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Stayveer

Active substance: bosentan

bosentan (as monohydrate)

Centralised EU authorisationActive

Marketing holder: Janssen-Cilag International NV

Verified 2026-10-09 · EMA

Analogues in other countries
Composition
  • bosentan (as monohydrate)
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
US 14
  • Bosentan
    TABLET, COATED · BOSENTAN 62.5 mg/1
    68382-446
    Zydus Pharmaceuticals USA Inc.
  • Bosentan
    TABLET, FOR SUSPENSION · BOSENTAN 32 mg/1
    68180-340
    Lupin Pharmaceuticals, Inc.
  • Bosentan
    TABLET · BOSENTAN 62.5 mg/1
    70771-1017
    Zydus Lifesciences Limited
  • Bosentan
    TABLET, COATED · BOSENTAN 125 mg/1
    68382-447
    Zydus Pharmaceuticals USA Inc.
  • Bosentan
    TABLET · BOSENTAN 125 mg/1
    70771-1018
    Zydus Lifesciences Limited
All products in this country (14)
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-30db-706a-8889-8d46a479cd45,01a1208d-8dc1-7ac9-98e9-7d17799344db,01a1208d-a86a-72c2-a74f-835866ce2447,01a1208d-c3ac-78dc-8c20-24d3518a1a2c,01a1208e-b0bc-787d-ad4b-ece7376cea85;count=14 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/002644
Registration status
Active
ATC code
C02KX01
Sources
  • product · EMA · EMEA/H/C/002644 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/002644 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/002644 · Verified 2026-10-09