Fingolimod Mylan: Withdrawal of the marketing authorisation application
fingolimod
Table of contents
Overview
Mylan Ireland Limited withdrew its application for a marketing authorisation of Fingolimod Mylan for the treatment of multiple sclerosis.
The company withdrew the application on 8 May 2020.
Key facts
Name |
Fingolimod Mylan |
Product number |
EMEA/H/C/005661 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
08/05/2020 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
-
List item
Withdrawal assessment report for Fingolimod Mylan (PDF/682.82 KB)
Adopted
First published: 17/06/2020
EMA/CHMP/267761/2020 -
List item
Withdrawal letter: Fingolimod Mylan (PDF/35.64 KB)
First published: 29/05/2020 -
List item
Questions and answers on the withdrawal of application for the marketing authorisation of Fingolimod Mylan (fingolimod) (PDF/137.81 KB)
First published: 29/05/2020
EMA/256974/2020 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').