This brand name is authorized in Austria, Canada, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Poland, Romania, United Kingdom
The drug KYMRIAH contains one active pharmaceutical ingredient (API):
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1
Tisagenlecleucel
UNII Q6C9WHR03O - TISAGENLECLEUCEL
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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. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| KYMRIAH Dispersion for infusion | European Medicines Agency (EU) | MPI, EU: SmPC |
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 |
| L01XL04 | L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01X Other antineoplastic agents → L01XL Antineoplastic cell and gene therapy | |
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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