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)
Table of contents
Overview
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 |
Positive
|
EU designation number |
EU/3/11/888
|
Date of designation |
05/08/2011
|
Sponsor |
GlaxoSmithKline Trading Services Limited |
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
Date | Update |
---|---|
September 2022 | The sponsorship was transferred to GlaxoSmithKline Trading Services Limited, Ireland. |
February 2019 | The sponsorship was transferred to Dlrc Pharma Services Limited, Ireland. |
May 2013 | The sponsorship was transferred to Gilead Sciences International Ltd, United Kingdom. |
February 2012 | The sponsorship was transferred to YM BioSciences (UK) Limited, United Kingdom. |
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: