Adempas

RSS

riociguat

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Adempas. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Adempas.

For practical information about using Adempas, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 11/02/2019

Authorisation details

Product details
Name
Adempas
Agency product number
EMEA/H/C/002737
Active substance
riociguat
International non-proprietary name (INN) or common name
riociguat
Therapeutic area (MeSH)
Hypertension, Pulmonary
Anatomical therapeutic chemical (ATC) code
C02KX05
OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Bayer AG
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
27/03/2014
Contact address
51368 Leverkusen
Germany

Product information

18/01/2019 Adempas - EMEA/H/C/002737 - R/0026

Contents

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Pharmacotherapeutic group

Antihypertensives for pulmonary arterial hypertension

Therapeutic indication

Chronic thromboembolic pulmonary hypertension (CTEPH) Adempas is indicated for the treatment of adult patients with WHO Functional Class (FC) II to III with

  • inoperable CTEPH,
  • persistent or recurrent CTEPH after surgical treatment,

to improve exercise capacity. Pulmonary arterial hypertension (PAH) Adempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (PAH) with WHO Functional Class (FC) II to III to improve exercise capacity. Efficacy has been shown in a PAH population including aetiologies of idiopathic or heritable PAH or PAH associated with connective tissue disease.

Assessment history

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