Efgratin: Withdrawal of the marketing authorisation application

pegfilgrastim

Overview

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
    EMA/912780/2019

  • Key facts

    Name
    Efgratin
    Product number
    EMEA/H/C/004789
    International non-proprietary name (INN) or common name
    • pegfilgrastim
    Active substance
    • pegfilgrastim
    Date of withdrawal
    20/12/2018
    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 (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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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