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: ema.europa.eu/en/medicines/human/orphan-designations/eu307518.
Adempas contains the active substance riociguat.
Adempas : EPAR - Summary for the public (PDF/142.63 KB)
First published: 10/04/2014
Last updated: 01/08/2023
Adempas : EPAR - Risk-management-plan summary (PDF/228.12 KB)
First published: 13/05/2014
Last updated: 01/08/2023
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31/05/2023 Adempas - EMEA/H/C/002737 - II/0037
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Product information documents contain:
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- labelling (annex IIIA);
- package leaflet (annex IIIB).
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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.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24 - 26 April 202326/04/2023
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 September 202117/09/2021
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 2016 (corrected)21/09/2016
Adempas not for use in patients with pulmonary hypertension caused by idiopathic interstitial pneumonia24/06/2016
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 January 201424/01/2014