Cerepro: Withdrawal of the marketing authorisation application
Table of contents
Overview
On 8 March 2010, Ark Therapeutics officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Cerepro, which was intended to be used with ganciclovir sodium to treat operable high grade glioma.
Key facts
Name |
Cerepro |
Product number |
EMEA/H/C/001103 |
Date of withdrawal |
08/03/2010 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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List item
Withdrawal assessment report for Cerepro (PDF/1.15 MB)
Adopted
First published: 01/02/2011
Last updated: 01/02/2011 -
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Withdrawal letter: Cerepro (PDF/33.9 KB)
First published: 23/03/2010
Last updated: 23/03/2010 -
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Ark Therapeutics Ltd withdraws its marketing authorisation application for Cerepro (sitimagene ceradenovec) (PDF/48.26 KB)
First published: 11/03/2010
Last updated: 11/03/2010
EMA/151854/2010 -
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Questions and answers on withdrawal of marketing authorisation application for Cerepro (PDF/59.67 KB)
First published: 23/03/2010
Last updated: 23/03/2010
EMA/152214/2010 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').