On 6 June 2012, orphan designation (EU/3/12/997) was granted by the European Commission to Sirius Regulatory Consulting Limited, United Kingdom, for N-hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide for the treatment of schwannoma.

The sponsorship was transferred to Sirius Regulatory Consulting EU Limited Ireland, in February 2019.

Key facts

Active substance
N-Hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide
Disease / condition
Treatment of schwannoma
Date of first decision
EU designation number

Review of designation

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

Sponsor's contact details

Sirius Regulatory Consulting EU Limited
The Black Church
ST. Mary's Place
Dublin D07 P4AX
Tel. +35319696679

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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