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Myfembree

Active substance: RELUGOLIX, ESTRADIOL HEMIHYDRATE, NORETHINDRONE ACETATE

TABLET, FILM COATED · RELUGOLIX 40 mg/1, ESTRADIOL HEMIHYDRATE 1 mg/1, NORETHINDRONE ACETATE .5 mg/1

United StatesActive

Marketing holder: Sumitomo Pharma America, Inc

Verified 2026-10-09 · openFDA NDC

Analogues in other countries
Composition
  • RELUGOLIX · 40 mg/1
  • ESTRADIOL HEMIHYDRATE · 1 mg/1
  • NORETHINDRONE ACETATE · .5 mg/1
Products containing relugolix in other countries

Showing products with this active substance, combinations included; the full composition is shown for each product.

CountryProducts
EU 2
  • Orgovyx
    relugolix
    EMEA/H/C/005353
    Accord Healthcare S.L.U.
  • Ryeqo
    relugolix, norethisterone acetate, estradiol hemihydrate
    EMEA/H/C/005267
    Gedeon Richter Plc.
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
72974-415
Registration status
Active
Dispensing
Prescription only
Route
ORAL
Sources
  • product · openFDA NDC · 72974-415 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 72974-415 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 72974-415 · Verified 2026-10-09 · open in source
  • ingredients.1 · openFDA NDC · 72974-415 · Verified 2026-10-09 · open in source
  • ingredients.2 · openFDA NDC · 72974-415 · Verified 2026-10-09 · open in source