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Naltrexone

Hazard - P - B - T - Risk Cannot be excluded

Information

Assessment report

Assessment report for Mysimba (naltrexone/bupropion) 18 December 2014 EMA/805547/2015.

Hazard

Persistence: "Planned but not conducted yet."

Bioaccumulation: "Estimated log Kow 1.92. However, this needs to be confirmed experimentally."

Toxicity: "Not performed yet. Will be submitted when report is available.

Risk

"PECsurfacewater, default or refined (e.g. prevalence, literature) 0.0061, conclusion > 0.01 threshold (N).

Naltrexone: the environmental risk assessment cannot be completed at present, as the studies are not yet completed, and therefore no results are available. The Applicant should send the study reports and an updated ERA upon completion of the planned studies.

Prior to the Applicant having performed and submitted the studies, a definite conclusion regarding the environmental risk assessment cannot be made. The Applicant should send the study reports and an updated ERA upon completion of the planned studies as part of a post approval commitment.

The Applicant is requested to perform all the planned studies for the environmental risk assessment for bupropion (e.g. OECD 106, 210 and 211) and naltrexone (OECD 106, 201, 209, 210, 211 and 301) as well as OECD 308 for both compounds, should the results from the respective OECD 301 studies deem this necessary."

No data has been submitted to the authority according to contact with the Swedish Medical Products Agency 2019-04-25 (case number 2.1.2-2019-034992).

Fass environmental information

Environmental information is missing on fass.se (2019-07-08). It is voluntary for manufacturers to provide information about environmental impact on fass.se.

Author: The Pharmaceutical unit of Region Stockholm