Stalevo: Withdrawal of the application to change the marketing authorisation

levodopa / carbidopa / entacapone

Overview

On 6 March 2009, Orion Corporation officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Stalevo, to add the treatment of early Parkinson's disease in adults who are starting levodopa treatment.

Key facts

Name
Stalevo
Product number
EMEA/H/C/000511
Date of issue of market authorisation valid throughout the European Union (if applicable)
17/10/2003
International non-proprietary name (INN) or common name
  • levodopa
  • carbidopa
  • entacapone
Active substance
  • levodopa
  • carbidopa
  • entacapone
Date of withdrawal
06/03/2009
Company making the application
Orion Corporation
Withdrawal type
Post-authorisation

Related content

Related information on withdrawals

The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, 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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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