Yuvanci (macitentan;tadalafil)
- Region
- 🇪🇺 EU
- Active substance
- macitentan;tadalafil
- Company
- Janssen-Cilag International NV
- Status
- Authorised
- Therapeutic area
- Pulmonary Arterial Hypertension
- CHMP opinion
- Thu 25 Jul 2024
- EU approval
- Fri 27 Sep 2024
- Application
- EMEA/H/C/005001
- ATC
- C02KX54
- Official record
- www.ema.europa.eu
Indication
Yuvanci is indicated as substitution therapy for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, who are already treated with the combination of macitentan and tadalafil given concurrently as separate tablets.
Regulatory milestones
No milestones recorded in the last year.
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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.