Nuzyra: Withdrawal of the marketing authorisation application

omadacycline

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
International non-proprietary name (INN) or common name
  • omadacycline
Active substance
  • omadacycline tosilate
Date of withdrawal
17/10/2019
Company making the application
Paratek Ireland 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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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