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GAMIFANT

Active substance: emapalumab

INJECTION · EMAPALUMAB 50 mg/2mL

United StatesActive

Marketing holder: Swedish Orphan Biovitrum AB (publ)

Verified 2026-10-09 · openFDA NDC

Analogues in other countries
Composition
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
EU 1
  • Gamifant
    emapalumab
    EMEA/H/C/004386
    Swedish Orphan Biovitrum AB (publ)
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-9bb4-7d20-8312-06d79a02feb3,01a1208d-7c67-78a0-9e9c-ffd973402680,01a12090-8cb3-758c-ad0b-75890a19a257,01a12090-8cb4-7caa-ab80-d1d5b71c5505,01a12090-8cb8-741b-88b6-b2e80a405346;count=7 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
66658-522
Registration status
Active
Dispensing
Prescription only
Route
INTRAVENOUS
Sources
  • product · openFDA NDC · 66658-522 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 66658-522 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 66658-522 · Verified 2026-10-09 · open in source