EMEA-001862-PIP01-15-M04 - paediatric investigation plan

brexucabtagene autoleucel
PIPHuman

Key facts

Invented name
Tecartus
Active Substance
brexucabtagene autoleucel
Therapeutic area
  • Neoplasms benign, malignant and unspecified (incl cysts and polyps)
  • Oncology
Decision number
P/0221/2024
PIP number
EMEA-001862-PIP01-15-M04
Pharmaceutical form(s)
Dispersion for infusion
Condition(s) / indication(s)
Treatment of acute lymphoblastic leukaemia
Route(s) of administration
Intravenous use
Contact for public enquiries

Kite Pharma EU B.V.

Tel. +1 4242091332
E-mail: regulatory@kitepharma.com

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

Decision

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