On 27 October 2011, orphan designation (EU/3/11/922) was granted by the European Commission to Prophylix Pharma AS, Norway, for human platelet antigen-1a immunoglobulin for the prevention of fetal and neonatal alloimmune thrombocytopenia due to human platelet antigen-1a incompatibility.
The sponsorship was transferred to FGK Representative Service GmbH in February 2020.
EU/3/11/922: Public summary of opinion on orphan designation: Human platelet antigen-1a immunoglobulin for the prevention of fetal and neonatal alloimmune thrombocytopenia due to human platelet antigen-1a incompatibility (PDF/137.5 KB)
First published: 23/11/2011
Last updated: 23/11/2011
Human platelet antigen-1a immunoglobulin
|Disease / condition||
Prevention of fetal and neonatal alloimmune thrombocytopenia
|Date of first decision||
|EU designation number||
Review of designation
The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.
Sponsor's contact details
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.