Dossier assessment

Relugolix/estradiol/norethisterone acetate (endometriosis) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A23-117
Last updated

Report documents

  1. Extract of dossier assessment

    Relugolix/estradiol/norethisterone acetate (endometriosis) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 345 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A23-117_en
  2. Dossier assessment

    Relugolix/estradiol/norethisterone acetate (endometriosis) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 902 kB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A23-117

Dossier assessment

Indication:

Symptomatic treatment of adult women of reproductive age with endometriosis who have a history of previous medical or surgical treatment

Result of dossier assessment:
  • Women who are eligible for treatment with dienogest: added benefit not proven
  • Women who are not (or no longer) eligible for treatment with dienogest: added benefit not proven

Project details

Project no.
A23-117
Commission
Commission awarded on 29.11.2023 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/A23-117_en

Connected Projects

  1. Dossier assessment

    Relugolix/estradiol/norethisterone (uterine fibroid) - Benefit assessment according to §35a Social Code Book V

    Project no.
    A21-112
    Last updated

    Status: Commission completed

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