EMEA-002432-PIP02-20-M01 - paediatric investigation plan

ralinepag

Key facts

• Active substance:
  ralinepag
• Therapeutic area:
  Respiratory, thoracic and mediastinal disorders
• Decision number:
  P/0230/2024
• PIP number:
  EMEA-002432-PIP02-20-M01
• Pharmaceutical form(s):
  • Age appropriate oral liquid dosage formulation
  • Age appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of pulmonary arterial hypertension
• Route(s) of administration:
  • Enteral use
  • Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  19/07/2024
• Compliance check done:
  No

Decision

P/0230/2024: EMA decision of 9 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for ralinepag (EMEA-002432-PIP02-20-M01)

Adopted Reference Number: EMA/291603/2024