EU/3/18/2059

About

On 22 November 2018, orphan designation (EU/3/18/2059) was granted by the European Commission to IntraBio Ltd, United Kingdom, for acetylleucine for the treatment of spinocerebellar ataxia.

The sponsorship was transferred to IntraBio Ireland Ltd, Ireland, in April 2019.

Key facts

Active substance
Acetylleucine
Disease / condition
Treatment of spinocerebellar ataxia
Date of first decision
22/11/2018
Outcome
Positive
EU designation number
EU/3/18/2059

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

IntraBio Ireland Ltd
10 Earlsfort Terrace
Dublin 2
Co. Dublin D02 T380
Ireland
Tel: +353 1 231 4600
E-mail: mm@intrabio.co.uk

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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