EMEA-002305-PIP01-17-M01 - paediatric investigation plan

hydrocortisone (hemisuccinate)

Key facts

• Active substance:
  hydrocortisone (hemisuccinate)
• Therapeutic area:
  Neonatology-Paediatric Intensive Care
• Decision number:
  P/0358/2020
• PIP number:
  EMEA-002305-PIP01-17-M01
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Prevention of bronchopulmonary dysplasia
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  09/09/2020
• Compliance check done:
  No

Decision

P/0358/2020 : EMA decision of 9 September 2020 on the acceptance of a modification of an agreed paediatric investigation plan for hydrocortisone (hemisuccinate) (EMEA-002305-PIP01-17-M01)

Adopted Reference Number: EMA/430122/2020