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Hazard 0 P 0 B 0 T 0 Risk Insignificant

Assessment report

Assessment report for Glyxambi (empagliflozin, linagliptin) 15 September 2016, EMA/749639/2016.


Persistence parent: DT50, water = 2.3/2.1 d (r/p), DT50, sediment = 4.9/3.6 d (r/p), DT50, whole system = 2.5/2.5 d (r/p), r=river, p=pond, DT50 values corrected to 12°C; Conclusion: not P
Persistence metabolite M3: DT50, sediment = 169/125 (r/p), DT50 values corrected to 12°C. Conclusion: P

Bioaccumulation: Log Kow = 1.73, i.e. not B

Chronic toxicity:There is NOEC for three trophic levels, lowest NOEC for fish 2.4 mg/L.


The risk, PEC/PNEC, calculated from data in the assessment report from a European perspective:
PEC = 0.125 microg/L.
PNEC = Lowest NOEC, 2 400 microg/L/10 (Assessment Factor (AF) for chronic studies with three species) = 240 microg/L.
PEC/PNEC = 0,000 52.

Fass environmental information

Fass environmental information for Jardiance (downloaded 2018-05-16)

The risk classification insignificant, according to Fass.se, is based on predicted sales amount API in Sweden five year after launch of the product and the toxicity of the substance. PEC/PNEC = 0,000 0083.

Author: Health and Medical Care Administration, Region Stockholm