EU/3/11/927: Orphan designation for the treatment of cystic fibrosis
sinapultide / Dipalmitoylphosphatidylcholine / palmitoyl-oleoyl phosphatidylglycerol sodium salt / palmitic acid
Table of contents
On 27 October 2011, orphan designation (EU/3/11/927) was granted by the European Commission to Pharm Research Associates (UK) Limited for sinapultide, dipalmitoylphosphatidylcholine palmitoyl-oleoyl phosphatidylglycerol, sodium salt and palmitic acid for the treatment of cystic fibrosis.
The sponsorship was transferred to Pharmaceutical Research Associates Group B.V., Netherlands in May 2019.
Treatment of cystic fibrosis
|Orphan designation status||
|EU designation number||
|Date of designation||
Pharmaceutical Research Associates Group B.V.
Review of designation
The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.
Documents related to this orphan designation evaluation
EU/03/11/927: Public summary of opinion on orphan designation: Sinapultide, dipalmitoylphosphatidylcholine palmitoyl-oleoyl phosphatidylglycerol, sodium salt and palmitic acid for the treatment of cystic fibrosis (PDF/134.31 KB)
First published: 23/11/2011
Last updated: 23/11/2011
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: