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.

An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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