EU/3/11/922

About

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.

Key facts

Active substance
Human platelet antigen-1a immunoglobulin
Disease / condition
Prevention of fetal and neonatal alloimmune thrombocytopenia
Date of first decision
27/10/2011
Outcome
Positive
EU designation number
EU/3/11/922

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

FGK Representative Service GmbH
Heimeranstrasse 35
80339 Munich
Germany
Tel. +49 8989 311922
E-mail: info@rallybio.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.

How useful was this page?

Add your rating