EU/3/04/216

Table of contents

About

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.

Key facts

Active substance
Sinapultide, dipalmitoylphosphatidylcholine, palmitoyloleoy phosphatidylglycerol and palmitic acid
Disease / condition
Respiratory distress syndrome in premature neonates of less than 32 weeks of gestational age
Date of first decision
29/07/2004
Outcome
Positive
EU designation number
EU/3/04/216

Sponsor's contact details

Pharmaceutical Research Associates Group B.V.
Van Swietenlaan 6
9728 NZ Groningen
Netherlands
E-mail: praregulatoryaffairs@prahs.com

Patients' organisations

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;

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