EU/3/11/925: Orphan designation for the treatment of hypercortisolism (Cushing's syndrome) of endogenous origin

mifepristone

Overview

On 27 October 2011, orphan designation (EU/3/11/925) was granted by the European Commission to Voisin Consulting S.A.R.L., France, for mifepristone for the treatment of hypercortisolism (Cushing's syndrome) of endogenous origin.

The sponsorship was transferred to Dr Ulrich Granzer, Germany, in December 2012 and subsequently to FGK Representative Service GmbH, Germany, in October 2013 and to Dr Ulrich Granzer, Germany, in August 2015.

The sponsorship was transferred to Granzer Regulatory Consulting & Services GmbH, Germany in March 2022.

Key facts

Active substance
mifepristone
Medicine name
Corluxin
Intended use
Treatment of hypercortisolism (Cushing's syndrome) of endogenous origin
Orphan designation status
Positive
EU designation number
EU/3/11/925
Date of designation
27/10/2011
Sponsor

Granzer Regulatory Consulting & Services GmbH
Kistlerhofstrasse 172c
81379 Munich
Germany
E-mail: info@granzer.biz

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

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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