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Dossier assessment

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

Status
Status: Commission completed
Project no.
A12-18
Last updated

Report documents

  1. Extract of dossier assessment

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

    published on
    Document type
    PDF-Dokument, 143 kB, EN, PDF
    Download file : Extract of dossier assessment (PDF-Dokument, 143 kB, EN, PDF)

  2. Dossier assessment

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

    published on
    Document type
    PDF-Dokument, 549 kB, DE, PDF
    Download file : Dossier assessment (PDF-Dokument, 549 kB, DE, PDF)

Press releases

Added benefit of dapagliflozin is not proven

Manufacturer's dossier did not contain suitable data for any therapeutic indication
Press release

Additional information

Federal Joint Committee (G-BA)

2013-06-06 A G-BA decision was published.

G-BA documents on this decision (German only)

Project details

Project no.
A12-18
Commission
Commission awarded on 14.12.2012 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
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.

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