EU/3/14/1357: Orphan designation for the treatment of acute respiratory distress syndrome (ARDS)

imatinib

Overview

The sponsorship was transferred to Quality Regulatory Clinical Ireland Limited, Ireland, in September 2019.

On 19 November 2014, orphan designation (EU/3/14/1357) was granted by the European Commission to Numedicus Ltd, United Kingdom, for imatinib for the treatment of acute respiratory distress syndrome.

The sponsorship was transferred to Exvastat - United Kingdom in March 2017.

The sponsorship was transferred to Exvastat (Ireland) Limited, Ireland, in August 2021.

Key facts

Active substance
imatinib
Intended use
Treatment of acute respiratory distress syndrome (ARDS)
Orphan designation status
Positive
EU designation number
EU/3/14/1357
Date of designation
19/11/2014
Sponsor

5th Floor
Nova Atria
North Road
Dublin 11
Co. Dublin
D18 F5X2
Ireland
Email: info@exvastat.com

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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