EU/3/03/172

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Please note that this product (marketed as Cufence) was withdrawn from the Community Register of designated orphan medicinal products in June 2019 upon request of the marketing authorisation holder at the time of the granting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Withdrawn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 PDF iconOrphan 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.

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