Nuzyra: Withdrawal of the marketing authorisation application
Table of contents
Overview
Paratek Ireland Limited withdrew its application for a marketing authorisation of Nuzyra for the treatment of infections.
The company withdrew the application on 9 October 2019.
Key facts
Name |
Nuzyra |
Product number |
EMEA/H/C/004715 |
Date of withdrawal |
17/10/2019 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
-
List item
Withdrawal assessment report for Nuzyra (PDF/4.19 MB)
Adopted
First published: 05/02/2020
EMA/595311/2019 -
List item
Withdrawal letter: Nuzyra (PDF/153.76 KB)
First published: 18/10/2019 -
List item
Questions and answers on the withdrawal of application for the marketing authorisation of Nuzyra (omadacycline) (PDF/80.08 KB)
First published: 18/10/2019
EMA/556620/2019 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').