Ebvallo

tabelecleucel · Pierre Fabre Medicament
ORPHAN ADVANCED THERAPY PRIME EXCEPTIONAL CIRCUMSTANCES AUTHORISED IN THE EU

What Ebvallo is used for

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.

Approved use, as published by the European Medicines Agency.

What the labels mean

  • Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).
  • Advanced therapy: a gene, cell or tissue-engineered medicine.
  • PRIME: a priority medicine that the EMA supported early because it may meet an unmet need.
  • Approved under exceptional circumstances: full data cannot be collected, usually because the disease is very rare.

Key facts

Brand
Ebvallo
Active substance
tabelecleucel
Disease area
Lymphoproliferative Disorders
Marketing authorisation holder
Pierre Fabre Medicament
Authorised in the EU since
2022

Official information

Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.

Common questions

What is Ebvallo used for?

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.

What is the active substance in Ebvallo?

Ebvallo contains tabelecleucel.

Who makes Ebvallo?

The EU marketing authorisation holder is Pierre Fabre Medicament.

Is Ebvallo an orphan medicine?

Yes. Ebvallo is designated an orphan medicine in the EU, for a rare disease (Lymphoproliferative Disorders).

Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.

← All specialty medicines, EU

For information only, not medical advice. This page is a plain-language summary written from standard prescribing information and the public guides linked below. Brands sometimes change their formula, so always check the composition printed on the pack. Doses here are typical adult doses; yours may differ. Do not start, stop or change a medicine without your doctor or pharmacist, and keep all medicines away from children. In an emergency, call 112 (India) or your local emergency number.