EU/3/11/888: Orphan designation for the treatment of primary myelofibrosis

N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt (momelotinib)


On 5 August 2011, orphan designation (EU/3/11/888) 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 primary myelofibrosis.

Key facts

Active substance
N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt (momelotinib)
Intended use
Treatment of primary myelofibrosis
Orphan designation status
EU designation number
Date of designation

GlaxoSmithKline Trading Services Limited
Riverwalk 12
Citywest Business Campus
Dublin 24
D24 YK11

Review of designation

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

Update history

September 2022The sponsorship was transferred to GlaxoSmithKline Trading Services Limited, Ireland.
February 2019The sponsorship was transferred to Dlrc Pharma Services Limited, Ireland.
May 2013The sponsorship was transferred to Gilead Sciences International Ltd, United Kingdom.
February 2012The sponsorship was transferred to YM BioSciences (UK) Limited, United Kingdom.

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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