Is Tabelecleucel authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Tabelecleucel: Ebvallo.

Is Tabelecleucel authorised in the United Kingdom?

The MHRA category lists of UK marketing authorisations include 1 product containing Tabelecleucel, including EBVALLO 2.8 X 10^7 - 7.3 X 10^7 CELLS/ML DISPERSION FOR INJECTION.

Active substance

Tabelecleucel

EMA 1
UK MHRA 1

Open in the medicines table

EMA European Union — centrally authorised medicines

Ebvallo Pierre Fabre Medicament · Authorised · authorised 16 Dec 2022

Therapeutic indication (EMA)

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.

UK MHRA United Kingdom — marketing authorisations

Product	Authorisation	Holder	Legal status
EBVALLO 2.8 X 10^7 - 7.3 X 10^7 CELLS/ML DISPERSION FOR INJECTION	PLGB 00603/0249	PIERRE FABRE LIMITED	POM

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.