Opsumit: Withdrawal of the application to change the marketing authorisation

macitentan

Overview

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.

Key facts

Name
Opsumit
Product number
EMEA/H/C/002697
Date of issue of market authorisation valid throughout the European Union (if applicable)
20/12/2013
International non-proprietary name (INN) or common name
  • macitentan
Active substance
  • Macitentan
Date of withdrawal
08/11/2019
Company making the application
Janssen-Cilag International N V  
Withdrawal type
Post-authorisation

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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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