EU/3/15/1471

About

Please note that this product (marketed as Cuprior) was withdrawn from the Community Register of designated Orphan Medicinal Products by the European Commission in July 2017, at the time of the granting of a marketing authorisation.

On 19 March 2015, orphan designation (EU/3/15/1471) was granted by the European Commission to GMP-Orphan SAS, France, for trientine tetrahydrochloride for the treatment of Wilson's disease.

In July 2015, GMP-Orphan SAS changed name to GMP-Orphan SA.

Key facts

Active substance
Trientine tetrahydrochloride
Disease / condition
Treatment of Wilson's disease
Date of decision
19/03/2015
Outcome
Withdrawn
Orphan decision number
EU/3/15/1471

Review of designation

Please note that this product (marketed as Cuprior) was withdrawn from the Community Register of designated Orphan Medicinal Products by the European Commission in July 2017, at the time of the granting of a marketing authorisation.

On 20 July 2017, the Committee for Orphan Medicinal Products (COMP) completed a review of the designation EU/3/15/1471 for Cuprior (trientine tetrahydrochloride) as an orphan medicinal product in the treatment of Wilson's disease. The COMP assessed whether, at the time of marketing authorisation, the medicinal product still met the criteria for orphan designation. The Committee looked at the seriousness and prevalence of the condition, and the existence of other methods of treatment. As other methods of treatment are authorised in the European Union (EU), the COMP also considered whether the medicine is of significant benefit to patients with Wilson's disease. As one of the criteria for orphan designation is no longer met, the COMP recommended that the orphan designation of the product should not be maintained1.


1 The removal of the orphan designation at time of marketing authorisation means that the product cannot benefit from 10 years of market exclusivity in the EU. This means that in the 10 years after its authorisation similar products with the same therapeutic indication can be placed on the market.

Sponsor's contact details

GMP-Orphan SA
Pépinière Paris Santé Cochin
27-29 rue Faubourg Saint-Jacques
75014 Paris
France
Tel. +33 685833905
E-mail: fred@gmp-o.com

Patients' organisations

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.

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