EU/3/03/172
Table of contents
About
On 24 October 2003, orphan designation (EU/3/03/172) was granted by the European Commission to Univar Limited, United Kingdom, for trientine dihydrochloride for the treatment of Wilson's disease.
The sponsorship was transferred to Univar BV, The Netherlands, in July 2013.
Please note that this product (marketed as Cufence) was withdrawn from the Community Register of designated orphan medicinal products in June 2019 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.
Key facts
Active substance |
trientine dihydrochloride
|
Disease / condition |
Treatment of Wilson's disease
|
Date of first decision |
24/10/2003
|
Outcome |
Withdrawn
|
EU designation number |
EU/3/03/172
|
Review of designation
The Committee for Orphan Medicinal Products reviewed the orphan designation of Cufence at the time of marketing authorisation.
The sponsor formally requested the withdrawal of the orphan designation prior to the Committee’s final opinion. More information is available in the
Orphan designation withdrawal assessment report.
Sponsor's contact details
Univar BV
Schouwburgplein 30
3012 CL Rodderdam
The Netherlands
Tel. +31 10 275 7840
E-mail: trientine@univareurope.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.