Efgratin: Withdrawal of the marketing authorisation application



On 20 December 2018, Gedeon Richter Plc officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Efgratin, for reducing neutropenia.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Efgratin (pegfilgrastim) (PDF/105.32 KB)

    First published: 01/02/2019
    Last updated: 05/04/2019

  • Key facts

    Product number
    International non-proprietary name (INN) or common name
    • pegfilgrastim
    Active substance
    • pegfilgrastim
    Date of withdrawal
    Company making the application
    Gedeon Richter Plc.
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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