EU/3/03/172: Orphan designation for the treatment of Wilson's disease

trientine dihydrochloride


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Please note that this product (marketed as Cufence) was withdrawn from the Community Register of designated orphan medicinal products in June 2019 upon request of the marketing authorisation holder at the time of the granting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
Intended use
Treatment of Wilson's disease
Orphan designation status
EU designation number
Date of designation

Univar BV
Schouwburgplein 30
3012 CL Rodderdam
The Netherlands
Tel. +31 10 275 7840

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 icon Orphan designation withdrawal assessment report.

Documents related to this orphan designation evaluation

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.

EU register of orphan medicines

The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

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