EMEA-001862-PIP03-20-M02 - paediatric investigation plan
brexucabtagene autoleucel
PIPHuman
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Key facts
- Invented name
- Tecartus
- Active substance
- brexucabtagene autoleucel
- Therapeutic area
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Decision number
- P/0176/2024
- PIP number
- EMEA-001862-PIP03-20-M02
- 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
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
- Compliance check done
- Non