EU/3/17/1901: Orphan designation for the treatment of naevoid basal-cell carcinoma syndrome (Gorlin syndrome)



On 23 August 2017, orphan designation (EU/3/17/1901) was granted by the European Commission to Mayne Pharma UK Limited, United Kingdom, for itraconazole for the treatment of naevoid basal-cell carcinoma syndrome (Gorlin syndrome).

The sponsorship was transferred to Voisin Consulting S.A.R.L., France, in February 2019.

In October 2021, Voisin Consulting S.A.R.L. changed name to Voisin Consulting Life Sciences.

Key facts

Active substance
Medicine name
Intended use
Treatment of naevoid basal-cell carcinoma syndrome (Gorlin syndrome)
Orphan designation status
EU designation number
Date of designation

Voisin Consulting Life Sciences 
64 Avenue Pierre Grenier
92100 Boulogne-Billancourt
Tel. +33 1413 18300

Review of designation

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

Update history

July 2023Please note that this product was withdrawn from the Union Register of orphan medicinal products in July 2023 on request of the Sponsor.

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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