EU/3/17/1902: Orphan designation for the treatment of hepatocellular carcinoma



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
Medicine name
Intended use
Treatment of hepatocellular carcinoma
Orphan designation status
EU designation number
Date of designation

Edmund-Rumpler-Straße 3
60549 Frankfurt am Main

Review of designation

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

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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