Dossier assessment

Apixaban (extension of approval) - Benefit assessment according to §35a Social Code Book V (dossier assessment)

Status
Status: Commission completed
Project no.
A14-28
Last updated

Report documents

  1. Extract of dossier assessment

    Apixaban (extension of approval) - Benefit assessment according to §35a Social Code Book V (dossier assessment)

    published on
    Document type
    PDF document, 366 kB, EN, not accessible
  2. Dossier assessment

    Apixaban (extension of approval) - Benefit assessment according to §35a Social Code Book V (dossier assessment)

    published on
    Document type
    PDF document, 624 kB, DE, not accessible

Press releases

Apixaban in deep vein thrombosis and pulmonary embolism: patients with high BMI benefit considerably

In contrast, no added benefit proven in initial treatment of patients with BMI up to 28 kg/m2 and in long-term prevention

Additional information

IQWiG health information

Deep vein thrombosis (DVT) occurs when a blood clot forms in a vein. This can cause symptoms like tenderness, skin redness, swelling in the lower leg, or warmth in the affected area. But DVT often causes no symptoms at all.

Federal Joint Committee (G-BA)

2015-02-19 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A14-28
Commission
Commission awarded on 25.08.2014 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Heart and circulation
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. Dossier assessment

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

    Project no.
    A12-20
    Last updated

    Status: Commission completed

  2. Dossier assessment

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

    Project no.
    A11-30
    Last updated

    Status: Commission completed

  3. Addendum

    Addendum to Commission A14-28 (apixaban)

    Project no.
    G15-01
    Last updated

    Status: Commission completed

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