Macitentan AccordPharma (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/006523
- ATC
- C02KX04
- Official record
- www.ema.europa.eu
Indication
AdultsMacitentan AccordPharma, as monotherapy or in combination, is indicated for the long-term treatmentof pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III (seesection 5.1)Paediatric populationMacitentan AccordPharma, as monotherapy or in combination, is indicated for the long-term treatmentof pulmonary arterial hypertension (PAH) in paediatric patients aged less than 18 years andbodyweight ≥ 40 kg with WHO Functional Class (FC) II to III (see section 5.1)
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Macitentan Accord 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.