KYMRIAH

This brand name is authorized in Austria, Canada, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Poland, Romania, United Kingdom

Active ingredients

The drug KYMRIAH contains one active pharmaceutical ingredient (API):

1 Tisagenlecleucel
UNII Q6C9WHR03O - TISAGENLECLEUCEL

Tisagenlecleucel is an autologous, immunocellular cancer therapy which involves reprogramming a patient’s own T cells with a transgene encoding a chimeric antigen receptor (CAR) to identify and eliminate CD19 expressing cells.

Read about Tisagenlecleucel

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
KYMRIAH Dispersion for infusion European Medicines Agency (EU) MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code Group title Classification
L01X Other antineoplastic agents L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents
Discover more medicines within L01X
L01XL04 L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01X Other antineoplastic agents → L01XL Antineoplastic cell and gene therapy
Discover more medicines within L01XL04

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
Country: CA Health Products and Food Branch Identifier(s): 02480514
Country: EE Ravimiamet Identifier(s): 1778430
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 1181297001
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 565299
Country: FR Base de données publique des médicaments Identifier(s): 65647882
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 381076
Country: HK Department of Health Drug Office Identifier(s): 66588
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 8481
Country: IT Agenzia del Farmaco Identifier(s): 046996017
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1086209
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100410189
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W65093001

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