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Orgovyx

Active substance: relugolix

relugolix

Centralised EU authorisationActive

Marketing holder: Accord Healthcare S.L.U.

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 2
  • Myfembree
    TABLET, FILM COATED · RELUGOLIX 40 mg/1, ESTRADIOL HEMIHYDRATE 1 mg/1, NORETHINDRONE ACETATE .5 mg/1
    72974-415
    Sumitomo Pharma America, Inc
  • Orgovyx
    TABLET, FILM COATED · RELUGOLIX 120 mg/1
    72974-120
    Sumitomo Pharma America, Inc.
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a12099-db41-7e55-99fe-83a0651e2f64;count=1 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/005353
Registration status
Active
ATC code
L02BX
Sources
  • product · EMA · EMEA/H/C/005353 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/005353 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/005353 · Verified 2026-10-09