[A16-21] Ospemifene - Benefit assessment according to §35a Social Code Book V

Last updated 20.10.2016

Project no.:
A16-21

Commission:
Commission awarded on 26.04.2016 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Digestion, metabolism and hormones

Note:

After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) 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 G-BA website.

01.08.2016

Ospemifene in vulvovaginal atrophy: added benefit not proven

Wrong study population, studies too short, requirements for comparator therapy not met

Federal Joint Committee (G-BA)

2016-10-20 A G-BA decision was published.

G-BA documents on this decision

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