Loulla: Withdrawal of the marketing authorisation application



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

Product number
International non-proprietary name (INN) or common name
  • mercaptopurine
Date of withdrawal
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.

An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').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