Iloprost

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.

EMA’s Scientific Discussion Ventavis 2005

EMA’s scientific discussion on Ventavis (iloprost), 2005-10-21.

"The predicted no-effect concentration (PNEC) in water was > 20 µg/L, which means that the estimated occurrence of iloprost in surface waters is of no concern. The potential occurrence in soil is insignificant. The route of administration of iloprost by inhalation does not seem to enhance the environmental risk. Exposure to the environment is considered very limited, and no risk of concern would be expected."

Assessment report Ventavis 2014

Assessment report for Ventavis 22 May 2014, EMA/134160/2014.

For this line extension application, an environmental risk assessment was conducted in accordance with Directive 2004/27/EC. The applicant calculated a PEC_surfacewater value of 0.000225 µg/L based on a maximum daily dose of 45 µg via nebulisation and a default Fpen of 1. A log K_ow of 1.6 was determined using OECD 107. As the PEC is below the action limit of 0.01 µg/L and iloprost is not a PBT substance, the new strength is not expected to pose an increased environmental risk.

Fass environmental information

Fass environmental information Ilomedin (iloprost) from Bayer (retrieved on 2025-07-08).

Hazard

Persistence: A ready biodegradability study (OECD 301E) using iloprost β-cyclodextrin clathrate showed 85% degradation after 28 days. However, the result cannot be clearly attributed to iloprost alone. Due to lack of suitable data, the phrase "The potential for persistence of iloprost trometamol cannot be excluded, due to lack of data" is justified.

Bioaccumulation: The log D_ow was reported with 1.6 (guideline OECD 107).

Acute toxicity: There are data for 1 trophic level crustacean EC₅₀ ≥ 100,000 microg/L. Comment: Values reported as greater than are not according to the guidelines. The actual value may be lower.

Risk

PPEC = 0.0000000548 μg/L is based on sales data in Sweden in year 2021. "Due to very limited ecotoxicological data a PNEC may not be determined, and a risk quotient may not be derived. This qualifies for the phrase "Risk of environmental impact of iloprost trometamol cannot be excluded, since there is not sufficient ecotoxicity data available.""