Linhaliq:

Withdrawal of the marketing authorisation application

ciprofloxacin

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
    International non-proprietary name (INN) or common name
    • ciprofloxacin
    Active substance
    • ciprofloxacin
    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 (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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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