Stalevo: Withdrawal of the application to change the marketing authorisation
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.
|Date of issue of market authorisation valid throughout the European Union (if applicable)||
|International non-proprietary name (INN) or common name||
|Date of withdrawal||
|Company making the application|
Orion Corporation withdraws its application for an extension of indication for Stalevo (levodopa/carbidopa/entacapone) (PDF/26.62 KB)
First published: 10/03/2009
Last updated: 10/03/2009
Withdrawal letter : Stalevo (PDF/25.08 KB)
First published: 06/03/2009
Last updated: 06/03/2009
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Stalevo (PDF/39.03 KB)
First published: 19/03/2009
Last updated: 19/03/2009
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').