ecleucel
KYMRIAH™
NDC 0078-0958-19
Human T cells
Rx only
Suspension for IV infusion
Cultured, genetically modified
For autologous use only
Dispense with Medication Guide
Novartis
PRINCIPAL DISPLAY PANEL tisagenlecleucel KYMRIAHtm NDC 0078-0958-19 Human T cells Rx only Suspension for IV infusion Cultured, genetically modified For autologous use only Dispense with Medication Guide Novartis
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
tisagenlecleucel
KYMRIAH™
NDC 0078-0846-19
Human T cells
Rx only
Suspension for IV infusion
Cultured, genetically modified
For autologous use only
Dispense with Medication Guide
Novartis
PRINCIPAL DISPLAY PANEL tisagenlecleucel KYMRIAHtm NDC 0078-0846-19 Human T cells Rx only Suspension for IV infusion Cultured, genetically modified For autologous use only Dispense with Medication Guide Novartis
INGREDIENTS AND APPEARANCE
KYMRIAH
tisagenlecleucel injection, suspension
Product Information
Product Type CELLULAR THERAPY Item Code (Source) NDC:0078-0846
Route of Administration INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
TISAGENLECLEUCEL (UNII: Q6C9WHR03O) (TISAGENLECLEUCEL - UNII:Q6C9WHR03O) TISAGENLECLEUCEL 2000000
Packaging
#
Item Code
Package Description
Marketing Start Date
Marketing End Date
1
NDC:0078-0846-19 1 in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing Category
Application Number or Monograph Citation
Mrketing Start Date
Marketing End Date
BLA BLA125646 08/30/2017
KYMRIAH
tisagenlecleucel injection, suspension
Product Information
Product Type CELLULAR THERAPY Item Code (Source) NDC:0078-0958
Route of Administration INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
TISAGENLECLEUCEL (UNII: Q6C9WHR03O) (TISAGENLECLEUCEL - UNII:Q6C9WHR03O) TISAGENLECLEUCEL 60000000
Packaging
#
Item Code
Package Description
Marketing Start Date
Marketing End Date
1
NDC:0078-0958-19 1 in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
BLA BLA125646 05/01/2018 https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aad3ba54-dfd3-4cb3-9e2b-c5ef89559189
