Loulla:

Withdrawal of the marketing authorisation application

mercaptopurine

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
  • mercaptopurine
Active substance
  • mercaptopurine
Date of withdrawal
19/12/2012
Company making the application
Only For Children Pharmaceuticals
Withdrawal type
Initial authorisation

Related content

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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

How useful was this page?

Add your rating