Please note that this product (marketed as NovoThirteen) was withdrawn from the Community Register of designated orphan medicinal products in July 2012 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.
On 12 December 2003, orphan designation (EU/3/03/179) was granted by the European Commission to Chiltern International Limited, United Kingdom, for recombinant human factor XIII (composed of two A subunits) for the treatment hereditary factor-XIII deficiency.
The sponsorship was transferred to Novo Nordisk A/S, Denmark, in December 2004.
For a list of the administrative updates to this public summary of opinion please refer to the PDF document below.
EU/3/03/179: Public summary of positive opinion for orphan designation of recombinant human factor XIII (composed of two A subunits) for the treatment of hereditary factor-XIII deficiency (PDF/135.15 KB)
First published: 12/12/2005
Last updated: 13/01/2014
EMA/COMP/1590/2003, Rev. 3
Recombinant human factor XIII (composed of two A subunits)
|Disease / condition||
Treatment of hereditary factor-XIII deficiency
|Date of first decision||
|EU designation number||
Review of designation
Sponsor's contact details
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
- Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;
- European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.