EU/3/17/1902: Orphan designation for the treatment of hepatocellular carcinoma
N-{2-[(6-{[(2,6-dichloro-3,5-dimethoxyphenyl)carbamoyl](methyl)amino}pyrimidin-4-yl)amino]-5-(4-ethylpiperazin-1-yl)phenyl}prop-2-enamide
Table of contents
Overview
On 23 August 2017, orphan designation (EU/3/17/1902) was granted by the European Commission to Eisai Europe Limited, United Kingdom, for N-{2-[(6-{[(2,6-dichloro-3,5-dimethoxyphenyl)carbamoyl](methyl)amino}pyrimidin-4-yl)amino]-5-(4-ethylpiperazin-1-yl)phenyl}prop-2-enamide (also known as H3B-6527) for the treatment of hepatocellular carcinoma.
The sponsorship was transferred to Eisai GmbH, Germany, in September 2018.
The sponsor’s address was updated in August 2020.
Key facts
Active substance |
N-{2-[(6-{[(2,6-dichloro-3,5-dimethoxyphenyl)carbamoyl](methyl)amino}pyrimidin-4-yl)amino]-5-(4-ethylpiperazin-1-yl)phenyl}prop-2-enamide
|
Medicine name |
-
|
Intended use |
Treatment of hepatocellular carcinoma
|
Orphan designation status |
Positive
|
EU designation number |
EU/3/17/1902
|
Date of designation |
23/08/2017
|
Sponsor |
Edmund-Rumpler-Straße 3 |
Review of designation
The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.
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: