Macitentan AccordPharma
Authorised
This medicine is authorised for use in the European Union
macitentan
MedicineHumanAuthorised
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- Application under evaluation
- CHMP opinion
- European Commission decision
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. For more information on generic medicines, see the question-and-answer document here.
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.
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.
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.
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.
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.
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.
Macitentan AccordPharma received a marketing authorisation valid throughout the EU on 24 September 2025.
Product information
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).
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
AntihypertensivesTherapeutic 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)
News on Macitentan AccordPharma
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