Macitentan AccordPharma

Opinion

EMA has issued an opinion on this medicine

macitentan

Overview

On 24 July 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Macitentan AccordPharma, intended for the treatment of adults and children with pulmonary arterial hypertension (PAH).

The applicant for this medicinal product is Accord Healthcare S.L.U.

Macitentan AccordPharma will be available as 10 mg film-coated tablets. The active substance of Macitentan AccordPharma is macitentan, an anti-hypertensive for PAH (ATC code:  C02KX04). Macitentan is an orally active, endothelin (ET)_A and ET_B receptor antagonist (ATC code:  C02KX04). Macitentan displays high affinity and sustained occupancy of the ET receptors in human pulmonary arterial smooth muscle cells. This prevents endothelin-mediated activation of second messenger systems that result in vasoconstriction and smooth muscle cell proliferation.

Macitentan AccordPharma is a generic of Opsumit, which was authorised in the EU since on 20 December 2013. Studies have demonstrated the satisfactory quality of Macitentan AccordPharma, and its bioequivalence to the reference product Opsumit.

The full indication is:

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).

Treatment with Macitentan AccordPharma should be initiated and monitored by physicians experienced in the treatment of PAH.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.

CHMP summary of positive opinion for Macitentan AccordPharma

Reference Number: EMA/CHMP/225527/2025

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
• 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 applicant:
  Accord Healthcare
• Opinion adopted:
  24/07/2025
• Opinion status:
  Positive