Ebvallo (tabelecleucel)
- Region
- 🇪🇺 EU
- Active substance
- tabelecleucel
- Company
- Pierre Fabre Medicament
- Status
- Authorised
- Therapeutic area
- Lymphoproliferative Disorders
- CHMP opinion
- Thu 13 Oct 2022
- EU approval
- Fri 16 Dec 2022
- Designations
- Orphan, PRIME, ATMP, Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/004577
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.