EMEA-001654-PIP01-14-M03

Key facts

Invented name
Kymriah
Active substance
tisagenlecleucel
Therapeutic area
Oncology
Decision number
P/0008/2019
PIP number
EMEA-001654-PIP01-14-M03
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

Tel. +41 6132 46715
E-mail: paediatric.enquiries@novartis.com

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

Decision

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