🇪🇺 Abecma in European Union

EMA authorised Abecma on 18 August 2021

Marketing authorisation

EMA — authorised 18 August 2021

  • Application: EMEA/H/C/004662
  • Marketing authorisation holder: Bristol-Myers Squibb Pharma EEIG
  • Local brand name: Abecma
  • Indication: Abecma is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti CD38 antibody and have demonstrated disease progression on the last therapy.
  • Pathway: orphan, ATMP, PRIME
  • Status: approved

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Abecma 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 Abecma approved in European Union?

Yes. EMA authorised it on 18 August 2021.

Who is the marketing authorisation holder for Abecma in European Union?

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