🇪🇺 Inotuzumab ozogamicin-dose level 1 in European Union

EMA authorised Inotuzumab ozogamicin-dose level 1 on 28 June 2017

Marketing authorisation

EMA — authorised 28 June 2017

  • Application: EMEA/H/C/004119
  • Marketing authorisation holder: Pfizer Europe MA EEIG
  • Local brand name: Besponsa
  • Indication: Besponsa is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult patients with Philadelphia chromosome positive (Ph+) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI).
  • Pathway: orphan
  • Status: approved

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Inotuzumab ozogamicin-dose level 1 in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Oncology approved in European Union

Frequently asked questions

Is Inotuzumab ozogamicin-dose level 1 approved in European Union?

Yes. EMA authorised it on 28 June 2017.

Who is the marketing authorisation holder for Inotuzumab ozogamicin-dose level 1 in European Union?

Pfizer Europe MA EEIG holds the EU marketing authorisation.