Rotigotine Mylan: Withdrawal of the marketing authorisation application

rotigotine

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.

  • List item

    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

  • Key facts

    Name
    Rotigotine Mylan
    Product number
    EMEA/H/C/004286
    International non-proprietary name (INN) or common name
    • rotigotine
    Active substance
    • rotigotine
    Date of withdrawal
    22/12/2017
    Company making the application
    Mylan S.A.S
    Withdrawal type
    Initial authorisation

    All documents

    Related content

    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 (withdrawal letter Doc. type, leave the 'Author' in properties blank).

    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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