EMEA-001654-PIP02-17-M01 - paediatric investigation plan

tisagenlecleucel
PIPHuman

Key facts

Invented name
Kymriah
Active Substance
tisagenlecleucel
Therapeutic area
Oncology
Decision number
P/0323/2019
PIP number
EMEA-001654-PIP02-17-M01
Pharmaceutical form(s)
Dispersion for infusion
Condition(s) / indication(s)
Treatment of mature B-cell neoplasms
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
Compliance procedure number
EMEA-C-001654-PIP02-17-M01
Compliance opinion date
Compliance outcome
Positive

Decision

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