Dossier assessment

Simoctocog alfa - Benefit assessment according to §35a Social Code Book V (dossier assessment)

Status
Status: Commission completed
Project no.
A14-41
Last updated

Report documents

  1. Extract of dossier assessment

    Simoctocog alfa - Benefit assessment according to §35a Social Code Book V (dossier assessment)

    published on
    Document type
    PDF document, 96 kB, EN, not accessible
  2. Dossier assessment

    Simoctocog alfa - Benefit assessment according to §35a Social Code Book V (dossier assessment)

    published on
    Document type
    PDF document, 417 kB, DE, not accessible

Press releases

Simoctocog alfa for haemophilia A: no suitable data

Duration of direct comparator studies too short / study pool on comparator therapy incomplete

Additional information

Federal Joint Committee (G-BA)

2015-05-07 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A14-41
Commission
Commission awarded on 30.10.2014 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Haematology
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.

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