Addendum

Relugolix/estradiol/norethisterone (uterine fibroids) - Addendum to Commission A21-112

Status
Status: Commission completed
Project no.
A22-01
Last updated

Report documents

  1. Addendum

    Relugolix/estradiol/norethisterone (uterine fibroids) - Addendum to Commission A21-112

    published on
    Document type
    PDF document, 349 kB, EN, not accessible

Dossier assessment

Indication:

Adult women of reproductive age with moderate to severe symptoms of uterine fibroids

Result of dossier assessment:

Unchanged after addendum:

  • Women for whom watchful waiting is the best individual choice: hint of considerable added benefit
  • Women for whom symptom-oriented treatment (with gestagens or ulipristal acetate) or an invasive treatment option is the best individual choice: added benefit not proven

Additional information

Federal Joint Committee (G-BA)

2022-02-18 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A22-01
Commission
Commission awarded on 11.01.2022 by the Federal Joint Committee (GBA).
Report type
Addendum
Status
Commission completed
Department/Division
Drug Assessment
Topic
Digestion, metabolism and hormones
Note

If the need for additional work on a project commissioned by the GBA arises during consultations, IQWiG submits an addendum. The subsequent decides on the extent of the added benefit concludes the early benefit assessment.

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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