Begedina: Withdrawal of the marketing authorisation application
Table of contents
Overview
On 4 July 2016, Adienne S.r.l. S.U. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Begedina, for the treatment of graft-versus-host disease.
Key facts
Name |
Begedina |
Product number |
EMEA/H/C/004144 |
Active substance |
|
Date of withdrawal |
04/07/2016 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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List item
Withdrawal assessment report for Begedina (PDF/1.4 MB)
First published: 17/01/2017
Last updated: 17/01/2017 -
List item
Withdrawal letter: Begedina (PDF/1.07 MB)
First published: 22/07/2016
Last updated: 22/07/2016 -
List item
Questions and answers on the withdrawal of the marketing authorisation application for Begedina (begelomab) (PDF/73.84 KB)
First published: 22/07/2016
Last updated: 17/01/2017
EMA/491291/2016 -
Related information on withdrawals
A question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the medicine at the time of the withdrawal of the application, and includes a link to the company's formal withdrawal letter.
An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').