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.

  • List item

    Questions and answers on the withdrawal of application to change the marketing authorisation for Opsumit (macitentan) (PDF/122.7 KB)


    First published: 15/11/2019
    EMA/613378/2019

  • 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

    All documents

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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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