🇪🇺 TABELECLEUCEL in European Union

EMA authorised TABELECLEUCEL on 16 December 2022

Marketing authorisation

EMA — authorised 16 December 2022

  • Application: EMEA/H/C/004577
  • Marketing authorisation holder: Pierre Fabre Medicament
  • Local brand name: Ebvallo
  • Indication: Ebvallo is indicated as monotherapy for treatment of adult and paediatric patients 2 years of age and older with relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate.
  • Pathway: exceptional circumstances, orphan, ATMP, PRIME
  • Status: approved

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TABELECLEUCEL 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 TABELECLEUCEL approved in European Union?

Yes. EMA authorised it on 16 December 2022.

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

Pierre Fabre Medicament holds the EU marketing authorisation.