Ramelteon: Withdrawal of the marketing authorisation application
Table of contents
Overview
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.
Key facts
Name |
Ramelteon |
Product number |
EMEA/H/C/000838 |
Date of withdrawal |
19/09/2008 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
-
List item
Withdrawal assessment report for Ramelteon (PDF/834.05 KB)
Adopted
First published: 16/12/2008
Last updated: 16/12/2008
EMEA/CHMP/551287/2008 -
List item
Takeda withdraws its marketing authorisation application for Ramelteon (PDF/24.8 KB)
First published: 25/09/2008
Last updated: 25/09/2008
EMEA/504716/2008 -
List item
Withdrawal letter : Ramelteon (PDF/32.51 KB)
First published: 19/09/2008
Last updated: 19/09/2008 -
List item
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
EMEA/CHMP/502946/2008 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').