EU/3/14/1305
Table of contents
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Please note that this product was withdrawn from the Community Register of designated Orphan Medicinal Products in October 2019 on request of the Sponsor.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Withdrawn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. +44 1628 925033
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.