EMEA-001780-PIP01-15 - paediatric investigation plan

Dipalmitoylphosphatidylcholine

1-palmitoyl-2-oleoyl-sn-glycero-3-phosphoglycerol sodium salt

synthetic surfactant protein C analogue

synthetic surfactant protein B analogue (CHF 5633)

Key facts

• Active substance:
  • Dipalmitoylphosphatidylcholine
  • 1-palmitoyl-2-oleoyl-sn-glycero-3-phosphoglycerol sodium salt
  • synthetic surfactant protein C analogue
  • synthetic surfactant protein B analogue (CHF 5633)
• Therapeutic area:
  Neonatology-Paediatric Intensive Care
• Decision number:
  P/0363/2016
• PIP number:
  EMEA-001780-PIP01-15
• Pharmaceutical form(s):
  • Endotracheopulmonary instillation
  • Suspension
• Condition(s) / indication(s):
  Treatment of respiratory distress syndrome
• Route(s) of administration:
  Endotracheopulmonary use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  21/12/2016
• Compliance check done:
  No

Decision

P/0363/2016: EMA decision of 21 December 2016 on the agreement of a paediatric investigation plan and on the granting of a waiver for dipalmitoylphosphatidylcholine / 1-palmitoyl-2-oleoyl-sn-glycero-3-phosphoglycerol so...

Adopted Reference Number: EMA/788583/2016