Ertapenem Hospira: Withdrawal of the marketing authorisation application

ertapenem

Overview

On 13 September 2016, Hospira UK Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ertapenem Hospira, for the treatment of certain infections and for the prevention of infection in colorectal surgery.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Ertapenem Hospira (ertapenem) (PDF/84.31 KB)


    First published: 14/10/2016
    Last updated: 14/10/2016
    EMA/610687/2016

  • Key facts

    Name
    Ertapenem Hospira
    Product number
    EMEA/H/C/004080
    International non-proprietary name (INN) or common name
    • ertapenem
    Active substance
    • ertapenem sodium
    Date of withdrawal
    13/09/2016
    Company making the application
    Hospira UK Limited
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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