Linhaliq: Withdrawal of the marketing authorisation application
Table of contents
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 |
Date of withdrawal |
29/10/2019 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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List item
Withdrawal assessment report for Linhaliq (PDF/8.93 MB)
Adopted
First published: 24/01/2020
EMA/595944/2019 -
List item
Withdrawal letter: Linhaliq (PDF/69.56 KB)
First published: 15/11/2019 -
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 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').