Mirabegron

Assessment report

Assessment report for Betmiga (mirabegron) 18 October 2012 EMA/706651/2012/corr.

Hazard

"During the Phase I of the assessment, the calculation of the predicted environmental concentration (PEC) has resulted in a PECsurfacewater above 0.01 μg/L, and consequently a Phase II environmental fate and effect analysis was carried out. The assessment of “Aerobic Transformation in Aquatic Systems’ study (OECD 308) was not carried out according to OECD recommendations. Although the guideline requests to conduct both aerobic and anaerobic transformation the study only included data on aerobic transformation. The Applicant justified the lack of including an anaerobic assessment in the study as the ’Questions and Answers on 'Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use' (EMA/CHMP/SWP/44609/2010), states that this type of study would not be required for this type of medicinal product. This was considered acceptable and no further clarification with respect to the ERA is warranted."

Persistence OECD 301: "Mean O2 consumption Day 19: 10%, Day 28: 21%." Anmärkning: "not readily biodegradable".

OECD 308: "DT50, water = 1.1–1.2, DT50, sediment =20–111, DT50, whole system =1.2–1.3, % shifting to sediment =10."

Bioaccumulation log P_ow: at pH 4 the value -0.4 is reported, at pH 7 the value 0.3 is reported and at pH 10 the value 2.0 is reported. Conclusion: not B.

Chronic toxicity: There are data for 3 trophic levels, lowest NOEC for crustacean (Daphnia sp.) 1 010 microg/L.

Risk

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

PEC = 0.25 microg/L.

PNEC = Lowest NOEC, 1 010 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 101 microg/L

PEC/PNEC = 0,00247 which gives the risk insignificant.

Fass environmental information

Environmental information is missing on fass.se (2018-10-30). It is voluntary for manufacturers to provide information about environmental impact on fass.se.