Tigecycline Accord: Withdrawal of the marketing authorisation application

tigecycline

Overview

On 12 September 2017, Accord Healthcare Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Tigecycline Accord, for the treatment of certain complicated infections.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Tigecycline Accord (tigecycline) (PDF/67.56 KB)


    First published: 15/09/2017
    Last updated: 15/09/2017
    EMA/589782/2017

  • Key facts

    Name
    Tigecycline Accord
    Product number
    EMEA/H/C/004419
    International non-proprietary name (INN) or common name
    • tigecycline
    Active substance
    • Tigecycline
    Date of withdrawal
    12/09/2017
    Company making the application
    Accord Healthcare Ltd
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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