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Orladeyo

Active substance: berotralstat

berotralstat dihydrochloride

Centralised EU authorisationActive

Marketing holder: Neopharmed Gentili Ireland Limited

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 6
  • Orladeyo
    CAPSULE · BEROTRALSTAT HYDROCHLORIDE 150 mg/1
    72769-101
    BioCryst Pharmaceuticals, Inc.
  • Orladeyo
    PELLET · BEROTRALSTAT HYDROCHLORIDE 96 mg/1
    72769-112
    BioCryst Pharmaceuticals, Inc.
  • Orladeyo
    CAPSULE · BEROTRALSTAT HYDROCHLORIDE 110 mg/1
    72769-102
    BioCryst Pharmaceuticals, Inc.
  • Orladeyo
    PELLET · BEROTRALSTAT HYDROCHLORIDE 108 mg/1
    72769-113
    BioCryst Pharmaceuticals, Inc.
  • Orladeyo
    PELLET · BEROTRALSTAT HYDROCHLORIDE 72 mg/1
    72769-111
    BioCryst Pharmaceuticals, Inc.
All products in this country (6)
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-2cf5-7456-995b-a93f6331f91e,01a1208c-ccd4-7915-83c6-318d47c95e58,01a1208d-bd25-7f15-9ae9-f2d700a8ee57,01a12092-b091-721e-89ae-0f9f2d8198f6,01a12099-d0b3-7619-b1a3-60af8b354c6a;count=6 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/005138
Registration status
Active
ATC code
B06AC06
Sources
  • product · EMA · EMEA/H/C/005138 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/005138 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/005138 · Verified 2026-10-09