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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/3/04/216   
Active ingredient: Sinapultide, dipalmitoylphosphatidylcholine, palmitoyl-oleoyl phosphatidylglycerol and palmitic acid
Indication: Prevention of respiratory distress syndrome in premature neonates of less than 32 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/018/04 (2004)2995 of 29/07/2004
27/05/2009 Centralised Orphan - Transfer of orphan designation EMEA/OD/018/04/T/01 (2009)4110 of 20/05/2009