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The Expert Committee, after evaluation, declines to list the medicine proposed in the application.
The Model List of Essential Medicines reports reasons that Committee Members have identified for denying listing.
Rejected
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Rejected
ATC codes: G03CA03
Indication
Gonadotropin deficiency ICD11 code: 5A61.2
INN
Estradiol
Medicine type
Chemical agent
List type
Core
Formulations
Oral > Solid > tablet: 0.5 mg ; 1 mg ; 2 mg
EML status history
Application rejected in 2023 (TRS 1049)
Sex
All
Age
Adolescents and adults
Therapeutic alternatives
The recommendation is for this specific medicine
Patent information
Patents have expired in most jurisdictions
Wikipedia
DrugBank
Summary of evidence and Expert Committee recommendations
The Expert Committee did not recommend inclusion of 17-ß-estradiol on the complementary list of the EML for the management of pubertal development in adolescents with primary or secondary ovarian failure. The Committee considered that the application reported insufficient information on the evidence supporting the use of estradiol for the proposed indication, including optimal dosages and formulations. The Committee noted that global prevalence of primary ovarian failure or primary ovarian insufficiency varies among different populations but is generally low. The Committee considered that re-evaluation of estradiol should be made considering additional indications for which estradiol is routinely used, such as hormone replacement therapy in menopause or following hysterectomy.