This medicine is authorised for use in the European Union.


Ebvallo is a medicine used to treat adults and children from 2 years of age who, after receiving an organ- or a bone marrow-transplantation, develop a blood cancer called Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD).

EBV+ PTLD is a potentially fatal complication that can occur after transplantation. Following a transplant, patients receive medicines that weaken their immune system (the body's natural defences) to prevent rejection of the transplant. However, their weakened immune system makes these patients vulnerable to infection with viruses such as the Epstein-Barr virus. In patients with EBV+ PTLD, the Epstein-Barr virus infects white blood cells called B cells after transplantation, causing changes to these cells that can lead to cancer.

Ebvallo is used in patients who have received at least one previous treatment, when the disease comes back (relapsed) or when the treatment does not work (refractory).

PTLD is rare, and Ebvallo was designated as an ‘orphan medicine’ (a medicine used in rare diseases) on 21 March 2016. Further information on the orphan designation can be found hereEU/3/16/1627

Ebvallo contains the active substance tabelecleucel. 

This EPAR was last updated on 10/03/2023

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Lymphoproliferative Disorders
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Exceptional circumstancesExceptional circumstances

This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.


This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Pierre Fabre Medicament
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Pierre Fabre Medicament
Les Cauquillous
81500 - Lavaur

Product information

09/03/2023 Ebvallo - EMEA/H/C/004577 - IAIN/0002

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Not yet assigned

Therapeutic 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.

Assessment history

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