Key facts

Invented name
  • Kymriah
  • 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
Tel. +41 6132 46715

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date

Decision

P/0215/2022: EMA decision of 10 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for tisagenlecleucel (Kymriah), (EMEA-001654-PIP01-14-M04)

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