Entolimod TMC: Withdrawal of the marketing authorisation application
On 31 July 2018, TMC Pharma Services Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Entolimod TMC, intended to be used to reduce the risk of death following exposure to potentially lethal amounts of radiation.
|International non-proprietary name (INN) or common name||
|Date of withdrawal||
|Company making the application|
Withdrawal assessment report for Entolimod TMC (PDF/3.31 MB)Adopted
First published: 12/12/2018
Withdrawal letter: Entolimod TMC (PDF/540.49 KB)
First published: 25/09/2018
Questions and answers on Entolimod TMC (PDF/75.01 KB)
First published: 26/09/2018
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 (withdrawal letter Doc. type, leave the 'Author' in properties blank).
An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').