Macitentan Accord

Macitentan Accord 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 Accord 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 Accord is used as monotherapy. Macitentan Accord contains the active substance macitentan and is a ‘generic medicine’. This means that Macitentan Accord 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 Accord is Opsumit. For more information on generic medicines, see the question-and-answer document [here](https://www.ema.europa.eu/en/documents/other/questions-and-answers-generic-medicines_en.pdf).