Adempas: Withdrawal of the application to change the marketing authorisation
riociguat
Table of contents
Overview
On 11 August 2016, Bayer Pharma AG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for Adempas, in the treatment of pulmonary arterial hypertension.
Key facts
Name |
Adempas |
Product number |
EMEA/H/C/002737 |
Date of issue of market authorisation valid throughout the European Union (if applicable) |
27/03/2014 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
11/08/2016 |
Company making the application | |
Withdrawal type |
Post-authorisation |
All documents
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List item
Withdrawal letter Adempas (PDF/19.87 KB)
First published: 16/09/2016
Last updated: 16/09/2016 -
List item
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Adempas (riociguat) (PDF/86.37 KB)
First published: 16/09/2016
Last updated: 16/09/2016
EMA/560099/2016
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24 - 26 April 202326/04/2023
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17/09/2021
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21/09/2016
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24/06/2016
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 January 201424/01/2014