Gå till innehåll

Kommersiellt obunden läkemedelsinformation riktad till läkare och sjukvårdspersonal

Prucalopride

Summary

Persistence. Prucalopride is persistent.

Bioaccumulation. Prucalopride has low potential for bioaccumulation.

Toxicity. Prucalopride has moderate chronic toxicity.

Risk. The use of prucalopride from a European perspective has been considered to result in insignificant environmental risk.


This summary information comes from assessment report for Resolor (prucalopride) 2015.

Detailed information

Assessment report

Assessment report for Resolor (prucalopride) 23 April 2015, EMA/CHMP/772340/2014 - adopted.

Hazard

Persistence: OECD 308: DT50, water = 2.2 days (river), 1.2 days (pond), DT50, sediment = DT50, whole system = 223 days (river), 240 days (pond) % shifting to sediment = 65–69%.

Bioaccumulation: log Kow = -0.43 to 2.09 (pH 5 to 9). Conclusion not B.

Chronic toxicity: There is NOEC for 3 trophic levels, lowest NOEC for alge, 440 microg/L.

Risk

The risk, PEC/PNEC, calculated from data in the assessment report from a European perspective:

PEC = 0.01 microg/L.

PNEC = Lowest NOEC, 440 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 44 microg/L.

PEC/PNEC = 0.000227, i.e. insignificant.

Fass environmental information

Environmental information is missing on fass.se (2022-11-16). It is voluntary for manufacturers to provide information about environmental impact on fass.se.

Author: Health and Medical Care Administration, Region Stockholm