🇪🇺 Zanubrutinib Oral Capsule in European Union

EMA authorised Zanubrutinib Oral Capsule on 22 November 2021

Marketing authorisation

EMA — authorised 22 November 2021

  • Application: EMEA/H/C/004978
  • Marketing authorisation holder: BeOne Medicines Ireland Limited
  • Local brand name: Brukinsa
  • Indication: Brukinsa as monotherapy is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. Brukinsa as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy. Brukinsa as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL). Brukinsa in combination with obinutuzumab is indicated for the t
  • Status: approved

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Frequently asked questions

Is Zanubrutinib Oral Capsule approved in European Union?

Yes. EMA authorised it on 22 November 2021.

Who is the marketing authorisation holder for Zanubrutinib Oral Capsule in European Union?

BeOne Medicines Ireland Limited holds the EU marketing authorisation.