EU/3/02/127

About

On 18 December 2002, orphan designation (EU/3/02/127) was granted by the European Commission to Agence Générale des Equipements et Produits de Santé - Etablissement Pharmaceutique des Hôpitaux de Paris (AGEPS - EPHP), France, for cholic acid for the treatment of inborn errors in primary-bile-acid synthesis.

The sponsorship was transferred to Laboratoires C.T.R.S., France, in July 2007.

Cholic acid has been authorised in the EU as Orphacol since 12 September 2013.

Key facts

Active substance
cholic acid
Medicine name
Orphacol
Disease / condition
Treatment of inborn errors in primary bile acid synthesis
Date of first decision
18/12/2002
Outcome
Positive
EU designation number
EU/3/02/127

Review of designation

During its meeting of 11-12 January 2011, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/02/127 for Orphacol (cholic acid) as an orphan medicinal product for the treatment of inborn errors in primary-bile-acid synthesis. 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 satisfactory methods of treatment. The COMP recommended that the orphan designation of the medicine be maintained*.


*The maintenance of the orphan designation at time of marketing authorisation would, except in specific situations, give an orphan medicinal product 10 years of market exclusivity in the European Union (EU). This means that in the 10 years after its authorisation, similar products with a comparable therapeutic indication cannot be placed on the market.

Sponsor's contact details

Laboratoires C.T.R.S.
63 rue de l’Est
92100 Boulogne Billancourt
France
Tel. + 33 1412 20970
Fax + 33 1412 20236
E-mail: ctrs@ctrs.fr

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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