Vivjoa: Withdrawal of the marketing authorisation application



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

Product number
International non-proprietary name (INN) or common name
  • Oteseconazole
Active substance
  • Oteseconazole
Date of withdrawal
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

How useful was this page?

Add your rating