EU/3/14/1305

About

Please note that this product was withdrawn from the Community Register of designated Orphan Medicinal Products in October 2019 on request of the Sponsor.


This medicine is now known as depatuxizumab mafodotin.

On 29 July 2014, orphan designation (EU/3/14/1305) was granted by the European Commission to AbbVie Ltd, the United Kingdom, for humanised recombinant monoclonal antibody against epidermal growth factor receptor conjugated to maleimidocaproyl monomethylauristatin F for the treatment of glioma.

The sponsorship was transferred to AbbVie Deutschland GmbH & Co. KG, Germany, in May 2018.

Key facts

Active substance
Humanised recombinant monoclonal antibody against epidermal growth factor receptor conjugated to maleimidocaproyl monomethylauristatin F(depatuxizumab mafodotin
Disease / condition
Treatment of glioma
Date of first decision
29/07/2014
Outcome
Withdrawn
EU designation number
EU/3/14/1305

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

AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen am Rhein
Tel. +49 621 589 3382
E-mail: eu-orphan-drug@abbvie.com

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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