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Dossier assessment

Linzagolix (endometriosis) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A24-123
Last updated

Report documents

  1. Extract of dossier assessment

    Linzagolix (endometriosis) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 244 kB, EN, PDF
    DOI-Link
    https://doi.org/10.60584/A24-123_en
    Download file : Extract of dossier assessment (PDF-Dokument, 244 kB, EN, PDF)

  2. Dossier assessment

    Linzagolix (endometriosis) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 423 kB, DE, PDF
    DOI-Link
    https://doi.org/10.60584/A24-123
    Download file : Dossier assessment (PDF-Dokument, 423 kB, DE, PDF)

Dossier assessment

Indication:

Symptomatic treatment of endometriosis in adult women of reproductive age with a history of previous medical or surgical treatment for their endometriosis; with concomitant hormonal add-back therapy

Result of dossier assessment:

Added benefit not proven

Press releases

Linzagolix for endometriosis: comparative data are lacking

For endometriosis, there are no comparative studies with established drugs. Placebo comparisons are unsuitable for assessing the added benefit.
Press release

Project details

Project no.
A24-123
Commission
Commission awarded on 16.12.2024 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.

DOI
https://doi.org/10.60584/A24-123_en

Connected Projects

  1. Dossier assessment

    Linzagolix (uterine fibroids) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A24-92
    Last updated

    Status: Commission completed

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