Opsumit: Withdrawal of the application to change the marketing authorisation
macitentan
Table of contents
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 |
|
Active substance |
|
Date of withdrawal |
08/11/2019 |
Company making the application | |
Withdrawal type |
Post-authorisation |
All documents
-
List item
Withdrawal assessment report for Opsumit (PDF/15.13 MB)
Adopted
First published: 17/02/2020
EMA/620481/2019 -
List item
Withdrawal letter: Opsumit (II-0029) (PDF/130.27 KB)
First published: 15/11/2019 -
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 -