Nomegestrol acetate

Detailed information

Assessment report

Assessment report for nomegestrol acetate from Zoely (nomegestrol acetate, estradiol), Merck Serono Europe, Procedure No. EMEA/H/C/001213, 2011-10-06.

Hazard

Persistence: "OECD 301B: Not readily biodegradable; There was essentially no degradation over the 28 day period."

Bioaccumulation: "NOMAC (nomegestrol acetate ed. note) was evaluated in a bioconcentration study in zebrafish aged 4-6 months, according to the guidelines of OECD 305 (Egeler et al., 2009). The results of the bioconcentration study in zebrafish indicate that only a small accumulation occurs in the uptake phase. BCF values expressed based on content of parent compound in water and fish were 14.8 and 15.0 for the low and high exposures, respectively. Two other radioactive peaks were identified in the fish and were considered to be polar metabolites of NOMAC. Depuration resulted in a rapid elimination of residues from the fish, with approximately 9.5% remaining after 10 days."

Toxicity: There are data for 3 trophic levels, most sensitive fish (Danio rerio) NOEC 1.3 microg/L.

Risk

"The PEC/PNEC ratios with respect to surface water, groundwater and micro-organisms are all substantially less than 1 and/or 0.1 for NOMAC. Based on these data, the use of NOMAC is not considered to be a cause for concern relative to these environmental compartments."

Report Goodpoint 2024

The report from Goodpoint 2024 aims to present an overall, comparative assessment for the treatment options recommended for all indications under the therapeutic area of ​​gynecology and obstetrics in the 2024 Wise list (the formulary for Region Stockholm, Sweden) containing either estrogens or progestogens + estetrol. The risk assessment does not aim to assess absolute or quantitative risk (which, for example, strongly depends on dilution in different recipients) but is primarily of a comparative nature, i.e., a ranking of the risk between different treatment options. For more information see the report.