Fingolimod Mylan: Withdrawal of the marketing authorisation application

fingolimod

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.

  • 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

  • Key facts

    Name
    Fingolimod Mylan
    Product number
    EMEA/H/C/005282
    International non-proprietary name (INN) or common name
    • fingolimod
    Active substance
    • fingolimod hydrochloride 
    Date of withdrawal
    08/05/2020
    Company making the application
    Mylan Ireland Limited
    Withdrawal type
    Initial authorisation

    All documents

    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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