Zefylti: Withdrawal of the marketing authorisation application



CuraTeQ Biologics s.r.o withdrew its application for a marketing authorisation of Zefylti, a medicine intended to stimulate the production of white blood cells, making patients less vulnerable to infection, and to prepare patients for blood stem cell transplantation.

The company withdrew the application on 8 June 2023.

  • List item

    Questions and answers on the withdrawal of application for the marketing authorisation of Zefylti (filgrastim) (PDF/147.56 KB)

    First published: 23/06/2023
    Last updated: 30/08/2023

  • Key facts

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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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