Dossier assessment

Linagliptin - Re-assessment of benefit according to § 35a, Para. 5b, Social Code Book V (dossier assessment)

Status
Status: Commission completed
Project no.
A12-11
Last updated

Report documents

  1. Extract of dossier assessment

    Linagliptin - Re-assessment of benefit according to § 35a, Para. 5b, Social Code Book V (dossier assessment)

    published on
    Document type
    PDF-Dokument, 264 kB, EN, PDF
  2. Dossier assessment

    Linagliptin - Re-assessment of benefit according to § 35a, Para. 5b, Social Code Book V (dossier assessment)

    published on
    Document type
    PDF-Dokument, 494 kB, DE, PDF

Press releases

Linagliptin: Once again, no proof of added benefit

Even from the new dossier, no added benefit can be derived/No suitable studies submitted

Additional information

Federal Joint Committee (G-BA)

2012-02-21 A G-BA decision was published.

G-BA documents on this decision (German only)

Project details

Project no.
A12-11
Commission
Commission awarded on 03.09.2012 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Digestion, metabolism and hormones
Note

According to § 35a (5b) Social Code Book V, concerning decisions published up to 31 December, a pharmaceutical company may apply for a renewed benefit assessment at any time if the added benefit is considered to be "not proven" because the necessary evidence was not completely presented by the company. 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. Dossier assessment

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

    Project no.
    A11-19
    Last updated

    Status: Commission completed

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