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.

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

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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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