orBec: Withdrawal of the marketing authorisation application
Table of contents
Overview
On 22 May 2008, DOR BIOPHARMA UK Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for orBec, for the treatment of gastrointestinal graft-versus-host disease. orBec was designated as an orphan medicinal product on 13 March 2002.
Key facts
Name |
orBec |
Product number |
EMEA/H/C/000803 |
Date of withdrawal |
22/05/2008 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
-
List item
Withdrawal assessment report for orBec (PDF/223.86 KB)
Adopted
First published: 07/07/2008
Last updated: 07/07/2008
EMEA/CHMP/277406/2008 -
List item
Withdrawal letter : orBec (PDF/52.25 KB)
First published: 23/05/2008
Last updated: 23/05/2008 -
List item
DOR BIOPHARMA UK Ltd withdraws marketing authorisation application for orBec (beclomethasone dipropionate) (PDF/24 KB)
First published: 23/05/2008
Last updated: 23/05/2008
EMEA/CHMP/274727/2008 -
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Questions and answers on the withdrawal of the marketing application for orBec (PDF/34.98 KB)
First published: 05/06/2008
Last updated: 05/06/2008
EMEA/266786/2008 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').