Solithromycin Triskel EU Services: Withdrawal of the marketing authorisation application

solithromycin

Overview

On 27 March 2017, Triskel EU Services Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Solithromycin Triskel EU Services, intended for the treatment of community-acquired pneumonia, inhaled anthrax and inhaled tularaemia.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Solithromycin Triskel EU Services (solithromycin) (PDF/78.81 KB)


    First published: 21/04/2017
    Last updated: 21/04/2017
    EMA/249992/2017

  • Key facts

    Name
    Solithromycin Triskel EU Services
    Product number
    EMEA/H/C/004179
    International non-proprietary name (INN) or common name
    • solithromycin
    Active substance
    • Solithromycin
    Date of withdrawal
    27/03/2017
    Company making the application
    Triskel EU Services 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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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