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Xyrem

Active substance: sodium oxybate

sodium oxybate

Centralised EU authorisationActive

Marketing holder: UCB Pharma Ltd

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 11
  • Lumryz
    FOR SUSPENSION, EXTENDED RELEASE · SODIUM OXYBATE 9 g/1
    13551-004
    Alkermes, Inc.
  • Lumryz
    FOR SUSPENSION, EXTENDED RELEASE · SODIUM OXYBATE 7.5 g/1
    13551-003
    Alkermes, Inc.
  • Lumryz
    KIT · sodium oxybate
    13551-005
    Alkermes, Inc.
  • Lumryz
    FOR SUSPENSION, EXTENDED RELEASE · SODIUM OXYBATE 4.5 g/1
    13551-001
    Alkermes, Inc.
  • Lumryz
    FOR SUSPENSION, EXTENDED RELEASE · SODIUM OXYBATE 6 g/1
    13551-002
    Alkermes, Inc.
All products in this country (11)
Import and control

Control by country

  • United StatescontrolledSchedule: CIII

    Source: openFDA NDC · record 01a1208e-1a11-7f92-acd1-70920ceb6891,01a12090-d18d-7ab4-83ef-8115f25f61f9,01a12091-6ce5-7279-84ac-348d457f6409,01a12095-7387-795b-9db2-e60e2d333cbc,01a12095-738b-72fc-9d80-e8f73d640896;count=10 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/000593
Registration status
Active
ATC code
N07XX04
Sources
  • product · EMA · EMEA/H/C/000593 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/000593 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/000593 · Verified 2026-10-09