Arikayce: Withdrawal of the marketing authorisation application
Table of contents
Overview
On 8 June 2016, Insmed Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Arikayce intended for the treatment of Mycobacterium avium complex (MAC) lung disease.
Key facts
Name |
Arikayce |
Product number |
EMEA/H/C/003936 |
Active substance |
|
Date of withdrawal |
08/06/2016 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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List item
Withdrawal assessment report for Arikayce (PDF/1.39 MB)
Adopted
First published: 14/10/2016
Last updated: 14/10/2016
EMA/493973/2016 -
List item
Withdrawal letter: Arikayce (PDF/995.41 KB)
First published: 24/06/2016
Last updated: 24/06/2016 -
List item
Questions and answers on the withdrawal of the marketing authorisation application for Arikayce (amikacin) (PDF/75.14 KB)
First published: 24/06/2016
Last updated: 14/10/2016
EMA/430267/2016 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').