Megestrol Alkermes: Withdrawal of the marketing authorisation application
On 6 March 2012, Alkermes Pharma Ireland Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Megestrol Alkermes, intended to treat weight loss and loss of appetite in patients with cancer or AIDS.
|Date of withdrawal||
|Company making the application|
Withdrawal assessment report for Megestrol Alkermes (megestrol) (PDF/151.07 KB)Adopted
First published: 07/06/2012
Last updated: 07/06/2012
Withdrawal letter: Megestrol Alkermes (megestrol) (PDF/754.11 KB)
First published: 19/03/2012
Last updated: 19/03/2012
Alkermes Pharma Ireland Limited withdraws its marketing authorisation application for Megestrol Alkermes (megestrol) (PDF/51.22 KB)
First published: 13/03/2012
Last updated: 13/03/2012
Questions and answers on the withdrawal of the marketing authorisation application for Megestrol Alkermes (megestrol) (PDF/97.78 KB)
First published: 20/03/2012
Last updated: 20/03/2012
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').