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Yuvanci

Active substance: macitentan, tadalafil

macitentan, tadalafil

Centralised EU authorisationActive

Marketing holder: Janssen-Cilag International NV

Verified 2026-10-09 · EMA

Analogues in other countries
Composition
Products containing macitentan in other countries

Showing products with this active substance, combinations included; the full composition is shown for each product.

CountryProducts
US 18
  • MACITENTAN
    TABLET, FILM COATED · MACITENTAN 10 mg/1
    70710-1166
    Zydus Pharmaceuticals USA Inc.
  • Macitentan
    TABLET, FILM COATED · MACITENTAN 10 mg/1
    42385-907
    Laurus Labs Limited
  • Macitentan
    TABLET, FILM COATED · MACITENTAN 10 mg/1
    69238-1327
    Amneal Pharmaceuticals NY LLC
  • Macitentan
    TABLET, FILM COATED · MACITENTAN 10 mg/1
    70954-025
    ANI Pharmaceuticals, Inc.
  • Macitentan
    TABLET, FILM COATED · MACITENTAN 10 mg/1
    47335-070
    Sun Pharmaceutical Industries, Inc.
All products in this country (18)
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-277c-7535-94f6-8882faa2ce1d,01a1208c-9b74-7414-8a97-d3af9c35e983,01a1208d-1677-7075-8ad3-9117770f9c8c,01a1208e-8f85-7b03-9be0-e01c64329f75,01a1208e-c5c7-7368-b12d-b719891ee518;count=16 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/005001
Registration status
Active
ATC code
C02KX54
Sources
  • product · EMA · EMEA/H/C/005001 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/005001 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/005001 · Verified 2026-10-09
  • ingredients.1 · EMA · EMEA/H/C/005001 · Verified 2026-10-09