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Community register of orphan medicinal products


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Product information

Dipalmitoylphosphatidylcholine, 1-palmitoyl-2-oleoyl-sn-glycero-3-phosphoglycerol, sodium salt, synthetic surfactant protein C analogue and synthetic surfactant protein B analogue

EU orphan designation number: EU/3/12/982   
Active ingredient: Dipalmitoylphosphatidylcholine, 1-palmitoyl-2-oleoyl-sn-glycero-3-phosphoglycerol, sodium salt, synthetic surfactant protein C analogue and synthetic surfactant protein B analogue
Indication: Treatment of respiratory distress syndrome in premature neonates of less than 37 weeks of gestational age
Sponsor: Chiesi Farmaceutici S.P.A.
Via Palermo 26/A, 43122 Parma, Italia

   Public summary of scientific opinion    

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
04/04/2012 Centralised Orphan - Designation EMA/OD/148/11 (2012)2352 of 02/04/2012