EMEA-001862-PIP01-15-M01

Key facts

Active substance
Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (KTE-X19)
Therapeutic area
Oncology
Decision number
P/0002/2019
PIP number
EMEA-001862-PIP01-15-M01
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

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