Dossier assessment

Dapagliflozin (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A19-53
Last updated

Report documents

  1. Extract of dossier assessment

    Dapagliflozin (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 177 kB, EN, not accessible
  2. Dossier assessment

    Dapagliflozin (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 1 MB, DE, not accessible

Dossier assessment

Indication:

Adults with type 2 diabetes mellitus

Result of dossier assessment:

Added benefit not proven for any of the 5 subindications specified by the G-BA because the drug manufacturer did not address these research questions in its dossier

Additional information

Federal Joint Committee (G-BA)

2019-12-19 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A19-53
Commission
Commission awarded on 18.06.2019 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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