Rotigotine Mylan: Withdrawal of the marketing authorisation application
rotigotine
Table of contents
Overview
On 22 December 2017, Mylan SAS officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Rotigotine Mylan, for the treatment of Parkinson's disease and restless-leg syndrome.
Key facts
Name |
Rotigotine Mylan |
Product number |
EMEA/H/C/004286 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
22/12/2017 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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Withdrawal assessment report for: Rotigotine Mylan (rotigotine) (PDF/1.62 MB)
First published: 11/07/2018
Last updated: 11/07/2018
EMA/29245/2018 -
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Withdrawal letter: Rotigotine Mylan (PDF/24.75 KB)
First published: 26/01/2018
Last updated: 26/01/2018 -
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Questions and answers on withdrawal of the marketing authorisation application for Rotigotine Mylan (rotigotine) (PDF/75.32 KB)
First published: 26/01/2018
Last updated: 11/07/2018
EMA/43037/2018 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').