EMEA-001780-PIP01-15

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
Contact for public enquiries
Chiesi Farmaceutici SpA
Italy
E-mail: info@chiesi.com
Tel.: 39 05212791
Fax: 39 0521774468
Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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