On 29 July 2004, orphan designation (EU/3/04/216) was granted by the European Commission to GMG BioBusiness Ltd., United Kingdom, for sinapultide, dipalmitoylphosphatidylcholine, palmitoyl-oleoyl phosphatidylglycerol and palmitic acid for the prevention of respiratory distress syndrome in premature neonates of less than 32 weeks of gestational age.
The sponsorship was transferred to Pharm Research Associates (UK) Limited, United Kingdom, in May 2009.
The sponsorship was transferred to Pharmaceutical Research Associates Group B.V., Netherlands in May 2019.
Respiratory distress syndrome in premature neonates of less than 32 weeks of gestational age
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Pharmaceutical Research Associates Group B.V.
Documents related to this orphan designation evaluation
EU/3/04/216: Public summary of positive opinion for orphan designation of sinapultide, dipalmitoylphosphatidylcholine, palmitoyl-oleoyl phosphatidylglycerol and palmitic acid for the prevention of respiratory distress sy... (PDF/118.96 KB)
First published: 23/09/2009
Last updated: 23/09/2009
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.
EU register of orphan medicines
The list of medicines that have received an orphan designation in the EU is available on the European Commission's website: