefore required."

Comment

Latanoprost has only undergone a phase I study in accordance with regulatory requirements for environmental risk assessments (Guideline on the environmental risk assessment of medicinal products for human use, EMEA/CHMP/SWP/4447/00 Rev. 1- Corr.) A phase I study includes data on bioaccumulation and an estimation of the environmental concentration of latanoprost (PEC_{Surface water}). If the specified threshold values are not exceeded, the company is not required to conduct a Phase II study, which includes data on toxicity, persistence, and risk assessment based on PEC/PNEC.

Assessment report Catiolanze

Assessment report for Catiolanze (latanoprost) 4 September 2023, EMA/CHMP/448508/2023.

"The applicant has provided a justification for not submitting ERA studies on the basis that latanoprost is already used in existing marketed products and no significant increase in environmental exposure is anticipated. Therefore, Catiolanze is not expected to pose a risk to the environment."

Fass environmental information

Environmental information is missing on fass.se for latanoprost (2025-05-13).

Pharmaceuticals residues in the aquatic environment in Region Stockholm, Sweden

In the report Pharmaceutial residues in the Stockholm aquatic environment, it was decided not to include latanoprost with the reasoning that is "natural".