EU/3/13/1222

About

On 16 January 2014, orphan designation (EU/3/13/1222) was granted by the European Commission to Eisai Europe Limited, United Kingdom, for amatuximab for the treatment of malignant mesothelioma.

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

The sponsor’s address was updated in August 2020.

Key facts

Active substance
Amatuximab
Disease / condition
Treatment of malignant mesothelioma
Date of first decision
16/01/2014
Outcome
Positive
EU designation number
EU/3/13/1222

Review of designation

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

Sponsor's contact details

Edmund-Rumpler-Straße 3
60549 Frankfurt am Main
Germany
E-mail: kontakt@eisai.net

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.

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