Oncophage: Withdrawal of the marketing authorisation application
On 23 November 2009, Antigenics Therapeutics Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Oncophage, intended as an add-on treatment after surgery for localised renal cell carcinoma at high risk of coming back.
|Date of withdrawal||
|Company making the application|
Withdrawal assessment report for Oncophage (PDF/916 KB)Adopted
First published: 12/03/2010
Last updated: 12/03/2010
Withdrawal letter : Oncophage (PDF/34.24 KB)
First published: 17/12/2009
Last updated: 17/12/2009
Antigenics Therapeutics Limited withdraws its marketing authorisation application for Oncophage (vitespen) (PDF/27.09 KB)
First published: 25/11/2009
Last updated: 02/12/2009
Questions and answers on the withdrawal of the marketing authorisation application for Oncophage (vitespen) (PDF/100.64 KB)
First published: 21/12/2009
Last updated: 21/12/2009
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').