EMEA-001654-PIP01-14-M04
Key facts
Invented name |
Kymriah
|
Active substance |
tisagenlecleucel
|
Therapeutic area |
Oncology
|
Decision number |
P/0215/2022
|
PIP number |
EMEA-001654-PIP01-14-M04
|
Pharmaceutical form(s) |
Dispersion for infusion
|
Condition(s) / indication(s) |
Treatment of B cell acute lymphoblastic leukaemia/lymphoblastic lymphoma
|
Route(s) of administration |
Intravenous use
|
Contact for public enquiries |
Novartis Europharm Limited
E-mail: paediatric.enquiries@novartis.com |
Decision type |
PM: decision on the application for modification of an agreed PIP
|