This medicine is authorised for use in the European Union.


Adempas is a medicine that is used to treat pulmonary hypertension (high blood pressure in the blood vessels of the lungs). It is used in the following types of PAH:

• Chronic thromboembolic pulmonary hypertension (CTEPH, where the blood vessels of the lungs are blocked or narrowed with blood clots). Adempas is used to treat adult 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) in adults and in children weighing more than 50 kg. In adults with PAH, Adempas can be used on its own or in combination with other medicines for PAH called ‘endothelin receptor antagonists’ whereas in children it is used with 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 a slight limitation of physical activity while ‘class III’ involves a 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:

Adempas contains the active substance riociguat.

This EPAR was last updated on 31/08/2023

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Hypertension, Pulmonary
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Bayer AG
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Kaiser-Wilhelm-Allee 1
51373 Leverkusen

Product information

31/05/2023 Adempas - EMEA/H/C/002737 - II/0037

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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.

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.

Adempas is indicated for the treatment of PAH in paediatric patients aged less than 18 years of age and body weight ≥ 50 kg with WHO Functional Class (FC) II to III in combination with endothelin receptor antagonists.

Assessment history

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