🇪🇺 Abemaciclib + Fulvestrant in European Union

EMA authorised Abemaciclib + Fulvestrant on 26 September 2018

Marketing authorisation

EMA — authorised 26 September 2018

  • Application: EMEA/H/C/004302
  • Marketing authorisation holder: Eli Lilly Nederland B.V.
  • Local brand name: Verzenios
  • Indication: Early Breast Cancer Verzenios in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, node positive early breast cancer at high risk of recurrence (see section 5.1). In pre or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. Advanced or Metastatic Breast Cancer Verzenios is indicated for the treatment of women with hormone receptor (HR) positive, human epidermal growth fa
  • Status: approved

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Other Oncology approved in European Union

Frequently asked questions

Is Abemaciclib + Fulvestrant approved in European Union?

Yes. EMA authorised it on 26 September 2018.

Who is the marketing authorisation holder for Abemaciclib + Fulvestrant in European Union?

Eli Lilly Nederland B.V. holds the EU marketing authorisation.