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. 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).
Therapeutic Indication
### 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)
Therapeutic Area (MeSH)
ATC Code
C02KX04
ATC Item
macitentan
Pharmacotherapeutic Group
N/A
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| macitentan | N/A | 马昔腾坦 |
EMA Name
Macitentan AccordPharma
Medicine Name
Macitentan AccordPharma
Aliases
N/ANo risk management plan link.