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Bylvay

Active substance: odevixibat

odevixibat

Centralised EU authorisationActive

Marketing holder: Ipsen Pharma

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 4
  • Bylvay
    CAPSULE, COATED PELLETS · ODEVIXIBAT 600 ug/1
    15054-3303
    Ipsen Biopharmaceuticals, Inc.
  • Bylvay
    CAPSULE, COATED PELLETS · ODEVIXIBAT 200 ug/1
    15054-3301
    Ipsen Biopharmaceuticals, Inc.
  • Bylvay
    CAPSULE · ODEVIXIBAT 400 ug/1
    15054-3302
    Ipsen Biopharmaceuticals, Inc.
  • Bylvay
    CAPSULE · ODEVIXIBAT 1200 ug/1
    15054-3304
    Ipsen Biopharmaceuticals, Inc.
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208e-060c-79f2-9cbe-3a73b846d1e3,01a12091-6df8-7907-b239-751d22791422,01a12091-6df9-7bd7-8cad-14f53d5b6915,01a12093-44bf-7387-8e7b-b72879d868d5;count=4 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/004691
Registration status
Active
ATC code
A05AX
Sources
  • product · EMA · EMEA/H/C/004691 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/004691 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/004691 · Verified 2026-10-09