EMEA-001862-PIP02-19
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/0433/2019
|
PIP number |
EMEA-001862-PIP02-19
|
Pharmaceutical form(s) |
Dispersion for infusion
|
Condition(s) / indication(s) |
Treatment of mantle cell lymphoma
|
Route(s) of administration |
Intravenous use
|
Contact for public enquiries |
Kite Pharma EU B.V.
Tel. +1 4242091332 |
Decision type |
W: decision granting a waiver in all age groups for all conditions or indications
|