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Hetlioz

Active substance: tasimelteon

tasimelteon

Centralised EU authorisationActive

Marketing holder: Vanda Pharmaceuticals Netherlands B.V.

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 5
  • Hetlioz
    CAPSULE · TASIMELTEON 20 mg/1
    43068-220
    Vanda Pharmaceuticals Inc.
  • Hetlioz LQ
    SUSPENSION · TASIMELTEON 4 mg/mL
    43068-304
    Vanda Pharmaceuticals Inc.
  • Tasimelteon
    CAPSULE, GELATIN COATED · TASIMELTEON 20 mg/1
    0480-4490
    Teva Pharmaceuticals, Inc.
  • Tasimelteon
    CAPSULE · TASIMELTEON 20 mg/1
    69238-2548
    Amneal Pharmaceuticals NY LLC
  • Tasimelteon
    CAPSULE · TASIMELTEON 20 mg/1
    60505-4665
    Apotex Corp.
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208d-18be-7e47-a269-36bf3c53630d,01a1208e-fde3-7a6a-adf4-7714b09a3bac,01a12094-8f54-7322-9ac7-29bbbea67f78,01a12096-7a4d-7234-bc21-0bc6714342e4,01a1209d-5343-7183-8e00-eb0e351b4c5d;count=5 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/003870
Registration status
Active
ATC code
N05CH
Sources
  • product · EMA · EMEA/H/C/003870 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/003870 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/003870 · Verified 2026-10-09