Cases / 2021-09-01-D-730
completed2021-09-01D series

Misoprostol

Bekannter Wirkstoff mit neuem Unterlagenschutz: Geburtseinleitung

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Brand
Angusta
Manufacturer
Norgine GmbH

G-BA action

final resolution

2022-02-17

Arzneimittel-Richtlinie/Anlage XII: Misoprostol (Geburtseinleitung)

Evidence-checked summary

The G-BA found no proven added benefit for Schwangere Frauen mit Indikation zur Geburtseinleitung bei unreifer Zervix (Bishop Score < 7). The appropriate comparator was − Dinoproston. The G-BA issued a final resolution on 2022-02-17. The official page states that it took effect as follows: 17.02.2022. The page lists Arzneimittel-Richtlinie as the normative target.

This is the latest validated public action attached to this case. It is separate from the IQWiG assessment result.

Final benefit result

G-BA result by patient group

Open decision 5289 →

Patient group

Schwangere Frauen mit Indikation zur Geburtseinleitung bei unreifer Zervix (Bishop Score < 7)

Added benefit not proven

Comparator
− Dinoproston

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Official case record

What happened, in source order

No inferred stages

Consultation record

Oral hearing and Wortprotokoll

1 hearing

2022-01-10

76 parsed turns

Oral hearing: Misoprostol (Bekannter Wirkstoff mit neuem Unterlagenschutz: Geburtseinleitung)

Official Wortprotokoll · 13 pages

IQWiG comparison

Assessment record versus G-BA action

1 reference

IQWiG assessment findings and the later G-BA action are separate records. Open both to compare them.

A21-114

matched

Misoprostol (induction of labour) - Benefit assessment according to §35a Social Code Book V

Official assessment PDF · 43 pages

G-BA decisions

Distinct actions and documents

1 decision

2022-02-17

final resolution

Arzneimittel-Richtlinie/Anlage XII: Misoprostol (Geburtseinleitung)

The G-BA found no proven added benefit for Schwangere Frauen mit Indikation zur Geburtseinleitung bei unreifer Zervix (Bishop Score < 7). The appropriate comparator was − Dinoproston. The G-BA issued a final resolution on 2022-02-17. The official page states that it took effect as follows: 17.02.2022. The page lists Arzneimittel-Richtlinie as the normative target.

3 official documents · 4 cited claims

Official sources

Case document package

9 source
Generic graph relations · 6