Ramelteon: Withdrawal of the marketing authorisation application
Table of contents
On 19 September 2008, Takeda Global Research & Development Centre (Europe) Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ramelteon, for the treatment of primary insomnia in adult patients.
|Date of withdrawal||
|Company making the application|
Withdrawal assessment report for Ramelteon (PDF/834.05 KB)Adopted
First published: 16/12/2008
Last updated: 16/12/2008
Takeda withdraws its marketing authorisation application for Ramelteon (PDF/24.8 KB)
First published: 25/09/2008
Last updated: 25/09/2008
Withdrawal letter : Ramelteon (PDF/32.51 KB)
First published: 19/09/2008
Last updated: 19/09/2008
Questions and answers on the withdrawal of the marketing application for Ramelteon (PDF/47.95 KB)
First published: 07/10/2008
Last updated: 07/10/2008
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').