🇪🇺 Venetoclax Oral Product in European Union

EMA authorised Venetoclax Oral Product on 4 December 2016

Marketing authorisation

EMA — authorised 4 December 2016

• Application: EMEA/H/C/004106
• Marketing authorisation holder: AbbVie Deutschland GmbH & Co. KG
• Local brand name: Venclyxto
• Indication: Venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1). 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 17p deletion or TP53 mutation in adult patients who have f
• Status: approved

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Frequently asked questions

Is Venetoclax Oral Product approved in European Union?

Yes. EMA authorised it on 4 December 2016.

Who is the marketing authorisation holder for Venetoclax Oral Product in European Union?

AbbVie Deutschland GmbH & Co. KG holds the EU marketing authorisation.