Linhaliq: Withdrawal of the marketing authorisation application

Overview

Aradigm Pharmaceuticals Limited withdrew its application for a marketing authorisation of Linhaliq for treating and preventing flare-ups of bronchiectasis in patients with long-term lung infection caused by Pseudomonas aeruginosa bacteria.

The company withdrew the application on 29 October 2019.

  • List item

    Questions and answers on the withdrawal of application for the marketing authorisation of Linhaliq (ciprofloxacin) (PDF/142.97 KB)


    First published: 15/11/2019
    EMA/610519/2019

  • Key facts

    Name
    Linhaliq
    Product number
    EMEA/H/C/004394
    Date of withdrawal
    29/10/2019
    Company making the application
    Aradigm Pharmaceuticals 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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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