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.
Adempas : EPAR - Summary for the public (PDF/142.88 KB)
First published: 10/04/2014
Last updated: 26/11/2021
Adempas : EPAR - Risk-management-plan summary (PDF/64.96 KB)
First published: 13/05/2014
Last updated: 13/05/2014
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11/11/2021 Adempas - EMEA/H/C/002737 - II/0033/G
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.
Chronic thromboembolic pulmonary hypertension (CTEPH)
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