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Orfadin

Active substance: nitisinone

nitisinone

Centralised EU authorisationActive

Marketing holder: Swedish Orphan Biovitrum International AB

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 23
  • HARLIKU
    TABLET · NITISINONE 2 mg/1
    70709-112
    Cycle Pharmaceuticals Ltd.
  • NITYR
    TABLET · NITISINONE 10 mg/1
    70709-000
    Cycle Pharmaceuticals Ltd.
  • NITYR
    TABLET · NITISINONE 2 mg/1
    70709-002
    Cycle Pharmaceuticals Ltd.
  • NITYR
    TABLET · NITISINONE 5 mg/1
    70709-005
    Cycle Pharmaceuticals Ltd.
  • Nitisinone
    CAPSULE · NITISINONE 5 mg/1
    0254-3021
    Par Health USA, LLC
All products in this country (23)
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208d-58a9-767e-8aa4-deb418f96789,01a1208d-6e38-709d-bb34-aae861293932,01a1208d-a6a8-70c0-8b19-7bed8d02e3a1,01a1208e-d842-7be2-9753-d483189fe227,01a1208e-dfd1-7ef6-a88f-49daee1fef92;count=23 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/000555
Registration status
Active
ATC code
A16AX04
Sources
  • product · EMA · EMEA/H/C/000555 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/000555 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/000555 · Verified 2026-10-09