Qizenday: Withdrawal of the marketing authorisation application

d-biotin

Overview

On 13 November 2017, Medday Pharmaceuticals officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Qizenday, for the treatment of progressive multiple sclerosis.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Qizenday (biotin) (PDF/67.46 KB)


    First published: 14/12/2017
    Last updated: 06/02/2018
    EMA/821654/2017

  • Key facts

    Name
    Qizenday
    Product number
    EMEA/H/C/004153
    International non-proprietary name (INN) or common name
    • d-biotin
    Active substance
    • d-biotin
    Date of withdrawal
    13/11/2017
    Company making the application
    Medday Pharmaceuticals
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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