Withdrawal of the marketing authorisation application
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.
|International non-proprietary name (INN) or common name||
|Date of withdrawal||
|Company making the application|
Withdrawal assessment report for Theraloc (PDF/224.49 KB)Adopted
First published: 07/05/2009
Last updated: 07/05/2009
Oncoscience AG withdraws its application for Theraloc (nimotuzumab) (PDF/23.95 KB)
First published: 04/12/2008
Last updated: 04/12/2008
Withdrawal letter : Theraloc (PDF/68.31 KB)
First published: 01/12/2008
Last updated: 01/12/2008
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
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').