Tigecycline Accord: Withdrawal of the marketing authorisation application
tigecycline
Table of contents
Overview
On 12 September 2017, Accord Healthcare Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Tigecycline Accord, for the treatment of certain complicated infections.
Key facts
Name |
Tigecycline Accord |
Product number |
EMEA/H/C/004419 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
12/09/2017 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
-
List item
Withdrawal assessment report for Tigecycline Accord (PDF/303.86 KB)
Adopted
First published: 10/10/2017
Last updated: 10/10/2017
EMA/CHMP/663395/2016 -
List item
Withdrawal letter: Tigecycline Accord (PDF/480.78 KB)
First published: 15/09/2017
Last updated: 15/09/2017 -
List item
Questions and answers on the withdrawal of the marketing authorisation application for Tigecycline Accord (tigecycline) (PDF/67.56 KB)
First published: 15/09/2017
Last updated: 15/09/2017
EMA/589782/2017 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').