EMEA-002578-PIP01-19-M01 - paediatric investigation plan

mozafancogene autotemcel

Key facts

• Active substance:
  mozafancogene autotemcel
• Therapeutic area:
  Blood and lymphatic system disorders
• Decision number:
  P/0002/2024
• PIP number:
  EMEA-002578-PIP01-19-M01
• Pharmaceutical form(s):
  Dispersion for infusion
• Condition(s) / indication(s):
  Treatment of Fanconi anaemia subtype A
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  03/01/2024
• Compliance check done:
  No

Decision

P/0002/2024 : EMA decision of 3 January 2024 on the acceptance of a modification of an agreed paediatric investigation plan for mozafancogene autotemcel, (EMEA-002578-PIP01-19-M01)

Adopted Reference Number: EMA/879/2024