EMEA-001957-PIP02-19-M01 - 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:
  P/0291/2024
• PIP number:
  EMEA-001957-PIP02-19-M01
• 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:
  16/08/2024
• Compliance check done:
  No

Decision

P/0291/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for dexamethasone (sodium phosphate) encapsulated in human autologous erthrocytes (EMEA-001957-PIP02-19-M01)

Adopted Reference Number: EMA/343784/2024