Egranli: Withdrawal of the marketing authorisation application

balugrastim

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
    International non-proprietary name (INN) or common name
    • balugrastim
    Active substance
    • balugrastim
    Date of withdrawal
    04/11/2014
    Withdrawal type
    Initial authorisation

    All documents

    Related content

    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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