EU/3/15/1460: Orphan designation for the treatment of hepatocellular carcinoma



Please note that this product (marketed as Lenvima) was withdrawn from the Community Register of designated orphan medicinal products in July 2018 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.

On 19 March 2015, orphan designation (EU/3/15/1460) was granted by the European Commission to Eisai Europe Limited, United Kingdom, for lenvatinib for the treatment of hepatocellular carcinoma.

The sponsorship was transferred to Eisai GmbH, Germany, in June 2018.

Key facts

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

Eisai GmbH
Lyoner Straße 36
60528 Frankfurt am Main
Tel. +49 (69) 66585-43

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of Lenvima at the time of marketing authorisation.

The sponsor formally requested the withdrawal of the orphan designation prior to the Committee’s final opinion. More information is available in the PDF icon withdrawal assessment report – orphan maintenance

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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