Nuzyra: Withdrawal of the marketing authorisation application

omadacycline

Overview

Paratek Ireland Limited withdrew its application for a marketing authorisation of Nuzyra for the treatment of infections.

The company withdrew the application on 9 October 2019.

  • List item

    Questions and answers on the withdrawal of application for the marketing authorisation of Nuzyra (omadacycline) (PDF/80.08 KB)


    First published: 18/10/2019
    EMA/556620/2019

  • Key facts

    Name
    Nuzyra
    Product number
    EMEA/H/C/004715
    International non-proprietary name (INN) or common name
    • omadacycline
    Active substance
    • omadacycline tosilate
    Date of withdrawal
    17/10/2019
    Company making the application
    Paratek Ireland Limited
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

    How useful was this page?

    Add your rating