Movectro: Withdrawal of the marketing authorisation application

cladribine

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
  • cladribine
Active substance
  • Cladribine
Date of withdrawal
08/02/2011
Company making the application
Merck Serono Europe Limited
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 (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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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