EMA/PE/0000261512 - paediatric investigation plan

Dexamethasone sodium phosphate encapsulated in human autologous erythrocytes

Key facts

• Active substance:
  Dexamethasone sodium phosphate encapsulated in human autologous erythrocytes
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  EMA/PE/0000261512
• PIP number:
  EMA/PE/0000261512
• Pharmaceutical form(s):
  Dispersion for infusion
• Condition(s) / indication(s):
  Treatment of ataxia telangiectasia
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  05/12/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000261512 : EMA decision of 5 December 2025 on the acceptance of a modification of an agreed paediatric investigation plan for dexamethasone sodium phosphate encapsulated in human autologous erythrocytes

Adopted Reference Number: EMADOC-1700519818-2653440