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
|