Detailed SMPC and OD register data for: Ebvallo 2.8 x 10^7 - 7.3 x 10^7 cells/mL dispersion for injection
Data as extracted from Orphan Designation Register
Product (OD)
Ebvallo 2.8 x 10^7 - 7.3 x 10^7 cells/mL dispersion for injection
PL number (OD)
PLGB 00603/0249
OD Designation ID (OD)
OD1
Active substance (OD)
TABELECLEUCEL
Data as extracted from SMPC. (PS: More information at bottom of the page)
Product (SMPC)
PL Number (SMPC)
Composition/ Active Substance (SMPC)
Dose form (SMPC)
Marketing Authorisation holder details (SMPC)
AI match to EMA Substance Dictionary
We analysed the SMPC composition text and searched for the closest equivalent in EMA's published substance dictionary. The suggested match and supporting details are shown below.
SMPC composition / active substance
Matched EMA substance
EMA SMS ID
Confidence
Higher confidence means the match is more likely to be correct.
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Further information for:
Select a section below to read the detailed content extracted from the SMPC / Orphan Designation register.
OD Indication (OD)
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’.
Full Designation Number(OD)
PLGB 00603/0249/OD1
Orphan Condition(OD)
Post transplant Epstein-Barr virus associated lymphoproliferative disorder
All Indications (SMPC)
All Contraindications (SMPC)
Warnings/Precautions (SMPC)
Interactions (SMPC)
Pregnancy/Lactation (SMPC)
Driving/Machines (SMPC)
Undesirable effects (SMPC)
Overdose (SMPC)
Shelf life (SMPC)
Storage (SMPC)
Container description (SMPC)
Handling/Disposal (SMPC)
SMPC_URL