Detailed SMPC and OD register data for: Kymriah
Data as extracted from Orphan Designation Register
Product (OD)
Kymriah
PL number (OD)
PLGB 00101/1101
OD Designation ID (OD)
OD2
Active substance (OD)
tisagenlecleucel Autologous T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19
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)
Kymriah is indicated for the treatment of: Adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) after two or more lines of systemic therapy.
Full Designation Number(OD)
PLGB 00101/1101/OD2
Orphan Condition(OD)
Diffuse large B-cell lymphoma
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