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Community register of orphan medicinal products


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Product information

Sinapultide, dipalmitoylphosphatidylcholine, palmitoyl-oleoyl phosphatidylglycerol and palmitic acid

EU orphan designation number: EU/3/04/217   
Active ingredient: Sinapultide, dipalmitoylphosphatidylcholine, palmitoyl-oleoyl phosphatidylglycerol and palmitic acid
Indication: Treatment of respiratory distress syndrome in premature neonates of less than 37 weeks of gestational age
Sponsor: Pharm Research Associates (UK) Limited
Pacific House, Imperial Way, Reading, Berkshire RG2 0TD, United Kingdom

   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
02/08/2004 Centralised Orphan - Designation EMEA/OD/019/04 (2004)2998 of 29/07/2004
28/05/2009 Centralised Orphan - Transfer of orphan designation EMEA/OD/019/04/T/01 (2009)4224 of 26/05/2009