Human medicines European public assessment report (EPAR): Macitentan AccordPharma, macitentan, Date of authorisation: 24/09/2025, Revision: 1, Status: Authorised

Overview Macitentan AccordPharma is a medicine used for the long-term treatment of pulmonary arterial hypertension (PAH), a condition in which there is abnormally high blood pressure in the arteries of the lungs, causing symptoms such as breathlessness and fatigue. Macitentan AccordPharma is used for adults, adolescents and children weighing at least 40 kg in whom PAH comes with moderate or marked limitations in physical activity (corresponding to WHO functional class II or III, respectively). Macitentan AccordPharma can be used alone or in combination with other PAH medicines. Macitentan AccordPharma contains the active substance macitentan and is a 'generic medicine'. This means that Macitentan AccordPharma contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU. The reference medicine for Macitentan AccordPharma is Opsumit. Expand section Collapse section How is Macitentan AccordPharma used? Macitentan AccordPharma can only be obtained with a prescription, and treatment should be started and monitored by a doctor experienced in treating PAH. The medicine is available as tablets to be taken once a day. For more information about using Macitentan AccordPharma, see the package leaflet or contact your doctor or pharmacist. How does Macitentan AccordPharma work? In PAH there is severe narrowing of the small blood vessels (arterioles) in the lungs. Because more pressure is needed to force blood through these narrowed vessels, this leads to high blood pressure in the arteries to the lungs. The active substance in Macitentan AccordPharma, macitentan, works by blocking endothelin receptors. These are part of a natural mechanism in the body that can cause the small blood vessels to narrow. In patients with PAH, this mechanism is overactive and, by blocking these receptors, macitentan helps widen the arterioles in the lungs and thereby bring down the blood pressure. How has Macitentan AccordPharma been studied? Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Opsumit, and do not need to be repeated for Macitentan AccordPharma. As for every medicine, the company provided studies on the quality of Macitentan AccordPharma. The company also carried out a study that showed that it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect. What are the benefits and risks of Macitentan AccordPharma? Because Macitentan AccordPharma is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's. Why is Macitentan AccordPharma authorised in the EU? The European Medicines Agency concluded that, in accordance with EU requirements, Macitentan AccordPharma has been shown to have comparable quality and to be bioequivalent to Opsumit. Therefore, the Agency's view was that, as for Opsumit, the benefits of Macitentan AccordPharma outweigh the identified risks and it can be authorised for use in the EU. What measures are being taken to ensure the safe and effective use of Macitentan AccordPharma? Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Macitentan AccordPharma have been included in the summary of product characteristics and the package leaflet. Any additional measures in place for Opsumit, such as a patient card with key safety information, also apply to Macitentan AccordPharma where appropriate. As for all medicines, data on the use of Macitentan AccordPharma are continuously monitored. Suspected side effects reported with Macitentan AccordPharma are carefully evaluated and any necessary action taken to protect patients. Other information about Macitentan AccordPharma Macitentan AccordPharma received a marketing authorisation valid throughout the EU on 24 September 2025. Macitentan AccordPharma : EPAR - Medicine overview Reference Number: EMA/251923/2025 English (EN) (143.88 KB - PDF) First published: 19/12/2025 View Macitentan AccordPharma : EPAR - Risk management plan English (EN) (1.12 MB - PDF) First published: 19/12/2025 View ## Product information Macitentan AccordPharma : EPAR - Product information English (EN) (300.92 KB - PDF) First published: 19/12/2025 Last updated: 27/07/2026 View Other languages (24) български (BG) (556.91 KB - PDF) First published: 19/12/2025 Last updated: 27/07/2026 View español (ES) (583.22 KB - PDF) First published: 19/12/2025 Last updated: 27/07/2026 View čeština (CS) (525.89 KB - PDF) First published: 19/12/2025 Last updated: 27/07/2026 View dansk (DA) (321.8 KB - PDF) First published: 19/12/2025 Last updated: 27/07/2026 View Deutsch (DE) (341.71 KB - PDF) First published: 19/12/2025 Last updated: 27/07/2026 View eesti (ET) (472.78 KB - PDF) First published: 19/12/2025 Last updated: 27/07/2026 View ελληνικά (EL) (479.19 KB - PDF) First published: 19/12/2025 Last updated: 27/07/2026 View français (FR) (536.16 KB - PDF) First published: 19/12/2025 Last updated: 27/07/2026 View hrvatski (HR) (482.43 KB - PDF) First published: 19/12/2025 Last updated: 27/07/2026 View italiano (IT) (445.33 KB - PDF) First published: 19/12/2025 Last updated: 27/07/2026 View latviešu (LV) (611.62 KB - PDF) First published: 19/12/2025 Last updated: 27/07/2026 View lietuvių (LT) (596.67 KB - PDF) First published: 19/12/2025 Last updated: 27/07/2026 View magyar (HU) (541.08 KB - PDF) First published: 19/12/2025 Last updated: 27/07/2026 View Malti (MT) (523.55 KB - PDF) First published: 19/12/2025 Last updated: 27/07/2026 View Nederlands (NL) (330.16 KB - PDF) First published: 19/12/2025 Last updated: 27/07/2026 View polski (PL) (602.17 KB - PDF) First published: 19/12/2025 Last updated: 27/07/2026 View português (PT) (490.02 KB - PDF) First published: 19/12/2025 Last updated: 27/07/2026 View română (RO) (592.17 KB - PDF) First published: 19/12/2025 Last updated: 27/07/2026 View slovenčina (SK) (460.06 KB - PDF) First published: 19/12/2025 Last updated: 27/07/2026 View slovenščina (SL) (372.83 KB - PDF) First published: 19/12/2025 Last updated: 27/07/2026 View suomi (FI) (309.39 KB - PDF) First published: 19/12/2025 Last updated: 27/07/2026 View svenska (SV) (359.68 KB - PDF) First published: 19/12/2025 Last updated: 27/07/2026 View Íslenska (IS) (315.49 KB - PDF) First published: 19/12/2025 Last updated: 27/07/2026 View norsk (NO) (332.84 KB - PDF) First published: 19/12/2025 Last updated: 27/07/2026 View Latest procedure affecting product information: VR/0000350552 23/07/2026 This medicine's product information is available in all official EU languages . Select 'available languages' to access the language you need. 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). Macitentan AccordPharma : EPAR - All authorised presentations English (EN) (70.79 KB - PDF) First published: 19/12/2025 View Other languages (24) български (BG) (80.87 KB - PDF) First published: 19/12/2025 View español (ES) (72.17 KB - PDF) First published: 19/12/2025 View čeština (CS) (70.41 KB - PDF) First published: 19/12/2025 View dansk (DA) (71.44 KB - PDF) First published: 19/12/2025 View Deutsch (DE) (72.86 KB - PDF) First published: 19/12/2025 View eesti (ET) (72.33 KB - PDF) First published: 19/12/2025 View ελληνικά (EL) (89.63 KB - PDF) First published: 19/12/2025 View français (FR) (74.72 KB - PDF) First published: 19/12/2025 View hrvatski (HR) (88.38 KB - PDF) First published: 19/12/2025 View italiano (IT) (70.94 KB - PDF) First published: 19/12/2025 View latviešu (LV) (89.28 KB - PDF) First published: 19/12/2025 View lietuvių (LT) (91.37 KB - PDF) First published: 19/12/2025 View magyar (HU) (80.14 KB - PDF) First published: 19/12/2025 View Malti (MT) (89.81 KB - PDF) First published: 19/12/2025 View Nederlands (NL) (73.14 KB - PDF) First published: 19/12/2025 View polski (PL) (81.79 KB - PDF) First published: 19/12/2025 View português (PT) (73.57 KB - PDF) First published: 19/12/2025 View română (RO) (81.41 KB - PDF) First published: 19/12/2025 View slovenčina (SK) (86.56 KB - PDF) First published: 19/12/2025 View slovenščina (SL) (89.26 KB - PDF) First published: 19/12/2025 View suomi (FI) (72.25 KB - PDF) First published: 19/12/2025 View svenska (SV) (70.54 KB - PDF) First published: 19/12/2025 View Íslenska (IS) (72.03 KB - PDF) First published: 19/12/2025 View norsk (NO) (72.35 KB - PDF) First published: 19/12/2025 View ## Product details Name of medicine Macitentan AccordPharma Active substance macitentan International non-proprietary name (INN) or common name macitentan Therapeutic area (MeSH) Hypertension, Pulmonary Anatomical therapeutic chemical (ATC) code C02KX04 Pharmacotherapeutic group Antihypertensives Therapeutic indication Adults Macitentan AccordPharma, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III (see section 5.1) Paediatric population Macitentan AccordPharma, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in paediatric patients aged less than 18 years and bodyweight ≥ 40 kg with WHO Functional Class (FC) II to III (see section 5.1) ## Authorisation details EMA product number EMEA/H/C/006523 Generic This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines . Marketing authorisation holder Accord Healthcare World Trade Center Moll de Barcelona S/N Edifici Est 6th Floor 08039 Barcelona SPAIN Opinion adopted 24/07/2025 Marketing authorisation issued 24/09/2025 Revision 1 ## Assessment history Expand section Collapse section Changes since initial authorisation of medicine Macitentan AccordPharma : EPAR - Procedural steps taken and scientific information after authorisation English (EN) (142.9 KB - PDF) First published: 27/07/2026 View Initial marketing authorisation documents Macitentan AccordPharma : EPAR - Public assessment report Adopted Reference Number: EMA/CHMP/216792/2025 English (EN) (714.26 KB - PDF) First published: 19/12/2025 View CHMP summary of positive opinion for Macitentan AccordPharma Reference Number: EMA/CHMP/225527/2025 English (EN) (158.11 KB - PDF) First published: 25/07/2025 View