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Dossier assessment

Nintedanib (idiopathic pulmonary fibrosis) - Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A19-36
Last updated

Report documents

  1. Extract of dossier assessment

    Nintedanib (idiopathic pulmonary fibrosis) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 602 kB, EN, PDF
    Download file : Extract of dossier assessment (PDF-Dokument, 602 kB, EN, PDF)

  2. Dossier assessment

    Nintedanib (idiopathic pulmonary fibrosis) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 1 MB, DE, PDF
    Download file : Dossier assessment (PDF-Dokument, 1 MB, DE, PDF)

Dossier assessment

Indication:

Adults with idiopathic pulmonary fibrosis

Result of dossier assessment:

The disadvantage regarding the side effects (gastrointestinal disorders) does not completely call into question the advantage in exacerbations; proof of a minor added benefit

Additional information

Federal Joint Committee (G-BA)

2019-10-17 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A19-36
Commission
Commission awarded on 11.04.2019 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Airways and respiratory system
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.

Connected Projects

  1. Addendum

    Nintedanib (idiopathic pulmonary fibrosis) - Addendum to Commission A19-36

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    Status: Commission completed

  2. Dossier assessment

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

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  3. Dossier assessment

    Nintedanib - Assessment according to §35a (para. 1., sentence 10) Social Code Book V (dossier assessment)

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  4. Dossier assessment

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    Status: Commission completed

  5. Dossier assessment

    Nintedanib (interstitial lung disease) - Benefit assessment according to §35a Social Code Book V

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    Status: Commission completed

  6. Dossier assessment

    Nintedanib (fibrosing interstitial lung diseases, 6 to < 18 years) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A25-30
    Last updated

    Status: Commission completed

  7. Dossier assessment

    Nintedanib (systemic sclerosis associated interstitial lung disease, 6 to < 18 years) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A25-29
    Last updated

    Status: Commission completed

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