Opsumit: Withdrawal of the application to change the marketing authorisation
Janssen-Cilag International NV withdrew its application for the use of Opsumit in the treatment of chronic thromboembolic pulmonary hypertension (CTEPH), a condition that causes high blood pressure in the lungs.
The company withdrew the application on 8 November 2019.
|Date of issue of market authorisation valid throughout the European Union (if applicable)||
|International non-proprietary name (INN) or common name||
|Date of withdrawal||
|Company making the application|
Related information on withdrawals
The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, 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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').