Movectro: Withdrawal of the marketing authorisation application
cladribine
Table of contents
Overview
On 8 February 2011, Merck Serono Europe Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Movectro, for the treatment of relapsing-remitting multiple sclerosis.
Key facts
Name |
Movectro |
Product number |
EMEA/H/C/001197 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
08/02/2011 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
-
List item
Withdrawal assessment report for Movectro (PDF/997.77 KB)
Adopted
First published: 30/03/2011
Last updated: 30/03/2011 -
List item
Movectro: Withdrawal letter (PDF/1.9 MB)
First published: 23/02/2011
Last updated: 23/02/2011 -
List item
Merck Serono Europe Limited withdraws its marketing authorisation application for Movectro (cladribine) (PDF/49.46 KB)
First published: 17/02/2011
Last updated: 17/02/2011
EMA/112512/2011
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').