Macitentan Accord (macitentan)
- Region
- 🇪🇺 EU
- Active substance
- macitentan
- Company
- Accord Healthcare
- Status
- Authorised
- Therapeutic area
- Hypertension, Pulmonary
- CHMP opinion
- Thu 24 Jul 2025
- EU approval
- Wed 24 Sep 2025
- Designations
- Generic
- Application
- EMEA/H/C/006524
- ATC
- C02KX04
- Official record
- www.ema.europa.eu
Indication
AdultsMacitentan Accord as monotherapy is indicated for the long-term treatment of pulmonary arterialhypertension (PAH) in adult patients of WHO Functional Class (FC) II to III (see section 5.1). Paediatric populationMacitentan Accord as monotherapy is indicated for the long-term treatment of pulmonary arterialhypertension (PAH) in paediatric patients aged less than 18 years and bodyweight ≥ 40 kg with WHOFunctional Class (FC) II to III (see section 5.1).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Macitentan AccordPharma Authorised · Accord Healthcare
- 🇪🇺 Opsumit Authorised ·
- 🇪🇺 Yuvanci Authorised · Janssen-Cilag International NV
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.