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Glycopyrronium bromide

Summary

This summary information comes from assessment reports and Fass.

Persistence. Glycopyrronium is potentially persistent.
Bioaccumulation. Glycopyrronium has low potential for bioaccumulation.
Toxicity. Glycopyrronium has moderate acute toxicity.
Risk. The use of glycopyrronium (sales data Sweden 2018) has been considered to result in insignificant environmental risk.

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 can be found in the public investigation report (PAR/EPAR for medicinal product through a centralized procedure). Since the benefit/risk assessment for human medicinal products at present does not include environmental effects, an update of the environmental risk assessment is not required for renewals of marketing authorizations. There is thus no requirement for companies to stay informed about the development of their substances from an environmental point of view and consequently to update the environmental risk assessment as new data are published.

Assessment report Trydonis

Assessment report for glycopyrronium bromide from Trydonis (beclometasone, formoterol, glycopyrronium) Chiesi Farmaceutici, 14 October 2021, EMA/619369/2021.

Hazard

Persistence: No data.

Bioaccumulation: Log Kow = -1.35.

Toxicity: No data.

Risk

PEC surfacewater, default = 0.00025 microg/L. Conclusion "> 0.01 threshold (N)".

Assessment report Trixeo Aerosphere

Assessment report for glycopyrronium bromide from Trixeo Aerosphere (formoterol, glycopyrronium bromide, budesonide) AstraZeneca, 15 October 2020, EMA/582495/2020.

Hazard

Persistence: No data.

Bioaccumulation: Log Kow = -1.63.

Toxicity: No data.

Risk

PECsurfacewater, default = 0.000144 microg/L. Conclusion "> 0.01 threshold (N)".

Assessment report Enerzair Breezhaler

Assessment report for glycopyrronium bromide from Enerzair Breezhaler (indacaterol, glycopyrronium bromide, mometasone) Novartis, 30 April 2020, EMA/271332/2020.

Hazard

Persistence: No data.

Bioaccumulation: Log Kow = -2.1 (at 20°C).

Toxicity: No data.

Risk

PECsurfacewater, default = 0.00025 microg/L. Conclusion "> 0.01 threshold (N)".

Fass environmental information for Bevespi Aerosphere

Fass environmental information for glycopyrronium bromide from Bevespi Aerosphere (formoterol, glycopyrronium bromide) form AstraZeneca (downloaded 2022-01-18).

Hazard

Persistence: 28 days 0% (OECD 301A). “Glycopyrronium bromide is potentially persistent.”

Bioaccumulation: Log Dow = -2.1 (OECD107).

Toxicity: There are data for 3 trophic levels, most sensitive crustacean (Daphnia magna) 33 000 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2017. PEC/PNEC = 0.0000013 which gives the risk insignificant.

Fass environmental information for Enerzair Breezhaler

Fass environmental information from Enerzair Breezhaler (indacaterol, glycopyrronium bromide, mometasone) from Novartis (downloaded 2022-01-18).

Hazard

Persistence: 28 days 0% (OECD 301A). “Glycopyrronium bromide is potentially persistent.”

Bioaccumulation: Log Dow = -2.1 (OECD107).

Toxicity: There are data for 3 trophic levels, most sensitive crustacean (Daphnia magna) 33 000 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2018. PEC/PNEC = 0.0000015 which gives the risk insignificant.

Author: Health and Medical Care Administration, Region Stockholm