EU/3/14/1366
Table of contents
About
On 19 November 2014, orphan designation (EU/3/14/1366) was granted by the European Commission to FGK Representative Service GmbH, Germany, for recombinant human pentraxin-2 for the treatment of primary myelofibrosis.
The sponsorship was transferred to Roche Registration GmbH, Germany, in June 2020.
Key facts
Active substance |
Recombinant human pentraxin-2
|
Disease / condition |
Treatment of primary myelofibrosis
|
Date of first decision |
19/11/2014
|
Outcome |
Positive
|
EU designation number |
EU/3/14/1366
|
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
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Tel. +49 7624 142892
E-mail: info.orphan@roche.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.