EU/3/11/887

About

On 5 August 2011, orphan designation (EU/3/11/887) was granted by the European Commission to Cres Pharmaceuticals Limited, United Kingdom, for N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt for the treatment of post-essential thrombocythaemia myelofibrosis.

The sponsorship was transferred to YM BioSciences (UK) Limited, United Kingdom, in February 2012, to Gilead Sciences International Ltd, United Kingdom, in May 2013 and finally to Dlrc Pharma Services Limited, Ireland, in February 2019.

 

Key facts

Active substance
N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt
Disease / condition
Treatment of post-essential thrombocythaemia myelofibrosis
Date of first decision
05/08/2011
Outcome
Positive
EU designation number
EU/3/11/887

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

Dlrc Pharma Services Limited
Chesterfield House
Clonmannon
Ashford
Co. Wicklow
A67 WR29
Ireland
Tel. +353 40478808
E-mail: regulatory.submissions@dlrc.eu

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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