Adempas: Withdrawal of the application to change the marketing authorisation

riociguat

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
  • riociguat
Active substance
  • riociguat
Date of withdrawal
11/08/2016
Company making the application
Bayer AG
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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