Venetoclax 400mg Tablet | Study Design

Venetoclax 400mg Tablet – EMA – BE Study Design

 

Regulatory Body EMA
Study Drug Information Test Product Reference Product
Strength 400 mg 100 mg VENCLYXTO
Formulation IR tablet IR tablet
Manufacturer Any Sponsor AbbVie Deutschland GmbH & Co.KG,
Ludwigshafen
Route Oral Oral
Therapeutic Indication Therapeutic Class: Oncology
Therapeutic Indication: Venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). Venclyxto in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy. Venclyxto monotherapy is indicated for the treatment of CLL: in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor, or in the absence of 17pdeletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.

 

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