EU/3/14/1357

About

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.

Key facts

Active substance
imatinib
Disease / condition
Treatment of acute respiratory distress syndrome (ARDS)
Date of first decision
19/11/2014
Outcome
Positive
EU designation number
EU/3/14/1357

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

Quality Regulatory Clinical Ireland Limited
Priory Office Park 21
Stillorgan
Co Dublin
A94 F660
Ireland
Tel. +353 1210 0440
E-mail: sarah.nicholson@qrcc.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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