Dossier assessment

Fezolinetant (vasomotor symptoms in menopause) – Benefit assessment according to §35a Social Code Book V

Report documents

Indication:

Menopausal women with moderate to severe vasomotor symptoms

Result of dossier assessment:

Patients for whom hormone therapy is an option and who have decided in favour of hormone replacement therapy after an individual risk-benefit assessment: added benefit not proven
Patients for whom hormone therapy is not an option or those who have decided against therapy after an individual risk-benefit assessment: added benefit not proven

2024-08-01 A G-BA decision was published.

Project no.: A24-15
Commission: Commission awarded on 01.03.2024 by the Federal Joint Committee (GBA).
Report type: Dossier assessment
Status: Commission completed
Department/Division: Drug Assessment
Topic: Reproductive health and birth
Note: After completion of the assessment by IQWiG the Federal Joint Committee (GBA) conducts a commenting procedure. This may provide supplementary information and as a result lead to a modified benefit assessment. Further information and the decision on the early benefit assessment can be found on the relevant page of the GBA website.

The current version 1.1 of the benefit assessment replaces version 1.0 published on 2024-05-02.
DOI: https://doi.org/10.60584/A24-15_V1.1_en

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