Please note that this product was withdrawn from the Community Register of designated Orphan Medicinal Products in May 2017 on request of the Sponsor.
On 16 January 2014, orphan designation (EU/3/13/1221) was granted by the European Commission to Chugai Pharma Europe Ltd, United Kingdom, for humanised monoclonal modified IgG4 antibody with bispecific structure targeting factors IX, IXa, X and Xa for the treatment of haemophilia A.
The sponsorship was transferred to Roche Registration Limited, United Kingdom, in December 2014.
This medicine is now known as emicizumab.
For a list of the administrative updates to this public summary of opinion please refer to the PDF document below.
EU/3/13/1221: Public summary of opinion on orphan designation: Humanised monoclonal modified IgG4 antibody with bispecific structure targeting factors IX, IXa, X and Xa for the treatment of haemophilia A (PDF/146.08 KB)
First published: 23/01/2014
Last updated: 12/03/2015
Humanised monoclonal modified IgG4 antibody with bispecific structure targeting factors IX, IXa, X and Xa (emicizumab)
|Disease / condition||
Treatment of haemophilia A
|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.