Egranli: Withdrawal of the marketing authorisation application

Overview

On 4 November 2014, Teva Pharma B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Egranli, for reduction in the duration of neutropenia and the occurrence of febrile neutropenia in adult cancer patients.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim) (PDF/72.42 KB)


    First published: 21/11/2014
    Last updated: 16/02/2015
    EMA/705109/2014

  • Key facts

    Name
    Egranli
    Product number
    EMEA/H/C/002637
    Date of withdrawal
    04/11/2014
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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