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Zurzuvae

Active substance: zuranolone

zuranolone

Centralised EU authorisationActive

Marketing holder: Biogen 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 3
  • ZURZUVAE
    CAPSULE · ZURANOLONE 20 mg/1
    64406-029
    Biogen MA Inc.
  • ZURZUVAE
    CAPSULE · ZURANOLONE 25 mg/1
    64406-030
    Biogen MA Inc.
  • ZURZUVAE
    CAPSULE · ZURANOLONE 30 mg/1
    64406-031
    Biogen MA Inc.
Import and control

Control by country

  • United StatescontrolledSchedule: CIV

    Source: openFDA NDC · record 01a1208c-959e-7d09-a4d5-303e0ac92520,01a1208d-73cf-7c54-8b05-b6a4619c1c98,01a1209d-dd06-7e52-8617-0a01b2923c90;count=3 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/006488
Registration status
Active
ATC code
N06A
Sources
  • product · EMA · EMEA/H/C/006488 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/006488 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/006488 · Verified 2026-10-09