Vivjoa: Withdrawal of the marketing authorisation application

Oteseconazole

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
  • Oteseconazole
Active substance
  • Oteseconazole
Date of withdrawal
24/08/2023
Company making the application
Gedeon Richter Plc.
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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