Adempas

RSS

riociguat

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

Overview

Adempas is a medicine that is used to increase the ability to carry out physical activity in adults with the following forms of pulmonary hypertension (high blood pressure in the blood vessels of the lungs):

  • Chronic thromboembolic pulmonary hypertension (CTEPH, where the blood vessels of the lungs are blocked or narrowed with blood clots). Adempas is used to treat patients with CTEPH who cannot have surgery, or in whom CTEPH remains or returns after surgery.
  • Pulmonary arterial hypertension (PAH, where the walls of the blood vessels of the lungs are thickened and the vessels become narrowed). Adempas can be used on its own or in combination with other medicines for PAH called ‘endothelin receptor antagonists’.

Adempas is used in patients with functional class II to III CTEPH or PAH. The ‘class’ reflects the seriousness of the disease: ‘class II’ involves slight limitation of physical activity while ‘class III’ involves marked limitation of physical activity.

CTEPH and PAH are rare, and Adempas was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 20 December 2007. Further information on the orphan designation can be found here: ema.europa.eu/en/medicines/human/orphan-designations/eu307518.

Adempas contains the active substance riociguat.

This EPAR was last updated on 14/06/2022

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
Publication details
Marketing-authorisation holder
Bayer AG
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
27/03/2014
Contact address

Kaiser-Wilhelm-Allee 1
51373 Leverkusen
Germany

Product information

11/11/2021 Adempas - EMEA/H/C/002737 - II/0033/G

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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 (see section 5.1).
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 (see section 5.1).

 

 

Assessment history

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