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Ambrisentan Zentiva

Active substance: ambrisentan

ambrisentan

Centralised EU authorisationActive

Marketing holder: Zentiva k.s.

Verified 2026-10-09 · EMA

Analogues in other countries
Composition
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
US 26
  • AMBRISENTAN
    TABLET, FILM COATED · AMBRISENTAN 5 mg/1
    42794-051
    Sigmapharm Laboratories, LLC
  • AMBRISENTAN
    TABLET, FILM COATED · AMBRISENTAN 10 mg/1
    42794-052
    Sigmapharm Laboratories, LLC
  • Ambrisentan
    TABLET, FILM COATED · AMBRISENTAN 5 mg/1
    69097-386
    Cipla USA Inc.
  • Ambrisentan
    TABLET, FILM COATED · AMBRISENTAN 10 mg/1
    0378-4271
    Mylan Pharmaceuticals Inc.
  • Ambrisentan
    TABLET, FILM COATED · AMBRISENTAN 5 mg/1
    70710-1179
    Zydus Pharmaceuticals USA Inc.
All products in this country (26)
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-abed-7cfd-9383-0a747ea9fc70,01a1208c-b3bc-7d68-8cdd-c333239f9687,01a1208c-bb3e-7e95-a488-f896d78443b7,01a1208c-d391-7f59-9d87-dde32e80bd4a,01a1208d-2e45-7678-9cae-a77d55146d86;count=26 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/004955
Registration status
Active
ATC code
C02KX02
Sources
  • product · EMA · EMEA/H/C/004955 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/004955 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/004955 · Verified 2026-10-09