Loulla: Withdrawal of the marketing authorisation application
mercaptopurine
Table of contents
Overview
On 19 December 2012, Only For Children Pharmaceuticals officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Loulla, for the maintenance treatment of acute lymphoblastic leukaemia.
Key facts
Name |
Loulla |
Product number |
EMEA/H/C/002501 |
International non-proprietary name (INN) or common name |
|
Date of withdrawal |
19/12/2012 |
Company making the application | |
Withdrawal type |
Initial authorisation |
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').