Vivjoa: Withdrawal of the marketing authorisation application
Oteseconazole
Table of contents
Overview
On 24 August 2023 Gedeon Richter plc withdrew its application for a marketing authorisation of Vivjoa for the treatment and prevention of vulvovaginal candidiasis (thrush, a fungal infection of the female genital area caused by Candida).
Key facts
Name |
Vivjoa |
Product number |
EMEA/H/C/005682 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
24/08/2023 |
Company making the application | |
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.
An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').