Raligize: Withdrawal of the marketing authorisation application

axalimogene filolisbac

Overview

On 10 July 2018, FGK Representative Service GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Raligize, for the treatment of cancer of the cervix (the neck of the womb).

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Raligize (axalimogene filolisbac) (PDF/74.1 KB)

    Adopted

    First published: 27/07/2018
    Last updated: 27/07/2018
    EMA/499771/2018

  • Key facts

    Name
    Raligize
    Product number
    EMEA/H/C/004473
    International non-proprietary name (INN) or common name
    • axalimogene filolisbac
    Active substance
    • axalimogene filolisbac
    Date of withdrawal
    10/07/2018
    Company making the application
    FGK Representative Service GmbH
    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 (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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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