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Gamifant

Active substance: emapalumab

emapalumab

Centralised EU authorisationActive

Marketing holder: Swedish Orphan Biovitrum AB (publ)

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 7
  • GAMIFANT
    INJECTION · EMAPALUMAB 500 mg/20mL
    66658-525
    Swedish Orphan Biovitrum AB (publ)
  • GAMIFANT
    INJECTION · EMAPALUMAB 50 mg/2mL
    66658-522
    Swedish Orphan Biovitrum AB (publ)
  • GAMIFANT
    INJECTION · EMAPALUMAB 10 mg/2mL
    66658-501
    Swedish Orphan Biovitrum AB (publ)
  • GAMIFANT
    INJECTION · EMAPALUMAB 50 mg/10mL
    66658-505
    Swedish Orphan Biovitrum AB (publ)
  • GAMIFANT
    INJECTION · EMAPALUMAB 100 mg/20mL
    66658-510
    Swedish Orphan Biovitrum AB (publ)
All products in this country (7)
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
EMEA/H/C/004386
Registration status
Active
ATC code
L04AA39
Sources
  • product · EMA · EMEA/H/C/004386 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/004386 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/004386 · Verified 2026-10-09