Stalevo: Withdrawal of the application to change the marketing authorisation

levodopa / carbidopa / entacapone


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

Product number
Date of issue of market authorisation valid throughout the European Union (if applicable)
International non-proprietary name (INN) or common name
  • levodopa
  • carbidopa
  • entacapone
Active substance
  • levodopa
  • carbidopa
  • entacapone
Date of withdrawal
Company making the application
Orion Corporation
Withdrawal type

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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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