Theraloc: Withdrawal of the marketing authorisation application
Table of contents
Overview
On 1 December 2008, Oncoscience AG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Theraloc, for the treatment of children and adolescents with resistant or recurrent high-grade glioma. Theraloc was designated as an orphan medicinal product on 2 September 2004.
Key facts
Name |
Theraloc |
Product number |
EMEA/H/C/000931 |
Active substance |
|
Date of withdrawal |
01/12/2008 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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List item
Withdrawal assessment report for Theraloc (PDF/224.49 KB)
Adopted
First published: 07/05/2009
Last updated: 07/05/2009
EMEA/67305/2009 -
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Oncoscience AG withdraws its application for Theraloc (nimotuzumab) (PDF/23.95 KB)
First published: 04/12/2008
Last updated: 04/12/2008
EMEA/645579/2008 -
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Withdrawal letter : Theraloc (PDF/68.31 KB)
First published: 01/12/2008
Last updated: 01/12/2008 -
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Questions and answers on the withdrawal of the marketing application for Theraloc (PDF/43.31 KB)
First published: 23/01/2009
Last updated: 23/01/2009
EMEA/651597/2008 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').