🇪🇺 Ipilimumab Injection in European Union

EMA authorised Ipilimumab Injection on 13 July 2011

Marketing authorisation

EMA — authorised 13 July 2011

  • Application: EMEA/H/C/002213
  • Marketing authorisation holder: Bristol-Myers Squibb Pharma EEIG
  • Local brand name: Yervoy
  • Indication: MelanomaYervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.4).  Yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression (see sections 4.4 and 5.1). Ren
  • Status: approved

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Other Oncology approved in European Union

Frequently asked questions

Is Ipilimumab Injection approved in European Union?

Yes. EMA authorised it on 13 July 2011.

Who is the marketing authorisation holder for Ipilimumab Injection in European Union?

Bristol-Myers Squibb Pharma EEIG holds the EU marketing authorisation.