EMEA-003025-PIP03-23-M01 - paediatric investigation plan

haematopoietic stem cells and blood progenitors umbilical cord-derived expanded with (1R,4R)-N1-(2-benzyl-7-(2-methyl-2H-tetrazol-5-yl)-9H-pyrimido[4,5-b]indol-4-yl)cyclohexane-1,4-diamine dihydrobromide dihydrate (ECT-001-CB)
PIPHuman

Key facts

Active Substance
haematopoietic stem cells and blood progenitors umbilical cord-derived expanded with (1R,4R)-N1-(2-benzyl-7-(2-methyl-2H-tetrazol-5-yl)-9H-pyrimido[4,5-b]indol-4-yl)cyclohexane-1,4-diamine dihydrobromide dihydrate (ECT-001-CB)
Therapeutic area
Blood and lymphatic system disorders
Decision number
P/0544/2023
PIP number
EMEA-003025-PIP03-23-M01
Pharmaceutical form(s)
Dispersion for infusion
Condition(s) / indication(s)
Treatment in haematopoietic stem cell transplantation in patients with haematological malignancies
Route(s) of administration
Intravenous use
Contact for public enquiries

ExCellThera
E-mail: david.millette@excellthera.com
Tel: +15143432369

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

Decision

P/0544/2023: EMA decision of 20 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for haematopoietic stem cells and blood progenitors umbilical cord-derived expanded with (1R,4R)-N1-(2-benzyl-7-(2-methyl- 2H-tetr

English (EN) (208.97 KB - PDF)

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